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Contamination Control Strategy Document

The document outlines the Contamination Control Strategy (CCS) for Kwality Pharmaceuticals Ltd. Unit-II, focusing on the prevention and management of contamination risks in the production of sterile products and oral solid dosages. It details the objectives, benefits, and essential elements of the CCS, including design, personnel, equipment, and validation processes. The strategy aims to ensure product quality, regulatory compliance, and cost savings while minimizing contamination risks.

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Contamination Control Strategy Document

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KWALITY PHARMACEUTICALS LTD.

UNIT-II MASTER COPY

VILL. NAG KALAN, MAJITHA ROAD STAMP
AMRITSAR- 143601 (INDIA)
CONTAMINATION CONTROL STRATEGY
DOCUMENT NO. : KPL2/QA/CCS-1 PAGE NO. : PAGE 1 OF 134
REVISION NO. : 02 SUPERSEDES NO. : 01
: NEXT REVIEW :
EFFECTIVE DATE:
DATE

CONTAMINATION
CONTROL
STRATEGY
LOCATION: BETA BLOCK

(FOR DRY POWDER INJECTION &

ORAL SOLID DOSAGE SECTION)

KWALITY PHARMACEUTICALS LTD. UNIT-II

VILL. NAG KALAN, MAJITHA ROAD

AMRITSAR- 143601 (INDIA)

Table of Constents
1.0 DOCUMENT APPROVAL.................................................................................................................................3

2.0 INTRODUCTION................................................................................................................................................4

3.0 OBJECTIVE.........................................................................................................................................................4

4.0 BENEFITS OF CONTAMINATION CONTROL STRATEGY....................................................................5

5.0 ROUTES OF CROSS CONTAMINATION & IT’S CONTROLS.................................................................6

6.0 BASIC PRINCIPLES (ETHICS TO AVOID CROSS‐CONTAMINATION).............................................26

7.0 DOCUMENTATION OF THE CONTAMINATION CONTROL STRATEGY........................................27

7.1 Design of the plant and processes including the associated documentation:-..............................................27

7.2 Premises and Equipment...................................................................................................................................38

7.3 Personnel.............................................................................................................................................................40

7.4 Utilities:...............................................................................................................................................................43

7.5 Raw Material Controls – including in-process controls.................................................................................47

7.6 Product Containers and Closures:-..................................................................................................................49

7.7 Vendor approval:-..............................................................................................................................................50

7.8 Process Risk Assessment:-.................................................................................................................................51

7.9 Validation & Qualification:-.............................................................................................................................52

7.10 Validation of sterilization processes.................................................................................................................53

7.11 Preventative Maintenance:-..............................................................................................................................54

7.12 Cleaning and Disinfection:-...............................................................................................................................54

7.13 Monitoring Systems:..........................................................................................................................................61

7.14 Prevention mechani[Link]

7.15 Continuous improvement based on information derived from the above:-.................................................66

8.0 CCS REVIEW FREQUENCY:........................................................................................................................67

9.0 SUMMARY AND CONCLUSION...................................................................................................................68

10.0 ATTACHMENTS:.............................................................................................................................................68
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11.0 ABBREVIATIONS............................................................................................................................................69

12.0 REFERENCES...................................................................................................................................................69

13.0 REVISION HISTORY......................................................................................................................................69

Name Department Designation Signature & Date

Checked By:

Name Department Designation Signature & Date

Approved By:

Name Department Designation Signature & Date

Authorized By:

Name Department Designation Signature & Date

Sr. No. Elements to be considered are listed below

1. Design of the plant and processes, including the associated documentation.
2. Premises and equipment.
3. Personnel
4. Utilities.
5. Raw material controls – including in-process controls.
6. Product containers and closures
Vendor approval includes key component suppliers, sterilization of components and single-use sys-
7.
tems (SUS), and critical service providers.
Management of outsourced activities and availability/transfer of critical information between parties,
8.
e.g. contract sterilization services.
9. Process risk assessment.
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Sr. No. Elements to be considered are listed below
10. Process validation.
11. Validation of sterilization processes.
Preventative maintenance – maintaining equipment, utilities, and premises (planned and unplanned
12.
maintenance) to a standard that will ensure there is no additional risk of contamination

13. Cleaning and disinfection

Monitoring systems – including an assessment of the feasibility of introducing scientifically sound,

14.
alternative methods that optimize the detection of environmental contamination

Prevention mechanisms – trend analysis, detailed, investigation, root cause determination, corrective
15.
and preventive actions (CAPA), and the need for comprehensive investigational tools
5.0 BENEFITS OF CONTAMINATION CONTROL STRATEGY
 Ensuring Product Quality:
Contamination control strategies help to maintain the purity and quality of pharmaceutical products. Contami-
nants such as bacteria, fungi, and viruses can compromise the integrity of these products, leading to reduced ef-
ficacy and potentially harmful side effects for patients. By implementing effective contamination control strate -
gies, manufacturers can minimize the risk of product contamination and ensure that their products are safe and
effective for patients.
 Regulatory Compliance:
The pharmaceutical industry is heavily regulated, and manufacturers are required to comply with strict quality
standards to ensure patient safety. Contamination control strategies are an essential component of these quality
standards, and failure to implement effective strategies can lead to regulatory non-compliance, fines, and legal
action.
 Cost Savings:
Contamination control strategies can also help to reduce costs associated with product recalls, rework, and
downtime. If a product is found to be contaminated, it may need to be recalled, which can be a costly and time-
consuming process. By implementing effective contamination control strategies, manufacturers can minimize
the risk of contamination and avoid these costs.
 Improved productivity:
Contamination control strategies can also improve productivity in the pharmaceutical industry by reducing the
number of production interruptions due to contamination events. By minimizing the risk of contamination, man-
ufacturers can keep their production lines running smoothly, leading to increased efficiency and productivity.
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6.0 DEFINITIONS:
 Contamination Control Strategy:
CCS is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best
achieved using quality risk management principles and supporting risk assessments for contamination control
and monitoring (detectability of contamination event).
 Contamination:
The definition of contamination is something that contaminates (causes an impurity) or is something that has
been made impure or spoiled. The process of making a material or surface unclean or unsuited for its intended
purpose, usually by the addition or attachment of undesirable foreign substances. The three types of contamina-
tion are biological, physical, and chemical.
 Cross Contamination:
Pharmaceutical product cross-contamination refers to the process by which foreign chemical, microbial, or
physical substances are unintentionally transferred from one substance or object to medicines with harmful ef-
fects that might affect the purity and quality of the product. Cross-contamination is the contamination of a start -
ing material, intermediate or finished product with another starting material or product.
 Airlock:
An enclosed space with interlocked doors, constructed to maintain air pressure control between adjoining rooms
(generally with different air cleanliness standards). The intent of an airlock is to preclude ingress of particle
matter and microorganism contamination from a lesser controlled area.
 Action limit:
An established relevant measure (e.g. microbial, or airborne particle limits) that, when exceeded, should trigger
appropriate investigation and corrective action based on the investigation.
 Alert level:
An established relevant measure (e.g. microbial, or airborne particle levels) giving early warning of potential
drift from normal operating conditions and validated state, which does not necessarily give grounds for correc -
tive action but triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are es -
tablished based on routine and qualification trend data and are periodically reviewed. The alert level can be
based on a number of parameters including adverse trends, individual excursions above a set limit and repeat
events.
 Aseptic preparation/processing:
The handling of sterile product, containers and/or devices in a controlled environment in which the air supply,
materials and personnel are regulated to prevent microbial, endotoxin/pyrogen and particle contamination.
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 Aseptic Process Simulation (APS):

A simulation of the entire aseptic manufacturing process in order to verify the capability of the process to assure
product sterility. Includes all aseptic operations associated with routine manufacturing, e.g. equipment assem-
bly, formulation, filling, lyophilization and sealing processes as necessary.
 Asepsis:
A state of control attained by using an aseptic work area and performing activities in a manner that precludes
microbial contamination of the exposed sterile product.
 Barrier :
A physical partition that affords aseptic processing area (usually grade A) protection by separating it from the
background environment. Such systems frequently use in part or totally the Barrier Technologies known as
RABS or isolators.
 Bioburden:
The total number of microorganisms associated with a specific item such as personnel, manufacturing environ-
ments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials,
or finished products.
 Bio-decontamination:
A process that eliminates viable bioburden via use of sporicidal chemical agents.
 Biological Indicators (BI):
A population of microorganisms inoculated onto a suitable medium (e.g. solution, container or closure) and
placed within a sterilizer or load or room locations to determine the sterilization or disinfection cycle efficacy of
a physical or chemical process. The challenge microorganism is selected and validated based upon its resistance
to the given process. Incoming lot D-value, microbiological count and purity define the quality of the BI.
 Classified area:
An area that contains a number of cleanrooms (see cleanroom definition).
 Cleaning:
A process for removing contamination e.g. product residues or disinfectant residues.
 Clean area:
An area with defined particle and microbiological cleanliness standards usually containing a number of joined
cleanrooms.
 Cleanroom:
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A room designed, maintained, and controlled to prevent particle and microbial contamination of drug products.
Such a room is assigned and reproducibly meets an appropriate air cleanliness level.

 Cleanroom classification:
A method of assessing the level of air cleanliness against a specification for a cleanroom or clean air equipment
by measuring the total particle concentration.
 Colony Forming Unit (CFU):
A microbiological term that describes a single detectable colony that originates from one or more microorgan -
isms. Colony forming units are typically expressed as CFU per ml for liquid samples, CFU per m 3 for air sam-
ple and CFU per sample for samples captured on solid medium such as settle or contact plates.
 Corrective intervention:
An intervention that is performed to correct or adjust an aseptic process during its execution. These may not oc-
cur at a set frequency in the routine aseptic process. Examples include such as clearing component jams, stop -
ping leaks, adjusting sensors, and replacing equipment components.
 Critical surfaces:
Surfaces that may come directly into contact with, or directly affect, a sterile product or its containers or clo -
sures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation, and sterility is
maintained throughout processing.
 Critical zone:
A location within the aseptic processing area in which product and critical surfaces are exposed to the environ -
ment.
 D-value:
The value of a parameter of sterilization (duration or absorbed dose) required to reduce the number of viable or-
ganisms to 10 per cent of the original number.
 Dead leg:
Length of non-circulating pipe (where fluid may remain static) that is greater than 3 internal pipe diameters.
 Decontamination:
The overall process of removal or reduction of any contaminants (chemical, waste, residue or microorganisms)
from an area, object, or person. The method of decontamination used (e.g. cleaning, disinfection, sterilization)
should be chosen and validated to achieve a level of cleanliness appropriate to the intended use of the item de-
contaminated. See also Bio-decontamination.
 Depyrogenation:
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A process designed to remove or inactivate pyrogenic material (e.g. endotoxin) to a specified minimum quan -
tity.
 Disinfection:
The process by which the reduction of the number of microorganisms is achieved by the irreversible action of a
product on their structure or metabolism, to a level deemed to be appropriate for a defined purpose.
 Endotoxin:
A pyrogenic product (i.e. lipopolysaccharide) present in the Gram negative bacterial cell wall. Endotoxin can
lead to reactions in patients receiving injections ranging from fever to death.
 Equilibration time:
Period which elapses between the attainment of the sterilization temperature at the reference measurement point
and the attainment of the sterilization temperature at all points within the load.
 First Air:
Refers to filtered air that has not been interrupted prior to contacting exposed product and product contact sur-
faces with the potential to add contamination to the air prior to reaching the critical zone.
 Filter Integrity test:
A test to confirm that a filter (product, gas or HVAC filter) retain their retentive properties and have not been
damaged during handling, installation or processing.
 Gowning qualification:
A programme that establishes, both initially and on a periodic basis, the capability of an individual to don the
complete gown.
 Grade A air supply:
Air which is passed through a filter qualified as capable of producing grade A total particle quality air, but
where there is no requirement to perform continuous total particle monitoring or meet grade A viable monitor -
ing limits. Specifically used for the protection of fully stoppered vials where the cap has not yet been crimped.
 HEPA filter:
High efficiency particulate air filter specified in accordance with a relevant international standard. Inherent in -
terventions – An intervention that is an integral part of the aseptic process and is required for either set-up, rou-
tine operation and/or monitoring (e.g. aseptic assembly, container replenishment, environmental sampling). In-
herent interventions are required by procedure or work instruction for the execution of the aseptic process.
 Isokinetic sampling head:
A sampling head designed to disturb the air as little as possible so that the same particles go into the nozzle as
would have passed the area if the nozzle had not been there (i.e. the sampling condition in which the mean ve -
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locity of the air entering the sample probe inlet is nearly the same (± 20 percent) as the mean velocity of the air -
flow at that location).
 Leachable:
Chemical entities that migrate into products from the product contact surface of the process equipment or con -
tainers under normal condition of use and/or storage.

 Local isolates:
Suitably representative microorganisms of the site that are frequently recovered through environmental moni-
toring within the classified zone/areas especially grade A and B areas, personnel monitoring or positive sterility
test results.
 Overkill sterilization:
A process that is sufficient to provide at least a 12-log10 reduction of microorganisms having a minimum D-
value of 1 minute.
 Raw material:
Any ingredient intended for use in the manufacture of a sterile product, including those that may not appear in
the final drug product.
 Restricted Access Barrier System (RABS):
System that provides an enclosed, but not fully sealed, environment meeting defined air quality conditions (for
aseptic processing grade A), and using a rigid-wall enclosure and integrated gloves to separate its interior from
the surrounding cleanroom environment.
 Sporicidal agent:
An agent that destroys bacterial and fungal spores when used in sufficient concentration for specified contact
time. It is expected to kill all vegetative microorganisms.
 Sterile Product:
For purpose of this guidance, sterile product refers to one or more of the sterilized elements exposed to aseptic
conditions and ultimately making up the sterile active substance or finished sterile product. These elements in -
clude the containers, closures, and components of the finished drug product.
 Sterilizing grade filter:
A filter that, when appropriately validated, will remove a defined microbial challenge from a fluid or gas pro -
ducing a sterile effluent. Usually such filters have a pore size equal or less than 0.22 μm.
 Turbulent airflow:
Air that is not unidirectional. Turbulent air in cleanrooms should flush the cleanroom via mixed flow dilution
and ensure maintenance of acceptable air quality.
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 Unidirectional airflow:
An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed, to repro -
ducibly sweep particles away from the critical processing or testing area.
 Laminar Air Flow Unit:
A cabinet supplied with filtered unidirectional airflow.

 Worst case:
A set of conditions encompassing processing limits and circumstances, including those within standard operat-
ing procedures, that pose the greatest chance of process or product failure (when compared with ideal condi -
tions). Such conditions have the highest potential to, but do not necessarily always result in product or process
failure.
 Water system:
A system for producing, storing and distributing water, usually compliant to a specific pharmacopeia grade (e.g.
purified water and water for injection (WFI)).
 Z-value:
The temperature difference that leads to a 10-fold change in the D-value of the biological indicators
7.0 SOURCES OF CONTAMINATION:
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A: Indicates the causes of contamination

B: Indicates the effects of contamination

 ROUTES OF CROSS CONTAMINATION & IT’S CONTROLS:

Facility Design Procedural Control

 Product Dedicated Facility  Warehouse Management Process.
 Unidirectional Man & Material  Labeling Process.
Flow.  Line Clearance Process.
 Process Automation.

Mix - Up Facility Cleaning

Facility Design  Cleaning method design.
(Pressure Gradient)  Area cleaning and sanitization
procedure.
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Cross Contamination
Airborne Cleaning
Transfer

Equipment Cleaning
 Cleaning procedure design
HVAC, LAF, and  Setting of cleaning limit
other Relevant System  Periodic Cleaning
(Air Filtration) Mechanical Transfer Verification.

Facility Design
Gowning  Air Lock System.
 Material Movement.
 Authorized personnel movement
and access control


 Mix-Up:
7..1 Approaches Related To Facility Design:
7..1.1 Product Dedicated facility:-
Kwality Pharmaceuticals Limited Unit II is dedicated manufacturing facility for Beta Lactam products (Dry
Powder Injection, Tablet, Capsule and Dry Syrup).
7..1.2 Unidirectional Man‐ Material Flow:-

Material
Uni-directional
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Flow

Personnel
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7..1.3 Process Automation:
The Beta-lactam facility is equipped with automated systems for manufacturing operations, reducing the risk of
contamination and manual intervention. A complete list of equipment can be found at Appendix-I and II, and im-
ages of major equipment are provided below:

HPHV Steam Sterilizer (Autoclave) Vial Washing Machine

Vial Filling and Stoppering Machine

Vial Sealing Machine

External Vial Washing Area

Granulation Area
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Roll Compactor Machine

Tablet Compression Machine

Coating Machine Vacuum Tray Dryer

Capsule Filling Machine

Dry Syrup Filling Machine

7..2.2 Labeling Process.

 Labeling process on RM/PM:
 To avoid errors with respect to correct name, description stage of material along with its storage.
 Labels with different colors are available and color coding is available for storage of materials as per be-
low table.
Sr. No. Area Color
01 Quarantine Grey
02 Under Test Yellow
03 Approved Green
04 Rejected Red
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Color coding for storage of materials in Warehouse area

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 Labeling process on different stages of material, equipment and area:
 To prevent contamination and ensure accuracy, predefined sample labels are available for various stages
of material status, equipment status, and area status. These labels include the correct name, description,
and stage of the material, along with appropriate storage details.
Sr. No. Title of format Format No.
1. Sample Quantity for Analysis KPL2/SOP/QA-005-F01
2. Label for Control sample KPL2/SOP/QA-005-F03
3. Label for stability sample/other sample KPL2/SOP/QA-005-F04
4. In-Process Sample Logbook KPL2/SOP/QA-005-F05
5. Finished Product sample Log book KPL2/SOP/QA-005-F06
6. Stability & Control Sample Log Book KPL2/SOP/QA-005-F07
7. To be cleaned KPL2/SOP/QA-004-F01
8. Cleaned Label KPL2/SOP/QA-004-F02
9. On line Rejection KPL2/SOP/QA-004-F03
10. Non-Recoverable Residue KPL2/SOP/QA-004-F04
11. Recoverable Residue KPL2/SOP/QA-004-F05
12. Under Maintenance KPL2/SOP/QA-004-F06
13. On Hold KPL2/SOP/QA-004-F07
14. Carton /shipper Weight range KPL2/SOP/QA-004-F08
15. Container Status Label KPL2/SOP/QA-004-F09
16. Rejected label KPL2/SOP/QA-004-F10
17. Approved label KPL2/SOP/QA-004-F11
18. Under test label KPL2/SOP/QA-004-F12
19. Sample label KPL2/SOP/QA-004-F13
20. Equipment in use label KPL2/SOP/QA-004-F16
21. Status label KPL2/SOP/QA-004-F17
22. Waste For Disposal label KPL2/SOP/QA-004-F18
23. Qualification Status label KPL2/SOP/QA-004-F19
24. Waste Bin KPL2/SOP/QA-004-F20
25. Temperature Mapping Status Label KPL2/SOP/QA-004-F21
7..2.3 Line clearance Process:
To ensure equipment/line is free from previous product traces to avoid mix up/cross contamination line
clearance procedure is available at each processing stage as per SOP No. KPL2/SOP/QA-012.
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 Cleaning:
7..1 Approaches Related to Facility Cleaning:
7..1.1 Cleaning method design:
Developed and validated cleaning procedures for each area is available to ensure effective removal of residues
and contaminants. Validated disinfectants used that are effective against a broad spectrum of microorganisms.
7..1.2 Area cleaning and sanitization procedure:
The method for area cleaning, sanitization and fogging defined in standard operating procedures for processing
area as well as for general area.
7..2 Approaches Related To Equipment Cleaning:
7..2.1 Cleaning Procedure Design:
The procedure for equipment cleaning & sanitization defined in standard operating procedures for all equipment.
Cleaning method design has been done based on below:
 Hard to clean Area: Hard to clean areas have been evaluated and cleaning validation has been performed
on the worst case as per cleaning validation report no. KPL2/QA/CVR-1 and KPL2/QA/CVR-2.
 Doer & checker Mechanism: Doer & Checker Mechanism is available for assuring/confirmation/ cross
checking of correct processing / cleaning activities by production and QA.
 Emphasizing the cleanliness check during line clearance.
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7..2.2 Setting of Cleaning Limit:
Cleaning limit have been set based on health base criteria, dose criteria & 10 ppm and cleaning validation
has been performed on the worst case as per cleaning validation report no. KPL2/QA/CVR-1 and KPL2/
QA/CVR-2.
7..2.3 Periodic Cleaning Verification:
Periodic Cleaning Verification schedule is available in VMP (KPL2/QA/VMP-1).
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 Mechanical Transfer Control:

7..1 Through Effective Gowning Practice:

7..1.1 Product operational Suites at Solid Oral Facility:

Additional over gowning procedure is followed for entry and exit from one process cubicle to another
process cubicle.
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7..1.2 Product operational Suites at Aseptic Area:
 Filling line has dedicated Entry & Exit change rooms.
 Sterile gowning available.
 Separate Washing area for washing of used garments is available.
7..2 Approach to control contamination from mechanical transfer through facility design:

7..2.1 Different Types of Airlock Design:-

7..2.1.2 Sink Airlock:

These type of airlocks have a lower pressure inside the airlock and higher pressure on both adjacent ar -
eas
Application:
Research facility, where substances that are experimented on are highly potent products and it is essen -
tial to keep them from being exposed. In few types of production processes, in a clean room, air from
contaminated area has to be contained in one place.

7..2.1.3 Cascade Airlock:-

7..2.2 Material Movement from Receipt to Dispensing in warehouse:

RECEIPT OF MATERIAL

Verification of Material Container and

Vehicle Condition before Unloading

Batch wise Segregation of Material at

Receipt Area during Unloading

Dedusting of received material

container

Discrepancy Note Initiated

IF any discrepancy observed

Material Status Label Pasted on all Physical Segregation of Material Container

Material Containers

Material shifted to Respective Storage Area as

per the Required Storage Conditions
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7..2.3 Authorized Personnel movement & access control:

 Access controls are available at the entry to restrict the entry of unauthorized persons in area.
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 Airborne Transfer:-
7..1 Approaches Related To Facility Design (Pressure Gradient):

Area Pressure differential

CNC NLT 15 Pascal

Grade D 15 Pascal (For OSD 5-15 Pascal)

Grade C NLT 15 Pascal

Grade B NLT 15 Pascal

Grade A 7-15 mmWC

7..2 Approaches Related to HVAC, LAF, and other Relevant System (Air Filtration):
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Sr. No. Grade Filtration Level

HEPA filter (0.3 micron)

1. Grade A
Pre filter (5 Micron)

Fresh Air filter (10 micron)

Pre filter (5 micron)

2. Grade B Fine Filter (3 micron)

HEPA Filter (0.3 micron)

Return Riser (10 micron)

Fresh Air filter (10 micron)

Pre filter (5 micron)

3. Grade C Fine Filter (3 micron)

HEPA Filter (0.3 micron)

Return Riser (10 micron)

Fresh Air filter (10 micron)

Pre filter (5 micron)

4. Grade D Fine Filter (3 micron)

HEPA Filter (0.3 micron)

Return Riser (10 micron)

Fresh Air filter (10 micron)

5. CNC (Controlled Not Classified) Pre Filter (5 micron)

Fine Filter (3 micron)

CROSS CONTAMINATION

Conversation
With Employees regarding cross-contamination

Follow
A Robust & Disciplined Process

Develop a Quality Culture

that empowers everyone to act on any issues they encounter during day-to-day activity.
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 A Holistic Contamination Control Program:
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9.0 DESIGN OF PLANT AND PROCESS:
 The Plant Overview:
9..1 General
The manufacturing facility of Kwality Pharmaceutical Limited Unit-II is located at Village Nag Kalan,
Majitha Road, Dist. Amritsar, Punjab – India, 20 km away from airport Amritsar and 240 km away from
capital Chandigarh The location benefits from well-developed infrastructure facilities, including consistent
power supply, ample water resources, and well-maintained road connectivity, ensuring seamless logistics and
operational efficiency. In addition, the site is well supported by robust communication and transportation
networks, which enhance accessibility and facilitate the smooth movement of raw materials and finished
goods.
Nature of construction of the building block consist of bricks, cement, steel, sand and aggregate. Clean rooms
are built up with High Pressure Laminate puff panel of Poly Urethane. The design of building protects the
inside atmosphere from heat and particulate penetration. More of this design facilitates ease for cleaning and
disinfection.
9..2 Manufacturing Capabilities and Infrastructure
The site houses dedicated production lines for the manufacturing of Dry powder injection vials and Oral Solid
Dosage forms, including capsules, tablets, dry syrup & sachet formulations. The facility layout supports
unidirectional flow of personnel and materials, significantly reducing the risk of cross-contamination and
enhancing operational hygiene.
All critical and aseptic operations are conducted in Grade A under Laminar Air Flow (LAF) units, ensuring
the highest level of sterility. Additionally, a separate Quality Control (QC) area has been designated, isolated
from the core manufacturing zones, to uphold product integrity and testing standards.
To maintain stringent security and monitoring, the entire facility is under CCTV surveillance, and access
control systems are implemented to restrict unauthorized entry into sensitive areas.
All aseptic activity (which includes Raw material Blending, Filling and Sealing of filled vials) is being
performed under LAF Grade A environment followed by a Grade B area.
The foundation of the facilities has been given termite treatment. The terrace has been treated with waterproof
compounds. The periphery of the building is constructed of brick walls and reinforced concrete cement (RCC)
roof. The inner walls and ceilings are constructed of washable modular Stainless Steel/ Powder coated PUFF
panels. The flooring of the manufacturing areas, primary and secondary packing areas, and all the corridors
are coated with epoxy resin. The coving wall-to wall and wall-to ceiling are of pre-coated Aluminium coving.
The coving between the wall and flooring is of epoxy coving. All the ducting, electrical lines, and utility lines
are either taken above the false ceiling or concealed within the wall.
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9..3 Site Layout and Area

The total plot area of the manufacturing site is 2896.36 square meters. The facility comprises the following
key structures:
 Security Complex, which includes Gate Office.
 Main manufacturing unit.
Layout has been designed for all floors i.e. Ground Floor, First Floor and Second Floor. Zone Classification is
defined in terms of different grades i.e. Grade A, Grade B, Grade C, Grade D, and control not classified area.
Man & Material movement is clearly defined in Layouts. Each grade maintained differential pressure as per
requirement i.e. 5-15 Pa for OSD section and NLT 15Pa for Injection Section.
These zones are strategically distributed to facilitate efficient workflow and optimal utilization of space. Brief
description of the built up area for manufacturing, primary packaging, secondary packaging or quality control
laboratories, etc. are as below:
Sr. No. Department Name of Floor Built up Area
1. Total Covered area Ground Floor 2896.36 square meter
2. Tablet ,Capsule, Dry syrup, Sachet section Ground Floor 464 square meter
3. Dry Injection section Ground Floor 424 square meter
4. Future Expansion Ground Floor 323 square meter
5. Primary & Secondary packing Ground Floor 200 square meter
6. Warehouse (RM,PM store) Ground Floor 149 square meter
7. Finished goods store Ground Floor 99.50 square meter
8. Administration Department Ground Floor 122 square meter
9. Quality Control Department ,Stability Chamber First Floor 196 square meter
10. Quality Assurance Ground Floor 41 square meter
11. Microbiology Second Floor 208 square meter
12. Service floor Second floor 2237 square meter
Purified water , WFI water system ,PSG, PSA Nitrogen
13. Second floor 96.0 square meter
Generator
9..4 Environmental Responsibility and Sustainability
Kwality Pharmaceuticals is committed to environmental stewardship. The facility is designed as an eco-friendly
unit with no emissions or discharges that could adversely affect the surrounding environment and ISO
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9001:2025 and ISO 14001:2015 certified. There are no neighboring industrial operations that produce air
pollutants, further ensuring a clean and safe operational atmosphere.
The company promotes green practices by maintaining landscaped gardens and trees within the premises,
reinforcing its dedication to sustainability and environmental care.
9..5 Product Operational Area:
Kwality Pharmaceuticals Ltd. Unit-II, Amritsar adheres to the highest standards of facility design, with a strong
emphasis on compliance, cleanliness, and operational efficiency. The internal finish and structural features of the
manufacturing, warehouse, and quality control (QC) microbiology areas reflect global best practices in
pharmaceutical manufacturing environments.
9..5.1 Internal Finishes:
The interiors of the manufacturing, warehouse, and QC microbiology areas are constructed with premium-
grade materials specifically selected to meet cleanroom standards
 Cleanroom Modular Panels: These are installed throughout critical areas, providing a durable,
contamination-resistant, and easy-to-maintain surface.
 Flush Doors: All doors are of flush design and are equipped with hydraulic concealed door closers,
enhancing airtightness, cleanliness, and smooth operation.
 Flooring: The entire facility features seamless epoxy flooring, which is microbial-resistant and includes
rounded covings at wall-floor junctions. This eliminates dust-trapping corners and supports ease of cleaning
and sterilization.
 Walls and Ceilings: Internal walls and ceilings are plastered with cement-based materials, finished to a
smooth, dust-free surface, ensuring minimal particle generation and easier maintenance.
 Overhead Utilities: The design eliminates overhead ducts or exposed piping in production areas, minimizing
any risk of particulate shedding or contamination.
 Windows: The facility is equipped with double-glazed, flush-mounted windows, maintaining a sterile
environment while allowing visual access between areas without compromising cleanliness.
9..5.2 Ceiling Construction:
The facility incorporates walkable modular false ceilings made of PUF (polyurethane foam) insulated panels
with high-quality lamination. These ceilings are robust, easy to maintain, and designed to support personnel
access for maintenance without disrupting production operations.
The seamless installation supports proper air circulation and contributes to maintaining classified area
conditions.
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9..5.3 Drainage and Utility Integration:
Drainage System: All drainage points are constructed with GMP-compliant trap systems, air gaps etc. to
prevent backflow and microbial ingress. No drains are installed in Grade B areas, aligning with global
cleanroom guidelines to minimize contamination risks in aseptic zones.
Flushed Fixtures and Symmetrical Installation:
 In critical manufacturing and primary packaging areas, all fixtures and fittings—including doors, windows,
lighting (tube lights), AHU inlets/exhausts, and other utilities—are flush-mounted and installed
symmetrically within wall structures.
 This design ensures there are no protrusions or crevices where dust or product residues could accumulate,
facilitating better cleaning, airflow, and compliance with aseptic conditions.
9..6 HVAC System & Environmental Controls
At Kwality Pharmaceuticals Ltd, Unit-II, Amritsar, a robust and meticulously designed HVAC system has
been implemented to ensure compliance with international standards for cleanroom environments, supporting
controlled manufacturing conditions for sterile and non-sterile pharmaceutical operations.
9..6.1 Air Handling Units (AHUs)/ Dehumidification unit (DHUs) and Area Classification:
The facility is equipped with dedicated double-skin AHUs, designed to meet the environmental requirements
of various classified zones including:
o Grade A
o Grade B
o Grade C
o Grade D
o CNC (Controlled Not Classified)
9..6.2 High-Efficiency Particulate Air (HEPA) filters are installed terminally in clean areas to maintain stringent
particulate control, Grade A, B, C and D zones.
9..6.3 Environmental Conditions Maintained: For critical manufacturing areas, the HVAC system ensures strict
control of environmental parameters:
o Temperature: Maintained at not more than 25°C (NMT 25°C) in Grade A, B, C, D and CNC areas.
o Relative Humidity (RH): Maintained at NMT 20% / 55%.
These parameters are essential for minimizing microbial and particulate contamination in sterile
manufacturing environments.
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9..6.4 AHU Distribution: Following AHUs are dedicated to various zones across the manufacturing facility:
 For Dry Powder Injection:
Temp. RH NMT Clas
AHU /DHU ID Room Name Room ID
NMT °C % s
KPL2/DHU-014 Vial Filling & Stoppering Room G-113 25 20 B
KPL2/DHU-015 Vial Sealing/Capping Room G-114 25 20 B
KPL2/DHU-016 Sampling/Dispensing Area G-115 25 20 B
KPL2/DHU-017 Corridor/Vial Area G-134 25 55 B
Corridor G-135 D
Personnel Air Lock for DPI G-131 D
Garment Washing G-106 D
Entry Air Lock-I for Aseptic G-120 D
Return Air Lock-II For Aseptic Area G-110 D
Personnel Air Lock-1 For Bung Washing And 25 55
KPL2/AHU-012 G-105 D
Sterilization
Personnel Air Lock for Disinfectant
G-121 D
Preparation
Vial Decartoning Room G-102 D
Corridor G-133 D
Entry Air Lock-II for Aseptic area G-119 25 55 C
Personnel Air Lock For Vail Washing &
G-103 C
KPL2/AHU-013 Sterilization 25 55
Vial Washing & Sterilization Room G-104 C
Personnel Air Lock-II For Bung washing &
G-107 C
Sterilization

KPL2/AHU-014 Bung Washing & Sterilization G-108 25 55 C

Unit Washing G-101 C

Unused Material G-109 C
KPL2/AHU-015 Cooling Zone G-112 25 55 B
KPL2/AHU-016 Entry Air Lock-III for Aseptic area G-118 25 55 B
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Temp. RH NMT Clas
AHU /DHU ID Room Name Room ID
NMT °C % s
Disinfectant Filtration G-117 B
KPL2/AHU-017 Return Air Lock-1 for Aseptic area G-111 25 55 B
Entry Air Lock-IV for Aseptic area G-124 B
External Vial Washing G-130 C
KPL2/AHU-018 Personnel Air Lock-II of Vial washing G-129 25 55 C
Disinfectant Preparation G-122 C
KPL2/DHU-022 Blending Room G-116 25 20 B
KPL2/AHU-020 Raw Material Store G-123 25 55 D
Packing Hall G-125 25 55 CNC
Vial Inspection G-127 25 55 CNC
KPL2/AHU-021
Personnel Air Lock-I of Vial Washing G-128 25 55 D
Secondary Packing Material Store G-126 25 55 CNC
 For Oral Solid Dosage Area:
RH
Temp.
AHU ID Room Name Room ID % Class
NMT ℃
NMT

Granulation-I G-60 25 20 D
KPL2/DHU-002
Personnel Air Lock Granulation-I G-59 25 20 D

Granulation-II G-63 25 20 D
KPL2/DHU-003

Personnel Air Lock Granulation-II G-62 25 20 D

Compression-I G-67 25 20 D
KPL2/DHU-004
Personnel Air Lock Compression-I G-66 25 20 D

Compression-II G-65 25 20 D
KPL2/DHU-005
Personnel Air Lock Compression-II G-64 25 20 D
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Temp. RH
AHU ID Room Name Room ID Class
NMT ℃ %
NMT
Coating-I G-72
KPL2/DHU-006 25 20 D
Personnel Air Lock Coating-I G-71
Coating-II G-70 25 20 D
KPL2/DHU-007
Personnel Air Lock Coating-II G-69 25 20 D

Vacuum Tray Drier-I & II G-76 25 20 D

KPL2/DHU-008
Personnel Air Lock Vacuum Tray Drier-I & II G-75 25 20 D
KPL2/DHU-009 Blending Area for Dry Granulation G-82 25 20 D

Dry Syrup G-87 25 20 D

KPL2/DHU-010
Personnel Air Lock Dry Syrup G-86 25 20 D

Sachet Filling G-88 25 20 D

KPL2/DHU-011
Personnel Air Lock Sachet Filling G-172 25 20 D
Compressed Tablet Storage Room G-54 25 20 D
KPL2/DHU-012
Coated Tablet Storage Area G-78 25 20 D
Blister Packing G-90 25 20 D
KPL2/DHU-013
Personnel Air Lock Blister Packing G-89 25 20 D
Granule Storage Room G-61 25 20 D
KPL2/DHU-018
Die Punch & Polishing Room G-57 25 20 D
Strip Packing G-92 25 20 D
KPL2/DHU-019
Personnel Air Lock Strip Packing G-91 25 20 D
KPL2/DHU-021 Tablet Inspection Room G-95 25 20 D
Personnel Air Lock(Gents) G-53 25 55 D
Corridor G-68 25 55 D
Raw Material Day Store G-58 25 55 D
KPL2/AHU-028
Clean Equipment G-56 25 55 D
Washing G-55 25 55 D
Corridor G-165 25 55 D
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Temp. RH
AHU ID Room Name Room ID Class
NMT ℃ %
Corridor G-93 25 NMT
55 D
Janitor G-79 25 55 D
KPL2/AHU-029
Change Part G-84 25 55 D
Primary Packing Material Day Store G-83 25 55 D

Packing Hall G-30 25 55 CNC

Label Store G-29 25 55 CNC

KPL2/AHU-031
Change Room G-32 25 55 CNC
Material Air Lock For Bottle G-100 25 55 CNC
Bottle Decartoning G-33 25 55 CNC
Change Parts Store G-31 25 55 CNC

Capsule Filling Room G-81 25 55 D

KPL2/AHU-033
Personnel Air Lock Capsule Filling Room G-80 25 55 D
KPL2/AHU-034 Bottle Cleaning Room G-85 25 55 D
Solution Preparation Room G-73 25 55 D
KPL2/AHU-035
IPQA G-74 25 55 D
Tablet Side CNC Corridor G-132 25 55 CNC
KPL2/AHU-036
Corridor G-34 25 55 CNC
 For Warehouse Section:
Temp. RH
AHU/DHU ID Room Name Room ID Class
NMT ℃ % NMT
KPL2/DHU- Dispensing Room-II G-43 25 20 D
001 Personnel Air Lock Dispensing Room-II G-41 25 20 D
KPL2/AHU-
022 Quarantine/ Under test G-04 25 55 CNC

Reject Room G-37 25 55 CNC

Corridor 2000mm G-35 25 55 CNC
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Temp. RH
AHU/DHU ID Room Name Room ID Class
NMT ℃ % NMT
Material Air Lock G-36 25 55 CNC

Cleaned Tool Room G-45 25 55 D

Tools Washing Room G-47 25 55 D

PAL Tools Washing Room G-46 25 55 D
KPL2/AHU-
023 Approved RM G-05 25 55 CNC

Capsule Room G-39 25 55 CNC

Solvent Room G-38 25 55 CNC

KPL2/DHU- Sampling Area G-52 25 20 D

020
Personnel Air Lock Sampling Area G-51 25 20 D
25 55 D
Liquid Sampling/ Dispensing G-50
KPL2/AHU- 25 55 D
026 Personnel Air Lock Liquid Sampling/
G-48 25 55 D
Dispensing
KPL2/AHU- Dispensing Area-I G-44 25 55 D
027 Personnel Air Lock Dispensing Area-I G-42 25 55 D

PPM Dispensing I G-97 25 55 D

KPL2/AHU- Personnel Air Lock PPM Dispensing I G-96 25 55 D

030 Primary Packing
G-99 25 55 CNC
Material Store I
Material Air Lock I G-94 25 55 CNC

Finished Goods Store G-23 25 55 CNC

KPL2/AHU-
032 Material Air Lock G-26 25 55 CNC
Material Air Lock For SPM Store G-27 25 55 CNC
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Temp. RH
AHU/DHU ID Room Name Room ID Class
NMT ℃ % NMT

SPM Store G-49 25 55 CNC

PPM Dispensing Room II G-21 25 55 D

Air Lock PPM Dispensing II G-20 25 55 D

PPM Store II G-03 25 55 CNC

KPL2/AHU-
Material Airlock PPM II G-139 25 55 CNC
044
CNC Corridor I G-15 25 55 CNC
CNC Corridor II G-22 25 55 CNC
Janitor Room G-19 25 55 CNC
QA Office G-16 25 55 CNC
Each AHU/ DHU is calibrated and configured to cater to the specific air quality and environmental control
requirements of its designated area.
9..6.5 Advance Control Features:
To enhance operational flexibility and energy efficiency, Variable Frequency Drives (VFDs) are installed on
supply air blowers of the AHUs. These allow:
o Precise control of airflow and air changes per hour (ACPH).
o Stable differential pressure maintenance across cleanroom zones.
Additionally, temperature, relative humidity (RH), and room pressure sensors are installed throughout the
facility for real-time monitoring and control, ensuring consistent environmental conditions.
o Heating, Cooling & Dehumidification Systems.
o Chilled Water Coils: Used for summer cooling.
o Hot Water Coils: Enable winter heating and monsoon re-heating, ensuring temperature and RH
consistency year-round
o Fresh Air Treatment and Filtration TFA (Treated Fresh Air) & Air Processing Unit (in case of FBD
and Autocoater) are available.
To maintain indoor air quality and compensate for exhaust air loss, Treated Fresh Air (TFA) is supplied to
AHU’s for classified area. The fresh air undergoes a staged filtration process:
o Primary Filtration (Fresh air & Pre filters).
o Secondary Filtration (Fine Filters).
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This system reduces the particulate load on the AHUs, enhancing filter longevity and overall air purity.

9..6.6 Filter Configuration by Area Classification:

Sr. Filtration
Grade Filter Efficiency
No. Level

HEPA filter
99.97 % of airborne particles as small as 0.3 microns
(0.3 micron)
1. Grade A Pre filters having filtration efficiency up to 95% down to 5 are
Pre filter
provided before cooling coil in the return air of the Air Handling
(5 Micron)
Unit to filter out the dust particles.
2. Grade B Fresh air filters having filtration efficiency up to 90 % down to
Fresh Air filter 10 are provided in the Fresh air intake of the AHU to filter out
(10 micron) dust particles from the service area air followed by 3 micron Fine
Filters efficiency up to 99 % down to 3 %.
Pre filters having filtration efficiency up to 95% down to 5 are
Pre filter
provided before cooling coil in the return air of the Air Handling
(5 micron)
Unit to filter out the dust particles.
Fine filters having filtration efficiency up to 99 % down to 3 are
Fine Filter
provided after the cooling coil, heating coil and blower to remove
(3 micron)
fine particles from the treated air.
HEPA filters having filtration efficiency up to 99.97 % down to
HEPA Filter
0.3 are provided in the terminal boxes on the classification and
(0.3 micron)
process requirement of the room.

Return Riser Return air riser filters having filtration efficiency up to 90 %

(10 micron) down to 10 are provided in room return air raisers to filter out
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Sr. Filtration
Grade Filter Efficiency
No. Level

the dust particles generated in the room.

Fresh air filters having filtration efficiency up to 90 % down to
Fresh Air filter 10 are provided in the Fresh air intake of the AHU to filter out
(10 micron) dust particles from the service area air followed by 3 micron Fine
Filters efficiency up to 99 % down to 3 %.
Pre filters having filtration efficiency up to 95% down to 5 are
Pre filter
provided before cooling coil in the return air of the Air Handling
(5 micron)
Unit to filter out the dust particles.
Fine filters having filtration efficiency up to 99 % down to 3 are
3. Grade C Fine Filter
provided after the cooling coil, heating coil and blower to remove
(3 micron)
fine particles from the treated air.
HEPA filters having filtration efficiency up to 99.97 % down to
HEPA Filter
0.3 are provided in the terminal boxes on the classification and
(0.3 micron)
process requirement of the room.
Return air riser filters having filtration efficiency up to 90 %
Return Riser
down to 10 are provided in room return air raisers to filter out
(10 micron)
the dust particles generated in the room.
4. Grade D Fresh air filters having filtration efficiency up to 90 % down to
Fresh Air filter 10 are provided in the Fresh air intake of the AHU to filter out
(10 micron) dust particles from the service area air followed by 3 micron Fine
Filters efficiency up to 99 % down to 3 %.
Pre filters having filtration efficiency up to 95% down to 5 are
Pre filter (5 mi-
provided before cooling coil in the return air of the Air Handling
cron)
Unit to filter out the dust particles.
Fine filters having filtration efficiency up to 99 % down to 3 are
Fine Filter (3
provided after the cooling coil, heating coil and blower to remove
micron)
fine particles from the treated air.

HEPA Filter HEPA filters having filtration efficiency up to 99.97 % down to

(0.3 micron) 0.3 are provided in the terminal boxes on the classification and
process requirement of the room.
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Sr. Filtration
Grade Filter Efficiency
No. Level

Return air riser filters having filtration efficiency up to 90 %

Return Riser
down to 10 are provided in room return air raisers to filter out
(10 micron)
the dust particles generated in the room.
Fresh air filters having filtration efficiency up to 90 % down to
Fresh Air filter 10 are provided in the Fresh air intake of the AHU to filter out
(10 micron) dust particles from the service area air followed by 3 micron Fine
Filters efficiency up to 99 % down to 3 %.
CNC (Con-
Pre filters having filtration efficiency up to 95% down to 5 are
5. trolled Not Pre Filter
provided before cooling coil in the return air of the Air Handling
Classified) (5 micron)
Unit to filter out the dust particles.
Fine filters having filtration efficiency up to 99 % down to 3 are
Fine Filter (3
provided after the cooling coil, heating coil and blower to remove
micron)
fine particles from the treated air.
This layered filtration system ensures cleanroom compliance, preventing microbial and particulate contamination in
critical processing zones.
The HVAC system is designed with the following room conditioning for various hygiene zones ;
For Dry Powder Injection Line
Designed Room condition
Grade Design ACPH
Temperature RH Pressure differential

CNC NMT 25°C NMT 55 % NA NLT 25

Grade D NMT 25°C NMT 55 % NMT 15 Pascal NLT 40

Grade C NMT 25°C NMT 55 % NMT 15 Pascal NLT 80

Grade B NMT 25°C NMT 20% / 55 % NMT 15 Pascal NLT 120

Grade Air Velocity of

Temperature RH Pressure differential
HEPA Filter

Grade A NMT 25°C NMT 55 % NMT 7-15 mmWC 90 FPM ±20% at fil-
ter face as well as at
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working position.

For Oral Solid Dosage Line

Designed Room condition
Grade Design ACPH
Temperature RH Pressure differential

CNC NMT 25°C NMT 55 % NA NLT 25

Grade D NMT 25°C NMT 20% / 55 % 5-15 Pascal NLT 40

 Above details of the system maintained in at-rest condition.

 The manufacturing area is covered with epoxy flooring with covings. Inner walls are made with clean room
partitions. The ceiling is also clean room partition with covings. All light fixtures, and windows panels are
flushed with the structure.
 The layout and design are such that the risk of errors is minimized. Effective cleaning and maintenance can
be done in order to avoid cross-contamination, and build-up of dust or dirt.
 All partitions in the manufacturing premises are made up of reinforced SS panels/ Powder coated panels.
These partitions are non-corrosive, non-shredding, and resistant to most chemicals, non-perspiring, smooth,
and impervious.
 Ancillary areas like refreshment rooms are separate from the production area. There is a separate change
room for staff/ visitor and worker for changing street clothes and shoes before entering to production area.
 Toilets are separate and do not directly communicate with the production area to avoid contamination.
 Maintenance workshops are separate from production areas.
 The storage area is sufficient to allow the orderly storage of various categories of materials and products.
The receipt area of incoming materials is designed and equipped to allow containers of incoming materials
to be cleaned before they are kept in the store. The design of the storage area is made in such a way as to
separate the receipt and dispatch of the material inside and out of the premises.
 There is a separate sampling area for the sampling of incoming raw materials and packing materials to avoid
cross-contamination. Segregation is provided for the storage of approved, under-tests and rejected materials.
 Packing materials are segregated and kept in separate racks.
 Dispensing/weighing of starting materials is carried out in RLAF station having weighing Balances with
controlled air received from HEPA filters and provision for dust removal.
 The Finished Good area is well designed for storing finished goods. The entire store area is under controlled
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temperature conditions.
 In the store area, separate provision of a closed chamber is provided for the storage of material with special
conditions of cold storage area (2-8 °C and NMT 25°C).
9..7 Aseptically Manufactured Products:
Process Step Clean Room Grade
Machine Parts Preparation Grade C area
Machine part sterilization Sterilization of machine parts and other accessories is done in autoclave
Unloading and temp storage of Unloading is done under Grade A LAF
Sterilized articles
Dispensing Dispensing of Sterile API is done in A grade with grade B back ground
Blending For the DPI products, wherever two or more API is mixed blending
processing is done under A grade.
Filling Filling is done in Grade A with Grade B background
Sealing Sealing is done in Grade A with Grade B background
9..8 Low Bio Burden Processes/ Bio Burden Controlled Processes:
Process Step Clean Room Grade
Aseptic dispensing of API in DPI in case of double API Grade A with grade B background
Blending done under A grade Area to reduce the bioburden
Grade A with grade B background
contamination
Vials are washed in the vial washing area before loading into
Grade C area
the tunnel
Vials are depyrogenate in the depyrogenation tunnel Grade A with grade C background
Vial Filling Grade with Grade B background
Vial Sealing Grade A with Grade B background
 The Processes:
9..1 Dry Powder injection Manufacturing (Aseptic Manufacturing):
 The manufacturing and filling operations are designed in suitable grade of clean room to support the product
quality minimizing risk of chemical, particulate microbial and endotoxin / pyrogen contamination. Aseptic
process like filling and sealing is supported under unidirectional flow unit and filling is in oRABs.
 Aseptic process simulation procedure (Ref. SOP no. KPL2/SOP/QA-064) is in place to evaluate aseptic
practices; APS is performed twice in a year by following a defined protocol and procedure.
9..1.1 Manufacturing Scope and Contamination Risk:
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The facility specializes in the manufacturing of Beta Lactam products. These products do not involve the use of living
cells, tissues, or microbial cultures during production. As a result, the likelihood of contamination from biological
sources is significantly reduced, making the risk of microbial penetration from these sources remote.
9..1.2 Process Design and Microbial Control:
Key process steps, such as aseptic filling under oRABS, are specifically designed to reduce or eliminate microbial
load and potential contamination. These steps play a critical role in maintaining the sterility of the product throughout
the manufacturing process.

9..1.3 Importance of Container Closure Integrity (CCIT)

o Any breach in the container or packaging can lead to microbial ingress or exposure to environmental gases,
potentially compromising product sterility and efficacy. Therefore, ensuring container closure integrity is a
fundamental requirement throughout the product lifecycle. The CCIT is being checked by Dye Ingress method as
per SOP No. KPL2/SOP/PD-098.
o CCIT is assessed using microbial ingress methods after media fill incubation, as well as dye ingress tests. These
evaluations are vital for demonstrating the package’s capability to maintain a sterile barrier over the product’s shelf
life.
9..1.4 Ongoing Stability and Product Quality Monitoring
Container closure integrity tests such as dye ingress leak testing are performed not only during product release but
also as part of ongoing stability studies. This practice confirms the container system's ability to prevent
contamination over the intended storage period.
9..1.5 Quality Risk Management (QRM):
o A structured QRM system is in place to proactively identify, analyze, and mitigate potential risks, including
contamination. The approach covers all stages of the product lifecycle—equipment, process, facility, and unit
operations.
o Risk assessment is conducted using the Failure Modes and Effects Analysis (FMEA) method as per SOP No.
KPL2/SOP/QA-017. This includes identifying potential failure modes, assessing their impact, and implementing
suitable mitigation strategies. Risk communication and documentation are integral to this process.
o QRM forms a core component of the overall Quality Management System (QMS).
9..1.6 Bioburden Reduction and Sterilization Processes:
o Moist heat sterilization is employed as an effective bioburden reduction method. This sterilization process is fully
validated and included in the re-qualification program.
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o Validation includes both physical measurements (e.g., thermometric evaluations) and, where applicable, biological
indicators (BIs). Loading patterns for sterilizers are qualified and requalified at defined intervals.
9..1.7 Sterilization of Equipments and components:
o All product-contact equipment and components are sterilized prior to use. This step ensures the absence of
contaminants that could compromise product sterility.
9..1.8 Equipment Design, Qualification, and Maintenance:
o Manufacturing equipment is of appropriate design, capacity, and placement to support its intended function, ease of
cleaning, sanitization, and maintenance.
o All critical equipment is uniquely identified and supported by Uninterruptible Power Supply (UPS) systems to
prevent data loss during power failures.
o Equipment undergoes qualification, routine calibration, and preventive maintenance. These activities are
scheduled, documented, and supported by established Standard Operating Procedures (SOPs) for operation,
calibration, and maintenance.
9..1.9 Cleaning and Sanitization Practices:
o Detailed written procedures guide the cleaning of equipment, ensuring it is suitable for reuse in manufacturing.
o Cleaning procedures are developed to enable consistent, effective cleaning by operators. Equipment and utensils
are cleaned, stored, and, where necessary, sanitized or sterilized to prevent contamination or cross-contamination.
o Cleaning validation confirms the effectiveness of the cleaning processes, particularly for product contact surfaces
as per Protocol No. KPL2/CVP/DI-001 and KPL2/CVP-OSD-001 for Dry Powder Injection section and Oral
Solid Dosage section respectively.
9..1.10 Personnel Training and Aseptic Practices:
o Personnel are comprehensively trained in facility entry/exit procedures, microbiological principles, aseptic
behaviors, and monitoring practices required for work in classified cleanroom areas as per SOP No.
KPL2/SOP/QA-058 and KPL2/SOP/PD-090.
9..1.11 Utility Monitoring and Testing:
o Routine sampling and testing are conducted for all critical utilities, including potable water, pre-treated water,
Reverse Osmosis (RO) water, Water for Injection (WFI), and pure steam. These activities ensure that utility
systems consistently meet microbiological and chemical quality specifications.
9..1.12 Raw Material and Packaging Quality Control:
o All raw materials and primary packaging materials are sampled according to a predefined sampling plan. Each lot
undergoes chemical and microbiological testing based on approved specifications. This ensures that only materials
of acceptable quality are used in product formulation.
9..1.13 Media Fill Studies (Process Simulation):
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o The aseptic process is routinely challenged and assessed through media fill studies, which simulate the entire
aseptic filling process using sterile nutrient media as per SOP No. KPL2/SOP/QA-064. These studies are
conducted using 'worst-case' conditions, such as:
 Maximum line speeds and slowdowns.
 Extended process duration.
 Multiple vial or sizes.
 Planned and unplanned equipment stoppages.
 Highest number and complexity of personnel interventions.
 All authorized and allowable interventions that may occur during actual production are replicated during
media fills to validate the robustness of the process.
 Media fill studies are a routine verification tool for assessing the ongoing control and effectiveness of the
aseptic process. They form a critical part of the facility’s contamination control and validation strategy.
9..1.14 Hold Time validation:
o All stages of aseptic preparation and processing, including sterilized equipment, product, and intermediate holding
steps, are subject to defined and validated hold times.
o These hold times are established to ensure that any delay between sterilization and usage does not compromise
sterility. They are determined through risk assessment and validation studies to avoid microbial proliferation or
contamination during holding.
o The maximum allowable duration for each step is established, documented, and strictly controlled as part of the
validated aseptic process parameters.
Refer below table for details of different processing sequential steps v/s area gradation designed considering
aseptically filled products.

Process Step Clean room grade High level Contamination control measures
Raw Material Grade-A under RLAF Fol-  Temperature, Humidity and Differential Pressure monitoring
Sampling and lowed by the Grade C area. is carried out on daily basis.
Dispensing.  Satellite samples are received for sterile raw materials analysis.
 Non-viable particulate monitoring under RLAF is carried out
during operation and daily if there is no activity.
 Viable particle monitoring is followed as per SOP No.
KPL2/SOP/QC-084.
 Material used for batch processing is received from approved
vendor source.
 Dedicated dispensing room available for API Dispensing.
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Process Step Clean room grade High level Contamination control measures
 Before transferring the raw material canister for dispensing
the details are verified from the BMR and required material
are transferred to the dispensing area.
 Raw material is transferred from approved storage area to
dispensing area after mopping the surface by disinfectant
Imagard HD 10%, transfer the container in dynamic pass
box, and hold it for 15 minutes under UV. Once again moped
the container with 70% IPA solution.
 Raw material is transferred through dynamic pass box, after
surface sanitization of the material.
 Raw material dispensing activity is carried out under RLAF
in Grade A environment surrounded by Grade B environ-
ment.
 HVAC/ LAF periodic requalification is carried out every six
months.
 All entry change rooms is having a provision for interlock-
ing.
 Separate entry and exit change room is available for personal
and material entering in to Sampling/Dispensing area.
 Hand disinfectant is carried out by using 70% filtered IPA
solution prior to unit operation.
Blending. Grade-A under LAF Fol-  Temperature, Humidity and Differential Pressure monitoring
lowed by Grade B area. is carried twice in a shift.
 Non-viable particulate monitoring under RLAF is carried out
during operation and daily if there is no activity.
 Viable particle monitoring is followed as per KPL2/SOP/QC-
084.
 Line clearance and in-process check procedure is available.
 One product processed at one time to avoid any cross-contami-
nation.
 Gowning procedure available for Entry in Grade B area.
 The Blending is done under Grade A provided by UDAF
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Process Step Clean room grade High level Contamination control measures
with LAF surrounded by Grade B environment.
 Equipment qualification is done and periodic requalification is
being performed as per the Validation Master Plan.
 After blending bulk sample send for chemical/microbial analy-
sis for every batch.
Loading takes place in Grade  LAF’s used for material storage transfer are maintained with
C area. laminar air with high pressure than the surrounding area to
Unloading of sterile articles prevent the ingress.
takes place in Grade-A under  Validated cycle parameters are part of SOP No. KPL2/
LAF followed by the Grade SOP/PD-061 and batch documents and the same is verified
Sterilization of B area. And material transfer before start-up of each sterilization cycle.
Articles. to the dedicated workplace  Rinse water results are ensured before sterilization.
by through  Vacuum leak test is performed daily as well as bowie dick
Mobile Trolley. (Grade A) test performed once in a week.
Area.  Viable monitoring is followed as per KPL2/SOP/QC-084.
 All the load pattern run for the material used in sterile area val-
idated twice in a year as part of Re-qualification.
 Viable monitoring is followed as per KPL2/SOP/QC-084.
 Line clearance and in-process checks procedures are available.
Vial Washing Grade C Area
 Equipment qualification is done and periodic requalification is
being performed.
 Vials are Depyrogenated in the closed depyrogenation tunnel
as per SOP No. KPL2/SOP/PD-074; air is supplied through
a HEPA filter.
Articles Depyrogenated in
Depyrogenation  Periodic re-qualification for the performance indicators of
Grade-A with background
Tunnel HEPA filter is in place as per approved validation master plan.
Grade-C Area
 Equipment’s have the alarm system wherein in case any de-
fined parameter goes out of limit; the alarm will alert the oper-
ator.
Vial Filling & Grade A  Online Non-Viable particulate monitoring is in place and is
Stoppering (Under LAF) with back- followed as per respective SOP No: KPL2/SOP/QA-069.
ground Grade B area  Viable monitoring is followed as per KPL2/SOP/QC-084.
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Process Step Clean room grade High level Contamination control measures
 Filling and stoppering zones are built with ORABS,
mounted with LAF’s at the top to have laminarity of air
with higher pressure than the surrounding (Grade B) area to
prevent the ingress of air.
 The use of oRABs minimizes the risk of both particulate
and microbial contamination, especially during critical in-
terventions. This controlled setup is instrumental in main-
taining aseptic integrity throughout the filling process.
 Periodic re-qualification for the performance indicators of
LAF is in place as per the approved validation master plan.
 All product-contact equipment and components used in
aseptic processing are sterilized prior to use to eliminate
potential contamination sources.
 Viable monitoring is followed as per KPL2/SOP/QC-084.
 Vial sealing is performed in a separate area are built with
ORABS, mounted with LAF’s at top to have laminar air with
higher pressure than the surrounding area to prevent the ingress
of air.
Grade A (Under LAF) with
Vial Sealing  Periodic re-qualification for the performance indicators of LAF
background Grade B area
is in place as per the approved validation master plan.
 Leak test of sealed vial is being performed at defined fre-
quency and same recorded in batch record.
 NVPC particle count test is performed as per KPL2/SOP/QA-
069.
 Viable particle monitoring is followed as per KPL2/SOP/QC-
084.
 Line clearance and in-process check procedure is available.
External Vial  Vials are in a sealed condition, and an external vial washing
Grade C Area
Washing machine is available to remove dry powder traces from the
outer surface, ensuring effective contamination control.
 SOP No. KPL2/SOP/PD-077 outlines the procedure for the
operation and cleaning of the external vial washing machine.
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Process Step Clean room grade High level Contamination control measures
 Filled and sealed vials eliminate the risk of cross-contamina-
tion during visual inspection.
 Visual inspection is being conducted for each individual filled
and sealed vial as per SOP No. KPL2/SOP/PD-078.
 Trained and qualified visual inspectors perform the inspection
to identify and remove defective vials, including those with
Visual Inspection CNC Area
high/low fill weight or visible particles.
 Reconstituted vial inspection is carried out as per SOP No.
KPL2/SOP/PD-117 to control any external contaminants.
 The AQL (Acceptable Quality Limit) procedure is followed as
per SOP No. KPL2/SOP/QA-057 to ensure quality compli-
ance.
 Filled and sealed vials prevent the risk of cross-contamination
during the labeling and packing process.
 SOP for operation and cleaning of equipment is in place to en-
Labelling and
CNC Area sure proper hygiene and contamination control.
Packing
 Status labeling is implemented as per SOP No. KPL2/SOP/
QA-004 to maintain accurate identification and traceability of
materials throughout the process
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 Flowchart:1 Vial Line (Aseptic manufacturing)

 Process Steps involved in manufacturing of oral solid dosage form manufactured mentioned below :-
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Process Step High level Contamination control measures
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance checks procedure is available.
Dispensing of
Material used for batch processing is received from approved vendor source.
API and Excipi-
Dedicated dispensing room available for API Dispensing.
ents
API and Excipients shall be dispensed in warehouse area under RLAF and transferred to pro-
duction area.
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance and in-process check procedure is available.
One product processed at one time to avoid any cross-contamination.
Material Sifting Vibro Sifter: - Pre & post Sieve Integrity & Rate of Sifting with respect to time shall be moni -
tored.
Equipment qualification is done and periodic requalification is being performed as per the
Validation Master Plan.
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance checks procedure is available.
One product processed at one time to avoid any cross-contamination.
Pre-Lubrication Equipment qualification is done and periodic requalification is being performed as per the Vali-
dation Master Plan
Blender:- Blending time & speed (RPM)
After pre-Lubrication sample send for chemical analysis.
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance checks procedure is available.
One product processed at one time to avoid any cross-contamination.
Lubrication Equipment qualification is done and periodic requalification is being performed as per the Vali-
dation Master Plan
Blender:- Blending time & speed (RPM)
After pre-Lubrication sample send for Quality Control for Analysis, Description and Assay.
Slugging Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance and in-process check procedure is available.
One product processed at one time to avoid any cross-contamination.
Equipment qualification is done and periodic requalification is being performed as per the Vali-
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Process Step High level Contamination control measures
dation Master Plan.
Roll Compactor Machine: Roller RPM & Feeder RPM.
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance and in-process check procedure is available.
One product processed at one time to avoid any cross-contamination.
Equipment qualification is done and periodic requalification is being performed as per the Vali-
dation Master Plan.
Compression
Compression Machine:- Machine speed & Metal detector challenge
In-process checks (IPQA & Production).
Description, Average weight, Individual weight , thickness, hardness, friability & DT
After compression sample send to Quality Control for Analysis: Description, Average weight,
Diameter, thickness, hardness, Dissolution, friability, DT & Assay.
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance and in-process check procedure is available.
One product processed at one time to avoid any cross-contamination.
Equipment qualification is done and periodic requalification is being performed as per the Vali-
Coating
dation Master Plan.
Coating Pan: - Pan Speed, Inlet Temp., Outlet Temp. & gun Valuation
In-process checks (IPQA & Production) performed by
Description, Average weight, thickness, & DT
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance and in-process check procedure is available.
One product processed at one time to avoid any cross-contamination.
VTD Equipment qualification is done and periodic requalification is being performed as per the Vali-
dation Master Plan.
After VTD sample send to Quality Control for Analysis: Description, average weight, Diame-
ter, thickness, hardness, Dissolution, water content, DT & Assay.
Visual Inspec- Viable particle monitoring is followed as per KPL2/SOP/QC-084.
tion Line clearance and in-process check procedure is available.
One product processed at one time to avoid any cross-contamination.
Equipment qualification is done and periodic requalification is being performed as per the Vali-
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Process Step High level Contamination control measures
dation Master Plan.
Conveyer speed
Defects of tablet checks (IPQA & Production):- Roughness, Twinning, Brocken, Picking &
Sticking.
Viable particle monitoring is followed as per KPL2/SOP/QC-084.
Line clearance and in-process check procedure is available.
Packing
One product processed at one time to avoid any cross-contamination.
After Packing Finish sample send to Quality Control and microbiology department.
 Flowchart 2: Capsules (Grade D)

 Flowchart 3: Tablets (Grade D)

3
 Flowchart 4: Sachet (Grade D):
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 Flowchart 5: Dry Syrup (Grade D)
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10.0 Premises and Equipment:
 Premises:
 Entry for people and materials is separate for manufacturing areas.
 All equipment, accessories, machinery, packing equipment, and manpower employed are separate for all
lines
 Premises are laid in such a way so as to allow the production to take place in areas connected in a logical
order corresponding to the sequence of operation and with the requisite cleanliness levels.
 Equipment’s are logically positioned. There is adequate space for working and storage of in-process
materials. This permits an orderly flow of materials and minimizes the risk of contamination between
different Pharmaceutical Products, or their components. It minimizes the risk of the wrong application of
any of the manufacturing or control steps.
 Drains are of adequate size and with deep seals and equipped to prevent backflow facilitating cleaning and
disinfection.
 Production areas have HVAC systems with air control facilities appropriate to the product handled
 The HVAC of dry powder injection system comprises of 09 AHUs & 05 DHU units.
 The HVAC of oral solid dosage area system comprises of 7 AHU and 15 DHU.
 The system is equipped with automatic control of all critical parameters with the aid of building
management and an environmental monitoring system (EMS) for monitoring purposes. In the building
Automation System temperature sensors, transmitters are provided Proficient design of the system facilitate
to achievement of desired indoor environmental conditions as per the defined hygiene zone for various
pharmaceutical manufacturing activities as per international cGMP standards.
 AHU is double skin with thermal break profile, having supply air and return air fans. Separate supply and
return blower provision in AHU adds benefits of excellent power saving in “ONCE THROUGH” mode
when outside Temperature & humidity meet inside temperature & humidity and excellent differential
pressure characteristics.
 Cooling coil is provided to offset the outdoor air heat and for the necessary dehumidification requirement.
Electrical heater is provided for winter heating and monsoon reheating
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10..1 Controlled Environment for Sterile Manufacturing

 Sterile product filling is performed under Laminar Airflow (oRABS) conditions, ensuring a
unidirectional, particle-free airflow over critical processing zones. The background environment for these
operations is classified as Grade B, as per cGMP guidelines.
 Personnel entry into cleanroom areas is facilitated through airlocks, designed to maintain a unidirectional
flow and graded transition from uncontrolled to controlled areas. The transition is from Controlled Non-
Classified (CNC) areas to Grade D, in alignment with SOP No. KPL2/SOP/PD-114 “Procedure for
Entry and Exit in controlled area of Dry powder injection”.
 Material and equipment entry is controlled through Material Airlocks (MAL) or Dynamic Pass Boxes,
which are operated according to SOP No. KPL2/SOP/PD-113 “Procedure for material movement in
dry powder injection area”. These provisions prevent contamination due to improper handling of
materials entering classified zones.
10..2 Cleanroom and Change Room Maintenance
10..2.1 Cleanliness levels in Grade C and D cleanrooms and associated change rooms are maintained through:
 Daily cleaning and disinfection as per SOP No. KPL2/SOP/PD-062 “Procedure For Cleaning And
Sanitization Of Dry Powder Injection Area”
 Maintaining qualified HVAC parameters, including air changes per hour (ACH), airflow velocity,
differential pressure, temperature, and relative humidity
 Use of HEPA-filtered Air Handling Units (AHUs) to supply particulate-free air to critical areas and
secondary change rooms
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 These activities are aimed at preventing microbial and particulate contamination and ensuring compliance
with applicable cleanroom classification standards (e.g., EU GMP Annex 1).
10..2.2 Environmental Monitoring and HVAC Control:
 The HVAC system, integrated with a Environmental Management System (EMS), provides automated
and continuous control and monitoring of key environmental parameters:
 Temperature.
 Relative Humidity.
 Pressure Differential.
 The EMS ensures real-time alerts, logging, and audit trails for deviations, ensuring traceability and rapid
response. Environmental conditions are maintained within specified ranges as defined in the Room Data
Sheet (RDS) for each classified area.
 All cleanrooms, airlocks, and pass-through hatches are subjected to facility qualification and routine
requalification to verify compliance with validated environmental conditions.
10..2.3 Operational Segregation and Contamination Control:
 Key operations such as dispensing and product blending are conducted in separate technical areas, each
supported by Grade A environments. This design ensures segregation of critical processing activities and
avoids the risk of cross-contamination.
 Filling operations are conducted under open Restricted Access Barrier Systems (oRABs), providing a
Grade A environment at the point of fill, with a Grade B background. The use of oRABs minimizes
human intervention and associated contamination risks in the most critical zones.
10..2.4 Use of Barrier Technologies
 Manufacturing lines are equipped with Restricted Access Barrier Systems (RABs), which play a vital role
in maintaining environmental integrity during sterile operations
 RABs offer a physical barrier between personnel and the sterile product, significantly reducing
contamination risks from direct human interaction.
 These systems are particularly effective in preserving the required aseptic conditions during critical
operations like vial filling, capping, and stoppering.
10..3 For the manufacturing of sterile products, there are three grades of cleanroom / zone
10..3.1 Grade A Environment – Critical Operations Under oRABs
 All high-risk aseptic operations—such as filling, stopper bowl management, and handling of open primary
packaging components—are performed under Grade A conditions using open Restricted Access Barrier
Systems (oRABs). This setup provides an effective physical and microbiological barrier, reducing the risk
of contamination from operator interventions.
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 Dedicated procedural controls and SOPs govern all high-risk activities conducted under oRABs, ensuring
consistent, reproducible aseptic practices by trained personnel.
 The maintenance and integrity of laminar airflow (unidirectional flow) within the Grade A zone is verified
and qualified through:
 Smoke visualization studies, which confirm the sweeping action of airflow over critical surfaces
 Aseptic process simulations (media fills), which validate the ability of the environment and procedures to
maintain sterility under operational conditions.
10..3.2 Grade B, C, and D Areas – Supporting Cleanroom Zones:
 The cleanroom layout is designed according to risk-based classification, in line with aseptic
manufacturing requirements:
 Grade B areas serve as background environments for critical Grade A operations.
 Grade C areas surround the aseptic processing lines (vial filling) where LAF units are used to create
localized Grade A zones.
 Grade D areas are used for less critical operations such as vial Decartoning or initial washing of equipment
and materials, serving as a controlled transition zone to higher-grade areas.
 The classification and environmental conditions of each area are designed and maintained in accordance
with EU GMP Annex 1 and validated through cleanroom qualification protocols.
10..3.3 Cleanroom and Critical Zone Surface Design
 All cleanroom areas, including Grade A, B, C, and D zones, are constructed using materials and finishes
that comply with regulatory expectations for aseptic environments.
 Surfaces are smooth, impervious, non-porous, and unbroken, minimizing the risk of microbial and
particulate accumulation and facilitating effective cleaning and disinfection.
 Corners are coved and sealed to prevent buildup of contaminants.
 Surfaces and joints are resistant to disinfectants and designed for durability under routine cleaning
protocols.
 These features were thoroughly verified during facility and equipment qualification, ensuring that the
physical environment supports microbial control and meets sterility assurance levels required for aseptic
manufacturing.
10..3.4 Cleanroom Architecture and Surface Design:
 The cleanroom facility is purpose-built with a flush, smooth, and non-porous finish to prevent particle
accumulation and microbial harboring. All projecting ledges, cupboards, and equipment installations are
minimized or recessed, facilitating easy cleaning and disinfection.
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 During facility qualification, each cleanroom undergoes a physical inspection for wall, ceiling, and floor
finishes to confirm appropriate material of construction (MOC), coving, seamless joints, and absence of
leakage or recesses.
 Doors are installed and verified as per layout, including appropriate swing direction, interlocks, and
biometric access controls to restrict unauthorized entry and ensure air pressure containment.
10..3.5 Sealing, Coving, and Ceiling Design:
 Sealants are applied at the joints between floors, walls, and ceilings to ensure air-tightness and Cleanability.
 Coving is installed at floor-to-wall and wall-to-ceiling transitions to eliminate recesses and facilitate
comprehensive cleaning.
 A walkable false ceiling is constructed above cleanroom ceilings to allow maintenance activities without
disrupting the cleanroom environment, preserving environmental integrity during upkeep
10..3.6 Drainage Controls:
 In alignment with aseptic design principles, floor drains are not available in Grade A & Grade B areas.
 In lower-grade cleanrooms, where drains are present, air breaks are used to prevent direct connection
between sinks or machines and the drain system, thereby minimizing contamination risks.
 Traps and water seals are fitted to floor drains to prevent backflow and microbial ingress.
 SOP No. KPL2/SOP/PD-086 “Procedure For Cleaning And Sanitization Of Drain Points” governs the
cleaning and disinfection of drains, which is performed daily and documented as part of the sanitation
program.
10..3.7 Airlocks and Segregation for Personnel and Material Flow:
 Separate airlocks for personnel and material movement are in place between different cleanroom grades to
ensure physical separation and prevent cross-contamination.
 Airlocks are continuously flushed with filtered air, designed with cascading air pressure (from higher to
lower grade) to control particulate movement. Differential pressures are monitored in real time through the
Environmental Management System (EMS) or via Pressure gauges.
 Dedicated change rooms for entry and exit to/from Grade C areas ensure Uni-directional personnel
movement and reduce contamination risks.
10..3.8 Personnel Airlocks and Hygiene Facilities:
 Personnel movement is designed with progressive cleanliness transitions, typically from Grade D to Grade
C, via interlocked airlocks and separate exit routes.
 Hand sanitization with 70 % Iso-Propyl Alcohol facilities are available in general change rooms, which are
not directly connected to the classified cleanroom areas, maintaining separation between controlled and
uncontrolled environments.
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10..3.9 Material Airlocks and Pass Boxes:

 Dynamic Pass Boxes are used for the transfer of materials and equipment between different cleanroom
grades. These are designed to:
 Prevent contamination through active filtered air flushing
 Allow movement only after surface disinfection
 Protect higher-grade environments during transfers from lower-grade areas
 Interlocks are installed on all dynamic pass boxes and airlocks to prevent simultaneous door openings,
thereby preserving pressure differentials and environmental segregation.
10..3.10Airflow and Pressure Differentials:
 Sterile manufacturing areas are maintained under positive pressure relative to adjacent lower-grade areas to
minimize the risk of contamination ingress.
 Smoke studies (Airflow Visualization Studies) have been performed to validate airflow direction, confirm
unidirectional flow, and ensure effective flushing of particulate matt.
 The facility is designed such that air flows from higher-grade to lower-grade areas, in accordance with
GMP zoning principles.
10..3.11Airflow Validation and Contamination Prevention:
 Airflow patterns within and between cleanrooms are validated via smoke studies under both "at rest" and
"in operation" conditions, demonstrating:
 No air ingress from lower-grade to higher-grade areas.
 Proper air displacement over equipment and away from critical zones.
 No airflow from contaminated sources (e.g., floors or personnel) toward critical processing areas.
 Airflow does not disturb closed containers during transfer to lower-grade zones.
These validations ensure robust contamination prevention and support the facility’s sterility assurance
levels.
10..3.12Monitoring and Documentation of Interventions:
 All airflow patterns are re-verified periodically, especially after major interventions or facility
modifications.
 Inherent and corrective interventions are video recorded during routine operations to monitor airflow
behaviour in real conditions. These records are reviewed and used to update the Environmental
Monitoring (EM) program, especially in areas identified as turbulence-prone or high-risk.
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10..3.13Details of manufacturing line and relevant system

Facility Description Line Provision
Vial Line Dry powder injection line oRABs
10..4 Barrier Technologies (Glove system perspective):
10..4.1 Overview of Glove System in Aseptic Processing
 In sterile manufacturing areas where open Restricted Access Barrier Systems (oRABs) are used, glove
ports serve as the only interface between operators and the aseptic core.
 To maintain the integrity of the sterile zone, comprehensive procedures are established for the
management, monitoring, and testing of glove systems. These procedures are integral to contamination
control, given that glove failure is a critical risk point in aseptic operations.
10..4.2 Glove Management Lifecycle
 A controlled program is in place for the receipt, handling, storage, sterilization, sanitization, and
replacement of gloves used in oRABs systems. This program ensures that gloves are:
 Procured from qualified suppliers.
 Sterilized using validated methods.
 Sanitized routinely before and during use.
 Replaced at defined frequencies or when integrity is compromised.
10..4.3 Glove Integrity Testing Procedure
 Glove integrity testing is conducted according to SOP No. KPL2/SOP/PD-112 “Procedure for handling,
cleaning, integrity testing, sterilization and destruction of Hypalon gloves in DPI area”.
 Testing is performed using a qualified glove integrity tester capable of detecting even minor leaks,
ensuring that gloves maintain their aseptic barrier function.
10..4.4 Sterility Assurance and Environmental Protection
 The integrity of the glove system is critical in maintaining Grade A conditions within the oRABs. Failure
to detect a breach could lead to microbial ingress and product contamination.
 Routine glove integrity testing ensures the continued effectiveness of the aseptic barrier throughout the
production lifecycle and supports compliance with Annex 1 requirements for sterile manufacturing.
10..4.5 Corrective Actions and Replacement Protocol
 In case of glove failure or a detected leak:
 The glove is immediately replaced following the approved replacement and sanitization procedure.
 A post-replacement integrity test is conducted to confirm the effectiveness of the new glove.
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 Root cause investigation and deviation management is initiated, if required, based on the risk and
recurrence pattern.

 EQUIPMENT:
10..1 Equipment Design Documentation:
 A comprehensive written description of equipment design is maintained as per SOP on Qualification
Program and Documentation Procedure (SOP No. KPL2/SOP/QA-033). This SOP governs the overall
qualification program and documentation for Equipment, Instruments, Utility systems, and Facilities,
providing a basis for reassessment of contamination control parameters.
10..1.1 Design Qualification (DQ):
 During the Design Qualification phase, detailed verification of equipment design specifications,
drawings, safety features, and controls is conducted. This includes review of the Instrumentation and
Process diagrams (P&ID), Material of Construction (MOC), major components, and electrical
switch/panel specifications (IP ratings). The MOC and instrumentation design are critical for ensuring
contamination control effectiveness.
10..1.2 User Requirements Specification (URS):
 The URS template is integrated within the dedicated SOP No. KPL2/SOP/QA-054. It captures detailed
equipment technical specifications, intended use, operational and monitoring requirements related to
contamination control. During Operational Qualification (OQ), critical alarms related to equipment and
utilities are tested against the URS to confirm their impact on product quality. All critical alarms are
documented during routine processing and evaluated for contamination or quality risks.
10..1.3 Operational Qualification (OQ):
 This stage verifies that the equipment operates correctly under normal conditions and meets all
operational specifications defined in the URS. Any deviations or alarms are investigated, documented,
and addressed to prevent adverse impacts on product quality.
10..1.4 Performance Qualification (PQ):
 PQ provides documented evidence that equipment performs reliably and consistently under specified
operating ranges and real process conditions. At least three replicate test runs are conducted under worst-
case scenarios to confirm reproducibility and consistency. In the event of failure to meet acceptance
criteria, thorough investigation and corrective actions are mandated, along with potential requalification
as per schedule.
10..2 Change Control and Documentation:
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 All equipment design information and qualification data are retained in the initial qualification package.
Any changes are managed through the site’s Quality Management System (QMS) as per SOP No.
KPL/SOP/CQ-002, ensuring updated documentation is maintained as part of the qualification records.

10..3 Maintenance Management:

 Planned maintenance requests are initiated by users and approved by operations after assessing potential
impact on area cleanliness and manufacturing activities. For unplanned maintenance, maintenance
breakdown are raised, and an impact assessment (if applicable) dictates the maintenance plan. Cleaning
and sanitization of all tools and spare parts are performed prior to entry into cleanrooms or aseptic zones.
Post-maintenance, the user department cleans the affected areas or equipment before returning them to
use as per SOP No. KPL2/SOP/EG-027 “Building Maintenance”.
10..4 Validated Cleaning Processes:
 Cleaning procedures for all equipment are validated as per Protocol No. KPL2/CVP/DI-001 (DPI
Section) and KPL2/CVP/OSD-001 (OSD Section) to remove residues or debris to predetermined
standards. This ensures surfaces are free from contaminants that might interfere with the effectiveness of
disinfectants. Standardized validated cleaning minimizes chemical, microbial, and particulate
contamination risks prior to disinfection.
10..5 Sterilization of Product Contact Parts:
 All direct product contact parts for aseptically manufactured products undergo validated sterilization
processes as per SOP No. KPL2/SOP/PD-061. Approved sterilization methods and validated cycles are
documented and strictly followed to ensure aseptic integrity.
10..6 Qualification and Periodic Maintenance:
 All manufacturing, processing, packing, and holding equipment are qualified prior to use (Ref. SOP
KPL2/SOP/QA-033). Equipment and utility systems are subject to routine preventive maintenance per
SOP No. KPL2/SOP/EG-018. Following maintenance, clearance for return to use is granted by
engineering and approved by the relevant user department.
10..7 Cleanroom and Clean Air Equipment Qualification:
10..7.1 Objective of Non-Viable Monitoring:
 Non-viable (particulate) monitoring is a critical component of the environmental monitoring (EM) program
in sterile manufacturing. It ensures that cleanrooms and clean air equipment—such as open Restricted
Access Barrier Systems (oRABs)—meet the specified cleanliness classifications required to protect sterile
products from particulate contamination.
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 Monitoring and control of non-viable particulates are essential to verify that manufacturing activities are
conducted within a controlled and qualified environment. The monitoring of Non Viable Particle Count is
done as per SOP NO. KPL2/SOP/PD-124.
10..7.2 Cleanroom Qualification and Zoning:
 All cleanroom areas, including those with Grade A (oRABS), Grade B, Grade C, and Grade D
classifications, are qualified and maintained as per GMP and ISO 14644-1 standards.
 Each manufacturing zone is supported by a dedicated Air Handling Unit (AHU), ensuring independent
control and preventing cross-contamination between areas.
 Environmental control parameters (airflow, temperature, RH, and differential pressure) are tailored to
meet the cleanliness requirements specific to each process zone.
10..7.3 Environmental States and Monitoring Scope:
 Non-viable particle monitoring is performed in both:
 “At rest” state – cleanroom is operational with equipment installed and operating, but without personnel
 “Operational” state – cleanroom is in normal production mode with personnel present and processing
ongoing
 Monitoring confirms compliance with the particle count limits for each grade of cleanroom, as per EU
GMP Annex 1 and ISO 14644-1.
10..7.4 Area wise limits for Non-viable particle counts:
 For Vial Line:
PARTICLES
AT REST IN OPERATION
GRADE
≤ 0.5µ ≤ 5.0 µ ≤ 0.5µ ≤ 5.0µ
Alarm Warning Alarm Warning Alarm Warning Alarm Warning
A 3,520 2000 20 16 3,520 2000 20 16
B 3,520 2000 29 23 3,52000 200000 2,900 1000
 For OSD Area:
PARTICLES
AT REST IN OPERATION
GRADE
≤ 0.5µ ≤ 0.5µ

D 3,520 3,52000

10..7.5 Monitoring Practices:

10..7.6 Compliance and Trending:

 Results from non-viable particle monitoring are:
 Documented and trended over time to detect early signs of environmental drift
 Investigated promptly in case of excursions beyond alert or action levels
 Used to support batch release decisions, ongoing process validation, and requalification schedules

10..8 Cleanroom and Clean Air Equipment Qualification:

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 The qualification of cleanrooms and clean air devices (e.g., LAF units, oRABs) is performed to
demonstrate that the classified environment consistently meets its intended level of control for the
manufacturing of sterile products.
 Qualification includes commissioning, installation, operational, and performance qualification
(IQ/OQ/PQ), with testing aligned to ISO 14644-1, EU GMP Annex 1, and site-specific standards.
10..8.1 Cleanroom Classification and Monitoring:
 Cleanroom classification is performed by measuring the concentration of airborne non-viable particles,
validating the assigned cleanroom grade (A, B, C, or D).
 Classification activities are pre-scheduled and controlled to avoid interference with production and to
ensure product and process integrity is maintained during testing.
 Classification and monitoring are carried out in both “at rest” and “in operation” conditions to confirm
environmental control under typical and worst-case scenarios.
10..8.2 Non-Viable Particle Counter (NVPC) System Management:
 All non-viable particle monitoring systems are qualified prior to use. This includes equipment used for both
routine monitoring and cleanroom classification.
 An SOP titled “Procedure for operation and cleaning of on-line and portable non- viable particle counter”
(KPL2/SOP/PD-124) governs the use, maintenance, and calibration of NVPC systems.
 The SOP ensures correct system setup, including:
 Use of tangle-free, uncompressed tubing
 Proper routing of sampling tubes to avoid bends or compression.
 The length of Sensor of OPC i.e. length of tube between Sensor to probe at location turn table, stoppering,
Filling B grade and cooling zone should not more than 1 meter.
 The length of Sensor of OPC i.e. length of tube between Sensors to probe at location filling in filling room
should not more than 2 meters.
 Strategic probe placement, ensuring accurate sampling at representative points near critical operations.
10..8.3 Rationale for Selection of Monitoring Locations:
 Sampling locations for routine monitoring and qualification are selected based on a risk-based rationale,
considering:
 Sterile component exposure risks
 Proximity to open product containers, critical machine parts, and primary packaging materials
 Personnel movement and operator interventions
10..8.4 Air Handling Unit (AHU) System Qualification:
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 The performance of each AHU system supporting cleanrooms is verified by conducting a series of critical
environmental and mechanical tests, including:
 Visual inspection of facility layout, material of construction, and surface condition
 Airflow velocity measurements and calculation of air changes per hour (ACPH)
 HEPA filter integrity testing (e.g., PAO testing)
 Measurement of temperature, relative humidity (RH), and differential pressure
 Viable and non-viable particulate monitoring
 Recovery time testing, confirming the area’s ability to return to acceptable particle levels after
contamination or intervention

10..8.5 Unidirectional Airflow Qualification:

 For clean air equipment like LAFs and oRABs, airflow velocity and direction are qualified to confirm
unidirectional airflow patterns that protect exposed product and components during aseptic operations.
 Air velocity is measured at defined points near working positions and critical exposure zones, ensuring
sufficient laminar flow to:
 Continuously sweep particles away from open product containers
 Protect critical zones during both “at rest” and “in operation” conditions
 Support high-risk operations such as aseptic filling, compounding, and equipment assembly.
10..8.6 Viable monitoring: -
 The cleanroom classification and environmental monitoring program is implemented in a phased and
systematic manner to ensure comprehensive control and validation of the manufacturing environment.
This approach facilitates clear understanding of the environmental monitoring philosophy and its
execution timeline.
Phase I: Design Phase
 A detailed risk assessment is conducted to evaluate contamination risks and to determine the total number
of environmental monitoring locations.
 Critical sites are identified and selected based on process flow, personnel movement, and potential
contamination sources.
 The aim is to design a monitoring strategy that adequately covers all critical points within the
manufacturing environment to ensure reliable and representative data collection.
Phase II: Execution Phase (Static and Dynamic Monitoring)
 During this phase, routine monitoring locations and frequencies are finalized based on scientific
rationale and operational justification.
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 Both static (at rest) and dynamic (in operation) conditions are considered to assess the
cleanroom’s performance under different operational states.
 Monitoring sites are strategically chosen to capture areas most susceptible to contamination,
considering process complexity, equipment layout, and personnel interventions.
Phase III: Routine Monitoring Phase
 This phase involves ongoing routine environmental monitoring as per the defined SOPs for each
area.
 The activities include sample collection, data recording, reporting, and documentation of
environmental parameters.
 Continuous trend analysis of collected data is performed to detect any deviations or excursions as
per SOP No. KPL2/SOP/QC-084 “Environment monitoring in Production areas, warehouse and
microbiology laboratory”.
 When excursions occur, appropriate investigations and corrective actions are initiated to maintain
process integrity and compliance.
Identification of Monitoring Locations:
 Locations for microbial monitoring are selected based on factors including:
 Microbial load attributed to personnel movement and activities, as humans are major
contamination sources.
 Microbial load influenced by process flow, material transfer, and equipment movement,
identifying areas where contamination is more likely.
 These sites provide meaningful and representative data, assuring that the manufacturing
environment maintains the required aseptic conditions.
Routine Environmental Monitoring Methods:
 Routine environmental monitoring encompasses multiple techniques to comprehensively assess
microbial and particulate contamination:
 Settle Plate Monitoring: Passive air sampling where agar plates are exposed to the environment to
capture settling airborne microorganisms.
 Active Air Sampling: Use of calibrated air samplers to draw a known volume of air through agar
media, enabling quantitative assessment of airborne microbial load.
 Surface Monitoring: Includes both
o Swab Sampling: Swabbing defined surface areas to detect microbial contamination
o RODAC (Replicate Organism Detection and Counting) Plates: Contact plates pressed
directly onto surfaces to capture microorganisms
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 Personnel Monitoring: Sampling of operators’ gloves, garments, and hands to assess microbial
contamination introduced via personnel.

 The maximum allowable microbial contamination level of the cleanrooms are determined,
qualified as a part of the cleanroom qualification and maintained throughout as follows. Selection
of viable monitoring is done based on risk assessment depending on criteria listed following table:

 The site strictly adheres to the periodic re-qualification procedures for cleanrooms as per SOP No.
KPL2/SOP/PD-033. In addition to scheduled periodic re-qualification, unscheduled re-
qualification is performed whenever major modifications or repairs are made to the cleanroom
infrastructure or HVAC systems to ensure continued compliance with regulatory standards and
operational requirements.
Re-Qualification Testing Scope:
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 During each re-qualification event, the following critical tests are conducted to verify that the
cleanroom environment and air handling systems continue to meet predefined acceptance criteria:
Integrity Test of Final Filters:
 Ensures that the terminal HEPA filters installed in the HVAC system are free from damage or
leaks that could compromise air quality.
 Performed using recognized aerosol challenge methods such as PAO (Polyalphaolefin).
Air Velocity Measurement:
 Measures the airflow velocity at specified points, particularly within Grade A zones and laminar
flow units.
 Confirms that airflow velocity is maintained within validated ranges to provide appropriate
unidirectional airflow for contamination control.
HEPA Filter Integrity Test:
 Confirms the physical and functional integrity of HEPA filters post-installation or maintenance.
 Detects any potential breaches or filter degradation that might allow particulate ingress.
Non-Viable Particle Count of HEPA Filters (as applicable):
 Monitors particulate levels downstream of HEPA filters to verify effective filtration.
 Conducted in critical locations to ensure compliance with cleanroom class specifications
Recovery Test:
 Evaluates the cleanroom’s ability to return to acceptable particle counts within a defined
timeframe after a disturbance (e.g., door opening, personnel movement).
 Demonstrates robustness of the air handling system and environmental control under operational
stresses.
The Frequency of the HVAC qualification/ requalification is:

S. No. Testing parameter Frequency

1. Air velocity and Air changes rate test Six months ± 1 month

2. HEPA Filter integrity test (PAO test) Six months ± 1 month

3. Non-viable Particle Count monitoring Six months ± 1 month

4. Air Flow Pattern Test Once in two year ± 1 month

Six months ± 1 month for Grade B

5. Recovery Test
Once a year ± 1 month for Grade C & D
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S. No. Testing parameter Frequency

6. Measurement of Differential Pressure Six months ± 1 month

7. Temperature and RH Monitoring Test Six months ± 1 month

8. Viable Particle Count Monitoring Six months ± 1 month

10..9 Equipments used in Dry Powder Injection Area.

Refer Appendix-I for List of Major equipments available in the dry powder Injection area.
10..10 Equipment in Oral Solid Dosage Area.
Refer Appendix-II for List of Major equipments available in the oral solid dosage area.
11.0 PERSONNEL:
 General:
Despite the implementation of robust facility design, validated systems, and detailed procedural controls, per -
sonnel remain the most critical and variable factor in contamination control. Human activity contributes signifi -
cantly to the microbial load in cleanrooms; therefore, strict personnel qualification, training, and behavior proto-
cols are essential to maintaining aseptic conditions and ensuring product sterility.
Appropriate Staffing and Qualifications:
The site ensures adequate staffing levels with appropriately qualified, trained, and experienced personnel in -
volved in the manufacturing and testing of sterile products.
 A minimum recruitment qualification criterion is defined and documented for all roles related to product
operations. Only candidates meeting these qualifications are considered for positions in manufacturing,
quality control, and related functions.
 Defined Roles and Responsibilities:
 Each individual has a clearly defined job role and responsibilities, outlined in job descriptions and area-
specific procedures.
 Personnel are empowered with appropriate authority to carry out their responsibilities in alignment with
quality and compliance expectations.
 Accountability and ownership are reinforced through performance evaluations, audit findings, and
continuous training programs.
 Training and Competency Development:
 All personnel undergo comprehensive training programs tailored to their respective job functions,
including manufacturing operations, cleanroom behavior, aseptic techniques, and Good Manufacturing
Practices (cGMP).
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 Initial training is followed by area-specific and task-specific training before individuals are authorized to
perform operations independently.
 Ongoing retraining and competency assessments are conducted at regular intervals and in response to
deviations, changes in procedures, or updated regulatory requirements.
 All trainings shall be conducted in accordance with SOP No. KPL2/SOP/QA-058.
 GMP Awareness and Aseptic Compliance:
 Personnel are trained on the principles of current Good Manufacturing Practices (cGMP), with a focus on
sterile product handling, contamination risks, and aseptic behavior annually.
 Continuous emphasis is placed on the criticality of human behavior in cleanrooms, including proper
gowning, controlled movements, adherence to entry/exit protocols, and minimizing interventions in Grade
A/B zones.
 All operations are conducted in alignment with approved SOPs, which incorporate GMP principles and
site-specific requirements for contamination control.
 Technology-Specific Expertise:
 Specialized training is provided for site-specific technologies and equipment used in sterile manufacturing
operations, ensuring compliance with global GMP standards relevant to aseptic processing.
 Personnel are familiarized with the risk controls integrated into equipment design, facility layout, and
environmental monitoring systems to reinforce contamination control strategies
 The training program includes the following:
11..1 Induction Training:
 Induction training covering company’s policies and general procedures like quality assurance procedures
and Good Manufacturing Practices, Good Documentation Practices, etc. is imparted to all employees at the
time of joining the company as per SOP No. KPL2/SOP/HR-005.
11..2 Identification of Training Needs and Job Specific / On Job Training:
 After completion of Induction training, the job specific / on job training needs shall be identified by
head/designee of the department based on job description. Based on identification of training needs the job
specific / on job training shall be provided to new inductees and evaluation to be done and documented as
per SOP No. KPL2/SOP/QA-058.
11..3 In house training and controls:
 Apart from on job specific training the In – house training shall be given to the employees in the relevant
Standard Operating Procedures, Technical topics and [Good manufacturing Practice] GMP topics. Its
effectiveness is evaluated on the basis of post training evaluation feedback. Additionally, the employees
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are sent for training to external training institutions, manufacturers of machinery and equipment whenever
necessary as per SOP No. KPL2/SOP/QA-058.
11..4 Personnel health and hygiene:
 Medical check-ups are conducted once in a year for all the employees. Employees involved in visual
inspection shall undergo eye examination every six months by company’s authorized doctor.
 To prevent contamination, street clothes are removed in to manufacturing premises and separate company
gowns/ uniform are provided to all employees. The gowning procedure is to be followed as per pictorial
diagrams displayed in the change rooms
 Wherever required clean sterile gowns shall be used for all critical areas. QC persons shall wear company
clean apron and shoes as displayed in the pictorial diagram available in the respective change rooms.
 All employees are responsible to report any symptoms like flu, sneezing, coughing, diarrhoea, any
communicable diseases, skin disease, and any lesions containing pus on hands, cuts, abrasions or burns.
Detail procedures are mentioned in SOP “Personnel Hygiene” KPL2/SOP/HR-002.
 Personnel involved in production activities are instructed to strictly adhere the personal hygiene norms
such as frequent hand washing, regular bath & clean clothes, and hand sanitizing. The canteen area is kept
clean before and after every break and proper sanitization is maintained. Eatable items are not allowed to
be stored in any lockers or inside the production/ QA/ QC/ warehouse areas. Smoking or chewing tobacco
is strictly prohibited in factory premises
11..5 Details of different training and relevant SOPs:
Reference Document
Type of Training
Title SOP No.
Induction training SOP for Induction Training of Employees KPL2/SOP/HR-005
General GMP-training Training Management KPL2/SOP/QA-058
Personal hygiene and safety in dry powder
KPL2/SOP/PD-053
injection area
Hygienic behavior
SOP for Personal Hygiene KPL2/SOP/HR-002
SOP for Medical Health Check-Up KPL2/SOP/HR-004
Procedure for gowning qualification of
Personnel Qualification KPL2/SOP/QC-089
personnel entering in aseptic area
 To ensure effective contamination control and compliance with Good Manufacturing Practices (GMP), all
personnel—including those involved in cleaning, maintenance, environmental monitoring, and routine
production activities—are trained, qualified, and experienced in the requirements of sterile product
manufacturing.
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11..6 Comprehensive Training Program:
 Every individual accessing cleanrooms or performing critical operations undergoes a structured training
program tailored to their role and responsibilities.
 Training includes both theoretical and practical modules covering:
o GMP and hygiene principles
o Microbial contamination risks and prevention
o Cleanroom classifications and behavioral discipline
o Aseptic techniques and intervention protocols
o Environmental monitoring practices
o Gowning procedures and contamination risk from personnel
11..7 Gowning Qualification and Requalification:
 Initial gowning qualification is mandatory prior to entry into classified areas. Personnel are assessed for their
ability to gown aseptically without contaminating the garments or environment.
 Requalification is conducted at defined intervals and in case of:
o Procedural updates
o Extended absence from cleanroom operations
o Observed non-compliance during operations
 Gowning assessments are documented and linked to personnel qualification records.
11..8 Special Focus for Grade A Access and Interventions:
 Personnel accessing Grade A or high-risk areas are provided with enhanced training on contamination control
and critical interventions.
 Topics include (but not limited to):
o Control of human-related contamination (skin flakes, respiratory particles, movement, etc.)
o Proper conduct during interventions under oRABs or LAF
o Minimizing disruption to unidirectional airflow
o Use of sterile tools and materials
 Only personnel certified for Grade A operations are permitted to perform direct interventions or handle open
sterile product.
11..9 Continuous Learning and Assessment:
 Regular refresher trainings ensure up-to-date knowledge of procedures and evolving regulatory expectations.
 Effectiveness of training is measured through written assessments, practical evaluations, and on-the-job
performance monitoring.
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 Training records are reviewed during audits and inspections to demonstrate compliance and personnel
readiness.
11..10 Details of training related SOPs on clean room:

Reference Document
Activity
Title SOP No.

SOP for Induction Training of

Induction training KPL2/SOP/HR-005
Employees

General GMP-training Training Management KPL2/SOP/QA-058

Personal hygiene and safety in dry

KPL2/SOP/PD-053
powder injection area
Hygienic behavior
SOP for Personal Hygiene KPL2/SOP/HR-002

SOP for Medical Health Check-Up KPL2/SOP/HR-004

Procedure for gowning qualification of

Personnel Qualification KPL2/SOP/QC-089
personnel entering in aseptic area
Procedure For Entry And Exit In Aseptic
Entry & Exit in Aseptic Area KPL2/SOP/PD-058
Area
Trends chart for Environmental
Personal Monitoring Report KPL2/SOP/QC-084-F14
monitoring
11..11 Personnel Training on Entry-Exit and Microbial Control:
All personnel receive comprehensive training on cleanroom entry and exit procedures, basics of microbiology,
personnel hygiene practices, and behavior within classified areas. Training content and frequency are tailored
to the criticality of the individual's job function and the cleanroom grade to which they have access. Training
needs are systematically identified and aligned with assigned job responsibilities to ensure ongoing
competency.
11..12 Gowning and Hand Hygiene Procedures:
Written procedures govern cleanroom gowning and handwashing to minimize contamination risks from
clothing and skin. Handwashing facilities providing both hot and cold water are installed in entry change
rooms. Use of 70% filtered isopropyl alcohol for hand sanitization during cleanroom entry is mandatory to
reduce microbial and particulate load.
11..13 Personal Hygiene Standards:
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Strict personal hygiene protocols, detailed in SOP No. KPL2/SOP/HR-002 “Personal Hygiene,” mandate
practices to prevent microbial contamination and excessive particle shedding. Personnel are trained to report
any health conditions, such as skin diseases, colds, communicable illnesses, cuts, or open lesions, which could
increase contamination risks. Affected personnel are restricted from cleanroom access until fully recovered,
safeguarding product and environment integrity.

11..14 Prohibited Items in Cleanroom Premises:

To maintain contamination control, non-essential personal items are strictly prohibited within manufacturing
and cleanroom areas and must be stored in designated personal lockers. Prohibited items include:
o Jewellery such as bracelets, rings, bangles, wristwatches, and ornaments
o Nail polish, cosmetics, perfumes, and deodorants
o Electronic devices including mobile phones, cameras
o Items like lighters and matchboxes
o Any eatables.
11..15 Cleanroom Garments:
Garments worn inside clean areas are made from non-shedding, non-absorbent, and antistatic materials
appropriate for the cleanroom grade and process requirements. Garments are designed and worn to prevent
contact with the floor or contaminated surfaces, thus protecting both the operator and product from
contamination. Garments undergo visual inspection for cleanliness and integrity before and after gowning,
facilitated by mirrors in changing areas. Sterile garments are labeled with sterilization cycle information, and
packaging integrity is verified prior to use. Reusable garments are sterilized and maintained for a maximum of
100 sterilization cycles to ensure continued performance and safety.
 Gowning Requirement:
11..1 Grade-B Area:
11..1.1 Gowning Provision with Autoclaved Coveralls (Grade B Cleanrooms):
Before personnel enter Grade B cleanrooms, autoclaved coveralls are provided as a mandatory gowning
provision to ensure contamination control. These garments undergo a strict sterilization process via
autoclaving to eliminate microbial contamination and are stored in a clean, controlled environment until use.
11..1.2 Garment Packaging and Wearing Technique:
The autoclaved garments are carefully packed and folded to allow operators to done the gowns without
touching the outer surface, thereby minimizing the risk of contamination transfer. This packing also prevents
the garment from accidentally contacting the floor during the gowning process.
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11..1.3 Pre-Gowning Hand Protection and Sanitization:
Prior to wearing the coverall, operators first don a pair of small, non-powdered rubber gloves. These gloves
are then sanitized thoroughly using 70% filtered isopropyl alcohol (IPA) to ensure that the hands are free of
contaminants before handling the sterile gown.
11..1.4 Gowning Methodology:
The coverall gown is worn starting from the top and progressing downward to reduce contact with any
external surfaces or the floor. Particular care is taken to tuck the flange of the headgear securely inside the
coverall to ensure that there are no exposed areas of skin or hair that could shed particles.
11..1.5 Integration of Garment Components:
The sleeves of the coverall are carefully tucked inside the booties (foot coverings) to create a continuous
protective barrier that prevents contaminants from escaping or entering. This overlapping design is crucial to
maintaining the integrity of the cleanroom gowning system.
11..1.6 Final Hand Protection and Sanitization:
After the coverall is fully donned, a second pair of sterilized, long gloves are worn over the initial rubber
gloves. These gloves extend up to the elbows and are sanitized thoroughly with 70% IPA, ensuring maximum
protection of the hands and forearms against contamination.
11..1.7 Garment Qualification and Performance Assessment:
The particle shedding and particle retention efficiency of the garments are assessed during the qualification
process. This ensures that the gowns effectively limit the release of particles into the cleanroom environment,
maintaining the high cleanliness standards required for sterile manufacturing.
11..1.8 Visual Aids and SOP Compliance:
The entire gowning procedure is documented in SOP No. KPL2/SOP/PD-058, which includes pictorial
diagrams to guide personnel through proper garment preparation and wearing techniques. This ensures
consistency and adherence to contamination control protocols.
11..2 Grade C Area:
11..2.1 Restricted Access Control at Grade C Area Entrance:
To ensure strict security and prevent unauthorized personnel from entering the Grade C area, biometric access
systems are installed at the entry points. This system uses unique physiological characteristics, such as
fingerprints or iris scans, to authenticate individuals, thereby enhancing the control and monitoring of access
and maintaining the integrity of the controlled environment.
11..2.2 Personal Protective Equipment (PPE) Protocol in Grade C Area:
Inside the Grade C area, stringent hygiene and contamination control measures are implemented. Personnel
must wear thoroughly cleaned and sanitized protective gear before entry. This includes:
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11..2.3 Headgear: Properly cleaned head coverings designed to prevent hair or skin particles from contaminating the
area.
11..2.4 Coveralls: Full-body suits that protect both the wearer and the environment by minimizing the risk of external
contamination.
11..2.5 Booties: Protective footwear covers that prevent the introduction of dirt or microbes from shoes.
Hand Hygiene and Glove Use:
 Hand hygiene is paramount in this controlled environment. Two pairs of gloves are worn to provide an
additional layer of protection. These gloves are sanitized using a solution of 70% Isopropyl Alcohol (IPA) that
has been filtered through a 0.22-micron filter to ensure the removal of any microbial contaminants. This
meticulous sanitization process ensures that gloves meet high standards of cleanliness.
11..2.6 Proper Gowning Technique:
 When donning the coverall, it is crucial to wear the gown in a manner that reduces the chance of
contamination. The gown is put on from top to bottom, carefully avoiding any unnecessary contact with
external surfaces or the floor, which could introduce contaminants.
 The headgear flange (the edge or rim of the head covering) is securely tucked inside the coverall. This ensures
that no skin or hair is exposed, maintaining a fully sealed protective barrier.
 Furthermore, the sleeves of the coverall are neatly tucked into the booties, creating a continuous barrier from
head to toe. This technique prevents any gaps where contaminants could enter or exit the protected
environment.
11..3 Grade D Area:
 According to the established SOP No. KPL2/SOP/PD-029 “Entry And Exit Procedure In Manufacturing
area of OSD” Section for entering and exiting the manufacturing department, all personnel must adhere to
strict hygiene and contamination control measures to maintain a clean and controlled environment.
 Upon entry, individuals are required to remove all outdoor clothing, including footwear, as well as any
personal belongings—except for their personal underwear. These items are then stored securely in designated
lockers provided for this purpose.
 Finally, personnel must don the factory-provided garments, which are designed to meet cleanliness and safety
standards within the manufacturing department.
11..4 Additional gowning details and controls:
Additional Gowning Controls
Gloves Appropriately sterilized, non-powdered, rubber Hand gloves used.
Goggles Sterilized after every usage
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 Following is the table illustrates different applicable procedures for gowning with respect to different
clean area:
Reference Document
Description
Title SOP No.
SOP for Entry and Exit in Plant KPL2/SOP/HR-001
Entry and Exit Procedure for Production Area KPL2/SOP/HR-012
Entry and Exit procedure for Washing Area KPL2/SOP/HR-015
Procedure for entry and exit Quality Control Department KPL2/SOP/QC-064
Entry Exit procedure for microbiology laboratory and microbiology
KPL2/SOP/QC-080
testing areas
Procedure For Entry & Exit In Tools Washing Room KPL2/SOP/WH-029
Gowning Procedure For Entry & Exit PPM I & PPM II Sampling &
KPL2/SOP/WH-030
requirements for the Dispensing Area
different clean room SOP For Entry And Exit In Dispensing/Sampling /Liquid Dispensing
KPL2/SOP/WH-013
grades are defined in Area In Warehouse
respective Entry Exit Procedure For Entry And Exit In Disinfectant Preparation Area KPL2/SOP/PD-054
SOP’s. Procedure For Entry And Exit In Vial Washing And Depyrogenation
KPL2/SOP/PD-055
Area
Procedure For Entry And Exit In Bung And Garment Washing Area KPL2/SOP/PD-056
Procedure For Entry And Exit In External Vial Washing Area KPL2/SOP/PD-057
Procedure For Entry And Exit In Aseptic Area KPL2/SOP/PD-058
Entry And Exit Procedure In Manufacturing area of OSD Section KPL2/SOP/PD-029
Entry And Exit Procedure For Filter Cleaning Room And Cleaned
KPL2/SOP/EG-035
Filter Room
11..5 CNC area Garments
11..5.1 Access Procedure:
 Before entering the CNC area, personnel press the push button to open the door. After unlocking, they should
push the door open using their elbow to maintain hygiene and avoid hand contact with surfaces.
11..5.2 Changing Out of Street Clothes:
 Upon entering the designated changing area personnel are required to remove their factory footwear, as well
as their street garments including trousers and shirts. All removed items should be placed neatly inside the
respective garment lockers provided within Change Room 1 for safe storage.
11..5.3 Donning CNC Area Garments:
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 Next, personnel should proceed to donning garments which are available in different sizes. These sets
typically include a cap (to cover hair), trousers, shirts, and shoes. The correct size should be selected from the
lockers and worn fully to maintain cleanliness and comply with the area’s hygiene standards.
11..6 Clean room Garments:
 Wearing Procedure:
 Before entering the aseptic (sterile) area, personnel must wear sterilized clean room garments over their
primary washed gowns. This two-layer gowning process ensures an additional barrier to contaminants,
maintaining the required sterile environment.
11..6.1 Cleaning and Maintenance:
 Clean room garments undergo a validated washing process designed specifically to eliminate any risk of
contamination, particularly for areas classified as D-grade (a controlled environment with specified
cleanliness). This validated process guarantees that the garments do not introduce particulates or
microorganisms into the cleanroom.
 The frequency for changing garments used in the filling area is strictly regulated. These garments are intended
for single-use only within this critical zone to minimize contamination risks. The exact timing and procedure
for garment changes are governed by the entry and exit Standard Operating Procedures (SOPs) established for
each controlled area, ensuring traceability and compliance.
11..6.2 Glove Hygiene and Garment Integrity:
 During operations, gloves are regularly disinfected using 70% filtered Isopropyl Alcohol (IPA) filtered
through a 0.22-micron filter, which ensures sterility without introducing particles. Both gloves and garments
must be changed immediately if they are damaged or compromised, as such damage increases the risk of
contamination and endangers product sterility.
11..6.3 Inspection and Damage Control:
 Improper handling or use of clean room garments can damage fibers, potentially leading to particle shedding
that contaminates the environment. To mitigate this risk, garments are visually inspected after washing and
before packaging for any signs of damage or uncleanliness.
 Any defects found—such as tears, stains, or loose components—are recorded, and affected garment sets are
discarded to maintain high standards of cleanliness and integrity.
 Garment management protocols also include rules on garment durability and the permitted number of
sterilization cycles a garment can undergo. This limit helps ensure that garments maintain their protective
qualities throughout their lifecycle.
11..6.4 Visual Inspection Criteria:
The following points summarize the key visual checks conducted during garment inspection:
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 Garments that have completed up to 100 sterilization cycles are monitored closely to avoid overuse.
 Inspection for damaged zippers, buttons, or drawstrings that could compromise the garment’s seal or integrity.
 Checking for loose fabric, tears, or frayed edges that might release particles.
 Identification of physical dirt or stains that are difficult or impossible to remove by washing, which could
harbor contaminants.

11..6.5 Documentation and SOPs:

 All garment management activities, including cleaning, inspection, usage cycles, and disposal, are
documented within specific Standard Operating Procedures. These SOPs provide clear guidelines to maintain
consistent garment quality and clean room safety standards across the facility.
 The list of procedures, which list the clean room clothing garment management processes.

Reference Document
Description Title No.
Personal hygiene and safety in dry Powder Injection
KPL2/SOP/PD-053
area

Procedure For Entry And Exit In Disinfectant

KPL2/SOP/PD-054
Preparation Area

Procedure For Entry And Exit In Vial Washing And

KPL2/SOP/PD-055
Material, quality, and design of Depyrogenation Area
clean room clothing is adequate for Procedure For Entry And Exit In Bung And Garment
KPL2/SOP/PD-056
the respective clean room Grade Washing Area

Procedure For Entry And Exit In External Vial

KPL2/SOP/PD-057
Washing Area
Procedure For Entry And Exit In Aseptic Area KPL2/SOP/PD-058
Procedure for gowning qualification of personnel
KPL2/SOP/QC-089
entering in aseptic area
Changing and replacement of Procedure For Preparation And Sterilization And
KPL2/SOP/PD-081
clean room clothing Handling Of Garments And Goggles
Procedure For Preparation And Sterilization And
Cleaning of clean room clothing KPL2/SOP/PD-081
Handling Of Garments And Goggles
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Reference Document
Description Title No.
Sterilization of clean room Procedure For Preparation And Sterilization And
KPL2/SOP/PD-081
clothing Handling Of Garments And Goggles
Procedure For Operation And Cleaning Of Closure
Validation of the sterilization KPL2/SOP/PD-061
Processing System Cum HPHV Steam Sterilizer
process
Procedure for Aseptic Process Simulation (Media fill) KPL2/SOP/QA-064

11..7 Training on Controlled Movements:

 All personnel working within the aseptic area receive comprehensive training on robotic, controlled, and
methodical movements. This training emphasizes minimizing excessive shedding of particles and
microorganisms caused by over-vigorous activity. Operators involved in aseptic operations are taught to
maintain strict adherence to aseptic practices and techniques at all times to preserve the sterile environment.
 Particular attention is given to minimizing disruptions in airflow patterns within the cleanroom. Movements
are designed to avoid altering air currents that could introduce lower-quality air into the critical zones. To
support this, movements adjacent to the critical zone are kept restricted, and care is taken to avoid obstructing
the path of unidirectional airflow (commonly known as "first air"). These protocols are validated and
monitored through airflow visualization (smoke) studies to ensure compliance and effectiveness.
11..8 Personnel Monitoring:
 Following SOPs describe the procedure for personnel monitoring:

Description Reference Document

Title No.
Procedure For Gowning Qualification of Personnel Entering
Procedure for Personnel KPL2/SOP/QC-089
In Aseptic Area
Monitoring
Environment Monitoring in production area & microbiology KPL2/SOP/QC-084
 Precautions as per Site Procedures (KPL2/SOP/PD-053):
The site follows the guidelines outlined in SOP No. KPL2/SOP/PD-053: Personal hygiene and
safety in dry Powder Injection area ", which provides detailed precautions to be observed during
manufacturing and filling in classified cleanroom areas, including:
1. Avoid coughing or sneezing within the aseptic area. If such an event is unavoidable, the
individual must leave the area immediately to prevent contamination.
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2. Disruption of the unidirectional airflow, particularly within the critical zones served by
Laminar Air Flow (LAF), is strictly prohibited, as it poses a significant risk to the sterility of
the product.
3. Avoid crowding inside the aseptic area to maintain optimal airflow and reduce contamination
risks.
4. If any operator is observed not properly gowning or following hooding procedures, they must
be immediately informed and guided to correct their gowning to maintain aseptic conditions.

12.0 UTILITIES:
 Water System:
12..1 Pre-Treatment System:
The pre-treatment phase is a critical step for preparing raw water to meet the quality requirements for
pharmaceutical use. The process flow is as follows:
o Borewell Water Source: Raw groundwater is extracted from a borewell.
o Sodium Hypochlorite (NaOCl) Dosing: Chlorination is performed to disinfect the water and
reduce microbial contamination.
o Sand Filter: This filtration removes suspended solids and particulate matter from the water.
o Sodium Metabisulfite (SMBS) Dosing: SMBS is added to reduce residual chlorine levels to
prevent damage to downstream equipment and maintain water quality.
o Water Softening: The water passes through a softener using a sodium-based ion exchange resin,
which removes hardness-causing minerals (calcium and magnesium ions).
o Soft Water Storage Tank: The softened water is collected in a storage tank for further processing
or usage.
12..2 Post Treatment system:
To produce Purified Water (PW) and Water for Injection (WFI), the soft water undergoes a rigorous post-
treatment process including:
o Anti-Scalant Treatment: Prevents scale formation in downstream membranes and equipment.
o pH Correction: To maintain the pH Sodium Hydroxide Dosing in place .
o SMBS Dosing: Continues to manage residual chlorine levels.
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o Reverse Osmosis (RO) Systems: Water passes through three RO units (ROH-101, ROH-201 &
ROH-202) to remove dissolved salts and impurities.
o Electro deionization (EDI): Further purifies water by removing ionized species without chemicals.
o Purified Water Storage Tank: The resulting purified water is stored for use in pharmaceutical
manufacturing processes.
o WFI and Pure Steam Generation: Further processing produces Water for Injection (WFI) and pure
steam, essential for sterile manufacturing environments.
12..3 Soft Water Generation and Storage:
Soft water is produced by treating potable water through the softener system, which removes hardness
minerals to prevent scale buildup in utility systems. Soft water is used primarily for non-potable
applications such as:
o Cooling towers.
o Boilers and other steam generation utilities.
o Soft water is stored in a storage tank, having a capacity of 2 X 3 KL.

Reference Document
Description
Title No.
Raw Water Specification KPL2/QC/RMS-3
Specification Procedure for Sampling and Analysis of
KPL2/SOP/QC-083
Different Grade of Water
 Purified Water:
12..1 Source, Generation & Storage:
o Raw water is drawn from the bore well through a pump at the rate of 10000 LPH.
o This raw water is chlorinated with 2 PPM Sodium hypochlorite solution before it is collected in
well-protected raw water storage tank (3000 L); from there it is pumped and transferred to the
pressure sand filter (PSF) at this stage suspended particles removed from the water and transferred to
the softener and softener is charged with help of NaCL solution.
o Softener is responsible for removal of the dissolved ions present in water. The hardness of the raw
water is reduced below 5 ppm after passing through softener units.
o The soft water is pumped to CSRO membrane (1st pass RO membrane i.e. chemical Sanitizable
Reverse Osmosis) where three dosing are carried out i.e. pH correction & anti-scalant dosing, and
Sodium Meta bisulphite (SMBS) transferred through high pressure pump to R.O. water storage tank
(1000 L) and then water is pumped to HSRO membrane 2nd.
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o The 2nd HSRO concentrate is split in to two streams, one goes to re-circulation pump suction and
other goes to drain and then water is collected in separate tank which is used for washroom/ lavatory
purpose then with help of high pressure pump water is transferred to the HSRO membrane or 2nd
Pass RO (Hot Water Sanitizable Reverse Osmosis) and then RO water is fed to the EDI (Electro de-
ionization) for further processing.
o The final purified water emanating from the EDI flows @ 1500 Ltrs per hour and collected in
purified water storage tank capacity 3000 Ltrs (01 Nos.) which is made of SS 316L stainless steel.
12..2 Distribution:
o Purified water is distributed to user points through loop system through UV treatment and return to
tank through online conductivity meter.
o Conductivity/TOC is continuously monitored for purified water distribution system & water is
drained in case of higher value of conductivity/TOC.
o Each user point is designed with zero dead leg diaphragm valves to keep the loop in continuous re-
circulation.
o The sanitization of purified water storage tank and distribution loop is performed as per SOP No.
KPL2/SOP/EG-010.
12..3 Flow and Pressure Design:
To maintain water quality, the distribution loop is designed to sustain turbulent flow conditions, which
discourage microbial growth and maintain system cleanliness. Key design parameters include:
12..4 Flow Velocity:
 Main loop velocity ranges NLT 1.2 m/sec to ensure turbulence.
12..5 Compliance and application:
 The purified water produced meets all specified chemical and microbiological quality limits as per
current United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards.
 The purified water is primarily utilized for:
o Cleaning of OSD equipments and Primary cleaning of critical equipments.
o Intermediate washing of primary containers such as vials, ensuring these components meet
cleanliness standards before use.
Reference Document
.Description
Title No.
Risk assessment for installation of Purified Water System in Beta
Risk Assessment KPA2/RA/23/004
Block
Specification Purified Water Specification KPL2/QC/RMS-2
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Reference Document
.Description
Title No.

Procedure for Sampling and Analysis of Different Grade of Water KPL2/SOP/QC-083

Preparation Operation And Monitoring of Purified Water Distribution Loop KPL2/SOP/EG-028
Distribution Operation And Monitoring of Purified Water Distribution Loop KPL2/SOP/EG-028
Monitoring Refer point no. 9.5
 Water For Injection (WFI):
12..1 Feed Source:
The water for injection in bulk is generated from purified water.
12..2 Generation:
 The purified water is stored in SS 316L tank of 3000 Liters capacity pass through feed pump to pre heater
then via Non-returnable valve pre-heated water goes to multicolumn (05 Nos. Columns) in multicolumn
temperature of purified water active up to 1200C then water with high temperature pass through the post
cooler.

12..3 Storage:
The final water for injection emanating from the post cooler and final flow of the generated water for
injection is 750 Ltrs per hour and collected in water for injection storage tank capacity 2000 Ltrs which is
made of SS 316L stainless steel.
12..4 Distribution:
Water for injection is distributed to user points through loop system and return to tank through online
conductivity meter. Conductivity/TOC is continuously monitored for water for injection distribution
system & water is drained in case of higher value of conductivity/TOC. Each user point is designed with
zero dead leg diaphragm valves to keep the loop in continuous re-circulation.
All the tanks used for storage of purified water and WFI including the distribution loop are made of SS
316L.
12..5 Sanitization:
The Sanitization of WFI storage tank and WFI distribution loop system is performed as per SOP No.
KPL2/SOP/EG-012.
12..6 Quality Compliance:
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The quality of both WFI and Pure Steam complies fully with the specifications outlined in the current
USP (United States Pharmacopeia) and EP (European Pharmacopoeia), including microbial limits,
conductivity, total organic carbon (TOC), and endotoxin levels.
12..7 Piping and Components:
 Distribution loops and storage tanks are fabricated from Stainless Steel 316 or better, using sanitary-grade
fittings and valves.
 Pipes are electro-polished to a finish of < 0.5 Ra, ensuring smooth internal surfaces to prevent microbial
adhesion
 Designed with zero dead legs and a minimum slope of 1:100, enabling complete drainage and
cleanability.
 All valves are diaphragm-type, constructed from SS 316 or better and extended spindles for improved
ease of handling and operator safety.
12..8 Flow & Pressure Design:
 Loop velocity is designed to maintain NMT 1.2m/sec, ensuring turbulent flow to reduce biofilm
formation.
 The return loop maintains a minimum velocity of 1.2 m/sec.
 Continuous Circulation at ≥ 80°C: WFI is maintained at a temperature of not less than 80°C throughout
the loop to inhibit microbial growth and maintain the integrity of the water quality.

12..9 Sanitization & maintenance:

Sanitization Procedures:
 RO-EDI System: Sanitized as per defined site SOPs using validated chemical and/or hot water
sanitization protocols.
 Purified Water System: The storage and distribution system is sanitized using hot water.
 WFI System: Sanitization is conducted using pure steam, ensuring complete microbial control
throughout the system
 Documentation:
 A comprehensive SOP is in place, outlining the operation, maintenance, and sanitization procedures for
all components of the water systems. This ensures compliance, traceability, and readiness for regulatory
audits.
 Applications of WFI:
 Water for Injection is used in critical operations, including:
 Final cleaning of equipment prior to sterilization
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 Final rinsing/washing of primary packaging materials, such as vials, to ensure sterility and absence of
contaminants.
 Manufacturing of sterile products, where the highest water quality is required to avoid any risk to product
integrity or patient safety.
Reference Document
Description
Title No.
Risk Assessment Risk assessment for installation of Water for Injection in Beta Block KPA2/RA/23/005
Water for Injection Specification KPL2/QC/RMS-1
Specification
Procedure for Sampling and Analysis of Different Grade of Water KPL2/SOP/QC-083
Preparation Operation and Monitoring of WFI Distribution Loop. KPL2/SOP/EG-029
Distribution Operation and Monitoring of WFI Distribution Loop. KPL2/SOP/EG-029
Monitoring Refer point no. 9.5
 Pure Steam:
 Pure Steam Generator is PLC controlled.
 The capacity of Pure Steam Generator (maximum quantity produced per hour) is 500 Kg/hour.
 The Pure Steam is supplied to the Autoclave.
 The Pure Steam quality is monitored by chemical and microbial testing including MLT & BET
periodically.

Reference Document
Description
Title No.
Pure Steam KPL2/QC/RMS-62
Specification Procedure for Sampling and Analysis of
KPL2/SOP/QC-083
Different Grade of Water
Preparation Operation Of Pure Steam Generator KPL2/SOP/EG-013

Distribution Operation Of Pure Steam Generator KPL2/SOP/EG-013

Monitoring Refer point no. 9.5

 Process Gases:
12..1 Utility Overview & Compliance:
The site utilizes filtered compressed air and nitrogen gas as critical utilities during the manufacturing
and packaging of sterile products. Both utilities are maintained to meet stringent chemical, particulate,
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and microbial quality specifications in accordance with the relevant Pharmacopoeial standards (e.g., USP,
Ph. Eur). This ensures that the gases do not compromise product quality or sterility.
12..2 Material of Construction:
All piping and components of the compressed air and nitrogen distribution systems are fabricated from
non-corrosive materials. This selection helps prevent contamination risks associated with corrosion by-
products and maintains system integrity over time.
12..3 Compressed Air:
 Compressed air is generated on-site using oil-free air compressors to eliminate the risk of oil
contamination.
 The compressed air is subsequently dried using air dryers and passed through filtration units ensuring
clean, dry air is supplied throughout the facility.
 Product-contact-compressed air (direct or indirect product contact).
 Compressed Air Generator is installed for generation of compressed air.
 The capacity of Air compressor is 101 CFM and 244 CFM sufficient as per the existing requirements.
The air quality is monitored by testing periodically.

Reference Document
Description
Title No.

Sampling And Microbiological Analysis Of

Specification KPL2/SOP/QC-115
Compressed Air And Nitrogen Gas
Sampling And Microbiological Analysis Of
Preparation KPL2/SOP/QC-115
Compressed Air And Nitrogen Gas
Operation and Filter Cleaning of Air Compressor
Distribution KPL2/SOP/EG-021
& Air Dryer
Sampling And Microbiological Analysis Of
Monitoring KPL2/SOP/QC-115
Compressed Air And Nitrogen Gas
12..4 Nitrogen:
 Nitrogen generator is installed for generation of Nitrogen. The capacity of Nitrogen generator is 3
Nm3/hour and 5 Nm3/hour. The air quality is monitored by testing periodically.
 Pure nitrogen is obtained by removing oxygen from air in two stages where nitrogen of purity of 99.99%
is obtained. This plant also has an oxygen analyser which is connected to an automatic dumping system
which operates when the oxygen content is more than1ppm.
 The Nitrogen is filtered through1.0 micron filter, followed by 0.1 micron at generation and 0.2 micron at
use a septic area user points.
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 The nitrogen supplied complies with USP-NF, European Pharmacopoeia (Ph. Eur), and Industrial
Hydrogen (IH) standards, ensuring pharmaceutical-grade quality.
 Final distribution piping for nitrogen gas is constructed using Stainless Steel 304 or 316, materials known
for excellent corrosion resistance and cleanliness.
 System Design and Operational Features
 The site has implemented dedicated valve systems at each user point for both compressed air and
nitrogen, allowing controlled and convenient access as needed.
 Both gas supply systems are powered by electric motor-driven compressors or pumps, operating under
high pressure to ensure adequate supply.
 Standby provisions are incorporated to maintain continuous uninterrupted flow, minimizing any
operational downtime or disturbance during critical manufacturing steps.
 Filtration and Integrity Testing.
 Both compressed air and nitrogen gases are filtered at the point of use through 0.22-micron filters,
effectively removing particulate and microbial contaminants.
 In manufacturing areas, especially where gases contact sterile products or critical equipment such as
compounding and holding vessels, hydrophobic filters are installed to prevent liquid ingress and
microbial contamination.
 These filters undergo regular integrity testing to ensure effectiveness and compliance with sterility
assurance requirements
 Nitrogen gas revalidation is done on yearly basis to cover the following test parameters:
Sr. No. Test
1. Dew Point,
2. Water content,
3. Oil mist
4. Carbon Dioxide,
5. Carbon Monoxide
6. Sulphur Dioxide
7. Nitrogen Oxide,
8. Nitrogen Di-Oxide,
9. Oxygen,
10. Hydrocarbon,
11. Non-Viable Particle count,
12. Viable Particle count
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Reference Document
Description
Title No.
Sampling And Microbiological Analysis Of
Specification KPL2/SOP/QC-115
Compressed Air And Nitrogen Gas

Storage Operation of Nitrogen Plant KPL2/SOP/EG-022

Sampling And Microbiological Analysis Of

Distribution KPL2/SOP/QC-115
Compressed Air And Nitrogen Gas
Sampling And Microbiological Analysis Of
Monitoring KPL2/SOP/QC-115
Compressed Air And Nitrogen Gas
12..5 Carbon Dioxide:
 There is no use of carbon dioxide in any product hence no risk of cross contamination
12..6 Oxygen:
 There is no requirement of any gas in any product processing hence no impact.
12..7 Further Gases:
 There are no other gas is used in the process hence no risk involved

13.0 RAW MATERIAL CONTROLS – INCLUDING IN-PROCESS CONTROLS

 Raw material controls:
 All raw materials are purchased from approved sources and that prior to use, it is approved by QC as
conforming to specifications. They are properly labeled with the name, code number and retest date.
They are stored under proper conditions.
 Dispensing of raw materials is carried out in a dedicated room in presence of representatives each from
production, QA and stores as per the standard operating procedures.
 During receipt of raw materials, the warehouse officer ensures that raw material is received in good and
intact condition from the approved vendor. The same is recorded for each consignment in "Checklist for
incoming Raw Materials”. In case of any discrepancy, it shall be informed to QA for necessary actions.
 To prevent external contamination during receipt of raw material, facilities like air curtains and
insectocutor are available at the raw material receiving area
13..1 Material receipt and initial inspection:
 Upon receipt, materials are verified to ensure they originate from an approved vendor and are
accompanied by relevant documentation including:
 All raw materials are TSE/BSE free and certificates of the same are available.
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 Material Safety Data Sheet (MSDS).
 Chemical & Microbial test is carried out for all raw materials.
 All raw materials are stored in temperature-controlled area and periodic temperature mapping is
carried out at defined time intervals as per the validation master plan.
 Residual solvent statements and any other pertinent documentation.
 Initial quality assessments are performed by reviewing the vendor CoA to confirm material
compliance before acceptance.
13..2 Sampling and testing:
 Sampling of raw materials kept in the quarantine area is carried out for each consignment received. After
satisfactory test results, “Approved” label is affixed on each container and all approved raw materials are
kept in separate “Approved” area in raw material store. Material is released for routine use only after
satisfactory test results.
 Dedicated sampling and dispensing tools are utilized for sampling and dispensing of raw materials to
prevent any possible cross-contamination
13..3 Sampling plan:
 A comprehensive, scientifically justified sampling plan is established for raw materials.
 For APIs, sampling is performed.
 The number of containers sampled and the quantity taken from each container are based on the sampling
SOP and applicable specifications, ensuring representative and compliant testing.
13..4 Storage Conditions:
 Raw materials and primary packaging materials are stored in their specified environmental conditions,
such as temperature and humidity controls, in tightly closed containers to prevent contamination or
degradation.
 Materials are never opened within the warehouse storage area to avoid contamination risks.
13..5 Supplier Qualification and Approval:
 Raw materials and packaging materials are procured exclusively from approved suppliers
 Suppliers undergo a thorough pre-assessment process which includes:
 On-site audits to verify compliance with current Good Manufacturing Practices (cGMP) and applicable
regulatory requirements
 Completion of a detailed vendor assessment checklist
 Verification of regulatory approvals and successful resolution of any audit observations
 Evaluation of Drug Master Files (DMF) when applicable, and assessment of their market reputation an d
presence.
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 Only after successful qualification and formal approval can procurement from the supplier begin.
 Supplier roles and responsibilities are clearly defined and documented within a Quality Agreement.
 Suppliers are subject to periodic re-evaluation based on predefined schedules, risk assessment results, or
triggered by specific events (for cause).
 APIs and excipients are securely stored in designated warehouses under appropriate conditions
13..6 Control samples and testing:
 Control samples are collected and stored separately under controlled conditions.
 Samples are analyzed according to the current version of the Standard testing procedure (STP) and
relevant specifications.
 When applicable, tests for microbiological contamination and endotoxin levels form part of the raw
material quality criteria.
13..7 Container variability test:
 For consignments comprising more than one container, a container variability test is performed
 Any components, containers, or closures that fail to meet the established specifications are rejected to
prevent their use in manufacturing operations

Raw Material (Starting Material) Reference Document

Controls Description
Title No.

Standard Operating procedure for

Preparation of Specification and Standard
Test specifications for each starting material
testing procedure of bulk/in-process, Raw KPL2/SOP/QC-001
are prepared and approved as per SOP.
Material, Finish Product and Packing
Material

SOP For Receipt And Storage Of Raw And KPL2/SOP/WH-002

Incoming goods' testing
Packing Materials
Sampling, Testing and Starting Material Procedure Of Sampling, Testing And KPL2/SOP/QC-011
release procedure Release of Raw Materials
 In-process controls:
13..1 Sampling and Testing responsibilities:
 Quality Assurance (QA) is responsible for the sampling of all in-process samples in accordance with the
plan defined within the batch record, protocol, product specifications, and established sampling plans.
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This is executed as per the SOP No. KPL2/SOP/QA-005 “Sampling procedure for In process and
Finished Product”
13..2 Scope of testing:
 Samples are collected at various critical stages of production and subjected to both chemical and
microbiological testing as applicable. The testing is guided by clearly defined acceptance criteria
specified in the product’s documentation to ensure that the intermediate product maintains reproducible
quality standards throughout manufacturing.
 Typical in process parameters monitored includes (But not limited to):
o Appearance: Visual clarity and color of the product at different stages
o pH: To ensure chemical stability and compliance with specification
o Assay: Quantitative measurement of active pharmaceutical ingredient (API) concentration to
confirm potency
o Bioburden (TAMC) testing: Total Aerobic Microbial Count on bulk solution before and after
filtration, where applicable, to monitor microbial contamination levels.
o Average Fill weight.
o Sterility testing.
o OSD section tests incudes hardness, Disintegration, Friability, Dissolution etc.
13..3 Compliance and Control:
 All tests are performed in accordance with the approved product specifications and validated methods,
ensuring that any deviation from acceptance criteria is identified and addressed promptly to maintain the
integrity of the manufacturing process and final product.
 There are procedures available for in-process checks, control and monitoring as below;

Reference Document
Description
Title No.
In-process sampling for : Sampling Procedure For In-Process And KPL2/SOP/QA-005
Sampling of sterile raw material, Finished Products
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Reference Document
Description
Title No.
Sampling of final blend sample,
Sampling of semi-finished (core tablets, coated
tablets, filled capsules & dry syrup) In process Controls and Checks For
Sampling of dry powder injections at filling and Tablets , Capsules, Dry Powder, Sachet KPL2/SOP/QA-006
sealing stage & Sampling of finished products of and Dry Injection
tablet, capsule, dry syrup and Dry Powder for
Injection.

Bioburden limits for the respective stages Microbial analysis of in process samples,
primary packing material and pre-sterilized KPL2/SOP/QC-104
items.
14.0 PRODUCT CONTAINERS & CLOSURES:
 Suppliers Qualification and procurement:
 All primary packing materials are procured from approved vendors only and each lot of container closures
is tested to ensure that it is meeting with predefined specifications.
 Suppliers undergo a comprehensive pre-qualification process that includes:
o A detailed vendor assessment checklist.
o On-site audits to verify compliance with current Good Manufacturing Practices (cGMP) and relevant
regulatory requirements.
o Confirmation of all necessary regulatory approvals
o Successful resolution of any audit observations
o Evaluation of supplier’s market presence and reputation.
 Procurement from a supplier is initiated only after formal approval.
 Supplier roles, responsibilities, and quality expectations are clearly defined within a Quality Agreement
 Suppliers are subjected to periodic re-evaluations based on a predefined schedule, risk assessments, or
triggered by specific incidents (for cause).
 Handling and control of packaging components:
 Detailed written procedures are in place for:
o Receiving of primary packaging materials
o Performing identification tests and other applicable quality control tests to ensure material conformity.
o Proper storage under specified conditions to prevent contamination or deterioration
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o Correct handling and dispensing of components and container/closure systems for drug substances.
 All activities follow standard operating procedures (SOPs) aligned with raw material control requirements
to maintain consistency and product safety.
 Importance of Container Closure Integrity (CCI)
 Packaging breaches can lead to significant product deterioration, including:
o Microbial contamination
o Exposure to atmosphere gases
o Moisture ingress (water vapor)
o Loss of solvents or product potency.
 Therefore, CCI is critical quality attribute throughout the lifecycle of the drug products (especially sterile)
 CCI is thoroughly evaluated during product development using
o Dye ingress tests.
o Microbial ingress methods.
 Container closure integrity testing in manufacturing:
 CCIT is an integral part of the manufacturing process to ensure packaging integrity of each batch
 Leak testing is performed using non-destructive methods in accordance with SOP No. KPL2/SOP/PD-
098
 This step guarantees that the container-closure system is free from defects that could compromise sterility
or product quality.
 Ongoing monitoring of CCI:
 CCIT is also conducted as part of finished product release testing and during stability studies
 These tests demonstrate the packaging’s ability to maintain integrity throughout the product’s shelf life or
expiration period.
 Ongoing integrity assurance helps prevent product contamination, ensuring patient safety and product
efficacy over time.
 Dispensing of primary packing materials are carried out only after satisfactory test results of primary
packing materials.
 After Filling and sealing, whole batch is inspected on vial inspection machine or through qualified visual
inspector depending on the products
 Accelerated and long term stability study has been performed for all products packed with above
mentioned primary packing materials and results of the same found satisfactory.
 BET test is carried out for primary packing materials like glass vials, and rubber stoppers to ensure that it
is within the limit. All vials are undergone through depyrogenation tunnel before filling to ensure that
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there will be no microbial and BET contamination. In addition, sterility and BET tests are carried out for
each manufactured batch and batch is released only after satisfactory test results.

Reference Document
Description
Title No.
USP Type 1 & 3 Glass vials used as container for all products. Specification
Container Type - Specification
for each vials size is available along with testing method.
Ready to Use/Ready to sterilized/Ready to washing and sterilized
Bromobutyl rubber stoppers used along with flip of Aluminium seals.
Closure Type - Specification
Specification for each type of rubber stoppers and seal caps is available along
with testing method.
Container System Qualification Aseptic process simulation KPL2/SOP/QA-064
Testing of media filled vials for container
Container Closure Integrity Testing KPL2/SOP/QC-097
closure integrity by microbial ingression.
In process Controls and Checks For
Routine tests for container closure
Tablets , Capsules, Dry Powder, Sachet KPL2/SOP/QA-006
integrity
and Dry Injection
Extractable and leachable documents are available for Primary Packing
Extractable & Leachable
Materials which are in direct product contact.
15.0 VENDOR APPROVAL:
 Scope of Vendor Qualification:
 All manufacturers, suppliers, and service providers are considered vendors. This includes:
o Suppliers of raw materials and packaging materials.
o Any other equipment.
 General Process
 Vendor qualification is a structured evaluation process designed to assess whether a vendor meets the
organization’s quality, regulatory, and operational expectations
 All materials used in the manufacture of drug substances and drug products, including raw materials and
primary, secondary, and tertiary packaging materials, must be sourced from qualified and approved
vendors only.
 Suppliers of critical starting materials, packing materials, and excipients are assessed based on the vendor
evaluation program, which consists detailed questionnaire and self-audit check list along with technical
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data package as per the vendor qualification procedure, and sample evaluation followed by site audits as
per reference SOP of Vendor Management Program KPL/SOP/CQ-008 with includes:
o New vendor qualification
o Periodic requalification
o Disqualification of vendor
o Reinstatement of disqualified vendors.
 Vendor qualification requirements are also applicable to miscellaneous materials that come into direct or
indirect product contact during manufacturing or packaging. This ensures that every material impacting
the product maintains a defined quality standard.
 Analysis of all starting materials, in process and the finished products are carried out at the site by our
own quality control laboratory.
 However, in case of any instrumental breakdown/maintenance or non-availability of any reference
standard and/or impurity standard at our own facility, analytical services of the following external
approved analytical laboratories are utilized. In case of Bioassay and Toxicity Analysis samples, samples
of several tests requiring sophisticated instrumentation techniques are sent to Outside Laboratory.
 Company uses outside expertise for Medical Test, Pest & rodent control, calibrations and Validation of
Instruments and Equipment’s with critical measuring, HVAC Validation and need based training. List of
contract agencies including the addresses and contact information, available in SMF. All the mentioned
Contract laboratories are qualified as per respective procedures.
 Periodic Requalification:
 All approved vendors are subject to periodic requalification based on predefined frequencies, risk
assessments, or specific triggers. This helps ensure continued compliance and performance reliability.
 Refer Appendix-III for Approved Vendor List of Raw materials, Primary Packing Material and
Secondary Packing Material.

Reference Document
Description
Title No.
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Vendor / Supplier Qualification process,

Vendor Management Program KPL/SOP/CQ-008
its evaluation and auditing

List of contract laboratories & Services

Site Master File KPL2/QA/SMF-1
Agencies

 Outsource Services:
 A comprehensive procedure as per SOP No. KPL2/SOP/QA-081 is established at the site. This outlines
the review, approval, qualification, and periodic evaluation processes for various outsourced GMP-
related services. This applies to a wide range of service providers including, but not limited to:
o External calibration and qualification agencies
o Pest & rodent control service providers.
o Any other GMP service providers.
 All such vendors are subject to evaluation, risk assessment, and approval prior to engagement in GMP
operations.
 Pest and Rodent control:
 A dedicated SOP (KPL2/SOP/HR-007) is in place, which governs the procedures and frequency
for pest management activities. Key points include:
o Pest control is outsourced to an approved third-party agency.
o The frequency and type of pest control activities are defined in the SOP (e.g., fogging,
spraying, baiting).
o Rodent boxes are strategically installed at pre-defined locations as per the approved Pest
Control Layout.
o All pest control activities are documented by HR and reviewed by the QA department
The impacted SOPs are as follows:
SOP No. Title
KPL2/SOP/HR-007 Procedure for Rodent and Pest control
KPL2/SOP/QA-081 SOP for Calibration of Equipment/ Instruments From Outside Agency
KPL2/SOP/QA-080 Assessment of Contract Analytical Laboratory For Qualification

 PROCESS RISK ASSESSMENT:

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 Quality risk management is a systematic process for the assessment, control, communication and review
of risks to the quality of the drug (medicinal) product across the product lifecycle.
 The Risk Management is to identify different risks pertaining to the product/specific
process/system/equipment/instrument to evaluate the impact of the risk on the quality of the product and
to take appropriate corrective and preventive actions for the management of the risk
 Standard Operating Procedure for Quality Risk Management (KPL2/SOP/QA-017) is in place
 For any risk related to System / Equipment / Instrument / Change Control / Deviation / Out of
Specification / Market Complaint / Product Recall / Facility / Material / Product / Process / OOS /
CAPA / major or critical non-conformance issued by regulatory authority to vendor contract laboratory /
Environment Monitoring/ Stability testing/ Distribution / Technology Transfer / Computer System /
Utilities / Self-inspection / etc., risk assessment shall be carried out as per SOP.
A typical Risk Management process consists of the following steps:
 Risk Assessment.
 Risk/ Hazard Identification.
 Risk Analysis.
 Risk Evaluation.
 Risk Control.
 Risk Mitigation/ Reduction .
 Risk Acceptance.
 Result / Outcome of Risk Management of Process.
 Risk Review.
QRM Framework:
 The site maintains a documented SOP on Quality Risk Management (KPL2/SOP/QA-017) which defines
a systematic, scientific approach to facilitate and improve decision-making related to quality risks.
 QRM is integrated into the overall Quality Management System and follows a continuous improvement
cycle composed of four key steps:
o Risk Assessment – Identification and evaluation of potential hazards and their impact
o Risk Control – Implementation of measures to mitigate identified risks.
o Risk Review – Periodic reassessment of risk status and effectiveness of controls.
o Risk Communication – Transparent sharing of risk information among relevant
stakeholders
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 The Risk assessment shall be made for Quality management, Development; Facility, equipment and
utilities, Material Management, Production, Laboratory control and stability testing, and computer and
Packaging.
 A cross-functional team of knowledgeable members shall be formed by the concerned department head to
discuss and evaluate the different aspects of risk. FMEA tool shall be used for risk assessment. This
includes Raw material, packaging material, testing procedure, Storage and distribution conditions,
Production process, Validation, Laboratory Control, Stability studies, Packaging, and labeling.
Application of QRM in site operations:
 Comprehensive risk assessments have been performed and documented for all critical operations
influencing product quality, including but not limited to:
o Manufacturing
o Filling and packaging
o Cleaning and sanitization
o Decontamination
o Sterilization
The effectiveness of these risk management activities and the implementation status of associated mitigation plans are
regularly reviewed through periodic management reviews and quality meetings to ensure continuous improvement .
 Refer Appendix-IV for List of Risk Assessment.
Reference Document
Description
Title No.
The concept of QRM is implemen-
ted throughout the organization Risk Management System KPL2/SOP/QA-017
(SOP)

 Validation and Qualification:

 Process validation & Qualification are carried out to establish that the process is under control and to
determine the process variables and acceptable limits for these variables and set up appropriate in-process
controls
 Validation is conducted for each product to assure the process established provides reproducible quality
output, consistently meeting pre-determSined specification. Following validated process assures to
deliver products where product inherent properties are uncompromised and product is with adequate
containment controls.
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 Process Validation is an integral part of the quality system in that all products prior to commercial launch
are subjected to a comprehensive validation. Three consecutive batches of a given strength are selected
unless otherwise justified. Where appropriate bracketing technique may be adopted. Manufacturing of the
process validation batches is preceded by a protocol that is approved by quality unit.
 SOP No. KPL2/SOP/QA-009 are in place for process validation and SOP No. KPL2/SOP/QA-033 for
Equipment qualification. Process revalidation shall be carried out for,
 Change in Batch Size.
 Change in Manufacturing site.
 Change in major equipment or major part of equipment impacting product quality.
 Change in Manufacturing formula.
 If any change in regulatory requirements.
 Change API source.
 As per review recommendation in APQR.
 The Process Validation activities are bifurcated in 3 stages i.e.
The commercial manufacturing process is defined during this stage
Stage – I Process Design
based on knowledge gained through development and scale-up activities
During this stage, the process design is evaluated to determine if the
Stage – II Process Qualification
process is capable of reproducible commercial manufacturing.
Continued Process Ongoing assurance is gained during routine production that the process
Stage– III
Verification remains in a state of control
 Qualification is the planning, carrying out and recording of tests on equipment and Systems, which form
part of the validated process, to demonstrate that it will perform as intended
Design Qualification
Installation Qualification
Qualification of Equipment Operational Qualification
Performance Qualification
Routine Re-Qualification
 Standard Operating Procedures (SOP No. KPL2/SOP/QA-064) for aseptic process simulation (media
fill) study is in place and periodic media fill validation is carried out as per defined schedule in validation
master plan.
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Reference Document
Description
Title No.

Process Validation KPL2/SOP/QA-009

The concept of Validation is

Cleaning Validation KPL2/SOP/QA-010
described in SOP

Qualification of Facility, Equipments And System KPL2/SOP/QA-033

The concept of continuous process

Process Validation KPL2/SOP/QA-009
verification is described in SOP
Aseptic process simulation is Procedure for Aseptic Process Simulation (Media
KPL2/SOP/QA-064
performed according to SOP fill)
 Refer Point No. 9.4 for more details.
 Refer Appendix-V for List of validation protocol and reports.
 Validation of sterilization process:
 Sterilization process validation is a critical part of ensuring that injectable pharmaceuticals are free from
viable microorganisms and safe for patient use. Validation involves proving that the sterilization method
reliably achieves the required Sterility Assurance Level (SAL), typically 10 ⁻⁶, without compromising the
quality or efficacy of the drug product
Component Sterilization (Before Batch Activity):
 Prior to the start of each manufacturing batch, all critical components such as closures (Rubber stoppers
and seals), tubing, and other equipment parts that come into contact with the drug product are sterilized
using validated sterilization methods (e.g., moist heat sterilization, autoclaving). This ensures that all
materials entering the production process are sterile, minimizing the risk of contamination from the
outset. Sterilization cycles for components are qualified, monitored, and documented to confirm
effectiveness.
Common sterilization Methods:
 Moist Heat Sterilization (Autoclaving): Uses saturated steam under pressure to inactivate
microorganisms.
 Dry Heat Sterilization: Used for depyrogenation and sterilization of heat-stable components through
depyrogenation tunnel.
 Validation Process includes:
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 Our facility follows a comprehensive and robust sterilization validation program to ensure consistent
product safety and efficacy for injectable pharmaceuticals. The following key activities are implemented
as part of the validation process:
 Defining Critical Parameters: At our plant, critical sterilization parameters such as temperature,
pressure, exposure time, are clearly defined, monitored, and controlled as per validated limits.
 Biological Indicators (BIs): We routinely use standardized biological indicators with known spore
preparations in sterilization cycles to confirm effective microbial inactivation. These indicators are
integral to every validation cycle.
 Physical and Chemical Monitoring: Our sterilization cycles are continuously monitored using
calibrated thermocouples, pressure gauges, and chemical indicators. These instruments ensure that all
critical parameters meet or exceed defined acceptance criteria during every run
 Load Configuration Qualification: Our facility conducts load configuration validation for sterilizers to
verify uniform sterilization throughout the entire chamber. This qualification is performed during initial
validation and repeated periodically to maintain assurance.
 Process Validation Runs: We perform multiple consecutive sterilization cycles under validated
conditions to demonstrate reproducibility and consistency of the sterilization process. These process
validation runs are documented and reviewed as per regulatory requirements.
 Ongoing Monitoring: Our plant has a stringent program for periodic re-validation and in-process control
monitoring of sterilization processes to ensure sustained performance and compliance with product
specifications throughout production through the PVP.
 Documentation: Comprehensive validation protocols and reports must be maintained, including
acceptance criteria, methods, results, deviations, and corrective actions
Description Reference Document
Title No.
The concept of SV is de- Procedure For Operation And Cleaning Of Closure
KPL2/SOP/PD-061
scribed in SOP or VMP Processing System Cum HPHV Steam Sterilizer
Procedure For Operation And Cleaning of Sterilizing And
KPL2/SOP/PD-074
Dehydrogenating Tunnel
Validation Master Plan KPL2/QA/VMP-1
The concept of continuous
process verification or re-valida-
Validation Master Plan KPL2/QA/VMP-1
tion of sterilization processes is
described in SOP or VMP
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Description Reference Document
Title No.
SV-reports for sterilization pro- Performance Qualification Protocol For Closure Processing
KPA2/PQR-010
cesses System Cum HPHV (Autoclave) Installed In DPI Section
Performance Qualification Protocol For Sterilization And
KPA2/PQR-016
Depyrogenation Tunnel Installed In DPI Section

 Preventive Maintenance:
 Maintaining equipment, utilities, and premises (planned and unplanned maintenance) to a standard that
will ensure there is no additional risk of contamination.
 Standard operating procedures are available for preventive maintenance of each processing equipment.
 SOP for preventive maintenance is identified at the qualification stage of the respective equipment
 Preventive maintenance of equipment is carried out as per planned preventive maintenance planner
prepared as per standard operating procedures (SOP No. KPL2/SOP/EG-018). The maintenance plan
includes a list of all equipment along with the frequency of maintenance tasks, identifies the highest-
risk equipment, and prioritizes their maintenance activities accordingly.
 Equipment wise PM checklist’s available to perform maintenance to individual equipment’s.
Preventive maintenance planner are to be prepared at the start of every calendar year for better tracking
and traceability of PM activity throughout the year.
 Adequate training is provided to maintenance personnel to ensure they are competent in performing
preventative maintenance tasks effectively. Training includes proper handling of equipment, adherence
to SOPs, and safety procedures
 Detailed records of all preventative maintenance activities are maintained including inspection
findings, maintenance performed, and any corrective actions taken.
Reference Document
Description
Title No.

Preventive Maintenance Of Equipment’s In Plant KPL2/SOP/EG-018

SOP for Maintenance
Breakdown Maintenance & History Log For
(Planned and KPL2/SOP/EG-026
Machineries, Equipment’s and Instruments
Unplanned)
Building Maintenance KPL2/SOP/EG-027
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 Cleaning and Disinfection:
 The disinfection process is a critical control measure that ensures the manufacturing environment
maintains a low bioburden level, thereby safeguarding the quality and sterility of the final product.
 Recognizing the crucial role of cleanroom hygiene, the site has established a comprehensive written
cleaning, disinfection, and sanitization program that covers both classified (cleanrooms) and non-
classified areas. This program aims to prevent microbial contamination as well as particulate buildup.
 The cleaning procedure is strategically designed to precede disinfection, ensuring that surfaces are free
from visible dirt and organic matter, which enhances the effectiveness of subsequent disinfectants.
 All cleaning processes undergo validation, confirming their ability to consistently remove surface
contaminants within predefined limits and meet established quality standards.
 To minimize the risk of microbial resistance, the site employs a rotational use of disinfecting agents
with differing modes of action. This rotation includes the periodic use of a sporicidal agent to
effectively target resilient bacterial spores and fungi.
 The disinfection program’s effectiveness is regularly assessed through routine environmental
monitoring. This includes detecting any shifts in the microbial flora—especially the emergence of
microorganisms resistant to the current disinfectants—allowing timely adjustments to the cleaning
regimen.
 In alignment with the site’s SOP No. KPL2/SOP/PD-062 “Procedure For Cleaning And Sanitization Of
Dry Powder Injection Area”, the cleaning program for classified areas utilizes four categories of
disinfectant solutions, each selected for its distinct mode of action, thus enhancing overall
antimicrobial efficacy and preventing microbial resistance development.
 Cleaning procedures for manufacturing equipment’s are well defined and are monitored.
 Procedure for preparation and handling of the sanitation solution is defined and record for preparation
is maintained. Sanitizing solution used for maintaining the area is rotated as per schedule
 Developed and validated cleaning procedures for each piece of equipment is available to ensure
effective removal of residues and contaminants. Implemented a routine cleaning and disinfection
schedule based on the criticality of the equipment. Validated disinfectants used that are effective
against a broad spectrum of microorganisms.
 All the critical areas are identified and based on the need the frequency of cleaning is schedule to daily/
weekly/ fortnightly/ monthly. The various validated disinfectants are used in rotation. 70%IPA solution
are used for hand disinfectant in the primary change rooms and unclassified areas.
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List of Disinfectants
Sr. Recommended Spectrum of
Disinfectant Active Ingredients Purpose
No. Concentration activity

20% Bactericidal, Fogging

Hydrogen peroxide -12% fungicidal
1 Imagard HD
Silver Nitrate -0.01 % 10% and Mopping
sporicidal
Didecyl dimethyl ammonium Bactericidal,
Imagard chloride: 10.0% fungicidal
2 1.0% Mopping
Biquat Polyhexamethylene biguanide: and
3.0% sporicidal
Didecyl dimethyl ammonium Bactericidal,
Imagard ID chloride: 8.70% fungicidal
3 0.4% Mopping
401 Alkyl dimethyl benzyl ammonium and
chloride: 8.19% sporicidal
Hand and
5 IPA Iso propyl alcohol 70% V/V Bactericidal surface
disinfectant
 Disinfectant Efficacy Testing (DET):
The site has established a rigorous Disinfectant Efficacy Test (DET) protocol (KPL2/QC/MSP-040) for
all disinfectants used within the facility. This testing validates the antimicrobial effectiveness of each
disinfectant against target organisms. DET studies have been performed on disinfectants applied to
various Materials of Construction (MOCs), including Stainless Steel (SS), Polyvinyl Chloride (PVC),
Glass, and others, ensuring suitability and efficacy across all relevant surfaces.
 Validation of Disinfection Process:
The disinfection process itself has been validated through detailed DET study reports that demonstrate
the ability of disinfectants to reduce or eliminate microbial contamination on different surface types,
confirming the robustness of the cleaning and disinfection program.
 Environmental Monitoring Trend Analysis:
An SOP No. KPL2/SOP/QC-084 dedicated to Trend Analysis is implemented to systematically analyze
environmental monitoring data from classified areas. The trend reports enable proactive identification of
potential cleanliness issues or deteriorations in environmental quality, thereby supporting continuous
improvement of cleaning and disinfection practices.
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 Preparation and Filtration of Disinfectants:
To maintain the highest quality standards, disinfectants used specifically in Grade A areas and
surrounding Grade C zones are subjected to 0.2-micron filtration prior to use. The preparation and
dilution of these disinfectants follow a controlled procedure as per SOP No. KPL2/SOP/PD-060
“Procedure For Disinfectant Preparation, Filtration, Distribution In Dry Powder Injection”. This
process takes place in a Grade C environment to minimize contamination risks during preparation
 Filtration Integrity and Sterility Assurance:
Filtration is conducted using validated 0.2 μm filters. To ensure filter integrity and sterility of the
disinfectant solution, Bubble Point Testing (BPT) is performed both before and after filtration. This test
verifies the filter’s intactness and its ability to retain microorganisms. Post-filtration, disinfectants are
stored in containers that are pre-cleaned and sterilized as applicable. The disinfectants are used within a
validated hold time, ensuring their effectiveness and preventing degradation or contamination over
storage periods.
 The method for area cleaning, sanitization and fogging defined in standard operating
procedures.
 The cleaning of critical area is done in a sequence from more critical area to less critical area.
The three bucket trolley system cleaning is followed for the cleaning of the aseptic area and
other area, the three buckets are designed to pour the scheduled disinfectant in the two of the
three buckets and one bucket is kept empty to squeeze the disinfectant to ensure the mop is free
from any types of remnants of dirty residues. The cleaning is such that the cleaning is done with
lint free mops, the cleaning procedure is described in the SOPs.

Reference Document
Description
Title No.
Procedure of the area Cleaning and sanitation of production area KPL2/SOP/PD-023
cleaning and sanitization
SOP for cleaning and sanitization of drainage system in
KPL2/SOP/PD-043
production area
Procedure for cleaning and disinfectant solution
KPL2/SOP/PD-044
preparation
Procedure for disinfectant preparation, filtration,
KPL2/SOP/PD-060
distribution In dry powder injection
Procedure For Cleaning And Sanitization Of Dry KPL2/SOP/PD-062
Powder Injection Area
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Reference Document
Description
Title No.
Procedure For Cleaning And Resuming Aseptic Area
KPL2/SOP/PD-089
After Maintenance Activities And Media Fill

SOP For Cleaning And Sanitization Of Warehouse KPL2/SOP/WH-006

SOP for Cleaning procedure except processing area KPL2/SOP/HR-006

Cleaning of Quality Control KPL2/SOP/QC-036

Procedure for Fogging in OSD area KPL2/SOP/PD-042

Procedure For Fogging In DPI Area KPL2/SOP/PD-063

Operation and cleaning of fogging machine KPL2/SOP/QC-090

Procedure for Fogging in Warehouse Area KPL2/SOP/WH-032

Decontamination and Neutralization procedure in beta-

KPL2/SOP/QA-060
lactam facility
 Equipment Cleaning:
The Equipment cleaning is performed as per following SOPs:
Reference Document
Equipment Type Activity
Title Title
Operation and Cleaning of Rapid Mixer
Cleaning KPL2/SOP/PD-004
Rapid Mixer Granulator with co-mill
Granulator Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Cleaning Operation and Cleaning of Fluid Bed Dryer KPL2/SOP/PD-003
Fluid Bed Dryer Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Cleaning Operation and Cleaning of Vibro Sifter KPL2/SOP/PD-001
Vibro Sifter Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Multimill Cleaning Operation and Cleaning of Multi Mill KPL2/SOP/PD-002
Disinfection Procedure for cleaning and disinfectant KPL2/SOP/PD-044
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Reference Document
Equipment Type Activity
Title Title
solution preparation
Octagonal Blender Cleaning Operation and Cleaning of Octagonal Blender KPL2/SOP/PD-005
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Compression Operation and Cleaning of Compression
Cleaning KPL2/SOP/PD-040
Machine (Make Saimach)
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Metal Detector Cleaning Operation and Cleaning of Metal Detector KPL2/SOP/PD-007
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
De-Duster Machine Operation and Cleaning of Tablet De dusting
Cleaning KPL2/SOP/PD-008
Machine
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Autocoater Cleaning Operation and Cleaning of Auto coater KPL2/SOP/PD-011
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
VTD Operation and Cleaning of Vacuum Tray
Cleaning KPL2/SOP/PD-012
Dryer
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Operation and Cleaning of visual inspection
Cleaning KPL2/SOP/PD-108
machine
Inspection machine
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation

Blister Packing Operation and Cleaning of Blister Packing

Cleaning KPL2/SOP/PD-017
machine (BQS) Machine (ACG-PAM BQS)
Disinfection Procedure for cleaning and disinfectant KPL2/SOP/PD-044
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Reference Document
Equipment Type Activity
Title Title
solution preparation
Strip Packing SOP for Operation and cleaning of Strip pack
Cleaning KPL2/SOP/PD-016
Machine machine
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Capsule filling SOP for Operation of Automatic Capsule
Cleaning KPL2/SOP/PD-013
machine Filling Machine A120
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Automatic Rotary SOP for Operation and Cleaning of dry syrup
Cleaning KPL2/SOP/PD-015
Volumetric Dry filling and sealing Machine
Syrup Filling With
Pick And Place Type Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
Screw Capping solution preparation
Machine
Powder Wheel
Piston
Procedure for cleaning, storage and
Secondary Hopper Cleaning KPL2/SOP/PD-070
sterilization of filling machine parts
Assembly
Primary Hopper
Assembly
Butterfly Valve
Silicone Gasket for
butter fly valve
Procedure for cleaning and disinfectant
Rubber stopper Disinfection KPL2/SOP/PD-044
solution preparation
hopper
Rubber stopper chute
Nitrogen Purging
Needles
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Reference Document
Equipment Type Activity
Title Title

Cleaning Procedure for utensil cleaning KPL2/SOP/PD-064

SS Container,
Spatula & Scoop Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation

Procedure for operation and cleaning of

Cleaning KPL2/SOP/PD-095
double cone blender in DPI
Blender
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Procedure for operation and cleaning of
Cleaning KPL2/SOP/QA-067
sampling rod
Sampling Rod
Procedure for cleaning and disinfectant
Disinfection KPL2/SOP/PD-044
solution preparation
Weighing Balance of Cleaning, operation, verification and
Cleaning KPL2/SOP/PD-099
Filling Room calibration of weighing balance
Procedure for disinfectant preparation,
Disinfection KPL2/SOP/PD-060
filtration, distribution In dry powder injection
Procedure for operation and cleaning of
Cleaning automatic injectable dry powder filling with KPL2/SOP/PD-075
Filling & Stoppering
rubber stoppering machine
Machine
Procedure for disinfectant preparation,
Disinfection KPL2/SOP/PD-060
filtration, distribution In dry powder injection
Procedure for cleaning and sanitization of dry
Cleaning KPL2/SOP/PD-062
Vial Filling & powder injection area
Stoppering Room Procedure for disinfectant preparation,
Disinfection KPL2/SOP/PD-060
filtration, distribution In dry powder injection
 Clean Room/ Clean Areas:
 All the critical areas are identified and based on the need the frequency of cleaning is scheduled to daily/
weekly/ fortnightly/ monthly. The various disinfectants are used in rotation 70 %IPA solution are for
hand disinfectant.
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 Each process area is fitted with independent air handling unit and critical areas are fitted with High
Efficiency Particulate Air (HEPA) Filters. Process areas are pressurized positively with respect to
adjoining areas in order to ensure containment. Independent AHUs are provided for manufacturing area,
filling area and quarantine area.
 The HVAC system is designed to meet specific requirements, including temperature, humidity, pressure
differentials, Unidirectional Airflow, appropriate air change rates in clean rooms and controlled
environments and air cleanliness levels, suitable for the manufacturing process and product being
produced. The design takes into account the flow of personnel, material, and equipment to minimize the
risk of cross-contamination.
Periodic qualification of HVAC system of respective area is carried out at defined time interval as per
validation master plan and following tests are performed during HVAC qualification study:
 Air velocity and Air Changes Per Hour (ACPH)
 Filter Integrity Test (Filter Leak Test)
 Air Flow Visualization Test (Smoke Test)
 Viable Particle Count Test
 Non-Viable Particle Count Test
 Recovery Test
 Temperature, Relative Humidity & Differential Pressure Monitoring.
The method for area cleaning, sanitization and fogging for different grades is defined in standard
operating procedures as mentioned below:
Reference Document
Section Cover Grade Activity
Title No.
A, B, C, D Cleaning and Procedure For Cleaning And Sanitization
KPL2/SOP/PD-062
& CNC Sanitization Of Dry Powder Injection Area
Procedure for disinfectant preparation,
A, B, C, D
DPI Disinfection filtration, distribution In dry powder KPL2/SOP/PD-060
& CNC
injection
A, B, C, D
Fogging Procedure For Fogging In DPI Area KPL2/SOP/PD-063
& CNC
D & CNC Cleaning Cleaning and sanitation of production area KPL2/SOP/PD-023
Procedure for cleaning and disinfectant
OSD D & CNC Disinfection KPL2/SOP/PD-044
solution preparation
D & CNC Fogging Procedure for Fogging in OSD area KPL2/SOP/PD-042
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Reference Document
Section Cover Grade Activity
Title No.
Cleaning SOP For Cleaning And Sanitization Of
D & CNC KPL2/SOP/WH-006
Warehouse
WH SOP For Cleaning And Sanitization Of
D & CNC Disinfection KPL2/SOP/WH-006
Warehouse
D & CNC Fogging Procedure for Fogging in Warehouse Area KPL2/SOP/WH-032
A, B, C, D & Cleaning General cleaning and sanitization of
KPL2/SOP/QC-079
CNC microbiology laboratory
Micro-
A, B, C, D & Procedure for issuance, preparation, storage,
biolog Disinfection KPL2/SOP/QC-081
CNC usage and disposal of disinfectant solution
y
A, B, C, D & Operation and cleaning of fogging machine
Fogging KPL2/SOP/QC-090
CNC

 Cleanroom Clothing:
 The clean room clothing is designed to ensure that there is no loose fiber or thread the garment are made
up of lint free polyester material to ensure that there is no particulate matter generation the material of
construction used in the clean room dress is such that there is no particulate matter generation in the clean
room area.
 The garments that are used in the cleanroom are sterilized as per the validated load pattern and the
number of Cycles to reuse the garments also established
 The SOP for garment management is in place to record and track the garment and its numberr of cycles.
Well-defined standard operating procedures are available for each type of cleaning activity.
 Monitoring System:
It including an assessment of the feasibility of the introduction of scientifically sound, alternative methods that
optimize the detection of environmental contamination
 General Procedures:
Reference Document
Description
Title No.
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Instruction on how to develop sam- Environment monitoring in Production areas,

pling points /frequency / warning and warehouse and microbiology laboratory

KPL2/SOP/QC-084
action limits

Instruction for the preparation of re- Environment monitoring in Production areas,

ports warehouse and microbiology laboratory KPL2/SOP/QC-084

Environment monitoring in Production areas,

SOP on how to perform trending
warehouse and microbiology laboratory KPL2/SOP/QC-084

 Monitoring systems:
 Environment:
 The KPL2/SOP/QC-084 is in place for the environment monitoring in the different area. The
environment monitoring of the classified area is done as per the approved procedure, The
monitoring of the area is done as per predefined frequency
 The monitoring location are decided based upon the risk assessment rational and risk to the
product and the number of locations are decided in such a way to ensure that the available system
of environmental monitoring is robust and provide the assurance to ensure that the area is
complying as per the specified acceptance limit.
 The monitored organism if identified during environment monitoring are identified to species
level and the library of the organism is maintained, the trending of environmental monitoring of
different area is done as per the approved procedure, action and alert limits are defined to control
the area for different types of organism.
 Water and Steam:
The Water system and steam has been monitored as per following documents:
Reference Document
Type Activity
Title No.
Procedure for sampling and microbiological
Monitoring SOP KPL2/SOP/QC-083
Raw analysis of different grade of water
Water Trend Chart for microbiological analysis of water KPL2/SOP/QC-083-F04
Summary Report
Trend Chart for chemical analysis KPL2/SOP/QC-083-F15
Purified Risk assessment for installation of Purified Water
Risk Assessment KPA2/RA/23/004
Water System in Beta Block
Monitoring SOP Procedure for sampling and microbiological KPL2/SOP/QC-083
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Reference Document
Type Activity
Title No.
analysis of different grade of water
Trend Chart for microbiological analysis of water KPL2/SOP/QC-083-F04
Summary Report
Trend Chart for chemical analysis KPL2/SOP/QC-083-F15
Risk assessment for installation of Water for
Risk Assessment KPA2/RA/23/005
Injection in Beta Block
Water for Procedure for sampling and microbiological
Monitoring SOP KPL2/SOP/QC-083
Injection analysis of different grade of water
Trend Chart for microbiological analysis of water KPL2/SOP/QC-083-F04
Summary Report
Trend Chart for chemical analysis KPL2/SOP/QC-083-F15
Risk assessment for installation of Pure Steam
Risk Assessment KPA2/RA/23/006
Generation System in Beta Block
Pure Procedure for sampling and microbiological
Monitoring SOP KPL2/SOP/QC-083
Steam analysis of different grade of water
Trend Chart for microbiological analysis of water KPL2/SOP/QC-083-F04
Summary Report
Trend Chart for chemical analysis KPL2/SOP/QC-083-F15

 Cleanrooms:
 For clean room classification, the total of particles equal to or greater than 0.5 µm and 5 µm is
measured. This measurement is performed both at rest and in simulated operations in accordance
with respect to limits specified in EU GMP Annexure-I.
 Non-viable particle monitor of clean room areas is performed as per approved procedure defined
in SOP No. KPL2/SOP/QA-069. In SOP location, frequency and run time for NVPC monitoring
is defined.
Reference Document
Type Activity
Title No.
Viable RA Risk assessment for environmental monitoring
Environmental in production, Warehouse, Oral solid dosage NA
Monitoring area and Microbiology Lab
Monitoring SOP Procedure for sampling and microbiological KPL2/SOP/QC-083
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Reference Document
Type Activity
Title No.
analysis of different grade of water
Summary Report Trend Chart for microbiological analysis of wa- KPL2/SOP/QC-
ter 083-F04
KPL2/SOP/QC-
Trend Chart for chemical analysis
083-F15
Non-viable (physical) en- Monitoring SOP Operation, Cleaning and Calibration of offline KPL2/SOP/QA-069
vironmental monitoring Non-Viable Particle Counter
 Process Gases:
Following are the documents related to the process gases:
Reference Document
Type Activity
Title No.
Product-contact-com- Risk assessment for installation of Com-
RA KPA2/RA/23/007
pressed air pressed Air System in Beta Block
Sampling and microbiological analysis of
Monitoring SOP KPL2/SOP/QC-115
compressed air and nitrogen gas
Trend chart for compressed air and nitro- KPL2/SOP/QC-115-F05
Summary Report
gen gas
Nitrogen Risk assessment for installation of Nitro-
RA KPA2/RA/23/008
gen Plant in Beta Block
Sampling and microbiological analysis of
Monitoring SOP KPL2/SOP/QC-115
compressed air and nitrogen gas
Trend chart for compressed air and nitro- KPL2/SOP/QC-115-F05
Summary Report
gen gas
 Prevention mechani[Link]
 Trend Analysis, detailed investigation, root cause determination, corrective and preventive actions
(CAPA), and the need for comprehensive investigational tools.
 Effective quality management system is in place. The system of Quality Assurance, appropriate for the
manufacture of pharmaceutical products ensures that formulations are manufactured in a way that takes into
account the requirements of Current Good Manufacturing Practices.
KWALITY PHARMACEUTICALS LTD. UNIT-II MASTER COPY
VILL. NAG KALAN, MAJITHA ROAD STAMP
AMRITSAR- 143601 (INDIA)
CONTAMINATION CONTROL STRATEGY
DOCUMENT NO. : KPL2/QA/CCS-1 PAGE NO. : PAGE 131 OF 134
REVISION NO. : 02 SUPERSEDES NO. : 01
: NEXT REVIEW :
EFFECTIVE DATE:
DATE
 The quality systems, such as investigation, deviations, change control, and corrective and preventive actions
(CAPA) - provide the mechanisms to continuously refine and improve controls and respond to unexpected
events.

Reference Document
Description
Title No.

Change Control Change Control Procedure KPL/SOP/CQ-002

Deviations Deviation Control Procedure KPL2/SOP/QA-013

Investigation of deviations (Root causes

Procedure For Investigation KPL2/SOP/QA-071
analyses) is described in SOP

Corrective and preventive actions (CAPAs) is Procedure for Corrective Action &
KPL2/SOP/QA-016
described in SOP Preventive Action
 Continuous improvement based on information derived from the above:
 Established and maintained a robust Quality Management System that supports a culture of continuous
improvement. The QMS include procedures for identifying opportunities for improvement and mechanisms
for implementing changes.
 All standard operating procedures/Protocols/specifications are periodically reviewed and updated as per
defined time interval.
 Site Master File and Validation Master Plan are periodically updated.
 Annual product quality review reports are prepared for each product annually as per standard operating
procedures (SOP No. KPL2/SOP/QA-050). Based on statistical analysis, it is concluded that all critical
process parameters are maintained in the state of control and manufacturing process meets predefined
specifications and quality attributes.
 All equipments’ are periodically qualified as per schedule in the validation master plan.
 Periodic calibration of all measuring components are carried out at a defined frequency as per validation
master plan.
 Periodic preventive maintenance of all equipment are carried out at defined frequency as per validation master
plan.
 Regular training is provided to personnel involved in contamination control and manufacturing processes.
Enhanced employee competency to improve adherence to best practices and regulatory requirements.
 Regular management reviews are conducted to assess the effectiveness of the Contamination Control Strategy
and identified opportunities for improvement. Used management review outcomes to set improvement targets
and allocate necessary resources.
KWALITY PHARMACEUTICALS LTD. UNIT-II MASTER COPY
VILL. NAG KALAN, MAJITHA ROAD STAMP
AMRITSAR- 143601 (INDIA)
CONTAMINATION CONTROL STRATEGY
DOCUMENT NO. : KPL2/QA/CCS-1 PAGE NO. : PAGE 132 OF 134
REVISION NO. : 02 SUPERSEDES NO. : 01
: NEXT REVIEW :
EFFECTIVE DATE:
DATE
 As part of healthy quality culture, open communication and feedback from all levels of the organization is
encouraged including front-line staff and management. Learn from past experiences, including both successes
and challenges, to continuously improve contamination control practices through change control management
system.
16.0 CCS REVIEW FREQUENCY:
The periodic review of the Contamination Control Strategy (CCS) shall be conducted every two years, or ear-
lier if required based on regulatory updates, risk assessment outcomes, or significant process changes. How-
ever, additional reviews will be triggered under the following circumstances:
 The Contamination Control Strategy (CCS) shall be reviewed during each Quality Review Meeting and
Management Review Meeting.
 Process Changes: Any modifications to the process will require a review of existing risk assessments,
where necessary, through the change control process.
 Deviation Trends: If deviations indicate deficiencies in the contamination control program, a reassess-
ment of existing risk assessments will be conducted.
 New Equipment or Products: The introduction of new equipment or products will necessitate the cre-
ation or review of relevant risk assessments.
 Data Analysis & Trending: Routine data monitoring and trend analysis identifying potential gaps in
CCS will trigger a review.
 Each appendix of the “Cross-Contamination Strategy” may have its own effective date, allowing for in-
dependent updates as needed.
17.0 SUMMARY AND CONCLUSION:
The details & control mentioned above conclude that there are sufficient measures and controls available to
mitigate any contamination with respect to chemical and microbial.
The purpose of the CCS is not solely to document all the measures and controls in place but also to enable
units to have an overview of their contamination control measures and how well they work or are utilized in
preventing contamination. The CCS considers all aspects of contamination control and undergoes periodic re-
view.
Evaluation of elements covered in CCS is being performed and no gap is identified.
QMS tools are available to handle any changes or investigate any event in routine activity.
System in place to qualify, PM, calibration of any existing or newly added equipment or detailed planner
available to track the same.
Routine data review and trend analysis are performed to evaluate the system and process.
The cleaning method is validated and the procedure is defined as per validation for routine cleaning.
KWALITY PHARMACEUTICALS LTD. UNIT-II MASTER COPY
VILL. NAG KALAN, MAJITHA ROAD STAMP
AMRITSAR- 143601 (INDIA)
CONTAMINATION CONTROL STRATEGY
DOCUMENT NO. : KPL2/QA/CCS-1 PAGE NO. : PAGE 133 OF 134
REVISION NO. : 02 SUPERSEDES NO. : 01
: NEXT REVIEW :
EFFECTIVE DATE:
DATE
Qualified personnel are available to perform activities. Refresher training is being provided to them as per
the defined training planner.
18.0 ATTACHMENTS:
Sr. No. Name of Appendix Appendix

1. List of Major equipment’s in the dry powder injection area Appendix-I

2. List of Major equipment’s in the oral solid dosage area Appendix-II

3. Approved Vendor List Appendix-III

4. List of Risk Assessment Appendix-IV

5. List of validation protocol and reports Appendix-V

6. GAP Assessment against EU Annex-1 Appendix-VI

19.0 ABBREVIATIONS:
Sr. No. Abbreviations Full form
1. CCS Contamination Control Strategy
2. SUS Single-use systems
3. QA Quality Assurance
4. SOP Standard operating procedure
5. SUS Single use system
6. CAPA Corrective action and preventive action
7. OSD Oral Solid Dosage
8. FG Finished Goods
9. DPI Dry Powder Injection

20.0 REFERENCES:
 Schedule M – Good Manufacturing Practices (GMP) for Pharmaceuticals in India.
 PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE-009-16 Part I.
 Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary
Use Annex 1 Manufacture of Sterile Medicinal Products (2022).
 ICH Q9 (Quality Risk Management).
 WHO TRS 1044 - Annex 2: WHO good manufacturing practices for sterile pharmaceutical products.
 PDA Technical Reports (TR No. 90: Contamination Control Strategy Development).
KWALITY PHARMACEUTICALS LTD. UNIT-II MASTER COPY
VILL. NAG KALAN, MAJITHA ROAD STAMP
AMRITSAR- 143601 (INDIA)
CONTAMINATION CONTROL STRATEGY
DOCUMENT NO. : KPL2/QA/CCS-1 PAGE NO. : PAGE 134 OF 134
REVISION NO. : 02 SUPERSEDES NO. : 01
: NEXT REVIEW :
EFFECTIVE DATE:
DATE
 An ECA Foundation guidance document on ‘How to Develop and Document a Contamination Control Strat -
egy.
21.0 REVISION HISTORY:
Revision No. Change Control No. Detail of Revision Effective Date
00 NA New Document Prepared 29/03/2025
 Numbering System of Cross-Contamination
Strategy has been updated.
 Specification no. of Raw Water, purified wa-
ter & water for Injection has been updated.
01 KPL2/CC/25/105
 A Roll Compactor machine has been added
to the Production (OSD) section.
 The review frequency of the Contamination
Control Strategy has been updated.
02 KPL2/CC/25/ 

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