KARNALI COLLEGE OF HEALTH SCIENCES

GAUSHALA, KATHMANDU

A REPORT ON
PHARMACEUTICAL INDUSTRY INTERNSHIP
AT
OHM PHARMACEUTICAL LABORATORIES PVT. LTD.

SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE

DEGREE OF
BACHELOR OF PHARMACY

SUBMITTED TO
OHM PHARMACEUTICAL LABORATORIES PVT. LTD.
TATHALI, BHAKTAPUR

SUBMITTED BY
MR. BOSH BAHADUR TAMANG
[Link] 2015 BATCH
KARNALI COLLEGE OF HEALTH SCIENCES
(PURBANCHAL UNIVERSITY)
GAUSHALA, KATHMANDU

February, 2020
i
 CERTIFICATION

This is to certify that the industrial internship report entitled “Pharmaceutical Industry
Internship at Ohm Pharmaceutical Laboratories” submitted by Mr. Bosh Bahadur
Tamang for the partial fulfillment of degree of Bachelor in Pharmacy is approved.

This report has not been submitted to any institution to acquire any other academic
degree or award.

Mrs. Prashansa Shrestha Dr. Annrodh Ghimire

General Manager (Technical) Principal, Department of Pharmacy
Ohm Pharmaceuticals Laboratories Pvt. Ltd. Karnali College of Health Sciences
Tathali, Bhaktapur, Nepal Gaushala, kathmandu

Approval Date:

i
 DECLARATION

I herby declared that this report entitled “pharmaceutical industry internship at Ohm
Pharmaceutical Laboratories” is a work carried out by me Mr. Bosh Bahadur
Tamang for the partial fulfillment of degree of Bachelor in Pharmacy.

I also declared that this report has not been submitted in part of full to another
institution for the award or any other degree or diploma.

Mr. Bosh Bahadur Tamang

[Link] 2015 Batch
Karnali College of Health Sciences
(Purbanchal University)
Gaushala, Kathmandu

Date:

ii
 ACKNOWLEDGEMENT

This internship program would not have been possible without the support of many
individuals. I would like to extend my sincere thanks to everyone.

I would like to express my deep sincere and gratitude to Mrs. Prashansa Shrestha
(General Manager, OPL) and Mr. Kiran suwal (QA officer, OPL) for arranging this
training and also for their support for completing this endeavor. I offer my sincere
appreciation for learning opportunities provided by industry.

I would like to thank Mrs. Anjana Shrestha (Sr. QA manager, OPL), Mr. Saroj
Acharya (Sr. QC manager, OPL), Mr. Tulsi Bade (Production head, OPL), Mr.
Ashish khadka (Sr. Production officer, OPL), Mr. Shree Krishna Prajapati (Store
In-charge, OPL) Mr. Dhruba Ojha (Maintenance supervisor, OPL) for their
expertise, sincere and valuable guidance and encouragement extended to me.

I sincerely thank Dr. Annrodh Ghimire (Principal, Karnali College of Health

Sciences) for his support and encouragement.

Furthermore, I especially express my thanks to all the QC, QA & Production

concerned personnel for their guidance, supervison and support.

I’m highly obliged in taking the opportunity to thank all the operators, helpers and
other staff member of Ohm Pharrmaceuticals for their help and guidance throughout
the time.

iii
 ABSTRACT

The internship program in [Link] is very beneficial to have practical exposure of

how things really operate in pharmaceutical industry. I have completed my internship
in Ohm Pharmaceuticals Laboratories Pvt. Ltd. (OPL), which is recognised as the
fastest growing pharmaceutical company in Nepal. It was a great opportunity to
experience and gather knowledge about different aspects of a pharmaceutical
industry. The absolute guidance and concern of higher management, perfect working
environment with immense cooperation of the staff of all departments facilitates my
internship a wonderful learning experience in all aspects. Through these projects, I
was able to get direct interaction with different pharmacists along with staff of quality
assurance, production, store and maintenance departments of OPL.

This internship report is based on my internship experience, academic knowledge and

mostly based on the secondary data. This report discusses about the rational and
objective of the internship, overview of OPL and different departments of the industry
such as quality assurance, quality control, store, production, store and maintenance
department including the activities performed and the equipments seen there. I have
discussed and concluded my experience in OPL at last also mentioning some
suggestions which will help the internee to perform, expose & learn better than
before.

iv
Table of Contents
1 RATIONALE OF THE INTERNSHIP .................................................................. 1
2 OBJECTIVES ......................................................................................................... 1
3 COMPANY PROFILE ........................................................................................... 2
3.1 Moto ................................................................................................................ 3
3.2 Vision .............................................................................................................. 3
3.3 OPL objectives ................................................................................................ 3
3.4 Manufacturing unit .......................................................................................... 4
3.5 OPL’s products ................................................................................................ 4
4 DEPARTMENTS OF OPL .................................................................................... 5
4.1 Ware house/store department .......................................................................... 5
4.1.1 Premises ................................................................................................... 5
4.1.2 Job description of the warehouse ............................................................. 6
4.1.3 Raw material store ................................................................................... 6
4.1.4 Purchase order for raw material ............................................................... 7
4.1.5 Documentation ......................................................................................... 8
4.2 Quality assurance department ......................................................................... 8
4.2.1 Functions of QA department .................................................................... 9
4.3 Production department .................................................................................. 10
4.3.1 Role of production department .............................................................. 11
4.3.2 General procedure of manufacturing in production area ....................... 11
4.3.3 Different section of Production .............................................................. 11
4.4 Packaging section .......................................................................................... 21
4.5 Hormone section ........................................................................................... 23
4.6 Quality control department............................................................................ 24
4.6.1 Quality policy......................................................................................... 24
4.6.2 OPL’S Quality Policy Statement ........................................................... 25
4.6.3 Functions of quality control ................................................................... 25
4.7 Research & development department ........................................................... 27
4.7.1 Functions of R & D ................................................................................ 28
4.8 Maintenance and engineering section ........................................................... 28
4.8.1 Heating, Ventilation and Air Conditioning Unit (HVAC system) ........ 29
4.8.2 Power Supply ......................................................................................... 36
5 DISCUSSION ....................................................................................................... 36

v
 5.1 Lessons Learn From OPL ............................................................................. 37
5.2 Some of the works that I have done during my internship............................ 37
5.3 Suggestions.................................................................................................... 38
6 CONCLUSION .................................................................................................... 38
7 REFERENCES ..................................................................................................... 39
ANNEX-I ..................................................................................................................... 40

vi
List of abbreviation

AHU Air handling unit

APL Active pharmaceutical ingredients
BMR Batch manufacturing record
BOD Board of director
Ca Calcium
cGMP Current good manufacturing practices
COA Certificate of analysis
DDA Department of drug administration
FBD Fluid bed dryer
FEFO First expiry first out
FIFO First in first out
FP Finished product
FT-IR Fourier transform infrared spectroscopy
GMP Good manufacturing practices
GRN Good receipt note
HCL Hydrogen chloride
HEPA High efficiency particulate air
HVAC Heating, ventilation and air conditioning
IPQC In-process quality control
ISO International standards organization
NaOH Sodium hydroxide
NSAID Nonsteroidal anti-inflammatory drug
NML National medicine laboratories
OPL Ohm pharmaceuticals laboratories
PM Packaging material
QA Quality assurance
QC Quality control
QCD Quality control department
R&D Research & development
RH Relative humidity
RM Raw material
RMG Rapid mixing granulator
RO Reverse osmosis
SOP Standard operating procedure
TGA Therapeutic goods administration
UK-MHRA United kingdom medicines and
healthcare products regulatory agency
USFDA United state food and drug administration
WFI Water for injection
WHO World health organization

vii
List of tables
Table 4-1 ISO 14644-1 Cleanroom standards.......................................................................... 33

List of figures
Figure 3-1 Building of OPL ........................................................................................... 2
Figure 3-2 Manufacturinng divison organogram ........................................................... 4
Figure 4-1 Different departments of OPL ...................................................................... 5
Figure 4-2 flowchart for manufacturing of products in production area ..................... 11
Figure 4-3 Capsule filling mechansim ......................................................................... 15
Figure 4-4 Tablet/capsule primary packing mechanism .............................................. 22
Figure 4-5 Schematic diagram of HVAC system ........................................................ 30
Figure 4-6 Diffferent filters in HVAC system ............................................................. 30
Figure 4-7 Different parts of HVAC system................................................................ 31
Figure 4-8 Mechanism of AHU ................................................................................... 32
Figure 4-9 HEPA filters ............................................................................................... 34
Figure 4-10 Water Purification system ........................................................................ 35

viii
1 RATIONALE OF THE INTERNSHIP
The aim of this internship program is to connect practical knowledge with theoretical
knowledge. Proper application of knowledge to theoretical field implies to get extra
benefit while understanding the matter related to subject. Internship program is also
important to fulfill the partial requirement of University as a full credit subject of the
[Link] program. In this regard I had got an opportunity to carry on my internship
program in Ohm Pharmaceutical Laboratories Pvt. Ltd. which is a very fastgrowing
industry in Nepal and now planning to export their products in foreign countries too. I
hope that this internship knowledge will help me to apply theoretical knowledge in
the practical aspect.

2 OBJECTIVES
 To fulfill the requirement of [Link] program and to apply the theoretical knowledge
obtained from the coursework in a specific field.
 To acquired the practical skills where ever possible
 To have a concept of implementation of the WHO-GMP principle in the
pharmaceutical industry.
 To know the organization behavior and environment of the company.
 To get an introduction about the organizational structure & how co-ordination among
different set of activities is made.
 To have an idea about the building design & constructions pharmaceutical industry.
 To observe and learn the quality assurance, manufacturing and quality control
activities carried in the different sections of the organization,
 To know the sequence of procurement, processing, production, handling
documentation & quality assurance during the various steps from raw materials to
finished products.
 To be familiar with the different equipments & Instruments used for the
manufacturing of the drugs in the pharmaceutical industries including their working
principle.
 To know the different process of quality control and in-process control of raw
materials & finished products.
 To have an idea on waste management system in pharmaceutical industry.

1
3 COMPANY PROFILE

Ohm Pharmaceuticals Lab. Pvt. Ltd (OPL) was registered in Asadh 3, 2060 B.S with
DDA registration in poush 10, 2060 B.S. with a pure aim of striving for Passion to
excellence. The company commenced its operation in the market on Asadh 15, 2066
B.S. OPL owns the collection of professional expertise as the people with the better
attitude, integrity and teamwork to zeal towards the excellence that is worthy of
world’s perception.
Being the first pharmaceutical company to receive WHO GMP for the hormonal
drugs, OPL constantly endeavors to fulfill its mission “Passion to Excellence” and
offers outstanding manufacturing services complying with the systematic disciplines
of WHO GMP.

Figure 3-1 Building of OPL

OPL believes in developing medicines and products that are cost-effective as well are
capable of providing high quality care to improve the health of the patients. OPL also
believes in obtaining, utilizing and maintaining a satisfied workforce in order to
achieve a well-managed corporation. OPL always binds with the corporate ethics and
provides a helping hand in the care of our human resources who are entrusted with the
corporation.

2
 OPL, as a corporation is organized and managed by the Board of Directors (BOD)
followed by the respective managers to help uplift the prestige of the company.

3.1 Moto
“Passion with excellence”

3.2 Vision
 Outstanding services and quality medicine are our practices for being acknowledged
as a trusted company among the valued customers.
 Paradigm shift in meeting the unmet therapeutic need of the nation by bringing new
molecules.
 Leading by innovative corporate culture to distinguish ourselves among all others

3.3 OPL objectives

 To meet the sheer expectations of Nepalese medical sector in designing and producing
the allopathic medicines.
 To ensure value, satisfaction, quality in terms of pharmaceutical production,
moreover, availability and according services to our intermediaries and valued
customer.
 To deliver optimal value creation process and transactions ethically, among the
associated trade organizations.
 To thrive for optimum utilization of the available resources to achieve the excellence
in the pharmaceutical production and promotion.
 To carry out “Research & Development” activities to meet our “P” vision.
 To set a benchmark for other by covering the milestones in the overall pharmaceutical
development.

3
3.4 Manufacturing unit

Managing Director

General Manager
(Technical)
Deputy General Manager
(Technical)

Sr. QC Sr. R & D Production Warehouse Maintenance

Sr. QA
Manager Officer Incharge (Supervisor)
Manager (supervisor)
QC Sr. Production Maintenance
Officer Warehouse (Operator)
[Link] Manager
Manager ( Assistant)
Asst. QC Maintenance
Asst. QC Production
Manager (Asst.
Sr. QA Manager Officer
Operator)
Officer (Micro.)
QC Officer Production
QA and Supervisor
IPQA
Officer Asst. Supervisor
QC Officer/ Sr.
QC Assistant ( Hormone)
Asst. Supervisor
(General)

Figure 3-2 Manufacturinng divison organogram

3.5 OPL’s products
OPL manufactures drug product of different categories in different dosages form
(Tablet, Capsule, Dry syrup, Suspension, Syrup) which are as follows:

 Abortifacient/Labor Induction  Antiulcer Agent

 Anti- Allergic  Benign Prostatic Hyperplasia
 Anti- Asthmatic Agents
 Anti-Cold  Neuropathic Pain Agents
 Anti-Obesity  NSAIDS
 Anti- Protozoal  Oral Contraceptives
 Anti-tussive  Osmotic Laxative
 Anti-Vertigo  Proton Pump Inhibitors
 Antibiotics  Urinary Alkalizer
 Antioxidants  Urinary Tract Spasmolytic
 Antispasmodic  Vitamins
List of OPL products are given in ANNEX-I

4
 4 DEPARTMENTS OF OPL
The Company is involved in the manufacturing of almost all segments of products
having its independent manufacturing sections for Hormone, Cephalosporin, Non-
penicillin which are controlled with centrally air-handling system. There are
following main departments of OPL.

OPL

Quality Quality R& D Production Packaging Store Maintenace

Assurance Control &
Engineering
Cephalosporin Hormone Primary
Section Section Packing
Non
Penicillin Secondary
Section Packing

Figure 4-1 Different departments of OPL

4.1 Ware house/store department

It receives raw [Link] this material is cleared it is remains there. Temperature
and humidity is kept under control. It is the body concerning with the storing of all
required materials and chemicals which may be API, excipients, packing materials or
any materials which may find use in near future and documentation of such materials.
Since, store is the first point of entry of material into the factory, it should therefore be
properly maintained to prevent deterioration, contamination of stored goods.

4.1.1 Premises
• It is was well situated, well laid out, tidy, clean and well secured enabling good
preservation of raw material, packaging material and finished products.
• Temperature was maintained between 15-30 °C.
• Humidity was set between 35-60%.

5
4.1.2 Job description of the warehouse
 Responsibility to control inventory of stocks (Finished, Packaging and Raw material
Stores).
 Checking physical stocks regularly.
 Preparing Stocks Reports.
 Holding and Keeping record of the materials that arrive at the store.
 Requesting QC for sampling.
 Storing of the pass material as per specification.
 Preparing dispensing slip.
 Informing QA about the rejected materials.

In OPL ware house was separated into:,

 De-dusting Area
 Raw material store
 API Store /Cold area
 Quarantine
 Rejected material store
 Finish good store.

4.1.3 Raw material store

Raw material store was further divided into following:
1. Quarantine area
o Packing material quarantine
o Raw material quarantine
2. Excipient area
3. Active pharmaceutical ingredients
4. Dispensing area
o For Hormone
o For Cephalosporin
o For Non-penicillin

Quarantine area
All raw materials, components, packaging, and labeling materials are held in our
quarantine area with orange coded label as “under test” until they are sampled,

6
 tested and/or examined, and released for use by our "quality control laboratory". The
sampling is performed according to specific procedures by trained personnel. This
area is divided into two sections

Packing material quarantine

In this section packing material for different dosage forms is kept under recommended
and controlled atmosphere.

Raw material quarantine

In this section raw material is kept under normal conditions active pharmaceutical
ingredients is kept in 15-25°C, excipients are kept at 25°C in subsection of this area
Dispensing area
Dispensing area is also present in nearby of raw material section where dispensing is
performed under manufacturing order of a product at time of dispensing 2 personnel’s
should be present there to check the process of dispensing according to SOP.
o QA or QC pharmacist
o Raw material dispenser from store

4.1.4 Purchase order for raw material

A stock delivery report is prepared. Checking of documentation is done. COA is
issued. The store supervisor receives the raw materials, crossed checked based on the
details provided in invoice, de-dusted, required information like control no, invoice
no, batch details, manufacturing date, expiry date are documented in good receipt
note (GRN). Orange “under test” label is pasted on each sample and request for
analysis is sent to QC for sampling. And then it is transferred to the quarantine
before getting it transfer to the bulk after clearance from Quality Control Department
(QCD). The QCD collects the sample and reports for its release, it is according to the
specifications or rejection if not. After this if report complies, QA approves and
pasted green “approved” slip on each of the quarantined material for release. If
rejection from QCD, red “rejected” slip is pasted on each of the Quarantined
material and removed from quarantine to rejected store.

The approved materials information is entered in the material log sheet based on the
storage conditions are stored as per location log book. Log book includes name, store
no., rack no. As per the requisition from the production department, raw material
7
 based on FIFO are dispensed in the dispensing booth strictly according to the BMR
record under the supervision of QA and Production Pharmacist to checks all the raw
material by weight/volume on the weighing balance. Primary and Secondary
packaging materials are dispensed as per requisition from the concerned department.
A copy of record of all the data are kept in dispensing area separately.

The store keeper manages to transfer the raw material (RM) to the bulk with
necessary information pasted on it. Copies of goods receipt note (GRN) after release
of RM from QC are proposed. The store keeper (Raw Material) transfers whole the
consignment of the material with the help of section workers by means of trolley,
lifter to the bulk store.

4.1.5 Documentation
Following documentations were done in ware house at different stages:
o Temperature/humidity chart.
o Dispensing log book.
o Raw material requisition.
o Certificate of analysis.
o Issuance of slips (Orange slip: issued as under test, Green slip:
approved from QA after analysis done and complies from QC).

4.2 Quality assurance department

Quality Assurance (QA) is the sum total of organized arrangements made with the
object of ensuring that product will be of the quality required by their intended use.
Quality assurance is the systematic monitoring and evaluation of the various aspects
of a project, service or facility to maximize the probability that minimum standards of
quality are being attained by the production process.

The QA department is responsible for monitoring the overall quality; the ultimate aim
being providing standard quality drugs to the people by monitoring, developing,
implementing & improving the quality of the product according to the WHO GMP
guidelines & DDA regulations.

In OPL, there was a pharmacist to maintain the reliability at every stage of

manufacturing process from starting to release of finished for distribution and

8
 provides information on appropriate use, and analyzes safety and information of the
products. This department assists in the strategic direction and development of
Quality Systems, standard operating procedures and document control programs, to
ensure with the company policies and regulatory requirement.

4.2.1 Functions of QA department

1. Plan and manage all the activities of Quality Assurance Dept. to assure the quality of
all products manufactured by the Company.
2. Co-ordinate with manufacturing department in controlling their process and products
at every stage of manufacturing to meet the established specifications through testing,
auditing and reporting.
3. Review the adequacy and relevance of specifications & analytical procedures in co-
ordination with QCD and R & D.
4. Co-ordinate technical audits of the Quality Control Laboratory to determine the
analytical Quality Systems are yielding the highest quality information and to ensure
that the analytical instrumentation is functioning properly and calibration and
servicing is as per schedule.
5. Review and approve or reject all things cGMP
6. Controlled Documentation and record keeping
7. Preparation of BMR and batch record review
8. Out of specification investigation
9. Dispensing monitoring
10. Reprocessing of non-conforming products
11. Ensuring proper warehousing practices
12. Handling quality crisis
13. Final release of drug products for distribution and sale
14. Complaints and product recall
15. Ensuring proper warehousing of finished products
16. Effective communication to all departments
17. Maintenance Records of
 Release,
 Quarantine or rejection of components and finished products,
 Containers, closures and labels based on Quality Control test results.

9
 18. Suggest and organize training programmers’ for development of technical and
administration skills of all the employees to meet with cGMP regulations on
continuous basis, co-coordinating with Plant and Quality Head.

4.3 Production department

Production team is committed to produce highest quality products, which can satisfy
the needs of both doctors and patients. The production team endeavors to manufacture
products that are cost-effective through best utilization of their resources. This
department is well equipped with latest equipment. The area of 100000 square feet of
OPL consists of a double-storeyed building which fulfills the latest Good
Manufacturing Practices (GMP) i.e. USFDA, UK-MHRA, TGA & WHO guidelines.
Operated by skilled and experienced technicians, OPL is the first company to receive
WHO-GMP for the hormonal drugs. Well-designed HVAC system serves fresh air in
the production unit as per the international standard through the Air Handling Unit
(AHU). Separate supply and return system has been installed in different
manufacturing section. Ultra-modern reverse osmosis and demineralization water
treatment plant has been installed which yield pharmaceutical grade water. All the
water distribution system is looped to rule out any microbial growth. The production
unit is equipped with latest and automated machines that manufacture quality
products.

Production area comes under grey zone and is maintained under class III grey area i.e.
particles in this zone should not be greater than 0.5 micron and should not exceed
100,000 per cubic feet. Corridor is the cleanest zone and must be maintained at
positive pressure difference of 15 Pascal (±5) than that of the room so as to prevent
cross-contamination. The walls and ceilings are painted by epoxy emulsion. The
pressure difference is monitored by the standard magnetic pressure gauges. Rooms are
cleaned periodically by disinfectants like Isopropyl alcohol, sodium hypochlorite, and
savlon to prevent resistance to microorganism. The end of walls are curved which
facilitates cleaning and prevent dust accumulation. Air handling unit log sheet,
machine log sheet, temperature and humidity record and sanitation record is
maintained for every product. There are clearly written SOPs for each instrument and

10
 the SOPs are reviewed in every two years interval. The major machines in the
production section in OPL are of latest design and automated.

4.3.1 Role of production department

 Whole pharmaceutical stand on this department
 Manufacturing of different pharmaceutical products are controlled by this
department
 This department produce tablets capsules oral liquid preparation in industry
and other pharmaceutical dosages
 Role of production department in industry is to make quality medicine

4.3.2 General procedure of manufacturing in production area

In production area following sequences is followed for proper manufacturing of
medicine.

Generation of Batch Manufacturing Record

(BMR) by QA

BMR is checked by Production Department

BMR is sent to raw material store

Dispense all the required materials in presence

of QA and Production pharmacist acc. to cGMP

Dispensed material is shifted into production area

for further processing and manufacturing

Figure 4-2 flowchart for manufacturing of products in production area

4.3.3 Different section of Production

In OPL, Production area is generally divided into following area and consists of
following equipments:

11
[Link] Dispensing room
Dispensing of raw material is carried out in the dispensing room and it consists of
dispensing booth. Dispensing booth is maintained with Class 100 by the help of
laminar air flow, primary filter, intermediate filter and HEPA filter. There was
perforated stainless steel table, clean stainless scoops, weighing balance and negative
pressure in dispensing booth. The air flow was a vertical laminar air flow. As per the
requirements of various departments materials are requested by filing the requisition
form stating the type and quantity of materials. Dispensing of raw material is carried
out by the store personnel as per requisition form in the presence of QA personnel. All
the dispensed materials are labelled properly and signed by QA officer. Raw materials
are dispensed on the basis of FIFO (First in First Out) and sometimes on the basis of
FEFO (First Expiry First Out) as necessary. The dispensed materials are then
dispatched to carry out production or transferred to pre-dispensing room for storage
until the production is carried out. The equipments in dispensing room are:

o Weighing balance
o Dispensing booth

[Link] Tablet Section

“Tablets are unit solid dosage form of medicament or medicaments with or without
suitable diluents.

I. Granulation Room I
In this room granulation of the materials for the large batches is carried out as follows
including mixing, milling, sieving and drying:
 Dry mixing: Ribbon mixer is used for mixing.
 Wet mixing: After dry mixing, wet mixing is done in the ribbon mixer.
 Wet granulation: Wet granulation is a widely employed method for the
production of compressed tablets.
 Drying: FBD (Fluidized Bed Dryer) Or Tray dryer is used for the purpose of
drying
 Dry granulation: Oscillating granulator is used for dry granulation.
 Direct compression: The machines used here are:
 Mechanical sifter

12
  Multi mill
 Rapid mixing granulator
 Fluidized Bed Drier
 Paste kettle
II. Mini granulation room: OPL uses this room for small batch production and it
consists of
 Tray drier
 Mass Mixer
 Mechanical sifter
 Oscillating granulator
III. Lubrication & final mixing room: Final mixing is done in DC (Double Cone)
mixer.
IV. Compression room: Granules or powders are blended in one of the compression
room containing
 Double Hopper 35 station rotary tablet press,
 Single Hopper 20 station rotary tablet press,
 Tablet De-duster.
V. Coating Room: Coating room is used either for enteric or film coating of tablets with
the following sets of equipments;
 Coating pan
 Hot air blower
 Spray gun
VI. Suspension preparation Room: In this room suspension for coating is prepared
which contains
 Colloid mill
 Stirrer
VII. Blending Room:
 Drum Blender

13
VIII. General step of tablet manufacturing:

Batch requisition

Batch Manufacturing Record (BMR) issued by QA

Dispensing of raw material by store (in presence of Production & QA personnel)

Counter checking by the production pharmacist

Line Clearance

Sieving: in vibratory shifter with different mess size and Milling (if required)

Mixing in RMG use impellors and chopper, blending

Wet granulation/ kneading in RMG

Wet screening (if necessary in oscillating granulator)

Drying (FBD/tray drier)

Dry screening

Store in quarantine
Lubrication of the final product
until QC clearance
IPQC
Compression
QC Analysis
Coating

Quarantine
QC Analysis
Primary packing (Blister or Strip) Leak test

Secondary packing

Finished product analysis

QC Analysis
QA Analysis and approved

Market dispatch
Fig: Flow chart of tablet manufacturing process

14
[Link] Capsule section
“Capsules are solid unit dosage form of medicament in which the drugs or mixture of
drugs is enclosed in a gelatin shell or any other suitable material to form various
shapes. Capsules generally contain a single dose of active ingredients and are taken
orally.”

I. Capsule filling room: This room is used to fill blended powders or granules or pellets
into capsules. At high moisture capsules become soft & tacky and at low moisture
they become brittle. So, temperature and relative humidity should be maintained at
22±2◦C and 45±5% respectively.
The capsule section machinery is
 Semi Automatic capsule filling machine
 Capsule inspection and sorting
 Manual capsule filling machine
 Capsule Loader

Figure 4-3 Capsule filling mechansim

II. Capsule polishing: After capsule filling capsules were polishes in full automatic
capsule polishing machine. If capsules are not de-dusted and polished, a lot of
residual dust may make its way into the packaging equipment, resulting in obscured
sensors, powder ingress in mechanical gears, belts, etc. This then leads to downtime
and higher maintenance costs in packaging, bottles or blisters not sealing product

15
properly, and patient compliance issues if the capsules do not appear cosmetically
clean.
Capsule Polishing Machine consisting of a stainless steel chambers installed with
filter cloth, a revolving variable speed spiral nylon brush stainless steel powder
collector. The capsules travel from one end to other end. During this travel they are
subjected to roll in between the nylon bristles and filter cloth. In this course the
powder on the capsules and at the edge are removed and sucked by the dust extractor.
The Capsules coming out of the chute are thoroughly polished, shiny & clean.

General step of Capsule Manufacturing

Batch requisition from production

Batch Manufacturing Record (BMR) issued by QA

Weighing and Dispensing of raw material (in presence of Production & QA

personnel)

Counter checking by the production pharmacist

Line Clearance

Sieving using sieve of suitable size

Geometrical mixing: As per BMR QC Analysis

Hard gelatin capsule loading in automatic capsule loader

Capsule filling and sealing using manual capsule filling machine

Capsule polishing and sorting QC Analysis

Packaging

Finished Product Stored QC Analysis

Dispatch

Fig: General steps of capsule manufacturing

16
[Link] Liquid Manufacturing section
This room is used to prepare liquid dosage syrup and suspension.
A. Syrup
“A viscous concentrated solution of 85 % sugar, such as sucrose, in water or other
aqueous liquid; combined with other ingredients, such a solution is used as a flavored
vehicle for medications.”

Steps involved in syrup manufacturing:

i. Dispensing of ingredients.
ii. Prepared simple syrup.
iii. Add ingredients one by one.
iv. Filling of syrup.
v. Labeling & Packing.
B. Suspension
Suspension is a disperse system in which internal system is dispersed uniformly as
finely divided insoluble particles throughout the external phase. The internal phase
consisting of insoluble solid particles having specific range of size which is
maintained uniformly throughout suspending vehicle with the aid of single or
combination of suspending agent. The external phase (suspending medium) is
generally aqueous in some instance, may be an organic or oily liquid for non oral use.

The liquid section has following machineries:

 Sugar melting vessel  Suction motor
 Manufacturing tank 2000 Ltr.  Filter Press
 Transfer Pump  R.O water pump
 Storage Tank  Automatic bottle filling.

C. Liquid filling room:

This room is used to fill the liquid dosage form where the bottle is washed, filled and
sealed.

17
General steps for liquid manufacturing

Batch requisition from production

Batch Manufacturing Record (BMR) issued by QA

Dispensing of raw material by store (in presence of Production & QA personnel)

Sieving

Primary Syrup/Base preparation

Mixing of Active and other excipients

Color and Flavor added

Volume make-up

Homogenization & PH adjustment

For syrup: Filtration QC Release For suspension: pass through

in filter press #60 or #40 (colloidal mill)
Storage Tank

Bottle Washing

Empty Bottle Inspection

Bottle Filling & Sealing

IPQC Volume check-up

Filled bottle Visual Inspection

Labeling & Packing

Storage

Dispatch

Fig: Flowchart of overall liquid production

18
[Link] IPQC room
IPQC (In Process Quality Control) is the controlling procedures involved in
manufacturing of dosage forms starting from raw material purchase to dispatch in
final packaging. It prevents errors during processing. In process quality control
(IPQC) is a planned system,
 To identify the materials, equipment, processes, and operators,
 To enforce the flow of manufacturing and packaging operations according to
the established rules and practices,
 To minimize human error or to detect the error if and when it does occur,
 And to pinpoint the responsibility to the personnel involved in each unit
operation of the entire process.
In general, In process control procedures are usually rapid and simple tests or
inspection that are performed when the manufacturing of the product batch is in
process.
The IPQC lab functions under the production department. The different task carried
out by IPQC personnel are:
I. IPQC of granules:
To control;
 Particle size & shape  Granule strength
 Surface area  Foreign Impurities
 Texture and fines  Flow properties
 Powder flow  Moisture
 Density (bulk, true & granular)
II. IPQC of Tablet
It includes;
 Environment control  Hardness & thickness
 Appearance (color, size, shape)  Leak test
 Wt. variation  Diameter
 Average wt.  Dissolution time
 Disintegration  Friability test
 Moisture content  Coating control: spray rate, rpm
 Shape size of tablet of coating pan, tablet bed
temperature, average

19
  weight of tablet before and  Problems associated with tablet
after coating manufacturing like capping,
lamination,
 mottling etc. control

III. IPQC of Capsule

IPQC checks during filling of empty capsule shells:
 flow property of granules or  Average wt.
powders  disintegration time
 Weight Variation :  Leak test
 Physical appearance  Record of room temperature
 Disintegration test and relative humidity

IV. IPQC of oral liquids

For Suspension:
 PH  Fill volume
 Physical appearance  Sedimentation volume
 Viscosity  Potency assay
 Weight per ml  Leak test etc.
For Syrup:
 Clarity  Weight per ml
 pH  Fill volume
 Physical appearance  Leak test e.t.c
 Viscosity

The operations must adhered rigidity to the established standards or specification as

determined through systemic inspection, sampling and testing should constantly strive
for improving the levels of the current standards or specifications. The facilities,
personnel, funds and environment necessary to perform their responsibilities
effectively should be adequately provided.

20
 This room consists of following equipment:
 Digital hardness tester  Friability testing apparatus
 Digital vernier caliper- For thickness,  Disintegration apparatus
diameter and length  Bulk density apparatus
 Moisture Balance
 Weighing balance
 pH meter- For liquids

4.4 Packaging section

Packaging is the final step of drug production. Packaging is a means of presenting
product to the customer protecting its quality. Packaging section consists of following
two areas:
1. Primary packaging area
2. Secondary packaging area
Primary Packaging Room: In primary packaging, the product comes in direct
contact with the packaging materials. It is the final step carried out in grey area. After
the drugs are packed into primary packaging, they are sent to the black area for
secondary packaging. Before that, the following are checked:
 printing mistake
 broken tablets inspected visually
 unfilled packs (strips, blisters, bottles)
 Particles, improper seals in bottles
Types of packaging
i. Blister packing:
This is useful for packaging of unit dose of pharmaceuticals. This packing mode has
been used extensively for several good reasons. It is a packaging configuration
capable of providing excellent environmental protection, coupled with an aesthetically
pleasing and efficacious appearance. It is used for the products that are not sensitive
to light and moisture. It also provides user functionally in terms of convenience, child
resistance and now temperature resistance. Blister packing consists of two principal
components:
1) A formed base web creating the cavity inside which the product fit.
2) The lid foil for dispensing the product out of the pack.

21
 Packaging materials:
PVC foil
PVDC foil
Aluminum foil

ii. Strip packing: The blister package is formed by heat softening a sheet of
thermoplastic resin and vacuum drawing the softened sheets of plastic into a
contoured mould. After coming, the sheet is released from the mould and proceeds to
the filling station of the packaging machine. The semi-rigid blister previously formed,
is filled with the product and lidded with a heat sealable backing material. The
backing material can be either a push through or peelable type. For a push through
type of blister, the backing material is usually heat seal coated aluminum foil. The
packaging of the final product is done in paper cartons, manually, and is finally sealed
using an automatic sealer. The machine can seal cartons.

Figure 4-4 Tablet/capsule primary packing mechanism

Sealing of filled liquid bottle

Liquids after mixing are filled and sealed in bottles with the liquid filling and sealing
room. Primary packaging materials used in OPL for liquid includes amber colored
glass bottle, plastic bottle and PP cap. After the drugs are packed into primary
packaging, they are sent to the black area for secondary packaging. Before that, the
following are checked:
 proper seals in bottles

22
  visual inspection of particles under white and black background light for
liquids
Secondary Packaging
The drug does not come into direct contact with the secondary packaging material.
The drugs which are packed from primary packaging (strip, blister and filled bottles)
are then conveyed to secondary packaging area by conveyer belt. While passes
through conveyer belt, integrity of packing, batch coding, visible defects, leak test and
printing mistake are observed and if found any, they are rejected. During secondary
packaging, blister and strips are packed in carton and they are also packed in
corrugated carton, and are released only after obtaining a release certificate from QA.
Following materials are used for secondary packaging:
 Printed carton
 Duplex box or corrugated box or packaging
 Printed label
 Measuring cap
 Middle plate

4.5 Hormone section

This unit is mainly focused on manufacturing of hormones. This is a separate and
segregated unit thus the access door, aprons and other allied material are different for
this section.
This room is equipped with:
1. Dispensing Room: Dispensing Booth & Weighing Balance
2. Granulation:
 Tray drier
 Mass mixer
 Sifter
 23 station single hopper rotary tablet press
3. Packing: Blister packing
4. IPQC room:
 Disintegration test apparatus
 Friability test apparatus
 Weighing balance

23
 4.6 Quality control department
The ISO definition states that quality control is the operational techniques and
activities that are used to fulfill requirements for quality. Quality control is a process
for maintaining standards and not for creating them. The quality control department
has the responsibility and authority to approve or reject all components, drug product
containers, closures, in-process materials, packaging material, labeling, and drug
products according to a rigorous written program designed to assure uniformity from
batch to batch. Every raw material received is tested for identity and conformance to
specifications. Every bottle, cap, and label is examined to assure that they match the
written specifications. During the manufacture of all batches of all products, in-
process samples are tested and the results documented. If any results fall outside of
the written specifications, the product is rejected and the information is submitted to
the research and development group for evaluation and further disposition. Samples of
finished, packaged product are tested for stability to allow for determination of
expiration dating. Accelerated stability testing as well as real time stability testing is
done concurrently to validate the results of the tests.
“Quality is never an accident, always the result of intelligent effort.” To build quality
in the end product, overall control should be maintained right from the starting
material to the manufacturing processes, building design, equipment and personnel
involved. In order to deliver quality drug to the people, OPL has been implementing
Good Manufacturing Practice which ensures that products are consistently produced
and controlled according to the quality standards.

4.6.1 Quality policy

o To gain customer’s satisfaction through manufacturing and providing high
quality pharmaceutical products, while believing in continual improvement
of system.
o To achieve sustained growth in market share by developing satisfied
customers.
o Healthy environment to develop dedicated professional teams in order to
serve in the best interest of external and internal customers. Suppliers and
share holders.
o To benefit the community by adopting environment friendly policies and
establishing standards of ethics.

24
 o To improve the standard of life through the value of developing innovative
products by research and development.
o And to pursue Total Quality Management.

4.6.2 OPL’S Quality Policy Statement

“We shall build-in current regulatory expectations of risk based approach in our
quality management system and work as integrated team to product safe, stable &
effective medicines at affordable price for the customers. Our actions shall be based
on passion for excellence, ethics & a positive culture with freedom of expression for
continual improvement.”

4.6.3 Functions of quality control

Activities of Quality control department in OPL were:
o Testing and release or rejection of all incoming raw materials, packing
materials, in-process / intermediates and finished products as per specified
specifications.
o Maintaining testing records as per standard procedures for raw materials,
packing materials, in-process / intermediates and finished products.
o Calibration of laboratory instrument / equipment.
o Performing stability study.
o Analytical method validation.
o Preparation of standard volumetric solutions and maintain standardization
record.
o Maintain Labeling procedure at all the stages and records.
o Maintain working / reference standard record of products.
o Analysis of complaint samples as and when required.
o Follow safety norms at all the stage during handling of chemicals and using
instruments.
o Follow good laboratory practices
o Swab analysis
o Water analysis
o Microbiological analysis
o Stability testing
Environmental monitoring of production area (Checking for bio-burden level)

25
 QC performs Raw Material, Packaging Material & Finished Product analysis as
follows:
Raw Material Packaging Material Finished Product

Receipt
RM analysis
 Physical characteristics (color,
odor, foreign material & Verification
particle size), identification
tests, purity test, assay, heavy For tablets/ capsules:
metal content, water content, Physical appearance,
Micro-bial limit, residue on Sampling
identification, assay,
evaporation & pH etc. dissolution time, DT,
packaging test etc.
PM analysis:
Under Test
Packing foil (length, breadth, For liquids:
thickness, correctness of Description, wt. variation,
printed text, coating), bottle, PH, viscosity, assay, cap
duplex label, pp cap, QC Testing sealing, identification etc.
measuring cap

Approved Rejected

For Manufacturing (RM/PM) Returns/Destruction

For market release (FP)

In-process checks Received in-process

requisition along with sample

Testing as per specification or

requisition

Results conveyed to
production

Fig: Analysis in Quality control

26
 Different instruments seen in Q.C department are as follows
1. FT-IR Spectrophotometer 15. Humidity chamber
2. UV/visible Spectrophotometer 16. Stability study chamber
3. High Performance Liquid 17. Water bath
Chromatography 18. Friability apparatus
4. Dissolution Apparatus 19. Vacuum pump filtration
5. Disintegration Test Apparatus assembly
6. Thin Layer Chromatography 20. PH meter
7. Hot Plate Magnetic Stirrer 21. Conductivity meter
8. Viscometer 22. Centrifuge Machine
9. Sonication bath 23. Autoclave
10. Melting Point Apparatus 24. Analytical Balance
11. Incubator 25. Desiccators
12. Laminar airflow cabinet 26. Karl-Fischer/ Potentiometric
13. Hot air over titration
14. Refrigerator 27. Muffle furnace

4.7 Research & development department

Their R&D team has all the necessary skills and equipment to formulate and produce
even unique and new combinations of medicine. There is a R&D department in OPL
which worked in discovering new knowledge about products, processes, and services
and then applying that knowledge to create new and improved products, processes
and services that fill market needs.
The marketing planning department (MPL) of the company conducts surveys and
researches to find out what sort of formulation and dosage form has higher demand
and higher scope in the market. The R &D department conducts the literature review,
the production department checks whether such formulation is feasible in the
company or not, whether they have sufficient instruments and machines or not.
Finally, if it is concluded that the product can be produced in the company then the
company applies for the product registration form in the DDA. Then after getting the
manufacturing license the R & D starts its work in small scale producing different
formulation changing the excipients and other ingredients and sends it to QC for the
effectiveness of the formulation. Side by side the stability test of the formulation is

27
 conducted. The stress testing is conducted to find out the shelf life. After satisfactory
result from the different trials the formulation is produced is large scale. Then some
samples are sent to the NML and after its approval, the company applies for
marketing permission. The real time stability test is also initiated right from the scale
up production. Then large scale production stars after the approval letter from DDA.

4.7.1 Functions of R & D

 New formulation development
 Upgrading of existing product
 Analytical method development
 In house specification development
 Stability study
 Troubleshooting during production
 Coordination with DDA and other authorities

4.8 Maintenance and engineering section

Maintenance section is the backbone of a pharmaceutical industry which provides a
suitable environment for manufacturing of different forms of drugs. They regulate all
the physical, instrumental requirements of industry so as to facilitate smooth
production and favorable environment. The major function of this department is
routine management of HVAC system, water plant system, electricity supply, power-
backup generator, compressed air supply, etc. The major units are described below.

Different instruments/machineries seen there:

 Air compressor (mainly for  Steam generator
Coating, Fluidized bed dryer,  RO water plant
Capsule separation and  Pressure vessel
polishing, Blister packing, To  WFI plant
run chopper of RMG, Bottle  WFI storage tank
de-dusting, etc.)  HVAC & AHU set system
 Air receiver tank  Power backup generator

28
4.8.1 Heating, Ventilation and Air Conditioning Unit (HVAC system)
An HVAC system is Heating Ventilation and Air Conditioning System. It plays an
important role in ensuring the manufacturing of quality pharmaceutical products.
HVAC system design influences architectural layouts with regard items such as
airlock positions, doorways, and lobbies. The architectural components have an effect
on room pressure differentials cascades and cross contamination control. The
prevention of contamination and cross contamination is an essential design
consideration of the HVAC. Temperature, relative humidity, particle count and
ventilation should be appropriate and should not adversely affect the quality of the
pharmaceutical product during their manufacture and storage or the accurate
functioning of the HVAC system. It is a system that controls the air temperature by
controlling their air filtration and the moistures, supply the area with fresh air by
controlling the carbon dioxide and oxygen level. It also controls the contamination of
airborne particles by regulating the movement of air.
The HVAC system can effectively control the air conditions of a given parameter
through heating by adding then thermal energy in an area to increase the temperature;
the cooling is done through decreasing the thermal energy in an area to decrease the
temperature. Humidifying is done by adding steam or water vapor in an area to
increase the relative humidity. The air is cleaned by removing the smoke, dust or
pollens that contaminate the air. The air is ventilated by maintaining the gas ratio
which can be done by adding external fresh air. Lastly, the system controls the air
movement that is supplied in a space which ensures that those supplied in the place
are comfortable.
The basic components of HVAC system is boiler, chiller cooling tower and air
handling unit (AHU).

In OPL, Double skin AHU is located inside mezzanine floor and air cooled chiller
located on terrace is dedicated to each critical area in order to avoid cross
contamination. Control panel along with thermostat is located on terrace near chiller
plant. All manufacturing and primary packing areas are provided with HVAC system.
Temperature and relative humidity is maintained by the HVAC system as per the
requirement of production being processed in the rooms. The air is passed through
double skin AHU with blower and then series of the filters and numerous rows of

29
 heating and cooling coils. Air distribution is through low particle shedding GI ducting
system insulated with arm flex insulation material. The Return air is collected from
rooms and 20% fresh air is added to the system, filtered, cooled/heated and supplied
to dedicated areas.

Mixing
chamber

Outside air

Figure 4-5 Schematic diagram of HVAC system

Figure 4-6 Diffferent filters in HVAC system

30
 Figure 4-7 Different parts of HVAC system

Ventilation system complies with 2 staged filters 10µprefilter, followed by 5µ bag

filter. Supply grill is production area have terminal 0.3µ superfine HEPA filters.
100% exhaust is ensured in the powder processing area. HVAC system is designed to
maintain an environment of 20⁰C-24⁰C and RH 45%±5% in case of manufacturing
area all the return air duct 10µ filters are provided to avoid powder contamination.
Dehumidifier along with AHU is provided at all critical location of tablet and capsule
manufacturing.

[Link] Air Handling Unit

An air handler, or air handling unit, is a device used to condition and circulate air as
part of a heating, ventilating, and air conditioning (HVAC) system. An air handler is
usually a large metal box containing a blower, heating or cooling elements filter racks
or chambers, sound attenuators, and dampers. Air handlers usually connect to a duct
work ventilation system that distributes the conditioned air through the building and
returns it to the AHU. Sometimes AHUs discharge (supply) and admit (return) air
directly to and from the space served without ductwork. Small air handlers, for local
use, are called terminal units, and may only include an air filter, coil, and blower;
these simple terminal units are called blower coils or fan coil units. A larger air

31
handler that conditions 100% outside air, and no re-circulated air, is known as a
makeup air unit (MAU).
The air inlet section consists of a funnel shaped inlet duct from where air enters the
AHU. From this place about 25% fresh air and 85% re-circulated air is transferred.
The fresh air and re-circulated air gets mixed in the mixing chamber. The so mixed air
gets filtered through various filters in the filter section. The filter section contains pre-
filter, bag filter, supply filter and return filter. The pre filter is of 10µ in its pore size
and is washable while the bag filter is of 0.5µ and is disposable. The supply filter is
kept at inlet of rooms. The filtered air is passed through conditioning unit where the
temperature and humidity is maintained at about 15-30º C and 20-60% respectively.
Re-circulated Air-
Fresh Air- 85%
15%

Mixing Chamber
Pre-filter (10µ) Bag Filter (5µ)

Blower/ Heater (Solenoid Coil) Condensing Unit (Chiller)

Fan

Controller HEPA Filter/ Biopack Room

filter (0.3µ)

Biopack Filter
Return Filter
(10- 20µ)

Figure 4-8 Mechanism of AHU

Then the air is supplied to the blower section which supplies the air to the supply
ducts. Each room and the corridors are provided with the inlet of air, which consists
of HEPA filter of pore size 0.3µ size, and corridor is positively pressurized which is
in accordance with WHO GMP which is double plus for corridor and plus for rooms.
Each room is provided with inlet of air at the top of the room and outlet at the
opposite side at the bottom of the room. Pressure cascade corridor must be positive to

32
operating room with 15 Pascal’s difference. Air change per hour must be 20-25
cycles. Standard Magnetic Pressure Gauge is installed in every door to monitor the
pressure difference.

Cleanroom standards
The closed area having controlled airborne particle concentration is considered as
clean zone or clean room where clean or aseptic work is carried out. These areas are
constructed to minimize the introduction, generation, and retention of airborne
particles in the area and to maintain low particle count of predefined limits. The
concentration of particles depends on their diameter; hence the bigger particles will be
less in number then the smaller particles in any cleanroom environment. The airborne
particles play a considerable role in aseptic processing because the viable particles i.e.
bacteria, fungus etc. are associated with non-viable particles and may cause
contamination in pharmaceutical preparations. Classification of these areas are given
in many guidelines but the base of all other guidelines is ISO i.e. ISO-14644-1. A
proper classification is given in ISO with formula which gives the concentration of
airborne non-viable particles in any class. There are 9 classes of cleanroom in ISO but
only ISO Class 5 to ISO Class 8 for 0.5 µm and 5.0 µm are applicable in
pharmaceuticals.

Table 4-1 ISO 14644-1 Cleanroom standards

33
[Link] HEPA filters
HEPA stands for High-efficiency particulate air. HEPA filters are one of the most
important elements of a cleanroom. They consist of a large, box shaped filter that
removes airborne particles of specific sizes very efficiently. They must also be
monitored and tested regularly to make sure they are still integral. HEPA filters are
composed of a mat of randomly arranged fibres, which are typically composed of
fiberglass with diameters between 0.5 and 2.0 microns. Key factors affecting
function are fibre diameter, filter thickness, and filter face velocity.

Common standards require that a HEPA air filter must remove from the air that passes
through at least 99.95% (European Standard) or 99.97% (ASME, U.S. DOE) of
particles whose diameter is equal to 0.3μm with the filtration efficiency increasing for
particle diameters both less than and greater than 0.3μm. The four primary filter
collection mechanisms are Diffusion, Interception, Inertial impaction, Electrostatic
attraction

Figure 4-9 HEPA filters

HEPA filters are used in industry where ever it is require to make the environment
free of particulate matter as well as free from microbial contaminants (bacterial,
viruses etc.) in clean room. A HEPA filter of efficiency 99.97% is usually used in
aseptic manufacturing, filling, packing, parenteral dosage manufacturing.

34
These filters are mounted on laminar air flow bench which are then used as clean area
for actual aseptic manipulations or aseptic filling where usually a clean area of class
100 are required, such laminar air flow bench are typically found within a clean area
of class 1000, which are again maintained by HEPA filters installed in a HVAC
system.

Water Purification System

Water is an essential ingredient to pharmaceutical manufacturing. Once purified, non-
compendial water, purified water or water for injection must be stored and distributed
in systems appropriately designed, installed, commissioned and validated. Controlling
the water quality in the distribution loop to ensure delivery to the point of use at the
required flow and temperature can be challenging.
In OPL, Water is stored in an underground reservoir tank of capacity 150000 liters,
which is then transferred to a raw water storage tank located at the roof of the building
Potable water is first passed through sand filter to remove any suspended particulate
matter. Sand filter consists of different size of particle, smaller size at upper bed and
larger size towards bottom.

Figure 4-10 Water Purification system

35
 Sand filter is rinsed daily, cleaned by back-pass of water and drain through bypass.
Then, it is passed through activated carbon filter, mainly to de-chlorinate water by
adsorption and also remove any odor or color. It is changed in every two weeks.
Water coming out of carbon filter is passed through water softener tank to reduce
hardness of water by removing Ca, Mg, and other metals with help of resins. Resins
are recharged with iodine free NaCl weekly or in 15 days. Resins are changed as
required, usually after 2 years.
Then this water can be used as tap water, also it is dosed with descalent to remove any
scale forming salts. It prevents scale formation in RO membrane and it’s choking. The
descalent dosed water passes through 5µ cartridge filter and then through serial RO
plant of 0.3 µ sized membrane pore. From RO plant, two lines of water are separated;
one of concentrated water which can be used in gardening and washroom, another line
of RO water is for pharmaceutical use which is stored in storage tank and which then
enters to mixed bed de-ionizer to maintain conductivity below 0.3µ Siemens/cm (In-
house limit). Mixed bed de-ionizer has mixed resins both cationic and anionic, which
removes anions and cations of water respectively. Anionic resins are recharged with
HCl whereas NaOH is used to recharge Cationic resins. Then after, the purified, de-
mineralized water is passed through UV light system to kill microorganisms and then
through the 0.2µ sized cartridge filter and collected into the distribution tank.
Distribution of water in every section occurs through PVP pipes.

4.8.2 Power Supply

OPL’s Electric Power supply: From Nepal electricity supply board.
Backup Power supply (generator): As for the alternate source of electricity
company is facilitated by two diesel based generators of 360KV and 20KV capacities
in case of power cut.

5 DISCUSSION
OPL enhanced understanding of my academic knowledge and skills. It indeed
polished my knowledge and experience. Classroom studies are confined only to books
and theoretical learning majorly. Application of these theories and lectures delivered
in classrooms differ a little from the specifically set format. Through this internship, I
not only got the opportunity to experience but I also learnt the applications of these
theories in actual the application. I got to observe the whole working environment of

36
 pharmaceutical industry & the important aspects regarding the production of high
quality pharmaceuticals & carrying out important quality control tests to ensure that
all the procedures carried out during production are according to GMP. I was able to
understand the working conditions of pharmaceutical industry much better than
before. It also improved my general knowledge about equipments commonly used in
industries.

Not only pharmacists in production areas but even workers helped me to understand
important procedures regarding the production. The entire journey of internship
allowed me to identify my strengths and weaknesses, and use both of them to the best
advantage of my career.

5.1 Lessons Learn From OPL

Working in OPL as an intern was my first experience where I get the chance of being
a part of an organization. This Internship will be very effective for the future. Some
of the lessons are given below which I learned during my internship.
 Corporate behavior and culture
 Punctuality
 Learn to follow supervisor instruction properly
 Learn to strict following of standard specification
 Discipline
 Taking responsibilities
 Professionalism
 Networking
 Taking initiative
 Maintaining good working environment

5.2 Some of the works that I have done during my internship

 Identification of raw material including solubility, limit test, sulphated ash, FT-IR
spectroscopy, heavy metals PH etc. according to compendia specification
 Packaging material analysis
 Swab analysis & water analysis
 IPQC test of tablets, capsules and liquids
 Finished product analysis ( wt. variation, hardness, thickness, PH, TLC, wt/ml etc)

37
  Round check for update of calibration of equipments
 Sampling of packing foil
 Checking and arrangement of some QA approved list of documents for any missing

5.3 Suggestions
As an internee I find it is very short duration to learn for me and to take a round of
practical work especially in the quality assurance & quality control area. Training
according to specific schedule on every related topic in every section would be better
for both internee as well as to your organization to produce qualified professionals.

6 CONCLUSION
Industrial training is very much essential for Pharmacy students. It is also a great
opportunity to acquire practical knowledge. During my training period I acquired lots
of experiences in Pharmaceutical production and management. This helped me to
clarify theory knowledge and it will help me much in my future profession.

During my training period I had seen the various instruments and apparatus in store,
production, QC, QA and engineering departments. The highly sophisticated
instruments that work precisely must be operated with intense care for optimum use.
We could acquire a lot of information regarding the latest instruments and working
procedures. We saw the actual working of BMR, BPR, SOP’s and how it acted along
in the production of a pharmaceutical product, maintaining GMP.

The training was very interesting with lots of things to be learned. It helped us to
acquire knowledge on punctuality, regularity and working environments in industries.
The friendly working environment, helpful and dedicated staff will remain in my
mind in near future. I got to learn from them, how to handle a problem in a real
setting, that which wouldn’t be found in books. Their guidance and support were
always valuable.

Hence, I can say that my goal of attending the industrial internship is fulfilled. I
acknowledge the great help of OPL and wish a great march towards the
pharmaceutical excellence always.

38
7 REFERENCES
1. Home | Ohm Pharmaceuticals Lab. Pvt. Ltd. : [Link]

2. Pharmaceutical Guidelines : Total Pharmaceutical Solution :

[Link]

3. Quality Assurance : Pharmaceutical Guidelines:

[Link]

4. Production : Pharmaceutical Guidelines:

[Link]

5. (PDF) In Process Quality Control Tests (IPQC) for Pharmaceutical Products:

[Link]
trol_Tests_IPQC_for_Pharmaceutical_Products

6. Swenson SD. HVAC : heating, ventilating, and air conditioning [Internet].

Homewood, Illinois: American Technical Publishers; 1995:
[Link]
Conditioning-0826906753/plp

7. (PDF) Pharmaceutical Air Handling system-A Review:

[Link]
dling_system-A_Review

9. First MW. Hepa Filters. J Am Biol Saf Assoc. 1998 Mar;3(1):33–42.

10. Understanding Cleanrooms & Particle Count | Hutchins & Hutchins:

[Link]
cleanrooms-and-particle-count

11. Pharma Research & Development - Strategic Drug Development Services:

[Link]

39
ANNEX-I
Category Dosage form S.N Product name Generic name
1 PREGNO Mifepristone
2 PREGNO KIT Mifepristone &
Abortifacient or Tablet Misoprostol
Labour induction 3 MISTOL Misoprostol
4 ALERT Cetrizine HCl
Tablet 5 KESTINE 10/20 Ebastine
Antiallergic 6 WELFEX Fexofenadine HCl
120/180
Syrup 7 ALERT syrup Cetrizine HCl
Suspension 8 WELFEX Fexofenadine HCl
suspension
Antiasthmatics Tablet 9 AIRY 10 Montelukast
sodium
Anticold Tablet 10 ACC tab. Paracetamol +
phenylephrine HCl
+
chlorpheniramine
HCl
11 ACC suspension Paracetamol +
Suspension phenylephrine HCl
+
chlorpheniramine
HCl
Antiobesity Capsule 12 OBESLIM Orlistat
Antiprotozoal or 13 ZOLBEN 400CT Albendazole
Antihelminthic Tablet 14 AGT 500/1000 Tinidazole

Antitussive Syrup 15 COFSY D Levodropropizine

Antivertigo Tablet 16 VERTIN 8/16 Betahistine HCl
17 XIFIM 100DT Cefixime
trihydrate eqv. to
anhydrous
Antibiotics cefixime
18 XIFIM 200 Cefixime
trihydrate eqv. to
anhydrous
Tablet cefixime
19 QUINFLOX Ofloxacin
200/400
20 OPIFLOX Ciprofloxacin HCl
21 LEFLOX Levofloxacin
250/500 hemihydrates eqv.
to levofloxacin
22 BACMAX Cefpodoxime
proxetil

40
 23 AZICARE Azithromycin
Suspension 24 BACMAX RPOS Cefpodoxime
proxetil
25 XIFIM-RPOS Cefixime
trihydrate eqv. to
anhydrous
cefixime
Antioxidants Capsule 26 COQ 30/60 Ubidecarenone

27 IBOSYN Mebeverine HCl

Antispasmodic Tablet 28 DOVE 40/80 Drotaverine HCl
29 BIOSPAN 10/20 Hyoscine
Butylbromide
Antiulcer agent Suspension 30 SOKOOL Sucralfate
31 PROSTIF Finasteride
Benign prostatic Tablet 32 PROSTAM 0.4 Tamsulosin HCl
hyperplasia agents 33 PROS D Dutasteride
Gastrokinetic Tablet 34 PROBEN 50 Itopride HCl
agents
Hepatoprotective Tablet 35 HEPACT Ursodeoxycholic
150/300 acid
Neuropathic pain Tablet 36 PREGALIN Pregabalin
agent 75/150
Tablet 37 OMNI Nimesulide
38 OMFLAM Ibuprofen and
Paracetamol
NSAIDs 39 ALOFEN Aceclofenac
Suspension 40 OFLAM Ibuprofen and
suspension Paracetamol
41 LOTEMP Paracetamol
Oral contraceptives Tablet 42 UNWANTED Levonorgestrol
Osmotic laxative Solution 43 EVALAX Lactulose
Progestin hormone Tablet 44 FEMININE Norethisterone
Proteolytic enzyme Tablet 45 SIDAZE Serratiopeptidase
Proton pump Tablet 46 PANOM 40 Pantoprazole
inhibitor Capsule 47 OMIRA Rabeprazole
sodium
Urinary alkalizer Syrup 48 ALIZER Dihydrogen
sodium citrate
Urinary tract Tablet 49 UROXATE Flavoxate HCl
spasmolytics
Tablet 50 MECOBAL Methylcobalamin
Vitamins 0.5/1.5

Capsule 51 B-COM Vitamin B

complex
(vit.B1+vit.
B2+vit. B3+vit.

41
 B5+vit. B6+vit.
B12+ ascorbic
acid)
Suspension 52 B-COM Vitamin B
suspension complex (vit.B1+
vit.B2+vit. B3+vit.
B5+vit. B6+
vit.B12)

42
43