International Quality Systems

presents
Training Cum Seminar

AYURVEDIC INDUSTRY
GMP NEEDS
GOOD HYGIENE & SANITATION
GOOD HOUSEKEEPING
Ayurvedic Pharma products
Safety
Never has ayurvedic products Safety come under
such scrutiny.

 Regulators are increasingly active in safeguarding

these ayurvedic products.

Globalisation and dismantling of trade barriers

means suppliers have to compete on equal terms.

International Quality Systems

9837097100, 0132-2660077 ,
Ayurvedic Pharma products
Safety
 Customers are better educated and informed
and are demanding:
Safety
Consistency of quality
Value for money

International Quality Systems

9837097100, 0132-2660077 ,
What’s Driving Ayurvedic product
Quality & Safety Issues?

 Customers (Better Educated/Preferences)

 Regulatory Bodies (Governments)
 World Health Organization (CODEX)
 Market Access (EC/USFDA )
 Shareholders, Insurers (Litigation/Claims)
 Retailers & Private Labels (Brand Protection)

International Quality Systems

9837097100, 0132-2660077 ,
 Ayurvedic productsSafety
`
Major medicinal scares, poisoning, GMO’s, chemical
residues have all highlighted the imperative to;

 Manage risk across the entire product chain

 Move from the old end of line product inspection
approach (often by government inspection
agencies) to a new environment of quality
assurance approach where the supplier assumes
responsibility for safety.

“BRAND PROTECTION”

International Quality Systems

9837097100, 0132-2660077 ,
The Answer to meet the needs?
An Integrated company-wide “Quality Management
System/ GMP” that;
 Manages product safety issues
 Builds in customer product quality
requirements
 Meets regulatory & market requirements
 Is cost effective and makes money

International Quality Systems

9837097100, 0132-2660077 ,
Product safety issues are prominent

•More people, more products variety,

more sources
•Better reporting of product safety :
Poisoning outbreaks
•Tougher legislation
•Greater Liability

International Quality Systems

9837097100, 0132-2660077 ,
The Solution

•Providing Safe products

•Managing Product Safety Hazards
•The Safe Handling of products across the chain
•GMP for Ayurvedic products Operations
•Sanitary Facilities and Equipment
•Cleaning and Sanitizing

International Quality Systems

9837097100, 0132-2660077 ,
All What Require :-
Action with Vision
 VISION WITHOUT ACTION IS JUST A
DREAM

 ACTION WITHOUT VISION IS TIME PASS

International Quality Systems

9837097100, 0132-2660077 ,
Change at heart

 IF YOU WANT TO CHANGE THE

ORGANISATION ,YOU SHOULD
BE READY TO CHANGE

International Quality Systems

9837097100, 0132-2660077 ,
Customer Focus
 Proactive,Interactive,Reactive
 The customer satisfaction enhancement
 Regulatory Requirements related to products
 Customer requirements identification,changes
 Communication with customer
 Customer satisfaction measurement
 Customer Complaint Redresser
 Customer requirements of whole contract not
just the quality of product
International Quality Systems
9837097100, 0132-2660077 ,
Customer Orientation

A customer is the most important visitor

in our premises.
He is not dependent on us,
We are dependent on him.
He is not an interruption on our work,
He is purpose of it.
He is not an outsider to our business,
He is part of it.
We are not doing him a favor by serving him,
He is doing us a favor by giving us an opportunity
to do so.
MAHAMA GHANDHI

International Quality Systems

9837097100, 0132-2660077 ,
 Your Goal as a Leader :

•Protecting People

•Keeping your Employees and

Customers

•Preventing Product-Safety errors

International Quality Systems

9837097100, 0132-2660077 ,
Paradigm Shift
 Market was productivity Oriented
 Now its Quality Oriented ,that promises
them better value
 Care for Value not only the Price
 Competitive arena
 Stringent Legislations
 Presence Global players
International Quality Systems
9837097100, 0132-2660077 ,
GMP: Answer to this shift
Reasonable Care - to be proved by you
• Sincere effort needed to promote industry
• As ayurvedic sector is not much organized
• GMP globally accepted
• Build Confidence into product quality
• Opportunity to internal improvements

International Quality Systems

9837097100, 0132-2660077 ,
Why GMP in Industry is so
popular
 It gives international credential.
 Companies are shopping for quality suppliers.
 It is mandatory in some industries and required in
every industries.
 It withstands the test of time and logic.
 The process of certification will
 Build processes
 Increase productivity

International Quality Systems

9837097100, 0132-2660077 ,
What it requires

If you follow religion religiously you tend to be extremist

but if you follow rationally you are really religious.
“Rationality is the Key”
GMP requires:
Utilize & Formalize existing systems.
Formalize system with quality orientation/ focus:
Results
• Monitoring
• Policies.
• Processes.

International Quality Systems

9837097100, 0132-2660077 ,
GMP CONSTITUENTS

 GOOD HYGIENE & SANITATIONS

 GOOD HOUSE KEEPING

 GOOD LAYOUS / GOOD PRIMESES

 GOOD DOCUMENTED SYSTEM

 EDUCATION & TRAINING OF

PERSONNEL

International Quality Systems

9837097100, 0132-2660077 ,
GMP : GOOD MANUFACTRING PRACTICES

Requires
• Written Standards

• Written Procedures

• Inspection Results

International Quality Systems

9837097100, 0132-2660077 ,
GOOD HYGIENE & SANITATION

 TODAYS TOPIC
 GOOD HYGIENE & SANITATION
 In this session, we are going to deal
with an area of importance to the good
functioning of a factory, sanitation and
hygiene
 It is addresses Section 3 of the WHO
GMP Guidelines
International Quality Systems
9837097100, 0132-2660077 ,
Good Hygiene : More Important
Definitions:

Clean - Lack of visible dirt

Sanitary - Free of harmful levels of micro-organisms and

contaminants

Note : What appears to be clean may not be sanitary

International Quality Systems

9837097100, 0132-2660077 ,
Objectives
 Review measures to ensure good sanitation in:
 Premises and personnel

 Equipment and apparatus

 Processes, materials and containers

 To review measures to ensure good personal

hygiene

International Quality Systems

9837097100, 0132-2660077 ,
Objective
 Firstly, To understand What is
hygiene? & what is its importance?
 We must look at the measures that
need to be taken to ensure that good
levels of hygiene are achieved during
manufacturing. These relate primarily to
the personnel.

International Quality Systems

9837097100, 0132-2660077 ,
Objective
 Secondly, we must look at the
measures that need to be taken to
ensure good sanitation during
manufacturing. These relate primarily
to the premises, the equipment and the
process to prevent any type of
contamination.

International Quality Systems

9837097100, 0132-2660077 ,
Why do we need such high
Hygiene Standards ?.
The COSTS of Poor The BENEFITS of Good
Hygiene
Hygiene
 One Satisfied Customer
 Ayurvedic Products are raw Leads to Another
products some times Poisoning
Outbreaks & Sometimes Death  A Good Reputation
 Customer Complaints  Increased Business
 Pest Infestation  Compliance with the Law
 Wasted Ayurvedic Products  Longer Ayurvedic Products
(spoilage) shelf Life
 Closure of premises (loss of  Better Working
jobs) environment
 Fines and costs of legal actions  Higher Staff Morale
 Civil action taken by Ayurvedic  Increased Profits
Products poisoning victims
 Loss of Profit
International Quality Systems
9837097100, 0132-2660077 ,
 Why is Good Hygiene Important to
Product Safety?

All of us carry disease-causing bacteria on

or in our bodies. These bacteria can be
carried to herbs/ medicines, where they
will make a customer or a co-worker
sick. By staying healthy and keeping
clean, you can prevent an outbreak of
product borne illness.

International Quality Systems

9837097100, 0132-2660077 ,
Good Hygiene & Sanitation
Programme
if well- organized:

• Protects Public and Employees

• Enhances Product Quality

• Decreases Liability

• Increases customer confidence

• Increases Profitability
International Quality Systems
9837097100, 0132-2660077 ,
Scope for Hygiene &
Sanitation in Organization
High level of sanitation and hygiene practised –
in every aspect of manufacturing. It covers:
 Personnel

 Premises

 Equipment and apparatus

 Production materials and containers

 Products for cleaning and disinfection

 All potential sources of cross-contamination

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
 Consideration must be given to all personnel,
both direct operators and other staff who
enter the manufacturing area for whatever
purpose.
 Personnel Hygiene parameter defined &
adhered
 Entrance to manufacturing area must be
controlled
 We must have properly defined SOP for
person entering the manufacturing
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene

Equipment Used should be

 Easily cleanable by normal methods

 Non-toxic, non-absorbent, corrosion

resistant, and non-reactive

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene
Equipment should be
designed so that:

it does not damage the

product

it can be taken apart for

cleaning

outside surfaces do not

allow dust, insects, and
microbes to accumulate

Products are protected

from contamination

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene
 All equipment and apparatus used in
manufacturing must be controlled,
together with production materials and
the containers in which they are held.
 Production materials (if not handled
properly) and the containers (if not
properly cleaned) can contribute to dirt
and contamination in the factory.
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene
 Secondary materials, such as cleaning
agents and disinfectants, must be
controlled to ensure that they do the
job for which they are designed but do
not cause any contamination to the
product. Cleaning tools, such as mops
and brushes, must also be controlled.

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene
 To summarize, the aim of sanitation and
hygiene measures is to eliminate all potential
sources of contamination and cross-
contamination from all areas where the
product is at risk.
 To summarize, the aim of sanitation and
hygiene measures is to eliminate all potential
sources of contamination and cross-
contamination from all areas where the
product is at risk.
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene

Personal Hygiene
Sanitation & Hygiene:
Personal Hygiene
MOST COMMON EXAMPLE OF PERSONAL
HYGIENE IS
 Working Healthy: Hand washing and Care

 Who? You!
 What? Washing hands.
 Where? At a hand-washing sink that
has hot water, soap, a
nailbrush and paper towels or
a hot-air dryer
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 When? Before starting work.
 After going to the restroom.

 During work after:

 Handling food eating or drinking

 Touching your hair, face cleaning or

body.
 Sneezing or coughing touching anything

that may contaminate hands

 Smoking.

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 Why? To prevent product borne
illness
 How? Use warm water
Moisten hands/apply soap
Use a clean nailbrush
Rub hands together for 20
seconds
Rinse thoroughly
Dry hands
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
Hand Care to Ensure personnel Hygiene
 Keep nails short  Wash hands before
and clean putting on any food
 Do not touch hair, preparation gloves
clothes or skin  Change gloves as soon
 Cover all cuts and as they become soiled
sores or torn and before
 Never touch the beginning any new
insides of mixers or task
eating surfaces of
tableware
International Quality Systems
9837097100, 0132-2660077 ,
 Sanitation & Hygiene:
Personal Hygiene
Personnel’s Illness and Injury must be taken
care to ensure hygiene
Illness: Employees Injury:
should never  All cuts, burns, boils,
participate in Product sores and infectious
preparation if they are areas of the body
experiencing: should be bandaged
 Fever while preparing product
 Diarrhea  Be safe! Employees

 Nausea or vomiting needing to be bandaged

 Sore throat or sinus
should not prepare
infection product
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
Other Hygiene Practices
 Not Touching product during
preparation
 Separate Eating and Smoking areas
 Storage Space of Personal items
 Rest-rooms separated from
manufacturing area
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
Common Personal Hygiene Checklist
Each day before starting work, check yourself for the following:
 Have no open cuts or burns.
 Finger-nails are trimmed and clean.

 Should not wear jewellery.

 Apron should be clean.
 Taken bath before coming to work.
 Hands are washed.
 Not wearing false finger-nails or nail polish.
 Uniform is clean.
 Wearing hair restraint (Head Gear).

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene: Ensuring
Personal Hygiene
What WHO GMP Guidelines says about
personnel Hygiene
 The hygiene of the personnel involved in
manufacturing
 Health examinations:
 Before and during employment : The recruitment
process for direct operators in particular should
include a medical examination. This should be
repeated on a regular basis during the employment
period. The definition of “regular” will obviously
depend on the activities being undertaken and the
products being processed.
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 Periodic eye examinations for those who do
visual inspections
 Training:
 Practices in personal hygiene: Induction training
for new operators should include basic training in
personal hygiene and should state the level of
hygiene that is required for working in
manufacturing areas.
 Written procedures and instructions : There
should be written procedures covering the need to
wash hands before entering a manufacturing area.
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 Written procedures
and instructions -
to wash hands
before entering
production areas

 Some also use

disinfectants

International Quality Systems

9837097100, 0132-2660077 ,
 Sanitation & Hygiene:
Personal Hygiene
 Wash hands
before entering
production
areas

 Signs in areas
(e.g. changing
rooms)

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 Must take care of Illness or open lesions of Employees:
 Staff who have an illness or open lesions that are likely to

present a risk to the product .May affect the quality of

products :
 Should not be allowed to carry out operations that involve
handling of starting materials, intermediates or finished
products until the condition has cleared up
 Instruction and encouragement to report to supervisors:
Since not all illnesses are going to be obvious, operators
must be trained to recognize such risks themselves and be
willing to report any illness to the area supervisor.

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene

 Direct contact between product and operator

Direct contact between the
Should be avoided :
operator and the product should be
avoided wherever possible. If direct
handling is unavoidable, then gloves should
be worn and, if appropriate, these should
be disinfected after being put on.
 Starting materials, primary packaging materials,
intermediate and bulk product

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 Protection of product from contamination by:
 Using Clean clothes appropriate to personnel activities
 Including hair covering (e.g. caps)
 Check change rooms/changing facilities
 Hand washing, signs, drying of hands
 Used clothing stored in separate closed containers while
awaiting cleaning
 Laundering of clean area clothing according to an SOP
(written procedures) and in an appropriate facility
 Procedure for disinfecting and sterilizing must be made
when required

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 Smoking, eating and drinking not allowed in
production areas, laboratories and storage areas
 No chewing (e.g. gum), or keeping food or drinks
allowed
 No plants kept inside these areas
 Rest and refreshment areas should be separate
from manufacturing and control areas
 Toilets should not open directly into production
area,However, there should be a reasonable
access procedure.

International Quality Systems

9837097100, 0132-2660077 ,
 Sanitation & Hygiene:
Personal Hygiene

Toilets should not

open directly into FACTORY
CHANGE
ROOM
AIR
LOCK
TOILETS

production or storage
areas

CANTEEN

All This should be taken into consideration when setting up

changing procedures for entry to manufacturing areas.
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 Personal hygiene procedures including wearing protective
clothing apply to all persons entering into production
areas:
 Full-time employees
 Temporary workers

 Contractor's employees

 Visitors

 Managers

 Inspectors

Well layed down Written Procedures for access to

production area must be defined & Visitor Policy
must be made & followed
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 VISITOR POLICY ;
Statement made by the organization to
ensure hygiene at the production area
by the visitor ,who are visiting the
Production area
VISITOR POLICY MUST BE CLEARLY
DEFINED & UNDERSTOOD IN
ORGANIZATION

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Personal Hygiene
 E.g. VISITOR POLICY
 1. Visitors are not allowed to enter production area without permission of CEO/ Plant
Head /Partner/ Factory Manager & without escort
 2. Visitors should answers if they are suffering from any of these disease
 - Jaundice
 - Diarrhea
 - Vomiting
 - Fever
 - Sore throat with fever
 - Visibly infected skin lesions (boils, cuts etc.)
 - Discharges from ears, eyes and nose.
 - If suffering they must let manager Informed
 3. Visitors should not allow to touch any material without permission
 4. Visitors wishing to go inside the Production and Packaging areas are provided with
protective equipment and clothing and they are made aware of personal hygiene
practices.
 5. Visitors has to follow organization GHP
 6. Visitors must follow the instruction given to him by manager or supervisor
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene

Design of Premises
Sanitation & Hygiene: Design of Premises
Following things taken into consideration while designing the
premises
 Proper design

 Proper equipment

 Utilities

 Lighting and Ventilation

 Appropriate Workflow Patterns

 Ensures Dry Storage

 Separated Restrooms

 Proper Flooring

 Crack free & properly painted Walls and Ceilings

International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene: Design of Premises

 Water - potable with sufficient pressure

 Plumbing - Avoid cross-connection,
backflow, and back siphonage situations
 Sewage - Keep sewer water and solids from
contaminating Product
 Electricity - Outlets and wiring should be
safe and sufficient for equipment

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene: Design of Premises
 Lighting -
- Bright enough to reveal dirt and stains
- Avoid placing where broken glass can
contaminate product
 Ventilation-
- doors and windows MUST be screened
- exhaust hoods over preparation areas
- use screened outside air intakes
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene: Design of Premises
What WHO GMP Guidelines says about
Design of Premises
 Then there are the premises in which
manufacturing takes place. The level of
attention to Design of premises aspect will
vary with the operation that is carried out
 In general following things must be taken into
consideration in context of premises to
adhere to the GMP guidelines to Sanitation &
Hygiene
International Quality Systems
9837097100, 0132-2660077 ,
 Sanitation & Hygiene: Design of Premises
 We have to take care of Designs of
 Walls, floors, ceilings, ledges, drains, air
supply, dust extraction etc
 Buildings should be constructed and maintained so that floors, walls, and ceilings
can be properly cleaned and kept clean and in good repair.

Cleanable, durable, Cracks allow bacteria

impervious to and molds to
moisture accumulate

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene: Design of Premises
 the design of any area depends on the
activities that are going to be performed
there. However, in general terms, all areas
should be designed in such a way that
prevents the build-up of dirt and dust. This
includes the absence of ledges and
unnecessary surfaces, sealing of all joints in
ceilings, coving at floor and ceiling and
installation of a ventilation system that
provides an appropriate flow of air.

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene: Design of Premises
 Prevention of build-up of dirt and dust to avoid
unnecessary risks of contamination
 Defined Cleaning programme, appropriate
cleaning, cleaning records
 There are a number of aspects to be covered in
looking at cleaning. An effective programme
should be designed that covers both cleaning and
disinfections. The frequency of each will vary with
the function of each area and the particular
activities undertaken there.

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Premises
 There must be a written procedure (SOP) covering
the programme, who is responsible for carrying it
out, the materials to be used and methodology.
The procedure should be appropriate to the area
being cleaned. For example, the procedure for
cleaning the warehouse would not be appropriate
for cleaning a sterile area.
 There should also be a written record of cleaning
that has been performed.

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Premises
Effective cleaning and disinfections
 choice of materials and chemicals, validation
 Design of Drains should able to prevent backflow
 While drains are inevitable in some manufacturing
areas, they should be kept to a minimum and
should certainly not be located in sterile areas.
Their design must prevent the possibility of back-
flow. Open channels should be easy to clean and
disinfect.

International Quality Systems

9837097100, 0132-2660077 ,
 Sanitation & Hygiene:
Premises
 Protection from
insects, birds,
vermin and
weather
 from receipt of
raw materials to
dispatch of
released product
There should be maximum protection against the entry of insects or
other animals. In loading bays in particular, there needs to be
protection against the weather
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene

Avoidance of Cross-Contamination
Sanitation & Hygiene:
Avoidance of Cross-Contamination

WHO-GMP emphasize on Avoidance of cross

contaminations
Generally it happens no precautions taken to avoid
cross contamination , multiple product with different
nature produce at the time, Stored without
precaution but GMP stress on avoidance of Cross
Contaminations . Main Reasons for Cross
Contamination takes .
 By Clothing
 By Lack of Proper Ventilation systems
 Open Processing Area
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination

 Un-Segregated area
Lack of proper Cleaning and decontamination
Poor Hygiene Practices leads Cross Contamination
• Hands - Raw material- Ready to eat

• Product contact surfaces

• Cleaning Cloths, sponges

• Touch or drip fluids

International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination

 Due to uncontrolled release of:

 dust, gas, particles, vapours, sprays,
organisms, residue, insects
 So Avoid Cross Contamination
 Special precautions should be taken to prevent
generation and dissemination of dust
 Proper air control – supply and extraction,
suitable quality

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination
Measures that can be
taken to prevent cross-
contamination also
include:
 Segregated areas
 Ventilation systems
 Airlocks
 Clothing
 Closed processing
systems
 Cleaning and
decontamination
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination

 Avoidance of Cross-Contamination

 Campaign production:
 Separation in time
 Followed by appropriate cleaning
 Validated cleaning procedure

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination
 Ventilation systems and airlocks
 Appropriately designed ventilation system with air
supply and extraction systems : An important measure
against cross-contamination is the design of the
ventilation system.
 Supply or incoming air should be filtered : All incoming
air should be filtered to an appropriate standard to
achieve the grades of cleanliness specified for the
room being supplied.
 The use of appropriate pressure differentials and air
extraction, together with airlocks, is one of the main
ways of achieving control over cross-contamination.
(Airflow patterns and equipment design are other
considerations .)
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination
 Recalculation of air versus 100% fresh air supply
:Additionally, the recirculation of air must be
examined carefully. If a ventilation system
supplies 100% fresh air, then different rooms can
be used for different products at the same time.
However, if a system includes recirculation, then
all rooms supplied by that system must be
processing the same product, or the air must be
filtered to an appropriate standard
 Appropriately designed airlocks
 If no filters are installed, then all ductwork will
have to be cleaned during product changeover.
International Quality Systems
9837097100, 0132-2660077 ,
 Sanitation & Hygiene:
Avoidance of Cross-Contamination

 Appropriately designed
ventilation system
with air supply and
extraction systems
 Supply or incoming air
should be filtered

 Detailed modules in the

supplementary training
deal with
recommendations for
HVAC systems

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination
 Clothing
 Protection of operator and product
 Highly potent products or those of particular risk -
need for special protective clothing
 Personnel should not move between areas producing
different products
 Garments need to be cleaned
 i.e Decontamination processes for these clothes need
to be in place. For all manufacturing areas where
there is any risk of the product contaminating the
clothing, the simple precaution of not moving between
areas producing different products should be adopted

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination
 Cleaning and decontamination
 Procedure for removing soil and dirt
 Remove all cleaning chemical residues or disinfectant
residues
 Remove and/or reduce micro-organisms
 Validated (known effectiveness of the procedure):
Cross reference to the module on validation can
be mentioned if questions arise on how and what
is cleaning validation
 Use cleanliness status labels
 Test for residues

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation & Hygiene:
Avoidance of Cross-Contamination

 Closed processing systems

 For example: totally enclosed water
purification systems
 Tanks fitted with appropriate filtration -
without
removable lids
 Present special cleaning difficulties, sometimes
use
clean-in-place (CIP)
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation and Hygiene

Production Operations – Cleaning &

Sanitation
Sanitation and Hygiene:
Production Operations – Sanitation

 All product contact surfaces MUST be

washed, rinsed, and sanitized
 Detergents - surfactants lessen the surface
tension and loosens soil; mild alkaline
detergents for fresh soil and strong alkaline
detergents for wax, grease and aged, or
burnt-on soil

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

 Solvent Cleaners - also known as de-

greasers - grills, oven surfaces, grease stains
 Acid Cleaners - used when alkaline cleaners
do not work - scaling in dishwashers, rust
stains, brass and copper
 Abrasive Cleaners - contain scouring agents
for rubbing or scrubbing on hard to remove
soils - floors or burnt-in soils

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

Sanitizing
 Reduces the harmful micro-organisms

 Is NOT a substitute for cleaning

 Heat Sanitizing - 165 degrees or higher (water or

air)
 Chemical Sanitizing - check label for proper use

 Chlorine and Iodine - use at a temperature

between 75 and 120 degrees
 DO NOT USE scented or oxygen bleaches

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

Cleaning Equipments
 Clean-in-Place Equipment - cleaning
solutions pumped through the equipment
 Fixed or Immobile Equipment - power,

detachable parts, wash - rinse - sanitize, air

dry, put everything back together

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

Facility Cleaning
 Floors - mark area to be cleaned, sweep the area,

mop the area with a cleaning solution (mop away

from walls and toward a drain), remove excess
water, rinse and sanitize
 Floor Drains - clean after all other cleaning is
accomplished, wear heavy rubber gloves, flush the
drain, pour in cleaning detergent and scrub,
sanitize
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

 Ceiling - check for soil, cobwebs and

condensation
 Restrooms - clean daily
 Storage Areas - store supplies and equipment in a
neat and orderly manner
 Cleaning Supplies - cloths, sponges and scrubbing
pads (air dry), brushes and mops (hang), buckets
and pails (store with other tools)

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

Waste Management
 Garbage - remove as soon as possible
(garbage from other areas should not be
carried to or through the product preparation
area): provide enough containers and
dumpsters (should be leak proof and easily
cleanable); and should be cleaned and
sanitized regularly

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

Pest Control
 Establish an Integrated Pest Control
Management (IPM) program
 Deny pests food, water, and shelter

 Pest-Proof the facility

 Pest Control methods, if not used correctly

can be hazardous to humans
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

Pest Control General Practices

 Use reputable and reliable suppliers

 Remove garbage quickly and properly

 Store recyclables away from the Product service

area
 Properly store all food and supplies

 Keep cleaning equipment dry

 Thoroughly clean and sanitize

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

WHO GMP GUIDELINES ON PRODUCTION OPERATION

– CLEANING & SANITATION
 Cleaning and cleaning validation
 Degree of cleaning depends on whether consecutive
batches are of same or different product
 Check cleaning agent is fully removed
 If possible hot water alone used for cleaning
 all cleaning and disinfecting solutions carefully
prepared and expiry dated
 Final rinse with purified water.
 Full records kept
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

 Water systems
 Water - major constituent of most products
 SOP for cleaning and sanitization of the water
purification system should include distribution
line
 Validation and removal of disinfectant before
reuse

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

 Maintenance and repair

 activities inevitable in manufacturing area
 Should present no risk to product
 Whenever possible, all planned maintenance
outside normal operating hours
 Emergency work in working area followed by
thorough clean down and disinfection before
manufacturing recommences
 Area clearance by QC
International Quality Systems
9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

 Simultaneous Processing: Processing of different

products simultaneously within a single room or area
supplied by the same ventilation system must not be
carried out unless there is no risk of cross-
contamination. Hence, it is permissible to dispense
materials for different products within adjacent
down-flow booths in a dispensary. This is because
each booth creates its own protected environment.
That is, it is not permissible to process different
products in different parts of a tabletting facility,

International Quality Systems

9837097100, 0132-2660077 ,
Sanitation and Hygiene:
Production Operations – Sanitation

 if the area is supplied by a single unfiltered

recirculating air system It is also permissible to carry
out secondary packaging activities for different
products within a packing hall, provided there is
adequate physical separation, such as a partition,
since the product is sealed and there is no risk of
airborne contamination. However, it is not
permissible to process different products in different
parts of a tabletting facility, if the area is supplied by
a single recirculating air system, unless appropriate
air filtration is used.
International Quality Systems
9837097100, 0132-2660077 ,
GMP Norms
Factory Premises
The manufacturing plant should have adequate space for:
1. Receiving and storing raw materials
2. Manufacturing process areas
3. Quality control unit including in-house testing facilities
4. Finished goods store
5. Office
6. Rejected goods store
(Minimum for any one system 1200 sq feet covered area
with separate cabins for each activity. Additional 400 sq
feet for each additional system)

International Quality Systems

9837097100, 0132-2660077 ,
General Requirements
 Location and Surroundings

 Away from open sewage, drain, public lavatory and

factories producing obnoxious odor, fumes, dust or
smoke.
 Buildings

 Hygienic and free from cobwebs, insects and rodents

 Designed to prevent Cross-contamination

 Water Supply

 Potable & Other

 Disposal of Waste

 Predisposal Treatment
International Quality Systems
9837097100, 0132-2660077 ,
International Quality Systems
9837097100, 0132-2660077 ,
Health, Clothing, Sanitation and Hygiene of Workers

 Workers to be free from contagious diseases

 Uniform
 Suitable for climate and nature of work including coverings for hands, feet
and head wherever required
 Illness or open lesions:
 May affect the quality of products
 Should not handle starting materials, intermediates or finished
products, etc.
 Instruction and encouragement to report to supervisors

 Direct contact between product and operator:

 Should be avoided
 Starting materials, primary packaging materials, intermediate and
bulk product

International Quality Systems

9837097100, 0132-2660077 ,
Illness & Injuries

jaundice, diarrhoea,
vomiting, fever, boils, cuts,
skin lesions, discharges
from ear, eye or nose etc.
should be reported to
Management

International Quality Systems

9837097100, 0132-2660077 ,
• Facilities for personal cleanliness
Clean towels, soap, scrubbing brushes,
lavatories, change rooms & place for keeping
personal belongings.

• Medical Services
First aid
Medical Examination: At the time of
employment and at least once in a year

International Quality Systems

9837097100, 0132-2660077 ,
Personnel Hygiene
 Personal hygiene procedures including wearing
protective clothing apply to all persons entering into
production areas:
 Full-time employees
 Temporary workers
 Contractor's employees
 Visitors
 Managers
 Inspectors

International Quality Systems

9837097100, 0132-2660077 ,
Raw Materials
 Separate and adequate facilities for

 Raw materials of metallic origin

 Raw materials of mineral origin

 Raw materials from animal source

 Fresh herbs

 Dry herbs or plant parts

 Excipients etc.

 Volatile oils, perfumes and flavors

 Plant extracts, exudates and resins

 Labeling: ‘UNDER TEST’ or ‘APPROVED’ or ‘REJECTED’

International Quality Systems

9837097100, 0132-2660077 ,
Packaging Material
 Proper Storage

 Proper Testing

 Cleaning

 Controls on printed materials to avoid

wrong labeling

International Quality Systems

9837097100, 0132-2660077 ,
Working Space
 Adequate for orderly placement of

equipments and materials

 To facilitate easy and safe working

 To minimize/ eliminate risk of mix-ups

and cross contamination

International Quality Systems

9837097100, 0132-2660077 ,
International Quality Systems
9837097100, 0132-2660077 ,
 Storage
 Easy maintenance &
Cleaning
 Should not in direct
contact of Floor/ wall/
ceiling
 Avoids pest entry and
harborage
 Protects materials and
products from Should taken care about direct
contamination contact with floor /ceiling

International Quality Systems

9837097100, 0132-2660077 ,
Equipments
 Nature, number and sizes

 Permits maintenance and cleaning

 Facilitates good hygiene practices
 Installation and maintenance record
 Cleaning SOPs and Records
 Operation SOPs
 e.g.Anjana/ Pisti: Kharel/ ball mill, sieves/ shifter
 Churna: Grinder/ disintegrator/ pulverizer, powder
mixer, sieves/ shifter
 Ark: Maceration tank, distillation plant, liquid filling
tank with filter/ filter press, visual inspection box
International Quality Systems
9837097100, 0132-2660077 ,
International Quality Systems
9837097100, 0132-2660077 ,
Finished Goods Store

 Separate Quarantine Area

 Separated Approved Finished Goods
Stock Area

International Quality Systems

9837097100, 0132-2660077 ,
Quality Control
 Lab

 Personnel: To be headed by an independent person.

 Duties:

 To prepare specifications and testing methods for raw

materials and finished products.
 To sample, test, approve or reject RMs, PMs, semi-
finished product and finished products.
 To supervise and monitor the adequacy of storage
conditions.
 Maintenance of the records of each process where
testing of finished product is not possible.
International Quality Systems
9837097100, 0132-2660077 ,
Records
 Batch Manufacturing Records (BMR)

 Distribution Records (to facilitate recall)

 Record of Market Complaints and

Adverse Drug Reactions

International Quality Systems

9837097100, 0132-2660077 ,
Quality Control, Legal
Aspects & Documentation
1. Quality Perspectives of Ayurvedic-herbal Products: Status of
quality standards for Ayurvedic-herbal products. Databases for
identification and authentication of materials. Chemoprofiling &
bio-profiling of Ayurvedic-herbal products. Protocols for
establishing purity of materials, identification of adulterants,
substitutes, pathogenic bacteria & fungi, heavy metals and
pesticide residues. Validation of traditional claims through
scientific studies and clinical trials.
2. Quality Control: Control of manufacturing processes, statistical
quality control, control charts, sampling plans, automated process
controls, dosage form controls, Testing programs methods.
Product identification systems, adulteration & misbranding.
Maintenance of records. Bioavailability & bio-equivalence.
Manufacturer’s reliability. Manufacturer/drug information
profile.

International Quality Systems

9837097100, 0132-2660077 ,
3. Good Manufacturing Practices: GMP in manufacturing,
processing, packaging and holding of drugs. Control of
Components, containers and closures. Packaging &
labeling controls. Inspection for compliance with GMP.
Potable water standards. Premises- design, construction,
maintenance, equipments. Warehousing.

4. Pharmaceutical Process Validation: Regulatory basis,

validation of sterile products & non-sterile products and
processes thereof. Analytical method validation. Validation
of computer assisted processes.

International Quality Systems

9837097100, 0132-2660077 ,
5. Drug Regulatory Aspects: National and international bodies
for drug regulation. Federal food, drug and cosmetic acts along
with recent amendments. New drug application, drug efficacy
study, implementation review, OTC drug review, drug listing.
Drug recalls, product liability, clinical trials. ICH guidelines. WHO
& ISO certification. Patents, copyright & trade marks.

6. Documentation: Relevance and importance of documentation,

statuary requirements and procedure for documentation, critical
examination of documents.

International Quality Systems

9837097100, 0132-2660077 ,
Good Practices
 Good Manufacturing Practices
 Good Laboratory Practices
 Good Agricultural Practices (WHO/ Feb 2004)

International Quality Systems

9837097100, 0132-2660077 ,
The Regulation
Drugs and Cosmetics Act 1940
(Section 33-N)

Drugs and Cosmetics Rules 1945

Drugs and Cosmetics (Amendment) Rules 1999

Schedule T

International Quality Systems

9837097100, 0132-2660077 ,
Schedule T
 Raw materials used in manufacturing of drugs are
authentic, of prescribed quality and free from
contamination.
 The manufacturing process is as has been prescribed
and maintains standards of purity.
 Adequate quality control measures are taken and
 The manufactured drug which is released for sale is
of acceptable quality.
To achieve the objectives listed above each licensee shall evolve
methodology and procedures for manufacture of drugs which
should be documented as a manual and kept for reference and
inspection.
(Vaidyas, Sidhdhas and Hakeems dispensing medicines to their own patients are exempted)
International Quality Systems
9837097100, 0132-2660077 ,