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Module - 1

The document provides an overview of basic principles of Good Manufacturing Practices (GMP) with a focus on sanitation and hygiene. It discusses the history and development of GMP regulations due to past medical tragedies. The key principles covered include personnel hygiene, premises sanitation, production operation cleaning, and practices to prevent cross-contamination. Specific guidelines are provided for cleaning facilities and equipment, personnel training, illness reporting, protective clothing, and segregating production areas. Maintaining high standards of sanitation and hygiene is important in GMP to ensure product quality and safety.

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vijayns_250355172
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© © All Rights Reserved
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
130 views

Module - 1

The document provides an overview of basic principles of Good Manufacturing Practices (GMP) with a focus on sanitation and hygiene. It discusses the history and development of GMP regulations due to past medical tragedies. The key principles covered include personnel hygiene, premises sanitation, production operation cleaning, and practices to prevent cross-contamination. Specific guidelines are provided for cleaning facilities and equipment, personnel training, illness reporting, protective clothing, and segregating production areas. Maintaining high standards of sanitation and hygiene is important in GMP to ensure product quality and safety.

Uploaded by

vijayns_250355172
Copyright
© © All Rights Reserved
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 25

Basic Principles of GMP

Introduction, History of
GMP, Sanitation &
Hygiene

Module 1

Slide 1 of 21

Introduction
Objective of the Programme
To

impart training on cGMP

Modules

and Trainers

Breakout

sessions

Evaluation

Module 1

and Certification of Trainees

Slide 2 of 21

Brief History of GMP


Year

Event

Act

Impact

1902

Tragedy of contaminated Diphtheria


vaccine.

Biologics
Control Act

Inspection
of
Biologics
Manufacturing Facilities.

1906

Revelations about contaminated meat


processing units at Chicago in the
book The Jungle written by Upton
Sinclair.

Pure Food
and Drug
Act

It made it illegal to sell


adulterated or misbranded food
or drugs.

1938

Tragedy due to usage of Sulfanimalide


formulated with Poisonous chemical
(diethylene glycol).

Federal
Food, Drug
and
Cosmetic
(FD&C) Act

Requires manufacturers to prove


the Safety of Products before
Marketing.

1941

Tragedy due to usage of Sulfathiazole


tablets contaminated with Sedative
drug Phenobarbital.

Public
Health
Services
(PHS) Act

FDA revised manufacturing and


Quality Control requirements
drastically (leading to what
would later be called as GMPs).

1962

Tragedy in Europe due to usage of


Thalidomide by pregnant women
resulted in birth defects of babies.

KefauverHarris Drug
Amendment
s

Manufacturers must prove


efficacy of Products before
marketing and ensure strict
control over testing.
Slide 3 of 21

Module 1

Brief History of GMP


Year

Event

Act

Impact

1976

Tragedy due to usage of defective


medical device (contraceptive
intrauterine device)

Medical
Device
Amendments

This
laws
strengthens
FDA
authority to oversee medical
revises.

1978

None

Code of
Federal
Regulations

21 CFR Part 210 and


211established current GMPs.

1982

Deaths due to Poisoned


Acetaminophen Capsules.

Federal 90
Tampering
Act in 1983

Introduction of Tamper Resistant


packaging in market.

Module 1

Slide 4 of 21

Basic Principles of GMP

Sanitation and
Hygiene

Module 1

Slide 5 of 21

Sanitation and Hygiene


Applicable to all aspects of manufacturing
1)

Personnel

2)

Premises

3)

Production Operations :
Equipment / Instrument sanitation / hygiene
Production materials and container handling
Products for cleaning and disinfection procedure
effectiveness

4)

Cross Contamination :
Avoid all potential sources of cross-contamination

Module 1

Slide 6 of 21

Sanitation and Hygiene


Personnel Hygiene

Smoking, eating and drinking should not be allowed in any


manufacturing area, including laboratories and storage rooms .
Chewing of gum should be banned.
Health examinations
On recruitment for direct operators , repeated on regular basis

Training - check
induction training for new operators includes basic personal
hygiene training
written procedures - to wash / disinfect hands before entering
a manufacturing area
signs in changing rooms to reinforce hand washing / disinfection

Illness
staff with illness or open lesions should not handle starting
materials, intermediates or finished products

Module 1

Slide 7 of 21

Sanitation and Hygiene


Personnel Hygiene

Adverse conditions
operators trained to recognize risks
willingness to report illness to the area supervisor

Contact between product and operator

avoid direct contact


if direct handling unavoidable, gloves should be worn
check glove disinfection (for sterile production) and disposal
dont touch equipment product contact surfaces with bare hands

Clothing and changing facilities


check changing rooms (handwashing, disinfectant dispensers hot air hand dryers)
check if used clothing stored in separate closed containers while awaiting cleaning

Module 1

Slide 8 of 21

Sanitation and Hygiene


Personnel Hygiene
laundering of clean area clothing must be to SOP and
in appropriate facility
check for procedure for sterilizing and storing
clothing for use in sterile area

Module 1

Slide 9 of 21

Sanitation and Hygiene


Premises

Design to meet Sanitary needs


Walls, floors, ceilings, ledges, drains, air supply, dust
extraction

Prevention of build-up of dirt and dust to avoid


unnecessary risks of contamination
Cleaning programme, appropriate cleaning, cleaning
records

Effective cleaning and disinfection


choice of materials and chemicals, validation

Protection from insects, vermin and weather


from receipt of raw materials to despatch of released
product

Module 1

Slide 10 of 21

Sanitation and Hygiene


Premises

There should be no living plants kept inside any


manufacturing areas.

Rest and refreshment areas should be separate


from manufacturing areas.

Toilets should not open directly into production or


storage areas.

Module 1

Slide 11 of 21

Sanitation and Hygiene


Production Operations

Work-flow
designed to avoid potential contamination.

Access
to production areas restricted to authorized personnel
direct operators, QC / QA staff, warehouse staff,
maintenance personnel, cleaners
the more critical the area - fewer number of persons
there

Simultaneous operations
not permissible to process different products in different areas
with a common ventilation/ air handling system

Module 1

Slide 12 of 21

Sanitation and Hygiene


Production Operations
Area clearance checks

Process of checking
all materials and documentation from the previous batch removed
all plant and equipment thoroughly cleaned and appropriate status
labelling
checklist useful

The area clearance check should be carried out by two people


between batches of same product
for product changeover, second check carried out by QA staff
all checks carried out in accordance with written SOP and results
recorded on the batch documentation.

Module 1

Slide 13 of 21

Sanitation and Hygiene


Production Operations

Cleaning and cleaning validation


degree of cleaning depends on whether consecutive
batches are of same or different product

Check cleaning agent is fully removed


all cleaning and disinfecting solutions carefully
prepared and expiry dated

Final rinse with purified water, or water for injection


(for sterile products)

Full records kept

Module 1

Slide 14 of 21

Sanitation and Hygiene


Production Operations

Water systems
Water - major constituent of most products
SOP for cleaning and sanitisation of the water
purification system should include distribution
pipework

Maintenance and repair


activities inevitable in manufacturing area.
Should present no risk to product

Module 1

Slide 15 of 21

Sanitation and Hygiene


Production Operations

Whenever possible, all planned maintenance


outside normal operating hours

Emergency work in working area followed by


thorough clean down and disinfection before
manufacturing recommences

Module 1

Slide 16 of 21

Sanitation and Hygiene


Practices to Avoid Cross-Contamination

Segregated areas and separate facilities for


harmonal products
penicillin products
campaign processing

Module 1

Slide 17 of 21

Sanitation and Hygiene


Practices to Avoid Cross-Contamination

Ventilation systems and airlocks


design of ventilation system
incoming air should be filtered
pressure differentials and air extraction
airlocks change over practices, movement
airflow patterns and equipment design
recirculation versus 100% fresh air supply

Module 1

Slide 18 of 21

Sanitation and Hygiene


Practices to Avoid 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

Module 1

Slide 19 of 21

Sanitation and Hygiene


Practices to Avoid Cross-Contamination

Closed processing systems


For example: totally enclosed water purification systems
tanks fitted with appropriate filtration - without
removable lids
in case of cleaning difficulties, sometimes use clean-in-place
(CIP)

Cleaning and decontamination


procedure for removing soil and dirt
remove all cleaning chemical residues or disinfectant
residues
must remove or reduce micro-organisms

Module 1

Slide 20 of 21

Sanitation and Hygiene


Breakout Session
Look at the photographs in the handout and record as many
sanitation
and hygiene issues as you can

Module 1

Slide 21 of 21

No analyst is having
worksheets / STPs / Records

Module 1

Slide 22 of 21

Module 1

Slide 23 of 21

Cleaning while
processing

Module 1

Slide 24 of 21

Module 1

Slide 25 of 21

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