Basic Principles of GMP: Sanitation and Hygiene

Basic Principles of GMP
Sanitation and
Hygiene
Module 3
Slide 1 of 26
WHO - EDM
Sanitation and Hygiene

Objectives
Review measures to ensure good sanitation in:

premises
equipment
processes
To review measures to ensure good personnel

hygiene
Group session - to discuss the situation in your

country and to look at some bad sanitation and
hygiene practices in some photographs.
Module 3
Slide 2 of 26
WHO - EDM

Scope
All aspects of manufacturing
Personnel
Premises
Equipment
Apparatus
Production materials and container
Products for cleaning and disinfection
All potential sources of cross-contamination
Module 3
Slide 3 of 26
WHO - EDM
Part One 4

Design of Premises
Design
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
Part One 11
Drains
Protection from insects, vermin and weather

from receipt of raw materials to despatch of released product
Module 3
Slide 4 of 26
WHO - EDM

Avoidance of Cross-Contamination I
Segregated areas
Ventilation systems and airlocks
Clothing
Closed processing systems
Cleaning and decontamination
Part Two 15.1 15.34
Module 3
Slide 5 of 26
WHO - EDM

Avoidance of Cross-Contamination II
Segregated areas and separate facilities for

live vaccines and other biological materials
penicillin products
campaign processing
Part Two 15.1 15.34
Module 3
Slide 6 of 26
WHO - EDM

Avoidance of Cross-Contamination III
Ventilation systems and airlocks

design of ventilation system
incoming air should be filtered
pressure differentials and air extraction
airlocks
airflow patterns and equipment design
recirculation versus 100% fresh air supply
Part Two 15.1 15.34
Module 3
Slide 7 of 26
WHO - EDM

Avoidance of Cross-Contamination IV
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
Part Two 15.1 15.34
Module 3
Slide 8 of 26
WHO - EDM

Avoidance of Cross-Contamination -V
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)
Part Two 15.1 15.34
Module 3
Slide 9 of 26
WHO - EDM

Avoidance of Cross-Contamination VI
Cleaning and decontamination

procedure for removing soil and dirt
remove all cleaning chemical residues or disinfectant
residues
must remove or reduce micro-organisms
Part Two 15.1 15.34
Module 3
Slide 10 of 26
WHO - EDM

Production Operations Sanitation I
Work-flow
designed to avoid potential contamination.
Access
to production areas restricted to authorized
personnel
direct operators, QC staff, warehouse staff,
maintenance personnel, cleaners
the more critical the area - fewer number of
persons there
Module 3
Slide 11 of 26
WHO - EDM

Production Operations Sanitation II
Simultaneous operations
not permissible to process different products in different

areas with a common ventilation system
permissible to carry out secondary packaging activities

for different products within a packing hall with
adequate physical separation
Module 3
Slide 12 of 26
WHO - EDM

Production Operations Sanitation III
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
Module 3
Slide 13 of 26
WHO - EDM

Production Operations Sanitation IV
Area clearance checks
The area clearance check should be carried out by

two people
between batches of same product, acceptable for
both checks to be carried out by production
personnel
for product changeover, second check carried out by
QC staff
all checks carried out in accordance with written SOP
and results recorded on the batch documentation.
Module 3
Slide 14 of 26
WHO - EDM

Production Operations Sanitation V
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, or water for injection

(for sterile products)
Full records kept
Module 3
Slide 15 of 26
WHO - EDM

Production Operations Sanitation VI
Water systems
Water - major constituent of most products
SOP for cleaning and sanitisation of the water

purification system should include distribution
pipework
Validation and removal of disinfectant before reuse
Module 3
Slide 16 of 26
WHO - EDM

Production Operations Sanitation VII
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
Module 3
Slide 17 of 26
WHO - EDM

Personnel Hygiene I
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 hands before entering
a manufacturing area
Part washing
One 10.16 10.23
signs in changing rooms to reinforce hand
Module 3
Slide 18 of 26
WHO - EDM

Personnel Hygiene II
Illness
staff with illness or open lesions should not handle
starting materials, intermediates or finished products
Adverse conditions
operators trained to recognize risks
willingness to report illness to the area supervisor
Part One 10.16 10.23
Module 3
Slide 19 of 26
WHO - EDM

Personnel Hygiene III
Contact between product and operator

avoid direct contact
if direct handling unavoidable, gloves should be worn
check glove disinfection (for sterile production) and
disposal
Part One 10.20 10.23, 11.7 11.8
Module 3
Slide 20 of 26
WHO - EDM

Personnel Hygiene IV
Clothing and changing facilities

check changing rooms (handwashing, towels or hot
air hand dryers)
check if used clothing stored in separate closed
containers while awaiting cleaning
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
Part One 10.20 10.23, 11.7 11.8
Module 3
Slide 21 of 26
WHO - EDM

Personnel Hygiene V
Smoking, eating and drinking should not be allowed

in any manufacturing area, including laboratories and
storage rooms.
Chewing of gum should be banned.
There should be no plants kept inside any factory

areas.
Rest and refreshment areas should be separate from

manufacturing areas.
Toilets should not open directly into production or

Part One 10.20 10.23, 11.7 11.8
storage areas.
Module 3
Slide 22 of 26
WHO - EDM

Group Session - Option 1
Look at the photographs in the handout and
record
as many sanitation and hygiene issues as you
can
Module 3
Slide 23 of 26
WHO - EDM

Group Session - Option 2
You are inspecting a new factory. What are the key
issues for sanitation and the key issues for
personnel hygiene that the company should have
in place?
Module 3
Slide 24 of 26
WHO - EDM

Possible Issues I
Sanitation
Mixed production
Penicillins
Product versus batch changeovers
Water systems
How long should a cleaned status last for?
What should happen if a clearance check is required

when no QC personnel are on duty?
Procedures and records
Module 3
Slide 25 of 26
WHO - EDM

Possible Issues II
Hygiene
Personal hygiene
Health checks
Dealing with health problems
Personal responsibility
Training records
Frequency of handwashing
Module 3
Slide 26 of 26
WHO - EDM

Basic Principles of GMP: Sanitation and Hygiene

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What are the key aspects of sanitation that should be considered in a manufacturing facility?

What are the key aspects of sanitation that should be considered in a manufacturing facility?

What are some important considerations for personnel hygiene in a manufacturing facility?

What are some important considerations for personnel hygiene in a manufacturing facility?

Basic Principles of GMP

Sanitation and Hygiene

Review measures to ensure good sanitation in:

To review measures to ensure good personnel

Group session - to discuss the situation in your

Sanitation and Hygiene

Production materials and container

Products for cleaning and disinfection

All potential sources of cross-contamination

Sanitation and Hygiene

Prevention of build-up of dirt and dust to avoid unnecessary

Effective cleaning and disinfection

Protection from insects, vermin and weather

Sanitation and Hygiene

Ventilation systems and airlocks

Closed processing systems

Cleaning and decontamination

Part Two 15.1 15.34

Sanitation and Hygiene

Segregated areas and separate facilities for

Part Two 15.1 15.34

Sanitation and Hygiene

Ventilation systems and airlocks

Sanitation and Hygiene

Sanitation and Hygiene

Closed processing systems

Sanitation and Hygiene

Cleaning and decontamination

Part Two 15.1 15.34

Sanitation and Hygiene

Sanitation and Hygiene

not permissible to process different products in different

permissible to carry out secondary packaging activities

Sanitation and Hygiene

Sanitation and Hygiene

The area clearance check should be carried out by

Sanitation and Hygiene

Cleaning and cleaning validation

Check cleaning agent is fully removed

If possible hot water alone used for cleaning

Final rinse with purified water, or water for injection

Full records kept

Sanitation and Hygiene

Water - major constituent of most products

SOP for cleaning and sanitisation of the water

Validation and removal of disinfectant before reuse

Sanitation and Hygiene

Maintenance and repair

Whenever possible, all planned maintenance

Emergency work in working area followed by

Sanitation and Hygiene

Sanitation and Hygiene

Part One 10.16 10.23

Sanitation and Hygiene