Basic Principles of GMP
Sanitation and Hygiene
Section 3
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January 2006
Sanitation and Hygiene
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
 Group session - to discuss the situation in your country and to look
at some bad sanitation and hygiene practices
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Sanitation and Hygiene
Scope
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
3.1
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Slide 3 of 30
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Sanitation and Hygiene
Personal Hygiene (1)
Health examinations:
 Before and during employment
 Periodic eye examinations for those who do visual inspections
Training:
 Practices in personal hygiene
 Written procedures and instructions
 Signs in areas
11.1 - 2
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Basic Principles of GMP
 Written procedures and
instructions - to wash hands
before entering production areas
 Some also use disinfectants
11.1 - 2
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Basic Principles of GMP
 Wash hands before entering
production areas
 Signs in areas (e.g. changing
rooms)
11.1 - 2
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Sanitation and Hygiene
Personal Hygiene (2)
 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
11.2 - 5
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Sanitation and Hygiene
Personnel Hygiene (3)
 Protection of product from contamination:
 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 and in an
appropriate facility
 Procedure for disinfecting and sterilizing when required
11.6
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Sanitation and Hygiene
Personnel Hygiene (4)
 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
11.7, 12.11
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Basic Principles of GMP
 Toilets should not open
directly into production
or storage areas
FACTORY
CHANGE
ROOM
12.12
CANTEEN
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Slide 10 of 30
January 2006
AIR
LOCK
TOILETS
Sanitation and Hygiene
Personnel Hygiene (5)
 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
11.8
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Sanitation and Hygiene
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
 Drains – prevent backflow
12.2, 12.3, 12.7, 12.9, 12.29
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
Protection from insects, birds,
vermin and weather
– from receipt of raw
materials to dispatch of
released product
12.9
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Sanitation and Hygiene
Avoidance of Cross-Contamination (1)
 Special precautions should be taken to prevent generation and
dissemination of dust
 Proper air control – supply and extraction, suitable quality
 Due to uncontrolled release of:
 dust, gas, particles, vapours, sprays, organisms, residue, insects
16.10 - 11
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Basic Principles of GMP
Measures that can be taken to
prevent cross-contamination also
include:
 Segregated areas
 Ventilation systems
 Airlocks
 Clothing
 Closed processing systems
 Cleaning and decontamination
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Sanitation and Hygiene
Avoidance of Cross-Contamination (2)

Dedicated and self-contained areas for:
 Live vaccines
 Live bacterial preparations
 Certain other biological materials
 Penicillin products
16.12(a)
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Slide 16 of 30
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Sanitation and Hygiene
Avoidance of Cross-Contamination (3)
 Campaign production:
 Separation in time
 Followed by appropriate cleaning
 Validated cleaning procedure
16.12(b)
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Sanitation and Hygiene
Avoidance of Cross-Contamination (4)
 Ventilation systems and airlocks
 Appropriately designed ventilation system with air supply and
extraction systems
 Supply or incoming air should be filtered
 Recirculation of air versus 100% fresh air supply
 Proper airflow patterns
 Pressure differentials
 Appropriately designed airlocks
16.12 (c and d)
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 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
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Slide 19 of 30
January 2006
Sanitation and Hygiene
Avoidance of Cross-Contamination (5)
 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
16.12(e)
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January 2006
Sanitation and Hygiene
Avoidance of Cross-Contamination (6)
 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)
 Use cleanliness status labels
 Test for residues
16.12(f, h and i)
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Sanitation and Hygiene
Avoidance of Cross-Contamination (7)
 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)
16.12(g)
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Sanitation and Hygiene
Production Operations – Sanitation (1)
 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
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Sanitation and Hygiene
Production Operations – Sanitation (2)
 Full records kept
 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
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Sanitation and Hygiene
Production Operations – Sanitation (3)
 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
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Sanitation and Hygiene
Group Session - Option 1
Look at the photographs in the handout and record
as many sanitation and hygiene issues as you can
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Sanitation and Hygiene
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?
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Slide 28 of 30
January 2006
Sanitation and Hygiene
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
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Sanitation and Hygiene
Possible Issues – II
Hygiene
 Personal hygiene
 Health checks
 Dealing with health problems
 Personal responsibility
 Training records
 Frequency of handwashing
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Slide 30 of 30
January 2006