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Module 3 | Slide 1 of 30 January 2006
Sanitation and Hygiene
Basic Principles of GMP
Section 3
Module 3 | Slide 2 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 3 of 30 January 2006
3.1
Sanitation and Hygiene 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
Module 3 | Slide 4 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 5 of 30 January 2006
Basic Principles of GMP Basic Principles of GMP
Written procedures and instructions - to wash hands before entering production areas
Some also use disinfectants
11.1 - 2
Module 3 | Slide 6 of 30 January 2006
Basic Principles of GMP Basic Principles of GMP
Wash hands before entering production areas
Signs in areas (e.g. changing rooms)
11.1 - 2
Module 3 | Slide 7 of 30 January 2006
11.2 - 5
Sanitation and Hygiene 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
Module 3 | Slide 8 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 9 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 10 of 30 January 2006
Basic Principles of GMP Basic Principles of GMP
Toilets should not open
directly into production
or storage areas
TOILETS
AIR
LOCK
CANTEEN
FACTORYCHANGE
ROOM
12.12
Module 3 | Slide 11 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 12 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 13 of 30 January 2006
Basic Principles of GMP Basic Principles of GMP
Protection from insects, birds,
vermin and weather
– from receipt of raw
materials to dispatch of
released product
12.9
Module 3 | Slide 14 of 30 January 2006
16.10 - 11
Sanitation and Hygiene 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
Module 3 | Slide 15 of 30 January 2006
Basic Principles of GMP 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
Module 3 | Slide 16 of 30 January 2006
16.12(a)
Sanitation and Hygiene 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
Module 3 | Slide 17 of 30 January 2006
16.12(b)
Sanitation and Hygiene Sanitation and Hygiene
Avoidance of Cross-Contamination (3)
Campaign production:
Separation in time
Followed by appropriate cleaning
Validated cleaning procedure
Module 3 | Slide 18 of 30 January 2006
16.12 (c and d)
Sanitation and Hygiene 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
Module 3 | Slide 19 of 30 January 2006
Basic Principles of GMP Basic Principles of GMP
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
Module 3 | Slide 20 of 30 January 2006
16.12(e)
Sanitation and Hygiene 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
Module 3 | Slide 21 of 30 January 2006
16.12(f, h and i)
Sanitation and Hygiene 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
Module 3 | Slide 22 of 30 January 2006
16.12(g)
Sanitation and Hygiene 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)
Module 3 | Slide 23 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 24 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 25 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 26 of 30 January 2006
Basic Principles of GMP Basic Principles of GMP
Module 3 | Slide 27 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 28 of 30 January 2006
Sanitation and Hygiene 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?
Module 3 | Slide 29 of 30 January 2006
Sanitation and Hygiene 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
Module 3 | Slide 30 of 30 January 2006
Sanitation and Hygiene Sanitation and Hygiene
Possible Issues – II Hygiene
Personal hygiene
Health checks
Dealing with health problems
Personal responsibility
Training records
Frequency of handwashing