Frederick Bediako
Sanbao (GH) Pharmaceuticals Ltd.
1
Objectives of this Introductory Session
 To outline the programme
 To introduce your trainers
 To introduce you to one another and to
understand your objectives and
background
 To understand the way these modules
work
1
Basic Principles of GMP
 1.
Introduction to the training programme
 2.
Quality Management
 3.
Sanitation and hygiene
 4.
Qualification and Validation
 5.
Complaints and recalls
2
Basic Principles of GMP
 6.
Contract production and analysis
 7.
Self Inspection and quality audits
 8.
Personnel
 9.
Premises
 10.
Equipment
3
Basic Principles of GMP
 11. Materials
 12. Documentation
 13. Good Practices in production and quality
control
 14. Sterile production
 15. Active pharmaceutical ingredients
4
GMP Inspection Process
 16. Introduction
 17. The role of the inspector
 18. Preparation for the inspection
 19. Types of GMP inspection
 20. The inspection
5
Your
Who
Team
are we?
6
Who am I?
 Name
 Experience
 Objectives
 Not
a lot of people know ...........
7
 To
introduce general elements on quality
management
 To train you in the WHO GMP texts for
pharmaceutical products
 To bring in your own experience
 To develop your own action plan
8
Our Way of Working
 A presentation on the subject of the module
- usually about 60 minutes
 - follows the WHO text as the basis of the
module
 - will have the WHO reference at the bottom
of the slide
 A 30-60 minute group session discussing
issues or a problem that will be set for you
 Group feedback in plenary session
 Multiple choice quiz
9
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
10
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
11
Protection from insects, birds, vermin and weather
 - from receipt of raw materials to dispatch of
released product
12
 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
13

Measures that can be taken to prevent crosscontamination also include:

Segregated areas

Ventilation systems

Airlocks

Clothing

Closed processing systems

Cleaning and decontamination
14
Dedicated and self-contained areas for:
-
Live vaccines
-
Live bacterial preparations
-
Certain other biological materials
-
Penicillin products
15
Campaign production:
-
Separation in time
-
Followed by appropriate cleaning
-
Validated cleaning procedure
16
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
17
-
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
18
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
19
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
20
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)
21
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
22
 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
23
 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
24
25

Look at the photographs in the handout and record as
many sanitation and hygiene issues as you can

We are now going to move into the group session.

In your groups, you should discuss the subjects of
sanitation and hygiene as they relate to the
pharmaceutical industry in your country.

Use your experience from inspections that you have
made and give concrete examples wherever possible
to illustrate the key issues that you are to check in a
new manufacturing facility.
26

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?

We are now going to move into the group session.

In your groups, you should discuss the subjects of
sanitation and hygiene as they relate to the
pharmaceutical industry in your country.

Use your experience from inspections that you have
made and give concrete examples wherever possible
to illustrate the key issues that you are to check in a
new manufacturing facility.
27