1 - WHO Basic Training Modules on GMP - INTRODUCTION TO COURSE.pptx

Understand the basic principles of WHO GMP.

1. WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 01): Introduction to the Training Course 1

2. Objectives 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

3. Programme Overview - I 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

4. Programme Overview - II Basic Principles of GMP 6. Contract production and analysis 7. Self Inspection and quality audits 8. Personnel 9. Premises 10. Equipment 3

5. Programme Overview - III Basic Principles of GMP 11. Materials 12. Documentation 13. Good Practices in production and quality control 14. Sterile production 15. Active pharmaceutical ingredients 4

6. Programme Overview - IV 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

7. Introduction Your Team Who are we? 6

8. Introduction Who am I? Name Experience Objectives Not a lot of people know ........... 7

9. Objectives of the training course 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

10. Basic Principles of GMP 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

11. 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 10

12. 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 11

13. Basic Principles of GMP Protection from insects, birds, vermin and weather - from receipt of raw materials to dispatch of released product 12

14. 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 13

15. 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 14

16. Avoidance of Cross-Contamination (2) Dedicated and self-contained areas for: - Live vaccines - Live bacterial preparations - Certain other biological materials - Penicillin products 15

17. Avoidance of Cross-Contamination (3) Campaign production: - Separation in time - Followed by appropriate cleaning - Validated cleaning procedure 16

18. 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 17

19. 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 18

20. 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 19

21. 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 20

22. 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) 21

23. 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 22

24. 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 23

25. 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 24

26. Basic Principles of GMP 25

27. Group Session - Option 1 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

28. Session Group - 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? 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