WHO TRS 996, 2016 Annex 2

WHO TRS (Technical Report Series) 996, 2016 Annex 2

WHO Good Manufacturing Practices For Biological Products

Replacement of Annex 1 of WHO Technical Report Series, No. 822

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TABLE OF CONTENTS

1. Introduction

2. Scope 

3. Terminology

4. Principles and general considerations 

5. Pharmaceutical quality system and quality risk management

6. Personnel

7. Starting materials 

8. Seed lots and cell banks 

9. Premises and equipment 

10. Containment 

11. Clean rooms 

12. Production 

13. Campaign production 

14. Labelling 

15. Validation 

16. Quality control 

17. Documentation (batch processing records)

18. Use of animals 

19. Authors and acknowledgements 

20. References

WHO TRS (Technical Report Series) 996, 2016 Annex 2