H WHO Guidelines H WHO Guidelines
as of 2019 - 05 - 07
H.8 WHO: Good manufacturing practices for biological products Technical Report Series No. 996 (2016), Annex 3
Abbreviations
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-
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