WHO GMP: Guidelines On Validation/ Annex 3

WHO Good Manufacturing Practices: Guidelines On Validation

Annex 3 

Click on the any titles below for complete guidelines


1. Introduction 

2. Scope 

3. Glossary 

4. Relationship between validation and qualification 

5. Validation 

6. Documentation 

7. Validation master plan 

8. Qualification and validation protocols 

9. Qualification and validation reports 

10. Qualification 

11. Revalidation 

12. Process validation 

13. Change management 

14. Deviation management 

15. Calibration and verification


Appendix 1 Validation of heating, ventilation and air-conditioning systems 

Appendix 2 Validation of water systems for pharmaceutical use 

Appendix 3 Cleaning validation 

Appendix 4 Analytical procedure validation 

Appendix 5 Validation of computerized systems 

Appendix 6 Guidelines on qualification 

Appendix 7 Non sterile process validation

WHO GMP: Guidelines On Validation/ Annex 3

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