WHO TRS 1019, 2019 Annex 3

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WHO TRS (Technical Report Series) 1019, 2019  Annex 3

WHO Good Manufacturing Practices: Guidelines On Validation


Click on the any titles below for complete guidelines


TABLE OF CONTENTS


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

References 

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 TRS (Technical Report Series) 1019, 2019  Annex 3


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