WHO TRS 996, 2016 Annex 4

Sathyanarayana M.Sc.
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WHO TRS (Technical Report Series) 996, 2016 Annex 4

Guidance On Good Manufacturing Practices | Inspection Report


WHO TRS 996, 2016 Annex 4: WHO TRS (Technical Report Series) 996, 2016 Annex 4 Guidance On Good Manufacturing Practices | Inspection Report.

Background:

The need for revision of the Guidance on good manufacturing practices: inspection report (World Health Organization (WHO) Technical Report Series, No. 908, Annex 6, 2003) was brought to the attention of the WHO Expert Committee on  Specifications for Pharmaceutical Preparations. The intent of this update is to bring it in line with the current format used by the Prequalification Team (PQT) for its inspections and the formats currently used internationally in national and regional inspectorates. In addition, the concepts of risk management, as, for example, included in the WHO guidelines on quality risk management (WHO Technical Report Series, No. 986, Annex 6, 2014), have been taken into consideration.


Click on the any titles below for complete guidelines


TABLE OF CONTENTS


1 Introduction 

2. Scope 

3. Glossary 

4. General principles 

Appendix 1 - Guidance on good manufacturing practices: inspection report 

Appendix 2 -  Example of a risk category assessment of the site depending on level of compliance and inspection frequency 


WHO TRS (Technical Report Series) 996, 2016 Annex 4:


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