Guidance On Good Manufacturing Practices | Inspection Report:
Annex 4
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.
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TABLE OF CONTENTS
Appendix 1 - Guidance on good manufacturing practices: inspection report
Guidance On Good Manufacturing Practices | Inspection Report:
