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Guidance on Good Manufacturing Practices: Inspection Report. (Including 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 Technical Report Series, No. 996, 2016, Annex 4
(2016; 16 pages)
(2016; 16 pages)
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. This guidance describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections. It aims to support convergence of practices in drawing up inspection reports so as to facilitate cooperation and information sharing. These guidelines apply to reports on inspections of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs). A separate template may be used for inspections of contract research organizations and quality control laboratories.