WHO TRS (Technical Report Series) 1025, 2020 Annex 5

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WHO TRS (Technical Report Series) 1025, 2020 Annex 5: Quality management system requirements for national inspectorates Background:  During the Joint Meeting on Regulatory Guidance for Multisource Products (Copenhagen, July 2016), several World Health Organization (WHO) guidance documents were identified for update. In October 2016, the Fiftieth WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) confirmed the need to update the selected guidelines.

Quality management system requirements for national inspectorates

Background:

During the Joint Meeting on Regulatory Guidance for Multisource Products (Copenhagen, July 2016), several World Health Organization (WHO) guidance documents were identified for update. In October 2016, the Fiftieth WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) confirmed the need to update the selected guidelines.

Following up on the recommendation from the Fiftieth ECSPP, the WHO Secretariat conducted a detailed analysis of the cluster of guidelines proposed for revision. The outcome of this analysis was discussed during the informal consultation on Good Practices for Health Products Manufacture and Inspection (Geneva, July 2018). In particular, considering that the WHO Quality systems requirements for national good manufacturing practice inspectorates (1) defines the basic requirements applicable to quality systems for the operation of inspection services within national regulatory authorities (NRAs) concerned with good manufacturing practices (GMP) inspections, the WHO Secretariat proposed a strategy for revision that includes aligning the guidance with the principles of ISO 9001:2015 (2) and with relevant Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) guidance (3), as well as broadening its scope to include all good practices (GXP)-related inspections conducted by an NRA.

The Fifty-second ECSPP endorsed the proposal for revision and recommended the WHO Secretariat to revise the WHO Quality systems requirements for national good manufacturing practice inspectorates (1), aligning its content to international standards and the latest quality management systems (QMS) principles, and to expanding the scope.

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WHO TRS (Technical Report Series) 1025, 2020 Annex 5:

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