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4 Nov 2015

Rx-360 Summary of WHO Guidance on Good Manufacturing Practices - Inspection Report

Describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections.

This draft guidance issued by the WHO describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections.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 to facilitate cooperation and information-sharing.

This proposed update incorporates review of the various formats and considers efforts of inspectorates and regulatory agencies, as well as PIC/S efforts toward convergence.

This guideline applies to reports on inspections of APIs and finished pharmaceutical products (FPPs). A separate template is provided for inspections of contract research organizations (CROs) and quality control laboratories. It also includes definitions of the following terms: correction, corrective action, corrective and preventive action, deficiency, inspection observation, nonconformity, observations, and preventive action.

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