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This draft guidance issued by the WHO describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections.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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