New Procedure for co-ordinating GCP-Inspections
Recommendation
2/3 April 2025
From QbD to Process Validation
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The GCP Inspectors Working Group of the European Medicines Agency (EMA) has finally published the Procedure for coordinating GCP inspections requested by the CHMP (EMA/INS/GCP/55482/2013).
This procedure describes the different steps of the Good Clinical Practice (GCP) inspection process and particularly the interfaces between Member States inspection services and the Committee for Medicinal Products for Human Use (CHMP)/European Medicines Agency (EMA).
It describes the overall process from preparation and adoption of the inspection request, designation of responsibilities within the inspection team up to the writing and circulation of inspection reports.
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