New Procedure for co-ordinating GCP-Inspections
Recommendation
18-20 November 2025
Heidelberg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
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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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