GCP Inspection Site Report Template on Behalf of the EMA

12 July 2022 — EMA published the updated GCP inspection procedures for appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP.

The GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the EMA Committee for Medicinal Products for Human Use (CHMP) in the context of the centralized procedure.

These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier or by other information such as previous inspection experience.

They are usually requested during the initial review of a marketing authorization application, but could arise post-authorization (e.g. inspection of studies conducted or completed as part of the condition of a marketing authorization, or because of concerns arising about the studies previously submitted).

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