EMA publishes Report on GCP Inspections

Recommendation
18-20 November 2025
Heidelberg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
The European Medicines Agency (EMA) has published a summary report about the findings in GCP inspections conducted worldwide between January 2000 and December 2012. This has been done in the course of the current transparency initiative.
The focus is on GCP inspections which have been performed within the scope of the centralised authorisation procedure at the request of the CHMP. The basis is an internal databsse of the EMA (Corporate DCP Database) which compiles all the significant findings.
Unfortunately, no information about each individual inspection can be derived. Nevertheless, the aim is to enable sponsors of clinical trials to take into account the information for a so-called "Risk based Quality Management" during the study planning and performance. The 50 page document contains very detailled statistical assessments - e.g. from the type and scope of the observed deficiencies, their category, up to the inspected party as well as further details about the inspections.
Related GMP News
17.06.2025EMA Policy on the Publication of Clinical Data
17.06.2025EMA Implementation of ICH E6, M11 & M12
03.04.2025Update on the ICH M11 CeSHArP Technical Specification
03.04.2025EU Map to Clinical Trials
03.04.2025EMA Concept Paper on Model Informed Drug Development