More GMP Inspections by EMA due to Increasing Quality Issues
Recommendation
2-4 July 2025
Copenhagen, Denmark
Part of the ICH Q7 Training Courses 2025
Register now for ECA's GMP Newsletter
In its annual report 2011, the European Medicines Agency (EMA) reported about the number of inspections performed in that year. According to the report, the number of GMP inspection requests exceeded the forecast (375 vs. 245). The EMA explained that the number of API inspections and many so-called "for cause" inspections are the reasons for the increase. Another reason for that increase is the large number of complex cases due to significant GMP or general quality issues.
It is remarkable that the quality defects reported have risen by 38% compared to the year 2010. The agency has started a project to identify the reasons for such quality defects. In parallel, the EMA has enhanced collaboration on sharing information about inspections with other agencies such as the US FDA. It is intended to involve further partners in this process. Already today, the US FDA has access to EudraGMP.
Source: EMA Annual Report 2011
Related GMP News
30.06.2025EFPIA Report on Current Inspections
18.06.2025FDA Warning Letter with Supplier Qualification Observations
11.06.2025Root Cause Investigations criticised at EU Company
21.05.2025More FDA Warning Letters citing Quality Oversight
21.05.2025New Version of GMP Auditors Handbook available
21.05.2025FDA: more unannounced Inspections also outside the US