More GMP Inspections by EMA due to Increasing Quality Issues
Recommendation
10-12 February 2025
The Impact of EU Legislation on the Supply Chain
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
05.02.2025Inadequate Analytical and Microbiological Controls - FDA Warning Letter to Indian Company
29.01.2025FDA Warning Letter to Chinese Manufacturer of OTC Products
29.01.2025Warning Letter - No Testing for EC/DEG and other Deficiencies
08.01.2025PIC/S publishes Guidance Documents on Remote Assessments
04.12.2024Discarded Batch Documentation again found during Inspection
30.10.2024From missing Analysis to Brand Protection Violations - FDA Warning Letter to Canadian Manufacturer