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

Conference Recommendations

Related GMP News
04/04/2013	MHRA implements new Software for risk based Inspection Planning
27/02/2013	Are 300 GMP Inspections necessary by 2 July 2013?
20/02/2013	India opens Drug Inspection Office in China
13/02/2013	Up to $190.389 for FDA's New Inspections Fees
12/12/2012	Swiss GMP standards and inspection equivalent to EU