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From time to time, the MHRA (U.K. Medicines and Healthcare Products Regulatory Agency) publishes a summary of the results of the inspections conducted by the agency. Now, a presentation of the data gathered between April 2008 and March 2009 has been published. During that period, a total of 359 inspections were performed, in which 33 so-called critical observations and 786 major observations were made. Among the most frequent observations were: 1. Investigation of anomalies
2. Change Control
3. Investigation of Anomalies - CAPA
4. Complaints and recalls
5. Documentation: PSF and SOPs On the following ranks, there are observations concerning product contamination, batch release, premises, PQR and supplier qualification. The presentation also includes a comparison between the occurrence of subject-specific observations within Great Britain and those from overseas. Here one can see significant differences, above all with regard to premises, equipment and impurities, where overseas firms show a clearly poorer performance. Compiled by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
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