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From time to time, the MHRA (Medicines and Healthcare Products Regulatory Agency, U.K.) publishes a summary of the results of inspections conducted by the authority. Now a presentation of the data from the time between April 2008 and March 2009 has been published. In the field of investigational medicinal products (IMPs), during that period 18 inspections were performed in which one so-called "critical observation" and 31 "major observations" were made. Among the most frequently made observations are: - Change Control
- Line Clearance
- Investigation of Anomalies
- Documentation: PSF and SOPs
- and the batch release
What is interesting is the first item, since many start from the fact that change control refers primarily to already registered products destined for the market. However, change control within the framework of pharmaceutical development is of inherent importance. So, technical modifications made to rooms, equipment and analytical instruments can e. g. have an impact on the quality of the investigational medicinal product and the contents of the IMPD. Moreover, a complete documentation of changes, evaluation of the changes as well as of possible follow-up measures facilitates the development of medicinal products, above all with regard to traceability. Besides in this context, CAPA systems gain more and more in importance in the field of development. Summarised by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
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