In the GMP News from 3 February 2010, we reported about a 9-page draft of the EC Commission with instructions for the creation of a Site Master File. This draft has been compared to the actual Pharmaceutical Inspection Conventions Scheme (PIC/S) document on Site Master File (PE 008-3). A Site Master File is essential for pharmaceutical companies as it is the basis for the regulatory authority to prepare for a GMP inspection.
The PIC/S document has been published in the beginning of January as Revision 4 (PE 008-4). Last week also the final version of the new EU Site Master File document has been published. Both documents are almost identical and present the current state of the art. In our GMP News from 10 February 2011, you could read about the first evaluation of the new PIC/S document.
The changes on the EC Commission's draft are significant. In particular a range of detail requirements have been deleted. In the following, examples of further interesting changes:
Conclusion: the new PIC/S document PE 008-4 / EU Site Master File differs fundamentally from the EC Commission's draft of December 2009. The main changes concern the deletion of many detail requirements. New specifications have been added (e.g. PQR, utilities, transport conditions, security of the supply chain, etc.) as well as the concretisation concerning the description of the supplier qualification. Yet, the main difference relies on the current PIC/S document, to which the actual Site Master Files refer. The version 4 / EU Site Master File has few common points with this document. This implies greater efforts to be made to revise the existing Site Master Files.
You can find an online step-by-step comparison in the ECA Members Area (EC Commission's draft vs. new version of the PIC/S / EU Site Master File document).Author: