In-depth analysis of the requirements on the new EU / PIC/S Site Master File

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:

  • Several possibilities regarding the indication of the geographic location of the site have been added
  • A listing of the GMP inspections conducted in the past 5 years must be included in the Site Master File
  • Higher importance is attached to the topic "supplier qualification" (the indication of the supply chain is now required)
  • Introduction of the PQR point
  • New requirement on the description of relevant utilities (steam, compressed air, nitrogen, etc.)
  • Concrete information on the storage of documents outside the premises is required
  • Description of the system which ensures appropriate environmental conditions during transportation
  • Measures taken against illegal infiltration in the supply chain

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.

The document PE 008-4 is available at the PIC/S Website. The EU Site Master File document is available here.

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).

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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