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Dun and Bradstreet Verification - 11 Sep 2013

With the recent revision of Chapter 4 of the EU GMP Guide describing the Site Master File, the document has therefore become obligatory for all pharmaceutical companies.  The detailed requirement regarding the content of such a Site Master File was published by the EU in Part III of the EU GMP Guide.  Even though Part III is not binding, the EU Site Master File described therein is considered as state of the art and expected in this format by the inspecting authorities who generally require a Site Master File prior to an Agency inspection.

The EU Site Master File contains a few essential changes to the previously applicable PIC/S Guideline PE 008-3.  In the new version for example under section 1.1 (short information about the company), identification of the site is now required.  This information may be provided as GPS details or as a D-U-N-S (Data Universal Numbering System) number.  This is a code comprising 9 figures provided by the company Dun & Bradstreet, New York, USA.  A footnote of the EU Site Master File stipulates that the DUNS numbers must be provided for sites located outside the EU/EEA.  This implies that GMP auditors who perform an audit outside the EU/EEA will scrutinise site identification of the company audited.

In a recent development, the US FDA also commenced an initiative for the DUNS identification for companies to be provided with respect to the location of their facilities to the Agency.  Consequently, firms registered with FDA, or of which FDA is otherwise aware, may expect to be contacted by Dun & Bradstreet personnel.  Although the FDA states that there is no legal requirement for companies to comply, the FDA asks for full collaboration. Read the FDA press release here.

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