With the binding mention of a Site Master File in revised Chapter 4 of the EU GMP Guide, the document has become obligatory for all pharmaceutical companies. Details regarding the content of such a Site Master File were published by the EU in Part III of the EU GMP Guide. Although Part III is not binding, the EU Site Master File described in it is considered as state of the art and expected in this form by the inspecting authorities who generally require a Site Master File before any authority inspection is performed.

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. Two possibilities are named: GPS details as well as a D-U-N-S (Data Universal Numbering System) number. This is a code composed of 9 figures provided by the company Dun & Bradstreet. A footnote of the EU Site Master File points out that the DUNS numbers is imperatively required for sites located outside the EU/EEA. This means that GMP auditors who perform an audit outside the EU/EEA should attach particular importance to the site identification of the company audited.

Chapter 4 Documentation (January 2011) (33 KB)

Site Master File (33 KB)