European Commission Publishes Proposal for Part 3 to the EC GMP Guide

On 4 January, the European Commission published a proposal for Part 3 to the EC GMP Guide. Part 1 concerning medicinal products and Part 2 for active pharmaceutical ingredients already exist. Part 3 does not deal with requirements on pharmaceutical excipients - as many had anticipated - but represents an informational part.

In the future, Part 3 is meant to include documents that are no GMP guidelines, but amend GMP guidelines or describe regulatory procedures. Against this backdrop, an explanation for pharmaceutical manufacturers for the preparation and on the contents of a Site Master File has now been published as a first document in Part 3. The Site Master File concept had been developed by the PIC/S and is expected as a standard in many EU GMP inspections today. Quite recently, the PIC/S had revised the requirements on Site Master Files. This new version was now published unchanged in Part 3 of the EC GMP Guide.

A Site Master File includes detailed information on the quality system and the activities of the enterprise, especially on the production and quality control of a respective manufacturing site. A Site Master File has usually about 20 up to a maximum of 30 pages, plus the appendices. The structure is quite similar to a quality assurance manual. In medium-sized companies, the two documents are sometimes combined. However, not every authority in Europe has always required a versioned Site Master File prior to an inspection. This will change when Part 3 comes into operation. A Site Master File provides the GMP inspector with a very comprehensive picture of the company's quality system even before the inspection. So it is certainly not a coincidence that this document was published at the same time as the proposals for changes to Chapters 1 and 2 of the EC GMP Guide. These new drafts serve the purpose of putting ICH Q10 (Pharmaceutical Quality Assurance System) into European legislation.

The scope is a bit unclear. Even though it follows from the title that the explanations regarding the Site Master File are addressed to pharmaceutical manufacturers, item 3 "Scope" includes the note: These Explanatory Notes apply for all kind of manufacturing operations such as production, packaging and labelling, testing, relabelling and repackaging of all types of medicinal products as well as active pharmaceutical ingredients. This guide could also be used in the preparation of a Site Master File or corresponding document by Blood and Tissue Establishments. Hence, a Site Master File would also have to be established by manufacturers of active pharmaceutical ingredients as well as by companies in the field of blood and tissue. On this question, the final version will certainly have to include more exact statements.

You can download the Explanatory notes for pharmaceutical manufacturers on the preparation of a Site Master here. The draft by the GMP/GDP Inspectors Working Groups was officially released for commenting on 15 December 2009, but has only been available on the Internet since 4 January 2010. Comments can be submitted until 31 March 2010. Please send them to the e-mail address

Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

Source: European Medicine Agency

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