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News about GMP/cGMP

New Part III EU GMP published (EC)

On Feburary 7, 2011 the European Commission (EC) published the new Part III "GMP related Documents" of the EU GMP Guide.

 

The EC adopted the Rules for establishing a Site Master File developed by the PIC/S.

The EC's notes are intended to provide guidance on the recommended content of a Site Master File. A requirement for a Site Master File is is referred to in Chapter 4 of the GMP Guide.

Outcome:

You can download the new Part III  "GMP related Documents" here. This document will be part of the next update of the GMP MANUAL (May 2011).

Source:

EC/ EU GMP Guide Part III

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