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News about GMP/cGMP

Revised Chapter 4 EU GMP Guide published

On January 12, 2011 the European Commission published the revised Chapter 4 "Documentation" of the EU GMP Guide. The document will come into operation on June 30, 2011.

 

The revised document replaces the version of 2004. The revision has become necessary because of the increasing use of electronic documents within the GMP environment.

The changes focus mainly the sections on "Generation and Control of Documentation" and "Retention of Documents".

Outcome:

Read the revised chapter 4. The document will come into operation on June 30, 2011.

Source:

EC/ Chapter 4

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