EU Documentation GMPs Updated to Reflect Electronic Records and Quality Systems Mindset

The European Union has updated its GMP expectations for documentation to reflect the realities of electronic record keeping and the evolving quality systems-based regulatory framework.

In mid-January, the European Commission released revisions of both the documentation chapter in its GMPs (Chapter 4) and Annex 11, which covers computerized systems (see the IPQ “In the News” companion story).

Drafts of the Chapter 4 and Annex 11 revisions were issued for public comment in April 2008.  The newly released final versions become effective at the end of June.

The two revisions are part of the EU effort to modernize its GMPs in accord with ICH Q8-10 concepts and current quality management expectations.

The effort began in 2008 with the inclusion of ICH’s risk management guideline Q9 into the EU GMPs as Annex 20 and the rewrite of Chapter 12 on quality management to mandate that risk management systems be part of the overall quality assurance program.  Various other revised chapters and annexes have been emerging through the EMA document pipeline.  These include draft rewrites of Chapter 5 (production) and 7 (outsourced activities), and a concept paper on redrafting chapter 6 (quality control) – all of which are out for public comment through the end of February (IPQ “In the News” Dec. 12)

[Further analysis of the changes to Chapter 4 and their significance is provided for subscribers here. Non-subscribers can purchase the full story for $95 by contacting Karen Bertani (  For subscription information click here.]