EU Annex 11 (Update)

In January 2011 the European Commission (EudraLex) released Annex 11 Computerised Systems (revision 1) which comes in to effect on 30 June 2011.

This has been a long awaited release of the GMP Guideline for Computerised Systems which was first issued for comment in April 2008 for public consultation. The final release of Annex 11 has been reduced considerably to that put out for public consultation however the principles are present in the final version.

Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems.

In addition to the revision of EU Annex 11, Chapter 4 has also been revised to take in to account the increasing use of electronic records (and signatures) in support of the release of batches and other GMP. This also becomes effective on 30 June 2011.

This is a major revision of the GMP for Computer Systems (last updated in 1997). Regulated pharmaceutical and biotech companies will need to ensure that the requirements of the GMPs are met.

While following the ISPE GAMP guidance will cover the majority of requirements relating to the revised EU Annex 11, it is important that the regulated pharmaceutical company reviews the requirements.

EU Annex 11 Post Update

Since the original I have added a page dedicated to EU GMP Annex 11 Computerised Systems. This page provides the full text from the EU Annex 11 guidance and links to comment and analyis against the relevant section.


Additionally you can check latest posts relating to EU Annex 11 update.

Link
The EudraLex Volume 4 Good manufacturing practice (GMP) Guidelines.