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GMP News No. 635
21 November 2005
Changes to the EU GMP Guide Passed
In our GMP News of 3 February 2004, we had already commented on the drafts for a Quality Product Review as a new Chapter 1.5 of the EU GMP Guide and for Ongoing Stability Programmes (subchapters 6.23-6.33). Now the EU Commission announced that the QPR will be included in the EU GMP Guide from 1 January 2006 and that the call for Ongoing Stability Programmes will be an official requirement from 1 June 2006. Furthermore, point 6.14 on reserve samples was revised. The change refers to Annex 19, which is dedicated exclusively to the topic of reserve samples and (still) a draft (see our GMP News of 21 July 2004). This indicates that Annex 19 will be finalised in the near future.
Directly after the new Chapter 1 (Quality Management) of the EU GMP Guide will come into force, according to the Commission, pharmaceutical companies will be expected to create QPRs in 2006 - at least for a period of 6 months. The announcement expressly states that most of the required information should already be available. However, the authority admits that the development and implementation of such a system needs time. From 2007 onwards, yearly QPRs are expected.
Those companies that are already required to create an Annual Product Review (APR) for the FDA in accordance with 21 CFR 211.180 have an advantage: you can extend your systems to the QPR. However, the EU requirements are much more concrete compared to the US.
In order to implement the requirements, the chapters 1 and 6 of the EU GMP Guide were published in new versions. You can view the two documents here:
Part I, Chapter 1, Quality Management - Quality Product Review
Part I, Chapter 6, Quality Control - Ongoing Stability