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
Author:
Sven Pommeranz
on behalf of the European Compliance Academy
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