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In January 2006 the revised version of the new Chapter 1 of the EU GMP
Guide became effective. It introduced the Product Quality Review (PQR)
with the expectation to provide the first PQR for 2006 with a minimum
review period of at least 6 months. Subsequent reports should cover a full
12 month period.
With the PQR European legislation added a powerful quality management
tool to the EC GMPs which covers all aspects of the supply chain from
starting materials via process and process environment to the process
output (product).
It is important to realise that even if the term and the intention are
similar to the Annual Product Review as required by US 21 CFR 211, there
are major differences in the expectations – as for example in the amount
of batches covered inclusion of the previous periods’ history and the
consideration of process environment and qualification status. In these
and other cases, the PQR exceeds the requirements of FDA’s Annual
Product Review.
This new requirement seems to put a tremendous additional workload on
the pharmaceutical industry. As with any other Quality Management program
though, the PQR can be an important and useful tool to control and improve
processes and the overall quality and also to avoid failure costs. The PQR
can take advantage of other quality systems already established in the
company (e.g. Change Control System, CAPA and the Validation Masterplan).
On 05 July, a Webinar on this topic was conducted via the Internet with
Dr Jörg Neuhaus, GMP-Inspector of the German regional authority in
Cologne (Bezirksregierung Cologne). Following are some of the agencies’
expectations he expressed:
- The inspection agencies will realise very soon that the PQR offers a
valuable compilation of information and that the PQR might serve as an
ideal entry in an inspection.
- The PQR is not intended to be a meaningless listing of huge amounts
of data only. Agencies do not want to see endless listings of
individual results.
It should be a meaningful review of the elements defined in article
1.5 with an appropriate evaluation, summary and interpretation of all
information available on the whole manufacturing process.
- The PQR should cover at least a one year period to be able to detect
long term trends; this is as well applicable to a system of rolling
reviews. In this case, a long term evaluation and interpretation
should be part of the system as well. The result "Nothing has
changed since the most previous review" is not sufficient.
Dr Neuhaus: "That means, already now, your company owes the
agencies a system to ensure the performance of a Product Quality Review in
2006. That means you should already have such a system. And if you don’t
have it, it’s about time really to establish such a system."
A free 5 min excerpt of the recorded Webinar with Dr. Neuhaus is
available here:
http://www.gmp-compliance.org/webinar/demo
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