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GMP News No. 788
7 September 2006
Product Quality Review Consequences from the EC GMP Guideline and Authority Expectations
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 FDAs 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:
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 dont have it, its about time really to establish such a system."
A free 5 min excerpt of the recorded Webinar with Dr. Neuhaus is
complete webinar Product Quality Review Requirements of the EC
GMP Guideline and Expectations of the Competent Authorities"
including questions from attendees and Dr Neuhaus answers is also
available as recorded
Further, find out more about webinars and currently offered live webinars as well about recorded webinars here.
Also, to learn more about all relevant aspects of the PQR, visit the 2-day
Product Quality Review compliant, reasonable,
efficient in Barcelona from 6-7 November 2006, organised by
Concept Heidelberg on behalf of the European Compliance Academy (ECA).