Product Quality Review - Consequences from the EC GMP Guideline and Authority Expectations

GMP News No. 788

GMP News
7 September 2006

Product Quality ReviewConsequences from the EC GMP Guideline and Authority Expectations

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:


The 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 webinar.

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 education course 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).

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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