PQR and Management Review: Increasing Importance

The European Commission has published a proposal for the revision of Chapter 1 Quality Management Systems of the EU GMP Guide. The new draft includes comprehensive changes and had become necessary to put the contents of ICH Q10 into European legislation.

This will result in an increasing focus on quality reviews like for example the Product Quality Review (PQR) and Management Reviews. Concerning this matter, the following new sections were included into the Chapter 1 draft:

  • Process Performance and Product Quality Monitoring System and Product Quality Review
  • Management of Review on the Quality Management System
  • Outcomes of Management Review and Monitoring

According to the new draft, the system of Quality Assurance should ensure that "there are formal systems in place for the periodic review of operation of the quality management system and to identify opportunities for continual improvement."
The Management should have a formal process for reviewing the quality management system on a periodic basis including measurement of achievement of quality management system objectives and assessing performance indicators that can be used to monitor the effectiveness.

Likewise the requirements of process performance, product quality monitoring system and PQR were linked to risk management. According to this, process performance and process capability are meant to be monitored, reviewed and reported continuously. It will become more and more important to meet these requirements and expectations fast and smoothly while keeping an eye on the economic and operational situation.

At the ECA Education Course "Improve your Quality Reviews", 06-07 May 2010 in Vienna, Austria, you will learn how you can realise and improve your Quality Reviews and use them more efficiently.

Here you can find the new Draft on Chapter 1 of the EU GMP Guide.

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

P.S. Every participant will get:

  • an example for a PQR SOP with Annexes
  • an example for a Management Review SOP
  • real PQR examples
  • extracts from real Management Reviews

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