EMA Reflection Paper provides Concrete Information about Risk based Quality Management

In the GMP News from 28 September 2011

 we announced the publication of EMA's "Reflection paper on risk based quality management in clinical trials". The 31-page document is a draft to be commented. It gets very interesting from page 14 on which presents an Annex 1 entitled "Points to consider when establishing a risk based quality management approach". Annex 1 is composed of a table which shows the points to consider for the risk identification and examples of how to control them and eventually mitigation and/or acceptance solutions. Clinical studies are - of course - a focus. However, the table is also interesting for other fields - e.g. following risks are discussed:
  • Contract issues
  • Project Management
  • Personnel Qualification
  • Quality Control Documentation
  • Deviations
  • GMP Compliance

Conclusion: Although the focus is on clinical studies, it is interesting to read about EMA's specific positions regarding risk control. The question is what the final document will look like? Now, it is already clear that risk based quality management will play a more significant role.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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