Quality Risk Management

Per ICH Q10 Quality risk management (QRM) is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality.

However, integrating the principles of QRM into our quality processes is complex especially in an R&D function. There is no question that the complexity of the risk involved in developing products is high but the practices  to mitigate and document risk often do not follow the traditional ICH Q9 principles. In addition, although considerable guidance has been documented on the application of QRM for commercial operations little guidance is available for its application within the R&D function especially outside the applications needed for Quality by Design.

The QRM Working Group plans to address these gaps and provide guidance on important aspects of QRM implementation within R&D. To that end, please find listed below three guidances that help with implementation. They include:

1. Establishing QRM Champions and Facilitators within an Organization
2. Guidance to Document a QRM Plan
3. Key QRM References

In the near future, we will establish a LinkedIn group to allow for discussion on QRM, as well as the submission of questions and requests. We encourage you to connect with us through this group.