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Drug Product Performance Characterization Working Group

Since 2002 when the FDA launched its “Pharmaceutical cGMPs for the 21st Century” initiative, the pharmaceutical industry has been encouraged to develop new processes and products using a scientific, risk-based approach. Central to this FDA initiative is the idea that quality should be built in by design.  For drug release, this implies a different approach to establishing an appropriate drug product performance control strategy versus the traditional approach of developing a simple Quality Control release test.

Our mission is to lay the groundwork for efforts in this area by providing pharmaceutical scientists with greater understanding of practices between Pharma and Excipient suppliers related to the evaluation of the impact of excipient variation on product performance.


Problem Statement: Excipient CoA is not representative of excipient received; Mind set to treat pharma-vendor as buyer-seller relationship

Activities:Conduct survey and recommend improvement opportunities to evaluate excipient impact on drug product performance