Product Quality Demonstration Strategy (PQDS)

The overall objectives of the PQDS Working Group are to explore improved methods for PQDS control; equip companies for successful discussion of appropriate PQDS controls with regulators; monitor, report on, analyze and react to ongoing developments affecting PQDS controls in OINDPs, including those in regulatory guidances, pharmacopeial chapters, ISO standards, conference presentations and published articles; and, as necessary, prepare comments on proposed standards and regulations affecting PQDS controls for OINDP.

Developing a framework for adopting aggregate approaches to lot testing (already standardized in other industries) to the context of pharmaceutical quality control, in particular PQDS testing of OINDPs, is our current focus.

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