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.

Publications and Presentations by the IPAC-RS  PQDS Working Group (WG) and its predecessors (Delivered Dose Uniformity (DDU) WG, and Dose Content Uniformity (DCU) WG)​

A Parametric Tolerance Interval Test 7 for Improved Control of  Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products (15 November 2001)

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