The overall objectives of the DDU Working Group are to explore improved methods for DDU control; equip companies for successful discussion of appropriate DDU controls with regulators; monitor, report on, analyze and react to ongoing developments affecting DDU 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 DDU 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 DDU testing of OINDPs, is our current focus.
The IPAC-RS DDU Subgroup on Product Quality Management Throughout Lifecycle has published an article in Inhalation entitled “Gaps in statistical approaches to control of delivered dose uniformity throughout product lifecycle.” The authors of the paper are Greg Larner, Dave Christopher, Helen Strickland, Emil Friedman, David Starbuck, Michael Golden, and Svetlana Lyapustina.
The Delivered Dose Uniformity (DDU) Working Group is focused on understanding regulatory proposals for DDU controls and developing a more comprehensive approach to DDU controls throughout the product lifecycle. In particular, the DDU Statistical Subgroup is currently analyzing the proposal from Yi Tsong (FDA), presented at the September 2013 workshop, which seems to further constrain the quality requirements compared to the 2005 FDA’s PTI-TOST (parametric tolerance interval two one sided test). A preliminary review of the graphs in Dr. Tsong’s slides suggests, for example, that the sample size could increase further without noticeable reduction in producer risk and possibly without controlling consumer risk..
By Working Group: Delivered Dose Uniformity (DDU).
Emil M. Friedman
AAPS PharmSciTech, 12(4):1144-1156