Biography
Biography: Diane Paskiet
Abstract
The Product Quality Research Institute (PQRI) is a non-profit consortium involving industry organizations, academia and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality. The collaborative activities of the PQRI Leachables and Extractables Working Group resulted in a systematic and science-based approach to identify and qualify leachables, including the concept of safety thresholds. Concepts from this widely accepted approach were formally publicized in 2006 for Orally Inhaled and Nasal Drug Products (OINDP) and are being extrapolated to parenteral and ophthalmic drug products (PODP). Chemist and Toxicologist are working together to generate and share data to demonstrate these same principles for parenteral dosage forms. The PODP recommendations consider factors associated with dose, duration, patient populations, and other product/user attributes. The recommendations for thresholds and best practices for PODP are currently being drafted. This presentation will give background on leachables and extractables from packaging materials and describe risk based approaches for qualifying leachables in parenteral drug products based on PQRI recommendations.