Diane Paskiet has over twenty years of experience in packaging analysis. She has served as a project advisor in support of qualification studies associated with drug containment systems for regulatory fi lings. Her current responsibilities include coordination of study plans for technical support of packaging components and R&D. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is serving a five year term on the United States Pharmacopeia (USP) Packaging, Storage and Distribution Expert Committee and a co-recipient of the USP award for Innovative Response to a Public Health Challenge. She is Chair of the PQRI Parenteral and Ophthalmic Drug Product (PODP) Leachables and Extractables Working Group and a faculty member of the PDA Training Institute, as well as author/co-author of papers on the subject of pharmaceutical packaging


The Product Quality Research Institute (PQRI) is a non-profi t 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 Extractable 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.

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