Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products (PODP) February 2011 Workshop

Acknowledgments • Thomas Feinberg, Director, Structural Chemistry, Laboratory Support Workshop Guest Speakers/Moderators Catalent Pharma Solutions, LLC Boehringer Ingelheim Catalent Pharma Solutions Prasad Peri, Ph.D., U.S. Food and Drug Administration In 2006, the Product Quality Research Institute’s (PQRI) Leachables and • Christopher Houston, Principal Scientist, Bausch & Lomb Daniel L. Norwood Paul Cvetich Ingrid Markovic, U.S. Food and Drug Administration Extractables for Orally Inhaled and Nasal Drug Products (OINDP) Working • Desmond G. Hunt, M.S., Ph.D. Scientist, Scott Pennino Kimberly Davis Rajendra (Raj) Uppoor, R.Ph., Ph.D., U.S. Food and Drug Administration Group established Thresholds and Best Practices that revolutionized the Department of Standards Development, USP James O. Mullis Michelle Cree Linda Ng, U.S. Food and Drug Administration safety qualification process for these dosage forms by providing clear, concise, • Kumudini Nicholas, Generic Drugs Quality Division, Bureau of Pharmaceutical Thomas Egert Tom Feinberg Anthony DeStefano, Ph.D., United States Pharmacopeia coherent, and comprehensive strategies and tactics for safety assessment. Sciences, Therapeutic Products Directorate, Health Canada Jurgen Mattes Alan Hendricker The success of these strategies has led to the proposal for Reporting and PQRI Member Organizations • Mike Ruberto, Ph.D., Material Needs Consulting, LLC David Strassburger Qualification Thresholds for Leachables in PODP, submitted to the PQRI AAPS • Daniel Norwood, M.S.P.H., Ph.D., Distinguished Research Fellow, Steering Committee in March 2007. The proposal was approved and the Work Pfizer, Inc. American Association of Pharmaceutical Scientists Boehringer Ingelheim Pharmaceuticals, Inc. Plan entitled Development of Scientifically Justifiable Thresholds and Best Cindy Zweiben CHPA • Edward Smith, Ph.D., Principal Consultant, Packaging Science Resources Demonstrated Characterization Practices for Leachables and Extractables Miguel Sandoval Consumer Healthcare Products Association • Michael Lynch, Ph.D., Associate Research Fellow, Pfizer in Parenterals and Ophthalmic Drug Products (PODP) was submitted and Art Shaw FDA/CDER subsequently approved in April 2008. Toxicology Chair Bausch & Lomb U.S. Food and Drug Administration, Center for Drug Evaluation and Research Douglas J. Ball, M.S., D.A.B.T., Research Fellow, Pfizer Christopher Houston HC The PODP Working Group has moved forward, guided by the principle that Health Canada Toxicology Team John Rider the OINDP recommendations could be transformed into PODP recommen- IPAC-RS • Stephen A. Barat, Ph.D., Director, Toxicology and Operations, Baxter dations by considering such factors as dose, duration, patient populations, International Pharmaceutical Aerosol Consortium on Regulation & Science Forest Research Institute Roopang Shah, Research Associate II and other product/user attributes. Toxicologists considered the safety profiles IPEC-Americas • William P. Beierschmitt Ph.D., D.A.B.T, Associate Research Fellow, Pfizer, Inc. Marek Ciesla, Research Associate II of nearly 500 known extractables/leachables compounds and analytical International Pharmaceutical Excipients Council of the Americas • Jacqueline A. Kunzler, Director Frank (Yousheng) Hua, Research Scientist chemists examined extractable analysis methods for characterizing materials USP of Drug and Device Safety and commonly utilized in PODP packaging systems. Both groups of scientists United States Pharmacopeia Efficacy, Life Sciences The following suppliers donated tests plates of general materials to be used utilized the generated information to begin the process of drafting PODP Division, Baxter Healthcare specifically for demonstration of best practices and are gratefully acknowledged: Board of Directors recommendations. The individuals responsible for the planning, data acquisition • Mary Richardson, Ph.D., DABT Mario L. Rocci, Jr., Ph.D., Chair and presentation of accumulated data are acknowledged herein: Cameo Craft Stephane Huibers Glenn Van Buskirk, Ph.D., Treasurer Director of Nonclinical Safety, CIBA Michael Ruberto Bausch & Lomb Anthony DeStefano, Ph.D. PQRI Parenteral and Ophthalmic Drug Product (PODP) Schott Horst Koller • Alisa Vespa, Ph.D., Assessment Avraham Yacobi, Ph.D. Work Group Members Tecknor/Apex Peter Galland Rachael Roehrig, Ph.D. Officer, Metabolic and West Jeff Smythe PQRI, Development Technical Committee Musculoskeletal Drugs Division, PQRI Steering Committee (REPRESENTATIVE AND ALTERNATES) Reggie Saraceno, Ph.D., Analytical Development, Bureau of Metabolism, Oncology Anthony DeStefano, Ph.D., Chair Boehringer Ingelheim Pharmaceuticals, Inc. and Reproductive Sciences AAPS PQRI Development Technical Committee Liaison Therapeutic Products Directorate, Lynn Van Campen, Ph.D., John Lisack, Jr., CAE, Stacey May, M.A. Frank Holcombe, Jr., Ph.D., U.S. Food and Drug Administration Health Canada CHPA Rachael Roehrig, Ph.D., Chair Elect PODP Chair Chemistry Support FDA Diane Paskiet, Associate Director Scientific Affairs, Alan D. Hendricker, Ph.D., Catalent Pharma Solutions Helen N. Winkle, Nakissa Sadrieh, Ph.D., Raj Uppoor, R.Ph., Ph.D. West Pharmaceutical Services, Inc. Art Shaw, Research Fellow, Pfizer HC Chemistry Chair Toxicology Support Anita DiFranco Dennis Jenke, Ph.D., Senior Research Scientist, Baxter HealthCare Steve Beck, CEMDD Liaison, GlaxoSmithKline IPAC-RS Chemistry Team David Jones, Principle Scientific Officer, New Chemical Entities Unit, MHRA Terrence Tougas, Ph.D., Mary Devlin Capizzi, Esq. • James Castner, Senior Principal Research Scientist, Brenda Seidman, Ph.D.,TOX-RSA, LLC IPEC-Americas Lantheus Medical Imaging Angela Howard, Ph.D., Cosmetic Ingredient Review Dave Schoneker • Thomas Egert, Research Scientist, Boehringer Ingelheim Pharma Russell Naven (QSAR [DEREK/Toxtree), Pfizer USP GmbH & Co. KG Patricia Ellis (QSAR [DEREK/Toxtree), Pfizer Kevin Hool, Ph.D.

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