Dra. Priscilla S. Zawislak
IPEC Significant Change Guideline: When does an Excipient Company need to notify their customers od changes they made?
Guia IPEC de Cambios Sifnificativos: Cuando una compañia de excipientes necesita notificar a sus clientes debido a cambios realizados?
Priscilla Zawislak is the Global Regulatory Affairs Advocacy Manager for The Dow Chemical Company’s Food, Pharma and Medical Solutions business. Her responsibilities include global coordination of Dow’s involvement with excipient, API and food additive trade associations and other regulatory advocacy activities.
Ms. Zawislak joined Dow in 2016 after more than 30 years with Ashland Inc. (formerly Hercules Incorporated) in Regulatory Affairs and Quality for excipients, food additives and personal care product ingredients. Prior to her retirement from Ashland she was the Global Regulatory Affairs Manager for the Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products for 10 years. She was also Quality Manager at FMC Health and Nutrition for several years.
Ms. Zawislak is currently the Chair of the International Pharmaceutical Excipients Council (IPEC)-Americas and has been an active member of IPEC-Americas’ committees since 2001, a member of the IPEC Americas Executive Committee, former chair of IPEC-America’s Compendial Review Committee and is the co-leader of the Atypical Actives Coalition organized by IPEC-Americas. She is currently the Vice-President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She has also been active in other trade associations such as the International Food Additives Council (IFAC), the Personal Care Products Council (PCPC) and several ASTM and ISO sub-committees, and a member of several professional organizations such as AAPS, Institute of Food Technologists (IFT), Regulatory Affairs Professional Society (RAPS) and ASQ. Ms. Zawislak serves as a U.S. Pharmacopeia (USP) Liaison for IPEC-Americas, is a Delegate to the USP Convention and is active in a number of industry-USP project teams, including Chair of USP’s Excipients Project Team.
Ms. Zawislak earned her B.A. degrees in Biological Sciences and Chemistry from the University of Delaware.
ABSTRACT OF THE PRESENTATION
Change notification is an important aspect of ensuring the quality of drug products and patient safety. Changes to ingredients, such as excipients, can impact the performance of the drug product. It is essential for suppliers to notify the users of their products of significant changes so they can evaluate the impact of those changes on the drug product. This presentation will cover the most current version of the IPEC Federation Significant Change Guide for Pharmaceutical Excipients and will review what types of changes are considered significant and the process excipient manufacturers and users should follow to evaluate changes.