While regulations regarding GMP for APIs clearly define compliance needs, the responsibility for defining necessary GMPs and controls for excipients in a specific medicinal product rests with the Manufacturing Authorization Holders (MAH). Pharmaceutical product manufacturers must develop risk assessments to determine the appropriate GMP’s and controls necessary for every excipient they use based on the excipient’s intended use. Excipient manufacturers will utilize appropriate GMPs for their major target market which may or may not be appropriate for the way in which a pharmaceutical product manufacturer intends to use the excipient. Therefore, the pharmaceutical product manufacturer may need to include various mitigation steps in their own process, if necessary. IPEC has various GMP guides that should be assessed during these evaluations. This webinar will present the expectations of International regulators like EMA, FDA and others about the responsibilities that pharmaceutical users have when qualifying their suppliers and determining the appropriate GMPs and controls for the excipients they use in their drug products.
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC where he provides consulting services related to the use of pharmaceutical excipients and food/color additives. He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program. Prior to this he was the Director of Global Regulatory Affairs at Colorcon Inc. for over 42 years where he coordinated Colorcon’ s worldwide regulatory activities. He was one of the founders of IPEC, is a past chair of IPEC Americas where he currently holds the position of Vice Chair for Science and Regulatory Policy and is also the IPEC Federation Global Expansion Coordinator where he helped start up IPEC India.