As SAFC Live previously reported, the ICH Q3D Metal Impurities Workshop was held from April 4-5, 2012 at the Marriott Bethesda North Hotel in Bethesda, Maryland. The program focused on the new limits for element impurities in drug products and how they may impact businesses in the pharma industry. On day one, SAFC Quality Assurance Director, Patty Benson, participated in a panel titled “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers”, along with a lineup of speakers from industry colleagues, the IPEC-Americas, CHPA and SOCMA’s Bulk Pharmaceutical Task Force (BPTF). The panel talked about draft guidelines and data implications, and their impact on pharmaceuticals. Patty’s input from an API maker’s perspective was complemented with an excipient user perspective from Janeen Skutnik-Wilkinson, Director of Quality and Regulatory Policy at Pfizer Inc. and an excipient maker perspective from David Schoneker, Director of Global Regulatory Affairs at Colorcon.
Patty’s presentation in the “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers” panel is available for reference here: Q3D BPTF 0412.
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