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Location: Insight Briefing Theater
Date: Tuesday, April 24
Time: 11:30am - 12:15pm
Pass Type: Conference Pass, Exhibitor, Expo Only, VIP Attendee - Get your pass now!
Track: Insight Briefing
Vault Recording: TBD
In the manufacture of potent active pharmaceuticals ingredients (APIs), process containment is required for both worker protection and product protection to prevent overexposure and cross-contamination, respectively. To verify the adequacy of controls, containment performance testing (CPT) is needed both at the vendor (factory acceptance testing) and site (site acceptance testing). Because of the nature of particulates, a dynamic test using surrogates or the API themselves is required to mimic the conditions of manufacture or R&D operations. In parallel, as the drug reaches Phase II or further, to adequately assess the potential for cross-contamination, a Permitted Daily Exposure (PDE) value is needed for the API and sometimes key intermediates in the process. The PDE is for patient safety purposes and is used to establish a Maximum Allowable Carry Over (MACO) from product to product needs to be developed to meet the European Medicines Agency (EMA) or other regulatory cross-contamination guidelines. The importance of process containment to product quality and worker protection, how to conduct CPT testing, and how to derive scientifically robust PDEs will be provided.