USP 665 and 1665 Extractables for Components in Pharmaceutical and Biopharmaceutical Manufacturing

USP monographs addressing extractables testing of plastic components used to manufacture pharmaceutical and biopharmaceutical drug products were developed, debated, and ultimately accepted with the overriding purpose of ensuring that both users of such components and regulators of drug products had sufficient and standardized extractables data upon which to base decisions concerning suitability for use of those components, specifically focusing on patient safety. The USP monographs were based on three fundamental tenants: 1. That extractables testing should be related to the risk that component-related leachables would be present in the manufactured drug product in unsafe quantities (greater risk – more extensive and rigorous testing), 2. The extractables testing should be performed in a comprehensive and standardized method so that data sets for individual components were complete and comparable across vendors, 3. That properly designed, executed and justified extractables testing could be used to qualify a component as safe to use without testing of manufactured drug product for manufacturing-related leachables. Although published with a delayed implementation, these chapters have already resulted in the generation of a significant body of data, which, when considered in the context of other published studies, may dictate how these Chapters are applied upon their implementation and how they may evolve after they are implemented. This presentation re-visits the development of these chapters, discusses their current contents and the implications thereof, reviews currently available relevant knowledge, and considers how the chapters could evolve after their implementation. Dr. Dennis Jenke, Principal Consultant – Nelson Labs