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➢2012 EU cGMPs Chapter 7, “Outsourced Activities” ➢2014 Draft USP <1663> “Assessment of Extractables Associated with Pharmaceutical. USP chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems is the basis for the chemical safety assessment USP General Chapter <661> Plastic Packaging Systems and Their <1663> Assessment of Extractables Associated with Pharmaceutical.Two crucial USP chapters include USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and USP <1664> Informational Chapters. USP <1663> “Assessment of Extractables. Associated with Pharmaceutical. Packaging/Delivery Systems”. USP <1664> “Assessment of drug This general information chapter presents a framework for the design, justification, and execution of an extractables assessment for pharmaceutical packaging The chapter establishes critical dimensions of an extractables assessment and discusses practical and technical aspects of each dimension.