1664 ASSESSMENT OF DRUG PRODUCT （1664年评估药物产品）.pdf

BRIEFING 〈1664〉Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems. In the 2010–2015 cycle, the Packaging, Storage, and Distribution Expert Committee determined the need to update general chapters that speak to the quality of the packaging systems used to store drug products. The Expert Committees initial focus was on the final packaging systems; however, it had been extended to include packaging systems components and their materials of construction. The suitability of a pharmaceutical packaging system for a drug product can be assessed by extractables and leachables testing. Out of these characterization studies, specific controls for a packaging system, its components, or its materials of construction can be established. The suite of general chapters for packaging systems begins with Plastic Packaging Systems and Their Materials of Construction 661.1 , which is used to characterize the materials of construction, and Plastic Packaging Systems 661.2 , which is used to characterize the final packaging system and/or component. Other chapters that will be proposed in the future to address the characterization of plastic materials used in the manufacturing process and medical devices are Plastic Systems Used for Manufacturing Pharmaceutical Products 661.3 and Plastic Medical Devices Used to Deliver or Administer Pharmaceutical Products 661.4 . As part of this continuation, the Packaging, Storage, and Distribution Expert Committee is proposing Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 1664, which presents a framework for the design, justification, and execution of a leachables assessment for pharmaceutical packaging and delivery systems. A workshop will be held December 9 and 10, 2013, at USP headquarters in Rockville, MD, to discuss comments on the suite of