USP：药品质量标准.pdfVIP

USP: Quality Standards for Medicines USP: 药品质量标准 操洪欣CRM, USP-China 美国与药品标准相关 的法律 US Drug Law • Federal Food, Drug, and Cosmetic Act (FFDCA) 联邦食品药品化妆品法 – Basic text that governs all pharmaceutical, medical device, food, cosmetics, dietary supplements 管理药品、医疗器械、食品、化妆品和膳食补充剂的基本法律 – Includes requirements for approval to market a drug 包括对药品上市批准的要求 – Portions relevant to USP also apply to biologics 涉及USP的部分同样适用于生物制品 • FDA regulations FDA的法规 – Developed by FDA under authority granted by FFDCA 在FFDCA法律框架下由FDA建立 • FDA guidance FDA指南 – Non-binding, but indicates FDA’s thinking 非法规，但体现FDA的考虑 Recognition of USP in FFDCA – Documentary Standards Section 501(b): • A drug is adulterated “if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium…” 以下情况判为假药“其声称为药典收录的药品名称，而其效力不同于、或其质 量或纯度低于药典中所设定的标准。对效力、质量或纯度的判断应当根据药典 中所设定的分析方法或测试而得到……” Section 501(a)(2)(B): • A drug is adulterated if it is not manufactured in accordance with current Good Manufacturing Practices (cGMPs) 若药品未按照cGMP规范生产视为假药 – cGMP regulations require testing of each batch of finished drug product to ensure that it meets defined specifications. cGMP法规要求最终产品每批检测，以保证产品符合既定的标准 Section 201(j): • The term “official compendium” means the official United States Pharmacopeia . . . National Formulary, or any supplement . . .” 术语“official compendium” 意思是法定美国药典…国家处方集及其增补本… FFDCA Requirements for Conformance to USP Documentary Standards • Ultimately, the product must conform to the