美国药典USP1225原稿及翻译稿－药典方法的验证.docx

1225VALIDATION OF COMPENDIAL PROCEDURES Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposal for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity. The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of Analytical Procedures and the Methodology extension text, which are concerned with analytical procedures included as part of registration applications submitted within the EC, Japan, and the USA. 药典方法的验证 评估药品质量水平的实验方法受到多种要求的影响。根据美国食品、药品、化妆品法案501款，美国药典和国家处方集的各论中的含量测定和质量标准构成了法定标准。现行药品生产质量管理规范【21 CFR 211.194(a)】要求，用于评价药物与既有质量标准之间的符合性的分析方法必须在准确度和可靠性方面达到适当的标准。并且根据【21 CFR 211.194(a)(2)】的这些规定，不要求USP-NF（《美国药典/国家处方集》）中描述的分析方法/方法的使用者去验证这些方法的准确度和可靠性，而仅需确认其在实际使用条件下的适用性。认识到USP和NF标准的法定地位，因此，提议采纳新的或更改过的药典分析方法时，必须有充分的实验室数据作为支持，以记录其有效性。 ?本信息章节的内容尽可能地与三方国际协调会议（ICH）文件分析方法的验证和方法学的延伸内容保持一致，那是与包括欧盟、日本和美国在内的注册申请中的分析方法相关的。 SUBMISSIONS TO THE COMPENDIA Submissions to the compendia for new or revised analytical procedures should contain sufficient inform