药典方法的验证.docVIP

1225 VALIDATION OF COMPENDIAL PROCEDURES 药典方法的验证 Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. 评估药品质量水平的实验方法要满足各种各样的要求。 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. 要依据美国食品、药品及化妆品法501节以及USP-NF各论中的分析和规定来构建法定标准。 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. 现行药品制造良好规范[21 CFR 211.194(a)] 要求应用于药品评估的实验方法符合现有的标准，必须符合准确度和可信度的适当标准。 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. 而且，根据[21 CFR 211.194(a)(2)]的这些规定，不要求USP-NF介绍的分析方法/程序的使用者去验证这些方法/程序的准确度和可信度，只要确认正确的使用条件下的适用性。 Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity. 要认识USP和NF标准的法定地位，因此，采纳新的或违背药典分析方法/程序的建议必须有充足的实验室数据支持以记录它们的有效性。 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. 此信息章尽可能与ICH分析方法验证与方法学的文件协调一致，那是与包含在欧盟、日本和美国注册申请内的分析方法相关的。 SUBMISSIONS TO THE COMPENDIA 提交给药典 Submissions to the compendia for new or revised analytical procedures should contain sufficient information to enable members of the USP C