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. 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 proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.用于评估药品质量的检验方法需要满足不同的要求。根据联邦食品，药品，和化妆品法案 501 章，美国药典和国家处方专题论文里的试验和法律规范构成了法律标准。CGMP 法规[21 CFR 211.194(a)]要求：用于评估药品满足已建立的法律规范的检验方法必须满足准确、可靠、适当的标准。此外，根据法规21 CFR 211.194(a)(2)，USP-NF 中叙述的分析方法的使用者不需要验证这些方法的准确度和可信度，仅仅需要确认在实际使用条件下的适用性。考虑到USP 和 NF 的法律地位，采纳新的或修改后的药典分析方法的建议，并且这个建议是由充分的实验室数据支持以证明其有效，这是十分必要的。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of Analytical Pro...
