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1、usp_1225 药典方法的验证 2011.02.26 验证: Validation 针对新方法(没有法定方法, 需要用户自己建立的 ) 按照 ICH Q2 或 USP的方式均可; 主要是需要满足使用目的. VALIDATION OF COMPENDIAL PROCEDURES药典规程的验证Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Feder
2、al 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 o
3、f 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, bu
4、t 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. 评估药
5、品质量水平的实验方法受到多种要求的影响。要依据美国食品、药品、化妆品法案 501 款以及美国药典和国家处方集的各论中的含量测定和质量标准来构建法定标准。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规程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/规程的使用者去验证这些规程的准确度和可靠性，而仅需确认其在正确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规
6、程时，必须有充分的实验室数据作为支持，以记录其有效性。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 inc
7、luded as part of registration applications submitted within the EC, Japan, and the USA. 本信息章节的内容尽可能地与三方国际协调会议（ICH）文件分析规程的验证和方法学的延伸内容保持一致，那是与包含欧盟、日本和美国注册申请内的分析方法相关的。SUBMISSIONS TO THE COMPENDIA向药典提交的文件Submissions to the compendia for new or revised analytical procedures should contain sufficient info
8、rmation to enable members of the USP Council of Experts and its Expert Committees to evaluate the relative merit of proposed procedures. In most cases, evaluations involve assessment of the clarity and completeness of the description of the analytical procedures, determination of the need for the pr
9、ocedures, and documentation that they have been appropriately validated. Information may vary depending upon the type of method involved. However, in most cases a submission will consist of the following sections. 向药典提交关于新的或更改过的分析规程的文件应该包括充足的信息，以使 USP 专家理事会和专家委员会能够评估拟议规程的相对优越性。在大多数情况下，这些评估涉及对分析规程描述的
10、清晰度和完整度的评估，对规程的需求的确定，以及它们已经进行了适当验证的记录文件。这些信息可以根据所涉及规程的种类而变化。但是，在大多数情况下，提交的文件将有下面的章节组成。Rationale- This section should identify the need for the procedure and describe the capability of the specific procedure proposed and why it is preferred over other types of determinations. For revised procedures,
11、a comparison should be provided of limitations of the current compendial procedure and advantages offered by the proposed procedure. 理论依据- 此部分应该辨明对于该规程的需求，并描述具体拟议中规程的能力，以及为什么优于其他种类检测。对于更改的方法/规程，应该提供对当前药典规程之缺陷与拟议中规程之优势的比较。Proposed Analytical Procedure- This section should contain a complete descripti
12、on of the analytical procedure sufficiently detailed to enable persons “skilled in the art” to replicate it. The write-up should include all important operational parameters and specific instructions such as preparation of reagents, performance of system suitability tests, description of blanks used
13、, precautions, and explicit formulas for calculation of test results.推荐的分析方法/规程- 此部分包含对该分析规程的完整描述，应足够具体以便能让业内技术熟练的人重复它。文章应该包括所有重要的操作参数和具体的指令，例如：试剂制备、系统适用性测试表现、所使用空白对照的描述、预防措施、用于计算测试结果的明确公式。Data Element- This section should provide thorough and complete documentation of the validation of the analytic
14、al procedure. It should include summaries of experimental data and calculations substantiating each of the applicable analytical performance characteristics. These characteristics are described in the following section. 数据要素- 此部分应该提供完全彻底的分析规程验证记录文件。其应该包括对于证明每一个实用功能特性的实验数据和计算的概况、总结。这些特性在下面的部分描述。VALID
15、ATION验证Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications. Typical analytical performance characteristics that should be considere
16、d in the validation of the types of procedures described in this document are listed in Table 1. Because opinions may differ with respect to terminology and use, each of the performance characteristics is defined in the next section of this chapter, along with a delineation of a typical method or methods by which it may be measured. 分析规程的验证是，通过实验室研究，确定该规程的工作特性达到了预定分析用途要求的过程。在此文件中所描述的规程种类的验证中，应当考虑的常见分析工作特性在表 1 中列出。因为对于术语和使用的意见可能不同，在此通则的下个部分定义了每个工作性能，以及可以对其进行测量的常用的一个
