USP40-1225--药典的验证中英文对照.docx

 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，采用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 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. 这一章节的内容尽可能地和ICH文献“分析方法的验证和方法学”（文献与包含在EC，日本和美国递交的注册申请中的分析方法相关）协调一致。 SUBMISSIONS TO THE COMPENDIA 递交至药典 Submissions to the compendia for new or revised analytical procedures should contain sufficient information 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 procedures, 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. 将新的或修改后的分析方法递交至药典，应包含足够的资料从而使得USP委员会专家和其专家委员会能够评估拟定方法的价值。绝大多数情况下，评估包括透明度的评估和分析方法叙述完整性的评估，确定方法需求，以及专家已经充分验证的文件。涉及方法的类别改变，资料可能也会改变。然而，大部分情况下，递交应包含如下的章节 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, a comparison should be provided of limitations of the current compendial procedure and advantages offered by the proposed procedure. 基本原理—此章节应确定方法的需求和叙述拟定的具体的方法的能力以及它优于其它类别测定方法的原因。对于已修改的方法，需比较当前方法的局限性和拟定方法的优点。 Proposed Analytical Procedure—This section should contain a complete description 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, precautions, and explicit formulas for calculation of test results. 拟定的分析方法—此章节应包含详细完整的分析方法的叙述，使得技术人员能够重现。应包括所有的重要的操作参数和具体的操作，如试剂的制备，系统适应性性能的测试，空白溶液使用的叙述，注意事项，和用于计算检测结果的明确的公式。 Data Elements—This section should provide thorough and complete documentation of the validation of the analytical 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. 资料组成—此章节应对分析方法的验证提供周密的和完整的文件。需要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。这些特征在下面章节中叙述。 VALIDATION 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 considered 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. 分析方法的验证是一个过程：通过实验室的研究确立了方法的性能参数可以满足预期的分析应用的要求。本文件叙述的几种方法的验证需要考虑的典型的分析性能参数列在表1中。因为对术语和使用的观点可能会有所不同，所以每个性能参数在此章节的下部分给出定义，以及典型方法或能够测量的方法的描述。 The definitions refer to “test results.” The description of the analytical procedure should define what the test results for the procedure are. As noted in ISO 5725-1 and 3534-1, a test result is “the