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1、wordI. INTRODUCTIONThis guidance provides remendations to applicants on submitting analytical procedures, validation data, and samples to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.1. 绪论本指南旨在为申请者提供建议，以帮助其提交分析方法，方法验证资料和样品用于支持
2、原料药和制剂的认定，剂量，质量，纯度和效力方面的文件。This guidance is intended to assist applicants in assembling information, submitting samples, and presenting data to support analytical methodologies. The remendations apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug
3、applications (ANDAs), biologics license applications (BLAs), product license applications (PLAs), and supplements to these applications.本指南旨在帮助申请者收集资料，递交样品并资料以支持分析方法。这些建议适用于NDA，ANDA，BLA，PLA与其它们的补充中所涉与的原料药和制剂。The principles also apply to drug substances and drug products covered in Type II drug maste
4、r files (DMFs). If a different approach is chosen, the applicant is encouraged to discuss the matter in advance with the center with product jurisdiction to prevent the expenditure of resources on preparing a submission that may later be determined to be unacceptable.这些原如此同样适用于二类DMF所涉与的原料药和制剂。如果使用了其
5、它方法，鼓励申请者事先和FDA药品评审中心的官员进展讨论，以免出现这种情况，那就是花了人力物力所准备起来的递交资料后来发现是不可用的。The principles of methods validation described in this guidance apply to all types of analytical procedures. However, the specific remendations in this guidance may not be applicable to certain unique analytical procedures for produc
6、ts such as biological, biotechnological, botanical, or radiopharmaceutical drugs.本指南中所述的分析方法验证的原如此适用于各种类型的分析方法。但是，本指南中特定的建议可能不适用于有些产品所用的特殊分析方法，如生物药，生物技术药，植物药或放射性药物等。For example, many bioassays are based on animal challenge models, 39immunogenicity assessments, or other immunoassays that have unique
7、features that should be considered when submitting analytical procedure and methods validation information.比如说，许多生物分析是建立在动物挑战模式，免疫原性评估或其它有着独特特性的免疫分析根底上的，在递交分析方法和分析方法验证资料时需考虑这些独特的性质。Furthermore, specific remendations for biological and immunochemical tests that may be necessary for characterization a
8、nd quality control of many drug substances and drug products are beyond the scope of this guidance document.而且，许多原料药和制剂的界定和质量控制所需的生物和免疫化学检测并不在本指南的X围之内。Although this guidance does not specifically address the submission of analytical procedures and validation data for raw materials, intermediates, ex
9、cipients, container closure ponents, and other materials used in the production of drug substances and drug products, validated analytical procedures should be used to analyze these materials.尽管本指南并不专门表示原料，中间体，赋形剂，包装材料与原料药和制剂生产中所用的其它物料的分析方法与分析方法验证资料的递交，但是应该应用验证过的分析方法来分析检测这些物质。For questions on approp
10、riate validation approaches for analytical procedures or submission of information not addressed in this guidance, applicants should consult with the appropriate chemistry review staff at FDA.对于本指南中未提与的关于分析方法验证和资料提交方面的问题，请向FDA相关的化学评审人员咨询。This guidance, when finalized, will replace the FDA guidance f
11、or industry on Submitting Samples and Analytical Data for Methods Validation (February 1987).本指南，一旦定稿，将取代FDA于1987年2月份发布的工业指南：分析方法验证所需提交的样品和分析资料。II. BACKGROUND Each NDA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug
12、 substance and drug product, including bioavailability of the drug product (21 CFR 314.50(d)(1) and 314.94(a)(9)(i). II. 背景每个NDA和ANDA都必需包括必要的分析方法以确保原料药和制剂的认定，剂量，质量，纯度和效力，还包括制剂的生物利用度(21 CFR 314.50(d)(1) 和314.94(a)(9)(i)。FDA验证文件现场备查，可以不与DMF一起交。Data must be available to establish that the analytical pr
13、ocedures used in testing meet proper standards of accuracy and reliability (21 CFR 211.165(e) and 211.194(a)(2).必须要有资料来论证所用的分析方法是符合一定的准确度和可靠性标准的。Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use. The methods validation process for analy
14、tical procedures begins with the planned and systematic collection by the applicant of the validation data to support the analytical procedures.分析方法验证是论证某一分析方法适用于其用途的过程。分析方法的验证过程是从申请者有计划地系统性收集验证资料以支持分析方法开始的。Thereview chemist evaluates the analytical procedures and validation data submitted in the ND
15、A or ANDA. 审评化学家会对NDA或ANDA中的分析方法和验证资料进展评审。On request from FDA, an NDA or ANDA applicant must submit samples of drug product, drug substance, nonpendial reference standards, and blanks so that the applicants drug substance and drug product analytical procedures can be evaluated by FDA laboratories (2
16、1 CFR 314.50(e) and 314.94(a)(10).一旦FDA有要求，如此NDA或ANDA的申请者必须提交制剂，原料药，非药典对照品和空白以使FDA实验室能对申请者所用分析方法进展评审(21 CFR 314.50(e) and 314.94(a)(10)。The FDA laboratory analysis demonstrates that the analytical procedures are reproducible by laboratory testing. The review chemists and laboratory analysts determine the suitability of the analytical procedures for regulatory purposes.FDA实验室的分析会论证该分析方法在实验室内是可以重现的。审评化学家和实验室分析家会从法规的角度确定该
