（中英对照）_美国FDA分析方法验证指南

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I. INTRODUCTION
This guidance provides recommendations 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 recommendations apply to drug substances and drug products covered in new
drug applications (NDAs), abbreviated new drug 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
及其它们的补充中所涉及的原料药和制剂。
The principles also apply to drug substances and drug products covered in Type II drug master 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.
这些原则同样适用于二类DMF所涉及的原料药和制剂。如果使用了其它方法，鼓励申请者事先和FDA药品评
审中心的官员进行讨论，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 recommendations in this guidance may not be applicable to certain unique analytical procedures for
products such as biological, biotechnological, botanical, or radiopharmaceutical drugs.
本指南中所述的分析方法验证的原则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, 39
immunogenicity assessments, or other immunoassays that have unique 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基础上的，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。
（中英对照）美国 FDA 分析方法验证指南(5/50)
翻译：胡剀 整理：chenpq
Furthermore, specific recommendations for biological and immunochemical tests that may be necessary for
characterization and 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范围之内。
Although this guidance does not specifically address the submission of analytical procedures and validation data for raw
materials, intermediates, excipients, container closure components, and other materials used in the production of drug
substances and drug products, validatedanalytical procedures should be used to analyze these materials.
尽管本指南并不专门叙述原料，中间体，赋形剂，包装材料及原料药和制剂生产中所用的其它物料的分析方法
及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 appropriate 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.
对于本指南中未提及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 for 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 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

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