ICH指导原则之方法论.doc

INTRODUCTION 简介 This document is complementary to the parent document, which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. In some cases (for example, demonstration of specificity), the overall capabilities of a number of analytical procedures in combination may be investigated in order to ensure the quality of the drug substance or drug product. In addition, the document provides an indication of the data, which should be presented in a registration application. 本文作为前文的补充，旨在讨论在分析方法验证过程中在每一个具体的项目需要考虑哪些内容。本文的目的是就不同类型的验证该涵盖哪些项目提供一个指导原则和建议。以专属性为例，为了确保原料药或制剂的质量，需要考察分析过程对化合物中杂质的全面综合分析能力。另外，文件提供的数据应该包含在注册申请材料中。 All relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate. 验证报告中的所有数据及每个验证项目的计算公式应一同提交并进行适当的论述(即得出相应结论)。 Approaches other than those set forth in this guideline may be applicable and acceptable. It is the responsibility of the applicant to choose the validation procedure and protocol most suitable for their product. However it is important to remember that the main objective of validation of an analytical procedure is to demonstrate that the procedure is suitable for its intended purpose. Due to their complex nature, analytical procedures for biological and biotechnological products in some cases may be approached differently than in this document. 本文阐述的原则之外的原则应该适用并可接受。申请者的职责是制定最适合申报产品的验证项目及验证方案。最重要的是记住分析方法验证的主要目的是证明该分析程序能达到预期目标。由于生物制品和生物科技产品本身的复杂性，有时候，其分析方法的验证也可能与本文提到的方法不同。 Well-characterized reference materials, with documented purity, should be used throughout the validation study. The degree of purity necessary depends on the intended use. 验证研究用到的参比物质需要经过完全鉴定并标定纯度。所需的纯度取决于其应用类型(预期用途)。 In accordance with the parent document, and for the sake of