洛施德gmp咨询 -ich q2(r1)：分析方法验证

1、SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 第1页 / 共22页 , Soltoris Management Consultants, Inc. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE 人用药品的注册要求人用药品的注册要求 ICH HARMONISED TRIPARTITE GUIDELINE ICH 协调的三方指导原则协调的三方指导原则 VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY 分析方法验证：正文和方法学分析方法验证：正文和方法学 Q2(R1) Current Step 4 version 现行第现行第 4 阶段版本阶段版本 Parent Guideline dated 27 October 1994 最初指导原则起于最初指导原则起于 1994 年年 10 月月 27 日日 (Complementary Guideline on Methodology dat

2、ed 6 November 1996 incorporated in November 2005) （方法学补充指导原则完成于（方法学补充指导原则完成于 1996 年年 11 月月 6 日，于日，于 2005 年年 11 月合并）月合并） This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 此指导原则由适当的 ICH 专家工作组起草，经调整团磋商，于 ICH 过程一致。在第四阶段，最终的草案 推荐给欧盟，日本和美国的监管机构采用

3、。 Q2(R1) Document History Q2(R1) 文件历史 First Codification 初次法典化 History 历史 Date 时间 New Codification November 2005 Parent Guideline: Text on Validation of Analytical Procedures 最初的指导原则：分析方法的验证 Q2 Approval by the Steering Committee under Step 2 and release for public consultation. 在第 2 阶段经策划委员会批准，作为公用的咨 26 October 2003 2003-10 Q2 SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 第2页 / 共22页 , Soltoris Management Consultants, Inc. 询 Q2A Approval by the Steering Committee under Step 4 and recomm

4、endation for adoption to the three ICH regulatory bodies. 在第 4 阶段经侧环委员会同意并推荐给三方 ICH 监管机构采用 27 October 1994 1994-10-2 7 Q2 Guideline on Validation of Analytical Procedures: Methodology developed to complement the Parent Guideline 分析方法验证的指导原则：扩展的方法学作为最初指导原则的补充 Q2B Approval by the Steering Committee under Step 2 and release for public consultation. 在第 2 阶段经策划委员会批准，作为公 用的咨询 29 November 1995 in Q2(R1) Q2B Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH

5、 regulatory bodies 在第 4 阶段经侧环委员会同意并推荐给三方 ICH 监管机构采用 Current Step 4 version 现行 Q2A and Q2B The parent guideline is now renamed Q2(R1) as the guideline Q2B on methology has been incorporated to the parent guideline. The new title is “Validation of Analytical Procedures: Text and Methodology”. 最初的指导原则现在更名为 Q2(R1)因为指导原则 Q2B 方法学已经合并到最初的指导原则中。新标题“分 析方法验证：正文和方法学” November 2005 Q2(R1) PART I: TEXT ON VALIDATION OF ANALYTICAL PROCEDURES 分析方法验证文件 ICH Harmonised Tripartite Guideline ICH 协调三方指导原则 Having rea

6、ched Step 4 of the ICH Process at the ICH Steering Committee meeting on 27 October 1994, this guideline is recommended for adoption to the three regulatory parties to ICH 1994 年 10 月 27 日的 ICH 策划委员会会议已经进入了 ICH 进程的第 4 阶段，此指导原则推荐给 ICH 三个 监管部门采纳 SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 第3页 / 共22页 , Soltoris Management Consultants, Inc. 1. Introduction This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures includ

7、ed as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and

8、regulators of the EC, Japan and USA. 1 介绍 作为递交给欧共体，日本和美国新药注册申请资料的一部分，对分析方法验证需考虑事项的特征的讨论 在此文件呈现出来。没有必要在此文件寻找覆盖在世界其他地区的药品的注册或出口所要求的测试。此外， 此文作为术语的收集，和他们的定义而服务的，并没有想提供怎样完成验证的指示。这些项目和定义是连接 那些常存在于欧共体，日本和美国的各种药典和规定之间的差异的桥梁。 The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included. Other analytical procedures may be

9、considered in future additions to this document. 分析方法验证的目的是为了阐述分析方法是适用于它要分析的目的的。应用于鉴别，杂质控制和含量测 定方法的特征项的综合，可能考虑会加入到今后的文件中。 2. Types of Analytical Procedures to be Validated 2所要验证的分析方法的类型 The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedures: 分析方法验证的讨论通常集中在以下分析方法的四个最通用的方面： - Identification tests; -鉴别试验； - Quantitative tests for impurities content; -杂质含量的定量测试； - Limit tests for the control of impurities; -杂质控制的限度测试； - Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product. -原料药或制剂或其他药品中选择性的组分的样品的活性部分的定量测试； Although there are many other analytical procedures, such as dissolution testing for drug products or particle size determination for drug substance, these have not been addressed in the initia

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