Four short words sum up what has lifted most successful individuals above the crowd: a little bit more.------------------------------------------author------------------------------------------dateQ2(R1)中英文对照REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USEREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE人用药品的注册要求ICH HARMONISED TRIPARTITE GUIDELINE ICH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Q2(R1) Current Step 4 version 现行第4阶段版本Parent Guideline dated 27 October 1994 最初指导原则起于1994年10月27日(Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005) （方法学补充指导原则完成于1996年11月6日，于2005年11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Q2(R1) Document HistoryQ2(R1) 文件历史First Codification 初次法典化History 历史Date 时间New Codification November 2005Parent 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，作为公用的咨询26 October 2003 2003-10Q2 Q2A Approval by the Steering Committee under Step 4 and recommendation 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 1994-10-27Q2 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 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 reached 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 ICH1994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1. Introduction This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included 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 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 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 initial text on validation of analytical procedures. Validation of these additional analytical procedures is equally important to those listed herein 。