REQUIREMENTS 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)
body是什么意思（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）plenty
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 History
三年级英语上鸭脖培训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 relea for public consultation. 在第2阶段经策划委员会批准，作为公用的咨询 | saudi arabia26 October 2003 拉丁文2003-10 | Q2 |
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 1994-10-27 | 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 relea 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 drill是什么意思 | 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) |
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PART I:
TEXT ON VALIDATION OF ANALYTICAL PROCEDURES
分析方法验证文件
ICH Harmonid 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 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
1. Introduction
This document prents 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 ek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text prentation rves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. The 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。
理事长英文
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpo. 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 lected 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, the have not been addresd in the initial text on validation of analytical procedures. Validation of the additional analytical procedures is equally important to tho listed herein and may be ad
dresd in subquent documents.
虽然有许多其他的分析方法，诸如药品的溶解性试验或药品微粒大小测试，在分析方法验证最初的正文中并未给出。那些额外的分析方法的验证和在这里列出来的分析方法同样重要，且有可能在后来的文件中提出。
A brief description of the types of tests considered in this document is provided below.
