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1、INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USEICH Harmonised Tripartite GuidelineStability Testing of New Drug Substances and ProductsQ1A(R2)Current Step 4 versiondated 6 February 2003This Guideline has been developed by the appr
2、opriate 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.ICH指导原则 新药物与新产品稳定性研究Q1A（R2） 2003.2.6
3、现行第4版Q1A(R2)Document HistoryFirst CodificationHistoryDateNew CodificationNovember 2005Q1Approval by the Steering Committee under Step 2 and release for public consultation.16 September 1992Q1Q1AApproval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulator
4、y bodies.Q1 was renamed Q1A.27 October 1993Q1AQ1A(R)Approval by the Steering Committee of the first revision under Step 2 and release for public consultation.7 October 1999Q1A(R1)Q1A(R)Approval by the Steering Committee of the first revision under Step 4 and recommendation for adoption to the three
5、ICH regulatory bodies.8 November 2000Q1A(R1)Current Step 4 versionQ1A(R2)Approval by the Steering Committee of the second revision directly under Step 4 without further public consultation, to include consequences of the adoption of Q1F (Stability Data Package for Registration Applications in Climat
6、ic Zones III and IV), and recommendation for adoption to the three ICH regulatory bodies.6 February 2003Q1A(R2)Cover Note for Revision of Q1A(R)Stability Testing of New Drug Substances and Products新药物与新产品稳定性研究Q1A（R）修正说明The purpose of this note is to outline the changes made in Q1A(R) that result fro
7、m adoption of ICH Q1F “Stability Data Package for Registration Applications in Climatic Zones III and IV”. These changes are:本注释的目的是概述R1A（R）的变化，这些变化是因采纳了ICH Q1F，即“在气候带III和IV地区注册申请的稳定性研究要求”这一指导原则而产生的，内容包括：1. The intermediate storage condition has been changed from 30C 2C/60% RH 5% RH to 30C 2C/65% RH
8、 5% RH in the following sections:2.1.7.1 Drug Substance - Storage Conditions - General Case2.2.7.1 Drug Product - Storage Conditions - General Case2.2.7.3 Drug products packaged in semi-permeable containers3 Glossary - “Intermediate testing”下列章节中，中间放置环境由302/60%RH5%修正为302/65%RH5%2.1.7.1 原料药-放置条件-一般情况
9、 2.2.7.1 制剂-放置条件-一般情况 2.2.7.3 半渗透容器包装的制剂 3 术语-“中间试验” 2. 30C 2C/65% RH 5% RH can be a suitable alternative long-term storage condition to 25C 2C/60% RH 5% in the following sections:2.1.7.1 Drug Substance - Storage Conditions - General Case2.2.7.1 Drug Product - Storage Conditions - General Case在下列章节中
10、，302/65%RH5%可作为长期试验放置条件252/60%RH5%的合适替代条件：2.1.7.1 原料药放置条件 一般情况2.2.7.1 制剂放置条件 一般情况3. 30C 2C/35% RH 5% RH has been added as a suitable alternative long-term storage condition to 25C 2C/40% RH 5% and the corresponding example for the ratio of water-loss rates has been included in the following section:
11、2.2.7.3 Drug products packaged in semi-permeable containers在下列章节中，302/35%RH5%已作为长期放置条件52/40%RH5%的合适替代条件，相应的计算失水率比值的例子已包括其中：2.2.7.3半渗透容器包装的制剂Mid-stream switch of the intermediate storage condition from 30C 2C/60% RH 5% RH to 30C 2C/65% RH 5% RH can be appropriate provided that the respective storage
12、conditions and the date of the switch are clearly documented and stated in the registration application.中间放置条件可从302/60%RH5%转为302/65%RH5%，但必须清楚记录转换前后的放置条件和转换日期并在注册申请中阐明。It is recommended that registration applications contain data from complete studies at the intermediate storage condition 30C 2C/65%
13、 RH 5% RH, if applicable, by three years after the date of publication of this revised guideline in the respective ICH tripartite region.本修正指南颁布三年内，建议向各ICH机关提交的注册申请内容包括中间放置条件302/65%RH5%的全部试验数据。TABLE OF CONTENTS 目 录1.INTRODUCTION引言61.1.Objectives of the Guideline目的61.2.Scope of the Guideline 范围61.3.G
14、eneral Principles 通则72.GUIDELINES 指导原则72.1.Drug Substance 原料药72.1.1.General 通则72.1.2.Stress Testing 影响因素试验72.1.3.Selection of Batches 批的选择82.1.4.Container Closure System 包装容器92.1.5.Specification 规范92.1.6.Testing Frequency 检测频率92.1.7.Storage Conditions 放置条件102.1.8.Stability Commitment 稳定性承诺142.1.9.Ev
15、aluation样品评价152.1.10.Statements/Labeling 说明/标签162.2.Drug Product 制剂（略）163.GLOSSARY 术语174.REFERENCES参考文献（略）20Stability Testing of New Drug Substances and Products新原料药及新制剂稳定性研究1. INTRODUCTION引言 1.1 Objectives of the Guideline目的 The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registra
