Q1A（R2）新原料药和制剂的稳定性试验中英文对照版_2020.4.16
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1A(R2)
新原料药和制剂的稳定性试验
Current Step4version
现第四版
Dated6February2003
2003年2月6日制定
1.INTRODUCTION导言 (3)
1.1.Objectives of the Guideline目的 (3)
1.2.Scope of the Guideline范围 (3)
1.3.General Principles通则 (4)
2.GUIDELINES指导 (5)
2.1.Drug Substance原料药 (5)
2.1.1.General概述 (5)
2.1.2.Stress Testing影响因素试验 (5)
2.1.3.Selection of Batches批次选择 (6)
2.1.4.Container Closure System包装容器系统 (6)
2.1.5.Specification质量标准 (7)
2.1.6.Testing Frequency检验频次 (7)
2.1.7.Storage Conditions贮藏条件 (8)
2.1.8.Stability Commitment稳定性承诺 (11)
2.1.9.Evaluation评估 (12)
2.1.10.Statements/Labeling说明书/标签 (14)
2.2.Drug Product制剂 (14)
2.2.1.General通则 (15)
2.2.2.Photostability Testing光稳定性试验 (15)
profile中文2.2.3.Selection of Batches批次选择 (15)
2.2.4.Container Closure System包装容器系统 (16)
2.2.5.Specification质量标准 (16)
2.2.6.Testing Frequency检验频次 (17)
2.2.7.Storage Conditions贮藏条件 (18)
2.2.8.Stability Commitment稳定性承诺 (26)
2.2.9.Evaluation评估 (27)
2.2.10.Statements/Labeling说明书/标签 (29)
3.GLOSSARY术语 (29)
4.REFERENCES参考文献 (38)
1.INTRODUCTION
导言
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 registration application within the three regions of the EC,Japan,and the United States.It do
es not seek necessarily to cover the testing for registration in or export to other areas of the world.
以下指导原则是ICH Q1A的修订版，定义了新原料药和制剂在欧洲、日本、美国三个地区注册所需要的稳定性资料要求。它并不涵盖世界其他地区或出口到这些地区的注册要求。
The guideline seeks to exemplify the core stability data package for new drug substances and products,but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated.Alternative approaches can be used when there are scientifically justifiable reasons.
本指导旨在例证新原料药和制剂的核心稳定性数据，但是留有足够的弹性空间来适应由于特殊的科学考虑和被评估物质的特殊性质而导致的各种不同的实际情况。如果能给出科学合理的解释证明，也可采用代替方案。
1.2.Scope of the Guideline
范围
The guideline addresses the information to be submitted in registration applications for new molecular entities and associated drug products.This guideline does not currently seek to cover the information to be submitted for abbreviated or abridged applications, variations,clinical trial applications,etc.
本指导文件阐述了新分子实体及其相关制剂注册时需提交的信息。本文件目前不包括简略或简化申请（仿制药申请），变更申请和临床试验申请的指导。
Specific details of the sampling and testing for particular dosage forms in their proposed container closures are not covered in this guideline.
在特定包装容器系统中的特殊剂型，其取样及检验的详细指导不在本文件范围内。
Further guidance on new dosage forms and on biotechnological/biological products can be found in ICH guidelines Q1C and Q5C,respectively.
有关新剂型和生物技术/生物制品的进一步指导请分别参考ICH Q1C和Q5C。
1.3.General Principles
通则
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature,humidity,and light,and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.
稳定性试验的目的是，为原料药或制剂在各种环境因素（如温度、湿度、光照等）影响下，质量随着时间推移发生变化的规律；从而分别为原料药和制剂制定复检期和有效期，并建立推荐的贮藏条件。
The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the EC,Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and th
e world can be divided into four climatic zones,I-IV.This guideline addresses climatic zones I and II.The principle has been established that stability information generated in any one of the three regions of the EC,Japan and the United States would be mutually acceptable to the other two regions,provided the information is consistent with this guideline and the labeling is in accord with national/regional requirements.
本指导的试验条件选择是根据对欧洲（欧共体）、日本及美国这三个地区的气候条件影响分析选定的。世界任何一个地带的平均动力学温度都可以从气象数据推出：世界被划分为四个气候带I~IV。本指导适用于气候带I与II。一个已被认可的通用原则如下：从欧洲、日本、美国中的任一地区获得的稳定性资料，只要该资料提供的信息符合本指导文件的规定，其标识符合国家/地区要求，则该稳定性资料应被其他两个地区互相接受。
2.GUIDELINES
指导
2.1.Drug Substance
原料药
2.1.1.General
概述
Information on the stability of the drug substance is an integral part of the systematic approach to stability evaluation.
原料药的稳定性资料是系统性评估稳定性的必要组成部分。
2.1.2.Stress Testing
影响因素试验
Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.The nature of the stress testing will depend on the individual drug substance and the type of dru
g product involved.

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