FDA行业指南《O1A新原料药和制剂稳定性试验》

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FDA 行业指南

《Q1A: 新原料药和制剂稳定性试验》

Guidance for Industry

Q1A Stability Testing of New Drug Substances and

Products

U.S.Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research(CDER)

Center for Biologics Evaluation and Research(CBER)

ICH

August 2001

Revision 1

Additional copies of this guidance are available from:

Office of Training and Communications

Division of Communications Management

Division of Drug Information,HFD-240

Center for Drug Evaluation and Research

Food and Drug Administration

5600 Fishers Lane

Rockville,MD 20857

(Tel)301-827-4573

(Internet) http://www.fda.gov/cder/guidance/index.htm

Office of Communication,Training and

Manufacturers Assistance,HFM-40

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike,Rockville,MD 20852-1448

Internet: http://www.fda.gov/cber/guidances.htm

Fax:1-888-CBERFAX or 301-827-3844

Mail:the Voice Information System at 800-835-4709 or 301-827-1800

ICH2001 年 8 月

第一此修订

ICH

August 2001

Revision 1

目录TABLE OF CONTENTS

I. 简介INTRODUCTION(1)

A. 指南目的Objectives of the Guidance(1.1)

B. 适用范围Scope of the Guidance(1.2)

C. 通用原则General Principles(1.3)

II. 指南 GUIDANCE(2)

A. 原料药Drug Substance(2.1)

1. 通则General (2.1.1)

2. 强化试验 Stress Testing(2.1.2)

3. 批选择Selection of Batches(2.1.3)

4. 包装密封系统Container Closure System

(2.1.4)

5. 参数Specification(2.1.5)

6. 试验频率Testing Frequency(2.1.6)

7. 存储条件Storage Conditions(2.1.7)

8. 稳定性承诺Stability Commitment (2.1.8)

9. 评估Evaluation(2.1.9)

10. 说明/标签Statements/Labeling(2.1.10)

B. 制剂产品Drug Product(2.2)

1. 通则General (2.2.1)

2. 光稳定性试验Photostability Testing

(2.2.2)

3. 批选择Selection of Batches(2.2.3)

4. 包装密封系统Container Closure System

(2.2.4)

5. 参数Specification (2.2.5)

6. 试验频率Testing Frequency(2.2.6)

7. 存储条件Storage Conditions(2.2.7)

8. 光稳定性承诺Stability Commitment

(2.2.8)

9. 评估Evaluation(2.2.9)

10. 说明/标签Statements/Labeling (2.2.10)

术语 GLOSSARY

参考文献REFERENCES

FDA 行业指南

《Q1A: 新原料药和制剂稳定性试验》

Guidance for Industry

Q1A Stability Testing of New Drug Substances and Products

本指南代表了FDA 在此领域的当前思路。它不赋予任何人任何权利，其

适用也不限制公众。替代的方法可以使用，如果它能满足相关法律和条例

的要求。This guidance represents the Food and Drug Administration's(FDA's)

current thinking on this topic.It does not create or confer any rights for or on

any person and does not operate to bind FDA or the public.An alternative

approach may be used if such approach satisfies the requirements of the

applicable statutes and regulations.

本指南是对1994年Q1A 的修订。本修订的目的是在一些部分增加了内容，

而在其他部分提供详细说明。This guidance is a revision of Q1A Stability

Testing ofNew Drug Substances and Products (September 1994).The purpose

of the revision is to add information to certain sections and to provide

clarification to other sections of the guidance.

I. 简介INTRODUCTION(1)

A. 目的Objectives of the Guidance(1.1)

本指南的目的在于定义新原料药在欧洲、日本、美国三个地区注册所需要

的稳定性资料。它并不解决注册所需要的化验或出口到世界其它地区的要

求。本指南详细论述新原料药和制剂的核心稳定性数据，同时，留有充足

的灵活性，以便适应具体科学考虑和被评估材料特征的不同具体情况。替

代方法在有科学根据的情况下可以使用。This guidance is intended to define

what stability data package for a new drug substance or drug product is

sufficient for a registration application within the three regions of the

European Union(EU),Japan,and the United States.It does not seek to

address the testing for registration in or export to other areas of the world.The

guidance exemplifies 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.

B.Scope of the Guidance(1.2)

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FDA行业指南《Q1A:新原料药和制剂稳定性试验》GuidanceforIndustryQ1AStabilityTestingofNewDrugSubstancesandProductsU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)ICHAugust2001Revision1Additionalcopiesofthisguidanceareavai...

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