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Stability Testing of New Drug Substances and Products新原料药及新制剂稳定性研究Q1a(R2)

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED TRIPARTITE GUIDELINE

STABILITY TESTING OF

NEW DRUG SUBSTANCES AND PRODUCTS

Q1A(R2)

Current Step 4 version dated 6 February 2003

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.

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Stability Testing of New Drug Substances and Products新原料药及新制剂稳定性研究Q1a(R2)

ICH指导原则

新药物与新产品稳定性研究Q1A（R2）

2003.2.6现行第4版

Q1A(R2) Document History

First Codification History Date New Codification November 2005 Q1 Approval by the Steering Committee under Step 2 and 16 September release for public consultation. Q1A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. Q1 was renamed Q1A. Q1A(R) Approval by the Steering Committee of the first revision under Step 2 and release for public consultation. Q1A(R) Approval by the Steering Committee of the first revision under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 7 October 1999 8 November 2000 Q1A(R1) Q1A(R1) 1992 27 October 1993 Q1A Q1 Current Step 4 version

Q1A(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 Climatic Zones III and IV), and recommendation for adoption to the three ICH regulatory bodies. 6 February 2003 Q1A(R2) 第 2 页 共 21 页

Stability Testing of New Drug Substances and Products新原料药及新制剂稳定性研究Q1a(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 from 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 30°C ± 2°C/60% RH ± 5% RH to

30°C ± 2°C/65% RH ± 5% RH in the following sections: 2.1.7.1 Drug Substance - Storage Conditions - General Case 2.2.7.1 Drug Product - Storage Conditions - General Case 2.2.7.3 Drug products packaged in semi-permeable containers 3 Glossary - “Intermediate testing”

下列章节中，中间放置环境由30℃±2℃/60%RH±5%修正为30℃±2℃/65%RH±5% 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 2.2.7.3 半渗透容器包装的制剂 3 术语-“中间试验”

2. 30°C ± 2°C/65% RH ± 5% RH can be a suitable alternative long-term storage condition to

25°C ± 2°C/60% RH ± 5% in the following sections:

2.1.7.1 Drug Substance - Storage Conditions - General Case 2.2.7.1 Drug Product - Storage Conditions - General Case

在下列章节中，30℃±2℃/65%RH±5%可作为长期试验放置条件25℃±2℃/60%RH±5% 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. 30°C ± 2°C/35% RH ± 5% RH has been added as a suitable alternative long-term storage

condition to 25°C ± 2°C/40% RH ± 5% and the corresponding example for the ratio of water-loss rates has been included in the following section: 2.2.7.3 Drug products packaged in semi-permeable containers

在下列章节中，30℃±2℃/35%RH±5%已作为长期放置条件5℃±2℃/40%RH±5%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

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