ICH Harmonised Tripartite Guideline - Q1A(R2) - Stability Testing of New Drug Substances and Products

Sep 25, 2026

ICH Harmonised Tripartite Guideline Q1A(R2) addresses stability testing for new drug substances and drug products, establishing objectives, scope, and general principles for regulatory evaluation. It provides guidance for stress testing, selection of batches, container closure systems, specifications, testing frequency, storage conditions, stability commitment, and evaluation. A revision cover note summarizes changes driven by adoption of ICH Q1F, including updated intermediate storage humidity conditions and alternative long-term storage options, along with documentation expectations for the switch and study data timing.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages24

Reading Time1 h 0 min

AccessFree to download

Introduction

Objectives of the Guideline

Scope of the Guideline

General Principles

Guidelines

Drug Substance

General

Stress Testing

Selection of Batches

Container Closure System

Specification

Testing Frequency

Storage Conditions

Stability Commitment

Evaluation

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. Q1A(R2) Document History | First
Codification | History | Date | New
Codification
November
2005 | | --- | --- | --- | --- | | Q1 | Approval by the Steering Committee under Step 2 and release for public consultation. | 16
September
1992 | Q1 | | Q1A | Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.
Q1 was renamed Q1A. | 27 October
1993 | Q1A | | Q1A(R) | Approval by the Steering Committee of the first revision under Step 2 and release for public consultation. | 7 October
1999 | Q1A(R1) | | Q1A(R) | Approval by the Steering Committee of the first revision under Step 4 and recommendation for adoption to the three ICH regulatory bodies. | 8
November
2000 | Q1A(R1) | 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) | | --- | --- | --- | --- | COVER NOTE FOR REVISION OF Q1A(R) STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS 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: 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](2.1.7.1) Drug Substance - Storage Conditions -General Case 􀁸 [2.2.7.1](2.2.7.1) Drug Product - Storage Conditions -General Case 􀁸 [2.2.7.3](2.2.7.3) Drug products packaged in semi-permeable containers 􀁸 3 Glossary - “Intermediate testing” 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](2.1.7.1) Drug Substance - Storage Conditions -General Case 􀁸 [2.2.7.1](2.2.7.1) Drug Product - Storage Conditions -General Case 3. 30°C ± 2°C/35% RH ± 5% RH has been added as a suitable alternative longterm 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](2.2.7.3) Drug products packaged in semi-permeable containers Mid-stream switch of the intermediate storage condition from 30°C ± 2°C/60% RH ± 5% RH to 30°C ± 2°C/65% RH ± 5% RH can be appropriate provided that the respective storage conditions and the date of the switch are clearly documented and stated in the registration application. It is recommended that registration applications contain data from complete studies at the intermediate storage condition 30°C ± 2°C/65% RH ± 5% RH, if applicable, by three years after the date of publication of this revised guideline in the respective ICH tripartite region. STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS ICH Harmonised Tripartite Guideline First Recommended for Adoption at Step 4 of the ICH Process on 27 October 1993. Revised under Step 2 of the ICH Process on 7 October 1999 and Recommended for Adoption at Step 4 of the ICH Process on 8 November 2000. This guideline has been Revised a second time and h

FAQs

What is the purpose of the Q1A(R2) guideline?

It outlines the approach and requirements for stability testing of new drug substances and products, including objectives, scope, and the general principles used for regulatory evaluation.

What changes were introduced in Q1A(R) due to adoption of ICH Q1F?

The cover note specifies updated intermediate storage conditions (notably changing humidity ranges) and adds alternative suitable storage conditions for certain sections, including semi-permeable container scenarios.

What documentation is recommended when switching intermediate storage conditions?

The guideline recommends that the date of the switch and the respective storage conditions be clearly documented and stated in the registration application, and that complete intermediate storage data be provided by a defined timeline after publication.

Sep 25, 2026

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