Q1F Step4.docVIP

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Harmonised Tripartite Guideline Stability Data Package for Registration Applications in Climatic Zones III and IV Q1F 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.  Q1FDocument History First Codification History Date New Codification November 2005 Q1F Approval by the Steering Committee under Step 2 and release for public consultation. 7 February 2002 Q1F Current Step 4 version Q1F Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 6 February 2003 Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 6 February 2003, this guideline is recommended for adoption to the three regulatory parties to ICH TABLE OF CONTENTS 1. INTRODUCTION 1 1.1 Objectives of the Guideline 1 1.2 Background 1 1.3 Scope of the Guideline 1 2. GUIDELINES 2 2.1 Continuity with the Parent Guideline 2 2.2 Storage Conditions 2 2.2.1 General Case 2 2.2.2 Aqueous-based drug products packaged in semi-permeable containers 3 2.2.3 Tests at elevated temperature and/or extremes of humidity 3 2.3 Additional Considerations 4 3. REFERENCES 4 Stability Data Package for Registration Applications in Climatic Zones III and IV 1. INTRODUCTION Objectives of the Guideline This guideline describes an approach to broader use of the ICH guideline “Q1A(R) Stability Testing of New Drug Substances and Products” (hereafter referred to as t