INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH Harmonised Tripartite Guideline
Impurities in New Drug Products
Q3B(R2)
Current Step 4 version
dated 2 June 2006
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 mended for adoption to the regulatory bodies of the European Union, Japan and USA.
Q3B(R2)
Document History
First Codification
History
Date
New Codification
November 2005
Q3B
Approval by the mittee under Step 2 and release for public consultation.
29 November 1995
Q3B
Q3B
Approval by the mittee under Step 4 and mendation for adoption to the three ICH regulatory bodies.
6 November 1996
Q3B
Q3B(R)
Approval by the mittee of the first Revision under Step 2 and release for public consultation.
7
October 1999
Q3B(R1)
Q3B(R)
Approval by the mittee of the first Revision under Step 4 and mendation for adoption to the three ICH regulatory bodies.
5 February 2003
Q3B(R1)
Current Step 4 version
Q3B(R2)
Approval by the mittee of the revision of the Attachment 2 directly under Step 4 without further public consultation.
2 June 2006
Q3B(R2)
Impurities in New Drug Products
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH mittee meeting
on 5 February 2003, this guideline is mended for
adoption to the three regulatory parties to ICH
Attachment 2 has been revised on 6 June 2006.
TABLE OF CONTENTS
1. INTRODUCTION 1
Objective of the guideline 1
Background 1
Scope of the guideline 1
2. RATIONALE FOR THE REPORTING AND CONTROL OF DEGRADATION PRODUCTS 1
3. ANALYTICAL PROCEDURES 2
4. REPORTING DEGRADATION PRODUCTS CONTENT OF BATCHES 2
5. LISTING OF DEGRADATION PRODUCTS IN SPECIFICATIONS 3
6. QUALIFICATION OF DEGRADATION PRODUCTS 4
7. GLOSSA
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