QA(R)原料药中的杂质(中英文).doc

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Harmonised Tripartite Guideline Impurities In New Drug Substances Q3A(R2) Current Step 4 version dated 25 October 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 recommended for adoption to the regulatory bodies of the European Union, Japan and USA.  Q3A(R2)Document History First Codification History Date New Codification November 2005 Q3 Approval by the Steering Committee under Step 2 and release for public consultation. 15March 1994 Q3A Q3A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. Q3 was renamed Q3A. 30March 1995 Q3A Q3A(R) Approval by the Steering Committee of the first Revision under Step 2 and release for public consultation. 7October 1999 Q3A(R1) Q3A(R) Approval by the Steering Committee of the first Revision under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 6 February 2002 Q3A(R1) Current Step 4 version Q3A(R2) Approval by the Steering Committee of the revision of the Attachment 2 directly under Step 4 without further public consultation. 25 October 2006 Q3A(R2) Impurities In New Drug Substances ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 7 February 2002, this guideline is recommended for adoption to the three regulatory parties to ICH. Attachment 2 has been revised on 25 October 2006. TABLE OF CONTENTS 1. PREAMBLE 1 2. CLASSIFICATION OF IMPURITIES 1 3. RATIONALE FOR THE REPORTING AND CONTROL OF IMPURITIES 2 3.1 Organic Impurities 2 3.2 Inorganic Impurities 4 3.3 Solvents 4 4. ANALYTICAL PROCEDURES 4 5. REPORTING IMPURITY CONTENT OF BATCHES 5 6. LISTING OF IMPURITIES IN SPECIFI