201506 ICH Q7官方问答(中英对照).doc

201506 ICH Q7官方问答 Q7 Implementation Working Group ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers Current version dated 10 June 2015 In order to facilitate the implementation of the Q7 Guidelines, the ICH Experts have developed a series of QAs: Q7 QAs Document History ICH Q7指南：原料药GMP指南 问答 2015-6-10 ? ? Code History Date Q7 QAs Approval by the ICH Steering Committee under?Step 4 10 June 2015 ? ? References These documents are published at?. ICH E2E Pharmacovigilance Planning November 2004 ICH Q1A(R2) Stability testing of new drug substance and products February 2003 ICH Q5A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin September 1999 ICH Q5B Quality of biotechnological products: Analysis of the construct in cells used for the productionof r-DNA derived protein products November 2005 ICH Q5D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products July 1997 ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products March 1999 ICH Q7 Good Manufacturing Practice of APIs November 2000 ICH Q8(R2) Pharmaceutical Development August 2009 Part I: ‘Pharmaceutical Development’ November 2006 Part II: ‘Annex to Pharmaceutical Development’, November 2008 ICH Q9 Quality Risk Management and the ICH Q9 Briefing pack November 2005 ICH Q10 Pharmaceutical Quality Systems June 2008 ICH Q-IWG Training Programme for ICH Q8/Q9/Q10 November 2010 ICH Q11 Development and Manufacturing of Active Pharmaceutical Ingredients May 2012 Legal Notice:?This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICHs copyright in the document is acknowledged at all times. In case of any adapti