Transcription of Q7 Implementation Working Group ICH Q7 …
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Q7 Implementation Working Group ICH Q7 …
Q7 Implementation Working Group ich q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers Current version dated 10 June 2015. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Secretariat, Chemin des Mines 9, Box 195, 1211 Geneva 20, Switzerland Telephone: +41 (22) 338 32 06 - Dated : 10 June 2015. Q7 Q&As In order to facilitate the Implementation of the Q7 Guidelines, the ICH Experts have developed a series of Q&As: Q7 Q&As Document History Code History Date Q7 Q&As 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.
Dated : 10 June 2015 Q7 Q&As 1 PREFACE Since the ICH Q7 Guidance was finalised, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due
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