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Quality Implementation Working Group On Q8, Q9 and Q10 Questions & Answers (R4)
Quality Implementation Working Group On Q8, Q9 and Q10 Questions & Answers (R4)
Current version
dated November 11, 2010
ICH Secretariat, c/o IFPMA, 15, chemin Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06 Telefax: +41 (22) 338 32 30
E-mail : admin@ich.org Web site : http://www.ich.org
In order to facilitate the implementation of the Q8/Q9/Q10 guidelines, the ICH Experts have developed a series
of Q&As:
Q8/Q9/Q10 Q&As
Document History
Q8/Q9/Q10 Approval by the ICH Steering Committee under Step 4 11 June 2009
Q&As (R1) of newly added questions
TABLE OF CONTENTS
1. INTRODUCTION .......................................................................................................................1
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Q8/Q9/Q10 Q&As (R4)
1. INTRODUCTION
This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of
Q8, Q9 and Q10 which have been approved by the ICH Steering Committee.
The benefits of harmonizing technical requirements across the ICH regions can only be reached if the various Q-ICH guidelines are
implemented and interpreted in a consistent way across the three regions. Implementation Working Group is tasked to develop Q&As to
facilitate implementation of existing guidelines.
References
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Q8/Q9/Q10 Q&As (R4)
Q8/Q9/Q10
Questions and Answers
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2.2 Real Time Release Testing
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4. ICH NEW QUALITY GUIDELINES’ IMPACT ON GMP INSPECTION PRACTICES
5. KNOWLEDGE MANAGEMENT
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6. SOFTWARE SOLUTIONS
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