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EMEA: ICH Topic Q8, Q9 and Q10 Note for guidance on Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System Questions and Answers

03.06.2009
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.