Q8, Q9, Q10: Quality Implementation Working Group Questions & Answers

Regulatory Resource: Q8, Q9, Q10: Quality Implementation Working Group Questions & Answers

Description:

Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the Q8, Q9 and Q10 guidelines have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues. The Questions & Answers document was finalised (Step 4) in April 2009. In October 2009, a third set of Q&As was developed and approved by the Steering Committee for integration in the Q&A document.

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