ICH Q8, Q9 and Q10 - questions and answers

Current effective version

PDF iconQuestions and answers

Reference number CHMP/ICH/265145/09
Published 01/06/2009
Keywords Pharmaceutical development, quality by design, real time release, control strategy, quality risk management, pharmaceutical quality system
Description This document provides guidance on the implementation of ICH guidelines Q8, Q9 and Q10. It answers the questions about the current procedure of the ICH Qaulity Implementation Working Group on those guidelines.


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