ICH Q8, Q9 and Q10 - questions and answers

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Questions and answers

Reference numberCHMP/ICH/265145/09
Published01/06/2009
KeywordsPharmaceutical development, quality by design, real time release, control strategy, quality risk management, pharmaceutical quality system
DescriptionThis 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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