ICH Quality Implementation Working Group: points to consider for ICH Q8/Q9/Q10 guidelines

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Points to consider

Reference numberEMA/CHMP/ICH/902964/2011
Published01/03/2012
KeywordsQuality risk management (QRM), critical quality attributes (CQAs), critical process parameters (CPPs), quality target product profile (QTPP), pharmaceutical quality system (PQS)
DescriptionThis document covers topics relevant to the implementation of ICH Q8(R2), Q9 and Q10, which supplement the existing questions and answers document and workshop training materials already produced by the ICH Quality Implementation Group. They should be considered all together.


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