ICH Quality Implementation Working Group: points to consider for ICH Q8/Q9/Q10 guidelines - Scientific guideline
HumanScientific guidelines
Polish is available via eTranslation, the European Commission's machine translation service.
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This 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.
Keywords: Quality risk management (QRM), critical quality attributes (CQAs), critical process parameters (CPPs), quality target product profile (QTPP), pharmaceutical quality system (PQS)