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

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)

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Quality Implementation Working Group: Points to consider for ICH Q8/Q9/Q10 guidelines

Reference Number: EMA/CHMP/ICH/902964/2011