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 Quality Implementation Working Group on those guidelines.

Keywords: Pharmaceutical development, quality by design, real time release, control strategy, quality risk management, pharmaceutical quality system

Current effective version

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4

Reference Number: EMEA/CHMP/ICH/265145/2009

English (EN) (173.48 KB - PDF)

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