This document describes a model for an effective quality management system. It applies to the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.

Keywords: Pharmaceutical quality system (PQS), control, lifecycle, knowledge management, change management, continual improvement

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human guideline Q10 on pharmaceutical quality system - Step 5

AdoptedLegal effective date: Reference Number: EMA/CHMP/ICH/214732/2007

English (EN) (361.39 KB - PDF)

First published: Last updated:
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