ICH Q10 Pharmaceutical quality system
Table of contents
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
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human guideline Q10 on pharmaceutical quality system - Step 5 (PDF/361.39 KB)Adopted
First published: 01/06/2008
Last updated: 28/05/2014
Legal effective date: 01/06/2008