ICH Q10 Pharmaceutical quality system

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/ICH/214732/2007
Published01/06/2008
Effective from01/06/2008
KeywordsPharmaceutical quality system (PQS), control, lifecycle, knowledge management, change management, continual improvement
DescriptionThis 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.


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