Q10 Pharmaceutical Quality System

Issue Date: April 8, 2009
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Quality
Status: Final

Q10 Pharmaceutical Quality System

This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model.

Download the Guidance Document

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