FDA: Q10 Pharmaceutical Quality System
10.04.2009
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.
The source of the news: http://www.fda.gov/cder/guidance/8515fnl.pdf
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