NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Monday 21 March 2011

FDA and EMA start QbD pilot

The US FDA and the European Medicines Agency (EMA) will launch a three-year pilot program on 1 April to evaluate relevant quality data for new medicines. The Quality by Design (QbD) of pharmaceuticals involves an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality.
Pharma Times

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