ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance 6 Control Strategy General Principles ■ Control Strategy is a planned set of controls, derived from current product and process. understanding, that assures process performance and product quality ■ Every drug substance manufacturing process whether developed through traditional or enhanced (or combination of both) has an associated control strategy ICI+ March 2012 Slide 26

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