ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Q11 Introduction ■ Traditional Approach * Defined set points and operating ranges for process parameters ✶ Drug Substance control strategy typically based on ■ Demonstration of process reproducibility ■ Testing to meet established acceptance criteria ■ Enhanced Approach * Risk management and more extensive scientific knowledge to select process parameters and unit operations * Evaluation in studies to establish design space and control strategies applicable over the lifecycle of the drug substance ICI+ March 2012 Slide 17

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