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 ■ Not mutually exclusive. Company can choose: * Traditional * Enhanced * Combination of both March 2012 ICI+ Slide 18

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