ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Value of Q11 1. Recognizes that traditional and enhanced are not mutually exclusive 2. Gives context for scientifically justifying control strategy (provides an example of risk management for process. parameters) 3. Provides general principles for defining Starting Material 4. Introduces the concept of "Platform Manufacturing" 5. Drug Substance CQA can reference a control strategy for "material attributes" upstream March 2012 Disclaimer: This is MY opinion ICH Slide 35

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