ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance What Q11 does not do: 1. Define or clarify regulatory flexibility 2. Define criticality (i.e. CPP) 3. Define starting material based strictly on number of steps 4. Clarify what goes into the manufacturing description section of CTD 5. Clarify what CPV? March 2012 ICI+ Slide 34

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