ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Why Q11? ■ New ICH Guidelines ✶ Q8 Pharmaceutical Development ✶ Q9 Quality Risk Management ✶ Q10 Pharmaceutical Quality System Q10 Q11 Q8 Q9 ■ Concepts of these guidelines apply to Drug Substance as well as Drug Product ■ Process for manufacture of Drug Substance very different from Drug Product - purification ■Need Q11 to clarify principles of Q8, Q9, and Q10 as they relate to Drug Substance and provide examples March 2012 ICH 55 Slide 5

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