Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...

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ICH Q11 – Development & Manufacture ofDrug SubstancesControl Strategy ‐ Considerations• Controls on material attributes (including raw materials, startingmaterials, intermediates, reagents, primary packaging materials forthe drug substance, etc.);• Controls implicit in the design of the manufacturing process (e.g.,sequence of purification steps (Biotechnological/BiologicalProducts), or order of addition of reagents (Chemical Products));• In-process controls (including in-process tests and processparameters);• Controls on drug substance (e.g., release testing).© 2011 ICH 14
ICH Q11 – Development & Manufacture ofDrug SubstancesControl strategy• Control strategy applies irrespective of developmentapproach adopted (traditional or enhanced)• Point of application of control may differ dependingon the nature of the attribute requiring control andprocess knowledge as a result of developmentstudieso Sterility assuranceo RTRT© 2011 ICH 15
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