Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
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ICH <strong>Q11</strong> – <strong>Development</strong> & Manufacture <strong>of</strong>Drug SubstancesManufacturing Process <strong>Development</strong>• Identifying CQA for drug substance in relation to drug producttarget product pr<strong>of</strong>ile• Defining a suitable manufacturing process• Defining a robust control strategy to ensure process performanceand drug substance quality• Systematic evaluation, understanding and refining <strong>of</strong> themanufacturing processoUse <strong>of</strong> risk assessment tools, prior knowledge and experimentationto identify the material attributes and process parameters that canhave an effect on drug substance CQAoDetermining the functional relationships that link material attributesand process parameters to drug substance CQA© 2011 ICH 9
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