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 SubstancesWhere to submit using CTD• Quality risk management & process development• Critical Quality Attributes• Design Space• Control Strategy© 2011 ICH 19