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 SubstancesWhat is the scope <strong>of</strong> ICH <strong>Q11</strong> ?• In scope: 3.2.S.2.2 – 2.6 <strong>of</strong> CTDo New Chemical Entities – as defined in ICH Q6Ao Biotechnological/Biological Products – as defined in ICH Q6B• Not in scope:o Clinical trial materialso Regional post approval change requirements© 2011 ICH 6
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