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 SubstancesDoes <strong>Q11</strong> impact other ICH guidance ?• Addresses principles & concepts <strong>of</strong> Q8, Q9 & Q10 inrelation to drug substance• Specific guidance applicable to substances <strong>of</strong>biotechnology provided in Q5 series• Additional guidance to ICH Q series but does notcreate new regulatory requirements.© 2011 ICH 7
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