Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
ICH <strong>Q11</strong> – <strong>Development</strong> & Manufacture <strong>of</strong>Drug SubstancesStarting / Source Materials• Different perspectives for NCE as compared to substances <strong>of</strong>biotechnology• For biotech substances, advice concerning cell banks is givenin Q5A, B & D• For NCE –o Considerations for selection <strong>of</strong> a given molecule in the syntheticsequence as the regulatory starting materialo Reassurance that the defined process and control strategy,operating within GMP will consistently provide drug substance<strong>of</strong> the required qualityo Example provided to illustrate application <strong>of</strong> considerations© 2011 ICH 12
Change language