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 SubstancesExamples• Linking Material Attributes & Process Parameters toDrug Substance CQAs – Chemical Entity• Use <strong>of</strong> Quality Risk Management to SupportLifecycle Management <strong>of</strong> Process Parameters forBiotech Unit Operation• Presentation <strong>of</strong> a Design Space for BiotechnologicalProduct Unit Operation• Selecting a Starting Material in an NCE Synthesis• Presentation <strong>of</strong> the Elements <strong>of</strong> a Control Strategyfor NCE and biotech substances© 2011 ICH 21
Change language