Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
ICH <strong>Q11</strong> – <strong>Development</strong> & Manufacture <strong>of</strong>Drug SubstancesControl strategy –what information tosubmit• Description <strong>of</strong> Manufacturing Process & Process Controls(3.2.S.2.2)• Control <strong>of</strong> Materials (3.2.S.2.3)• Control <strong>of</strong> Critical Steps & Intermediates (3.2.S.2.4)• Container Closure System (3.2.S.6)• Control <strong>of</strong> Drug Substance (3.2.S.4)Example <strong>of</strong> presentation <strong>of</strong> an overview <strong>of</strong> this information forNCE & biotech substances is provided© 2011 ICH 16
Change language