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 SubstancesWhy is a new ICH guideline for activesubstances required ?• ICH Q Round-table – Washington 2007o Region specific data packages and data presentationo Differences in data requirement between regions presentadministrative burden to industryo Inefficient use <strong>of</strong> industry & regulatory authority resources• Application <strong>of</strong> concepts <strong>of</strong> the new quality paradigm (ICH Q8,Q9 & Q10) to drug substance• Facilitate innovation in approaches to development andcontrol <strong>of</strong> drug substance manufacturing processes, enabledby application <strong>of</strong> on-, at- and in- line analytical technologiescoupled with robust risk management strategies© 2011 ICH 5
Change language