ICH Q11 Development and Manufacture of Drug Substance slide image

ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance 4 Manufacturing Description ■ Description of DS manufacturing process represents applicant's commitment Information to adequately describe mfg process and process controls ✶ Flow diagram * Sequential process narrative ✶ In-process controls * Scale-factors (when process is scale dependent) * Any design spaces in the mfg process should be included as part of the mfg process description ICI+ March 2012 Slide 20
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