Harmonization of Viral Segregation Strategy for a Manufacturing Network with Multiple Facility Designs and Production Scales
Posted on April 30, 2018
Background ICH Guidance for Industry, Q7 (2016) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients section 18.5 specifies that appropriate precautions should be taken to prevent potential viral contamination from pre-viral to post-viral removal/inactivation steps, but no direct ...
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Related Topics and Keywords
Bonnie K. Shum, Cell culture, clearance processes, drug substance, Genentech Inc, Harmonization, ICH, ICH Guidance for Industry, Manufacturing Network, Multiple Facility Designs, post-viral, pre-viral, Production Scales, Roche Group, viral, viral clearance, viral segregation, Viral Segregation Strategy
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