Harmonization of Viral Segregation Strategy for a Manufacturing Network with Multiple Facility Designs and Production Scales
Posted on April 30, 2018
Bonnie K. Shum, Engineer II (Global Biologics MSAT)
Genentech Inc., A member of the Roche Group
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 ...
To read the full article and other articles in this issue, please register for a free account or log in.
We will not sell or give your information to a third party. See our Privacy Policy
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
Subscribe to our FREE newsletter and WEBINAR UPDATES
We will not sell or give your information to a third party. See our Privacy Policy
