Risk Mitigation Plan for Biologics Manufacturing using a Quality by Design (QbD) approach
Source: Biosafety Risk Mitigation Plan Overview
The FDA and the biopharmaceutical industry collaborated to move forward a Quality by Design (QbD) approach to biopharmacuetical manufacturing. QbD was created as a way to ensure that all critical quality attributes for a product are maintained throughout the manufacturing process. This week’s Two Minute Tuesday educational video provides an overview for creating as biosafety risk mitigation plan, an important part of the QbD process. Regulatory bodies have made it clear that testing alone is not a sufficient risk management strategy and this video walks through a risk management approach. For the full video, please see the video below titled, “Biosafety Risk Mitigation Plan Overview“.
The Keck Graduate Institute and WuXi Biologics have teamed together to provide technical training videos called Two Minute Tuesday videos for the bioprocessing industry. They will deliver a new video topic every Tuesday that can quickly get you up-to-speed in understanding the complexities of biologics drug development and manufacturing.