Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections.

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) There are potential risks for adventitious agent contamination at every stage in the lifecycle of a product. This can range from an impact on product quality that must be investigated and corrected to the temporary shutdown of manufacturing altogether. An assessment of the risk management plans and the associated testing and proper manufacturing controls will be part of the review and inspection at the pre-approval stage in the product lifecycle, and the effectiveness of the mitigating activities will be monitored as part of the activities as well. Appropriate measures aiming at preventing or reducing adventitious agents should be considered as part of the overall plan to ensure both product quality and continued manufacturing.