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OtherConference Proceeding

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

John Eltermann
PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 694-697; DOI: https://doi.org/10.5731/pdajpst.2011.00845
John Eltermann
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Abstract

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.

  • © PDA, Inc. 2011
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PDA Journal of Pharmaceutical Science and Technology: 65 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 6
November/December 2011
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Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections
John Eltermann
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 694-697; DOI: 10.5731/pdajpst.2011.00845

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Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections
John Eltermann
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 694-697; DOI: 10.5731/pdajpst.2011.00845
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  • Article
    • Abstract
    • Lessons from Post-Approval Issues
    • Identification of the Risk and Control Issues
    • Facilities and Equipment
    • Personnel
    • Materials
    • Manufacturing Process
    • Testing
    • Reviews and Inspectional issues—Appropriate Controls Start at the IND Phase of the Product Lifecycle
    • Conclusion
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Plenary Session 6: Facility Control and GMP Expectations

  • FDA Post-Approval Expectations for Adventitious Virus Contamination Prevention
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