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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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Article Information

vol. 65 no. 6 694-697
DOI 
https://doi.org/10.5731/pdajpst.2011.00845
PubMed 
22294603

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online January 4, 2012.

Copyright & Usage 
© PDA, Inc. 2011

Author Information

  1. John Eltermann
  1. Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD
  1. John Eltermann, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852. E-mail: john.eltermann{at}fda.hhs.gov.
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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
    • Conflict of Interest
    • Acknowledgments
    • References
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