FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply

Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative...

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Bibliographic Details
Published in:Journal of pharmaceutical innovation 2022-06, Vol.17 (2), p.269-282
Main Authors: Almeter, Philip J., Isaacs, James T., Hunter, Aaron N., Henderson, Bradley S., Platt, Thomas, Mitchell, Billie J., Do, David, Brainard, Alyssa B., Brown, Joshua E., Stone, Rachael M., Nguyen, Bao-Han, Warren, Matthew F., Bhaktawara, Smaran A., Bossle, Megan N., Long, Lindsey M., Zapata, Stephanie P., Larkin, Cinnamon R., Lyman, Thomas A., Larkin, Seth A., Labuhn, Jonathan A., Reynolds, Jeffrey W., Schuler, Erin E., Naseman, Ryan W., Johnson, Gary L., Lodder, Robert A.
Format: Article
Language:English
Subjects:
Biochemical Engineering
Biomedical and Life Sciences
Biomedicine
Biotechnology
Industrial and Production Engineering
Pharmacology/Toxicology
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Summary:Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.
ISSN:1872-5120
1939-8042
DOI:10.1007/s12247-022-09659-5