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Review
. 2022;17(2):269-282.
doi: 10.1007/s12247-022-09659-5. Epub 2022 Jun 3.

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

Philip J Almeter  1   2 , James T Isaacs  1 , Aaron N Hunter  1 , Bradley S Henderson  1 , Thomas Platt  1   2 , Billie J Mitchell  1   2 , David Do  1   2 , Alyssa B Brainard  1   2 , Joshua E Brown  1   2 , Rachael M Stone  1   3 , Bao-Han Nguyen  1   2 , Matthew F Warren  1   2 , Smaran A Bhaktawara  1   2 , Megan N Bossle  1   2 , Lindsey M Long  1   2 , Stephanie P Zapata  1 , Cinnamon R Larkin  1 , Thomas A Lyman  1 , Seth A Larkin  1   2 , Jonathan A Labuhn  1   2 , Jeffrey W Reynolds  4 , Erin E Schuler  5 , Ryan W Naseman  1   2 , Gary L Johnson  1   2 , Robert A Lodder  6
Affiliations
Review

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

Philip J Almeter et al. J Pharm Innov. 2022.

Abstract

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.

Keywords: Drug quality; FDA; Globalization.

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Conflict of interest statement

Conflict of InterestThe authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Triangle depicting competing priorities of cost, speed, and quality in the manufacturing process with economic forces outlined in this review
Fig. 2
Fig. 2
Spectra of 12 MMR vaccine doses from the same lot, U006488, vary considerably. In general, drugs in the same lot have similar spectra. However, in this figure, two distinct groups of spectra are found, with 6 in each group. One group of spectra has peaks at 4490, 4580, 4832, and 4687 cm−1 that the other group does not have. In the other group, the location of the major peak varies, appearing sometimes at 4592 cm−1 and other times at 4604 cm−1
Fig. 3
Fig. 3
Spectra of 12 MMR vaccine doses from the same lot, U006488, in a different spectral region from Fig. 2. Again, 2 distinct groups of spectra are found, with 6 spectra in each group. Peaks at 5863, 5973, and 6020 cm−1 are present in one group of spectra, but absent in the other
Fig. 4
Fig. 4
3-D PC plot of the spectral library of MMR vaccine. A total of 198 vials were scanned from 12 different lots. The tight ellipsoidal group on the right contains 140 of the 198 vials
Fig. 5
Fig. 5
A sentinel screening network of academic health systems could provide independent data on drug quality to FDA
See this image and copyright information in PMC

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