Abstract

Purpose

Pharmaceutical manufacturers execute quality control operations and Good Manufacturing Practices (GMP) to provide safe drugs. The Federal Drug and Food Administration (FDA) is tasked with ensuring manufacturers are performing such procedures. Faced with limited resources the FDA has developed novel tools to aid pharmaceutical manufacturing oversight. This paper briefly reviews these tools.

Methods

Current inspection approaches employed by the FDA are identified by searching the FDA’s guidances, the Code of Federal Regulations, public reports and other online resources.

Outcomes

Industry

A risk-based site selection model (SSM) is used to prioritize on-site inspections for FDA investigators. Theoretically, the SSM allows FDA investigators to focus on critical firms that are at high risk of failing to meet quality standards. Analytical testing of drugs is performed by FDA laboratories as well as manufacturers’ laboratories. Despite this, two of the highest profile recalls in the last couple years (valsartan and ranitidine) were not initially identified by the FDA. Instead, Valisure, an online pharmacy that tests each batch of inventory, detected the issues.

Physicians and Consumers

The FDA has provided easy-to-use online tools for patient and physician reporting of drug quality problems. The FDA has also created consumer education campaigns to aid in protecting patients from fraud and counterfeiting.

Conclusion

The FDA has developed novel methods of redistributing their workforce to maximize product quality and consumer safety with limited resources. The methods include a risk-based SSM for prioritizing on-site inspections, providing education tools, and online reporting of quality problems. FDA laboratories also provide analytical testing to ensure purity standards are met. The recent publicized discoveries of Valisure are leading other pharmacies such as the University of Kentucky Central Pharmacy to begin testing incoming drugs. It is critical for these pharmacies and the FDA to cooperate to protect the pharmaceutical supply chain.

Document Type

Article

Publication Date

Spring 1-2021

Notes/Citation Information

Published in CIC Pharmaceutical Sciences.

© 2021 Authors

The copyright holders have granted the permission for posting the article here.

This article has been updated and the version available for download as of July 7, 2021 is a revised version.

Funding Information

The project described was supported in part by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR001998, and by the University of Kentucky Department of Pharmaceutical Sciences.

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