Tablets & Capsules

usp.org US Pharmacopeia This article discusses the recent decreases in the FDA's manufacturing inspections due to COVID-19 and explains how USP's programs and resources can help drug-prod- uct manufacturers and ingredient suppliers manage po- tential quality risks in the global supply chain. COVID-19 has impacted virtually every industry, and drug manufacturing is no exception. While changes in the de- mand for certain drug products is reshaping the indus- try and capturing headlines, another issue permeating the conversation is how the pandemic has disrupted the Food and Drug Administration's (FDA's) inspection pro- cess. As of August 11, 2020, the FDA reported more than 18,000 inspections of domestic and foreign pharmaceuti- cal manufacturers in 2019, the last year untouched by the pandemic, compared to only 4,180 inspections through June 11, 2020 [1]. The decrease in on-site inspections has the potential to increase quality risks to the global supply chain and puts more of the burden on manufacturers and suppliers to ensure the quality of their drug products and ingredients. Per a July 10, 2020 FDA statement, the agency "deter- mined that for the foreseeable future, prioritized domes- tic inspections will be pre-announced" [2]. Also, the FDA has been forced to use different tactics for foreign manu- facturers to ensure safety and is relying on methods such as denying entry of unsafe products into the US, conduct- ing physical examinations and/or product sampling at US borders, reviewing a firm's previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agree- ments, and requesting records "in advance of or in lieu of" on-site drug inspections [3]. The cost of disruption The global drug supply chain is complex and has always been vulnerable to disruptions. In fact, the past 200 years have been defined by a series of disruptions to the indus- try. The 40 years preceding COVID-19 were characterized by growth, distribution, and consolidation—all potential drivers of disruption [4]. Today, more companies manu- facture drug products outside the US, and only 28 percent of active pharmaceutical ingredient (API) manufacturing sites are in the US [5]. Many intermediaries play a role in a drug product's production, distribution, and delivery. In fact, a 2011 survey showed that 79 percent of manufactur- ers of pharmaceuticals rely on at least one component, manufacturing material, or finished product from a non- US supplier [6]. The COVID-19 pandemic is a disrupter unlike any the glob- al supply chain has seen, and with increased disruption comes increased risk. Manufacturers must streamline and simplify operations more than ever before, which could By John Giannone, Ed Wyszumiala, Danita Broyles, and Joy Brown 2

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