Tablets & Capsules

© Copyright Tablets & Capsules 2020 usp.org come at a cost to quality assurance. Additionally, high demand for certain ingredients and products is causing shortages, which, in turn, are leading to surges in produc- tion of those ingredients or products [7]. While shortages are worrisome, so are surges—materials coming from new suppliers to combat shortages may lack quality. For the same reason, there is increased risk of adulteration by bad actors motivated by economic gain and not dedicated to quality [8]. Country of origin and supply chain complexities are two major external risk factors for manufacturers working to produce quality drug products and ingredients. Other ex- ternal risk factors include material value and economic motivation for adulteration, the reputation of manufactur- ers and distributors, and transportation practices. Internal factors can also increase risk, including source of material, amount and type of processing, lack of compendial stan- dards, complexity of material, and product variability due to season or temperature conditions. For example, nizatidine capsules were voluntarily recalled in 2020 due to contamination of the API with NDMA (N-nitrosodimethylamine) to prevent any potential ad- verse events [9]. These risks can also lead to serious consequences. Recently, the excipient, propylene glycol, contained in ColdBest-PC cough syrup, was contaminat- ed with chemical diethylene glycol (DEG)—causing the death of nine children [10]. Manufacturers must mitigate these internal and external risks and prevent them from compromising the quality of their products and impact- ing people's lives. Prioritizing quality With the industry facing so many concerns, many man- ufacturers are seeking solutions to ensure that consum- ers can trust their products. Quality standards serve as a roadmap for helping to ensure quality and prevent fraud. The United States Pharmacopeia—National Formulary (USP-NF) is a comprehensive source for medicine quality standards including more than 5,000 quality standards for chemical and biologic medicines, APIs, and excipients (inactive ingredients) [11]. The standards in USP-NF are used to help ensure the quality of medicines and their in- gredients and to protect the safety of patients. In fact, USP is an official quality standard for medicines marketed in the US and is used in over 140 countries world- wide and integrated into the laws of more than 40 coun- tries. USP-NF includes three types of quality standards for medicines and dietary supplements: monographs, general chapters, and material reference standards. Ma- terial reference standards are used in conjunction with monographs and general chapters to verify that a med- icine and its ingredients can pass tests to ensure adher- ence to quality requirements. USP is committed during these extraordinary times to supporting manufacturers by providing auditing and test- ing services to verify ingredient quality through the USP Ingredient Verification Program. USP recognizes that the increased demand for certain ingredients might require manufacturers to source ingredients from new suppliers. 3 The COVID-19 pandemic is a disrupter unlike any the global supply chain has seen, and with increased disruption comes increased risk.

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