Ensuring Quality and Resilience in the Pharmaceutical Supply Chain

U.S. Pharmaceutical Manufacturers relying on foreign vendors are causing a shortage in the supply chain. To combat this, companies need to take action to improve their manufacturing sites domestically.

In recent years, the quality of the pharmaceutical supply chain has been under scrutiny in the United States. This critical examination pays particular attention to the country’s dependence on global manufacturers for key ingredients and the finished products used to produce safe and effective medications Americans rely on.

Relying more on foreign pharmaceutical manufacturers is causing a pharmaceutical supply shortage in America made even more severe due to the COVID-19 pandemic. Experts say emergency departments and outpatient clinics across the nation have seen a shortage of routine medications for a year or more.

In 2020, the national drug shortage and the resulting impact on patient health prompted the American Medical Association (AMA) to update its policies and treat the shortage as an urgent public health crisis. The U.S. Food and Drug Administration (FDA)  reports only about 29% of the 158 drugs or active ingredients currently in short supply have been resolved, leaving 110 crucial drugs or active ingredients in short supply. These drugs range in use from blood pressure control and pain management to fighting infection, saline hydration, and sedation for people on ventilators.

How to Improve Domestic Manufacturing for a High-Quality Pharmaceutical Supply Chain

One of the critical challenges of domestic pharmaceutical manufacturing is finding a less expensive, environmentally sound way to complete the following requirements:

• Incorporate Active Pharmaceutical Ingredients (APIs) production in the manufacturing flow for viable and complete medicines
• Improve the quality and stability of APIs, drugs, or active ingredients
• Increase the yield of complete medicines

For years, the domestic pharmaceutical industry has struggled with providing quality in the pharmaceutical supply chain through a batch manufacturing process that relies on one completed step at a time before the full production of a medicine or active ingredient can continue. Since each batch is different, the process is both inefficient and costly.

Companies active in transforming the domestic production of APIs and finished pharmaceutical products critical to the nation’s healthcare industry suggest that moving to a continuous model of manufacturing can:

• Enable more efficiency and scalability of manufacturing programs
• Improve quality in the pharmaceutical supply chain
• Have more control of product quality
• Reduce overall costs of producing pharmaceuticals domestically
• Reduce the environmental footprint of batch manufacture
• Allow U.S. producers to compete globally in API and whole medicine production
• Create a rapid response to demand
• Help replenish the Strategic National Stockpile (SNS) of drugs, medical supplies, and medical devices to respond to a short-term disaster or biological attack
• Help increase the shelf life of the Strategic Active Pharmaceutical Ingredient Reserve (SAPIR) to quickly supply medications required during a crisis situation

To strengthen the U.S. drug supply chain and support the adoption of a continuous manufacturing model, the United States Pharmacopeia (USP) recently formed a strategic alliance to develop a new laboratory that will certify and validate pharmaceutical continuous manufacturing processes, making them available for use by domestic generics manufacturers.