Quality parameters and increased national production aim to avoid supply disruptions and drug shortages.
Despite the pandemic, the FDA has worked to maintain proper oversight of biopharmaceutical manufacturing activities, while advancing strategies to encourage industry adoption of advanced manufacturing systems. The broader goals of improved quality production are to prevent drug shortages and ensure an adequate supply of needed medical products, as outlined in a number of studies and initiatives. Several policies and programs encourage purchasers of pharmaceutical ingredients and finished products to consider a company’s ability to consistently produce high-quality products, an approach that is part of broader federal “Buy from the States” programs. States” aimed at avoiding supply chain problems that arise from delays and import difficulties. .
In this sense, a report by the National Academies of Sciences, Engineering and Medicine (NASEM) on strategies for preventing drug shortages and ensuring supply chain resilience encourages health systems to purchase from suppliers demonstrating superior quality and reliability. To that end, the report recommends that the FDA publicly disclose the location of all manufacturing facilities that supply ingredients and components for drugs and medical products (1). This information would include the FDA Establishment Identifier (FEI) and location of finished dosage forms, active ingredients, and excipients for drugs sold in the United States.
The annual report of the Office of Product Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) similarly discusses efforts to assess manufacturing facilities and avoid drug shortages. during a period of reduced on-site inspections (2). OPQ describes greater reliance on alternative monitoring tools, including analyzes reported under CDER’s Drug Evaluation and Structured Applications (KASA) program and its technologies program (ETP) – initiatives that support companies’ adoption of advanced manufacturing systems and quality assessment methods to better ensure timely production.
And a broader February 2022 report on efforts to strengthen the U.S. medical supply chain from the Department of Health and Human Services (HHS) highlights efforts to increase U.S. production of raw materials and capacity. filler/finisher for vaccine production, as well as increased vial manufacturing, as part of HHS efforts to ensure access to vaccines, treatments, and diagnostic tests during the pandemic (3).
Concerns about ensuring the quality of pharmaceutical ingredients and foreign-made products are also reflected in congressional efforts to strengthen the FDA’s foreign inspection program. The FDA’s recently approved $6 billion budget for fiscal year 2022 directs the agency to conduct real-time, unannounced factory inspections in foreign countries and directs the FDA to spend $5 million dollars of its additional funding to hire additional foreign investigators for this purpose (4). Due to the logistical difficulties of conducting surprise inspections abroad, FDA officials are planning an analysis comparing the impact of announced and unannounced foreign site visits to better understand the value of these efforts.
In search of new quality indicators
Meanwhile, the FDA continues to design a program for manufacturers to collect and report a list of metrics designed to indicate quality production. The agency recently presented a revised approach for this initiative, which builds on previous efforts to design a system for companies to measure and track data on the performance of manufacturing processes and the effectiveness of quality systems. pharmaceutical.
The new plan asks manufacturers to report data on the proportion of manufacturing batches accepted within a certain time frame, the effectiveness of corrective and preventive actions (CAPA), the proportion of laboratory tests completed on time and product shipments. delivered correctly and on time. time, as noted in a Federal Register notice published March 9, 2022 (5).
This proposal is intended to address strong industry opposition to the FDA’s efforts in 2015 and 2016 to establish such a quality measurement program. The underlying logic is that by collecting data on manufacturing operations and product quality, companies can help the FDA — and themselves — identify risk factors that could lead to shutdowns and shortages. . Industry has strongly opposed the FDA’s initial data submission plan, prompting the agency to start over and work with academics and industry to conduct pilot programs to assess business impact. Voluntarily providing Quality Management Maturity (QMM) data.
At the same time, the pandemic has drawn broader government and public attention to how quality drug manufacturing and operations affect national security and public health.
The FDA’s new performance metrics system aims to provide more flexibility for manufacturers to report data on key quality indicators. The agency asks manufacturers to act by June 7, 2022 on the plan, in particular if each establishment must report this data, how contract manufacturers must be measured, the process for reviewing metric reports in the future and the importance of trying to measure a company’s “quality culture”.
- NASEM et al., Strengthen the resilience of the country’s medical product supply chains, National Academies Press, Washington, DC, 2022.
- FDA, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 2021 Annual Report, Ensuring Quality Medicines Are Available to the American PublicFebruary 2022.
- ASPR, Public Health Supply Chain
and Industrial Base One-Year Report, February 2022.
- United States House of Representatives, Bills-117RCP35 JES Division A, Division A – Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act of 2022, Congressional Guidance.
- FDA, Federal Register, vol. 87, No. 46March 9, 2022.
About the Author
Jill Wechsler is the managing editor in Washington for Pharmaceutical technology.
Volume 46, number 4
When referring to this article, please cite it as. J. Wechsler, “FDA Maps Strategies to Advance Pharmaceutical Quality,” Pharmaceutical technology 46 (4) (2022).