US Office of Pharmaceutical Quality Issues Annual Report on the State of Manufacturers and their Products

Drug manufacturers are responsible for complying with regulations and ensuring their products meet quality standards. The mission of the US Office of Pharmaceutical Quality (OPQ) in the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is to assure that quality medicines are available to the American public.

The OPQ’s new Fiscal Year 2022 Report on the State of Pharmaceutical Quality, presents key data that characterizes drug and manufacturing site quality, revealing insights about pharmaceutical manufacturers and their products. Data from the associated inspections, assessments, and drug industry production can provide more effective knowledge management and better supply chain transparency, enabling the FDA to better prevent and mitigate quality issues that may lead to drug shortages and supply chain vulnerability.

OPQ’s catalog includes more than 4,800 manufacturing sites around the world making more than 140,000 drug products for U.S. patients and consumers. Most of these manufacturing sites are located outside of the U.S.  Ninety percent of the 227 drug and biological products deemed essential medicines have at least one manufacturer in the U.S., with most active pharmaceutical ingredients made solely by foreign manufacturers.

The quality of a finished drug product depends on several factors, including the quality of the process that made it, the facility that housed the process, and the supply chain that feeds to and from the facility. OPQ employs overlapping surveillance tools to make this task more achievable:

Drug Sampling and Testing

Manufacturers are responsible for designing and implementing processes that produce drugs that meet high quality standards. Since no single entity can sample and test 140,000 drug products, FDA uses risk-based analytics to target and test potentially noncompliant products. This strategy proved effective in 2022 as 57.5% of 1,552 samples tested were found to be noncompliant, the majority of which were imported.

Surveillance Inspections

OPQ also surveils the entire U.S. pharmaceutical market using complementary tools such as inspections. Though surveillance inspections nearly tripled in 2022, travel restrictions due to the COVID-19 pandemic continued to pose challenges. OPQ was able to conduct remote regulatory assessments of facilities using tools such as records requests and Mutual Recognition Agreements with other trusted global regulators.

Analyzing Quality Defects

Analysis of product quality defects is done in part by examining field alert reports, in which application holders must notify the US FDA about significant product quality defects within three working days. Field alert reports decreased by 15% in 2022, owing to less demand for potentially problematic injectable products.

Taking Action and Moving Forward

In 2022 the FDA issued 28 import alerts, handled 912 product recalls, and issued 72 warning letters to facilities. Most of the sites receiving warning letters (68%) were manufacturers of non-sterile, non-application products (which include over-the-counter products), though such sites represented only 30% of inspections.

Manufacturers must now annually report the amount of each listed drug in commercial distribution to FDA. Yet, by the end of 2021, the distribution amounts for more than three-quarters of drugs had not been reported.