QMM: Participants scored well on commitment to quality, lower on advanced manufacturing

Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.

Eric Twum, a regulatory specialist for the Division of Quality II in the Office of Quality Surveillance (OQS) within the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER), shared these insights on the QMM pilot at the Generic Drugs Forum held online and in White Oak, MD, on 22 April.

Insights were gathered from nine companies participating in the voluntary QMM pilot, held in 2024. This pilot focused on five key practice areas: management's commitment to quality, business continuity to ensure supply chain resilience, implementation of advanced pharmaceutical quality systems, use of advanced manufacturing processes to demonstrate technical excellence, and employee engagement and empowerment.

FDA first proposed a QMM program in 2019, following a recommendation from an interagency task force. This task force called for the development of a new system to measure and assess the quality metrics of drug manufacturing facilities. The aim was to address the root causes of drug shortages and explore potential solutions (RELATED: FDA Task Force Recommends Rating System for Drug Manufacturing Quality, Regulatory Focus, 29 October 2019; FDA proposes to rate pharmaceutical manufacturing facilities, Regulatory Focus, 7 April 2022).

For the program, FDA used independent third-party assessors to evaluate each firm’s quality maturity level. Evaluations were conducted in teams of three to reduce bias, and the assessors rated the establishment using a rubric.

Assessors awarded the highest scores for management's commitment to quality and for employee engagement and empowerment, with many organizations receiving a score of 4 out of 5. In contrast, the lowest scores were given to areas related to advanced pharmaceutical quality and technical excellence, where many companies averaged 3 out of 5.

The pilot demonstrated measurable differences in maturity across various practice areas and establishments, Twum said. However, some rubrics need to be simplified to reduce scoring inconsistencies among assessors, and certain questions should be revised to clarify their intent.

To participate in the pilot, companies were required to have a clean FDA inspection record, manufacture at least one CDER-regulated API or finished drug product, and be willing to participate in an on-site or hybrid assessment.

Twum explained that the program encouraged pharmaceutical manufacturers to implement QMM practices that “go beyond the minimum regulatory expectations.” He further noted that the need for the QMM program arose from the perception that the market does not adequately recognize or reward manufacturers with mature quality systems.

Twum emphasized that ongoing quality issues remain a significant contributor to drug shortages. According to data collected from 2022 to 2024, 42% of newly reported drug shortages are attributed to quality problems and manufacturing delays. In comparison, 32% of shortages result from increased demand, 10% from the availability of active pharmaceutical ingredients (APIs), and 4% each from natural disasters, public health emergencies (PHE), or discontinued products.

In February 2026, FDA announced it is continuing its voluntary QMM program for selected companies.

Generic Drug Forum (via YouTube