FDA Notice Shows How Its Quality Management Maturity Program Rates Drug Plants

The Food and Drug Administration published a notice in the Federal Register on February 11 inviting drug manufacturing establishments to volunteer for the third year of its Quality Management Maturity, or QMM, Prototype Assessment Protocol Evaluation Program. The Center for Drug Evaluation and Research intends to select up to nine participants and will accept requests through April 13, 2026, the notice says.

The program is one of the less familiar ways FDA looks at drug factories. It is voluntary, it is not an inspection, and it scores how well a plant manages quality rather than whether it meets the legal minimum.

Beyond the legal floor

Drug makers must follow current good manufacturing practice, or CGMP, regulations, and FDA inspections check compliance with them. The notice defines QMM as the extent to which establishments implement quality management practices that "prioritize patients, drive continual improvement, and enhance supply chain reliability" by integrating business decisions and manufacturing operations with quality practices and technology. It says CDER developed the program to encourage manufacturers "to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements."

FDA's QMM program page lists four goals: fostering a strong quality culture, recognizing establishments with advanced practices, identifying areas for improvement, and minimizing risks to product availability. It links the effort to drug shortages, saying a multi-agency federal task force reported that a root cause for many shortages is the absence of incentives for manufacturers to do more than meet CGMP rules. The page says FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously in November 2022 that CDER should set up such a program.

How an assessment works

To qualify, an establishment must be registered with FDA, make at least one CDER-regulated drug or active ingredient in US commercial distribution, have had at least one human drug surveillance inspection, and hold a current inspection classification of No Action Indicated or Voluntary Action Indicated. A footnote says inspections by Mutual Recognition Agreement partners that FDA has classified also count. CDER says it will pick participants that reflect the diversity of the industry and will respond to each request within 60 days.

Selected plants get a pre-assessment questionnaire, then an onsite or hybrid assessment that may take up to five days. Each is run by three assessors from CDER, and the team "will not include FDA personnel from the Office of Inspections and Investigations charged with the responsibility of ensuring CGMP compliance," the notice says.

Afterward, each establishment receives a report with its score in each practice area, along with two to three strengths and two to three improvement opportunities per area. CDER asks participants to choose at least one opportunity, share an improvement plan, and meet with the agency about three months after the assessment, with a final check-in about six months out.

Still a prototype

The notice says CDER evaluated nine establishments in 2024, the program's first year, spanning generic and brand drug makers and a contract testing laboratory. It reports that the protocol and rubric distinguished maturity levels between practice areas at a single plant and between plants, and that CDER then streamlined the tool. The second year is ongoing. The stated purpose of the third round is to gain more experience with the assessment tool and to judge whether it allows meaningful assessments and actionable feedback.