FDA's quality management maturity program, and the plan to rate drug factories

Between October 2020 and March 2022, FDA's drug center sent assessment teams to 15 manufacturing sites that had volunteered to be graded on something federal law does not require. Seven were US plants that make finished tablets, capsules and other dosage forms. Eight were overseas plants that make active ingredients. The goal, FDA staff wrote in a 2023 paper in The AAPS Journal², was to learn whether the agency could measure a site's "quality management maturity," or QMM, and turn the result into a rating.

That idea grew out of the drug shortage problem. A federal task force led by FDA reported in 2019 that 62 percent of the 163 drugs that went into shortage between 2013 and 2017 did so after supply disruptions tied to manufacturing or product quality problems. One of its three root causes was that the market "does not recognize and reward manufacturers for mature quality management systems," according to the task force report¹. Its second recommendation was a rating system.

Seven years on, FDA's Center for Drug Evaluation and Research (CDER) has run two pilots, built a prototype assessment protocol, and opened three yearly rounds for volunteer sites. It has not announced a public score for any named factory. This explainer traces the program through its Federal Register notices and white papers: what an assessment covers, what a site gets back, and the question FDA itself has put to the public about whether results should ever be published.

What the 2019 shortage report asked for

Drugs in the task force's sample were old, cheap and mostly generic. Sixty-three percent were sterile injectables, 67 percent had a generic on the market, and the median time since first approval was almost 35 years. In the year before each drug went short, its median price was $8.73 per unit, $11.05 for injectables and $2.27 for oral drugs, the report found¹.

Its argument was about information. Buyers can see price and little else. "The lack of information does not enable the market to reward drug manufacturers with price premiums for mature quality management, back-up manufacturing capabilities, or risk-management plans," the task force wrote. A rating, it said, "could be used to inform purchasers, GPOs, and even consumers" about the plant making the drugs they buy. (GPOs are the group purchasing organizations that negotiate for hospitals.)

CDER's Office of Pharmaceutical Quality picked up the theme in an April 2022 white paper³. Without ratings, it warned, "there is risk that price competition and cost minimization will continue to be key market drivers, especially for generic drugs, without direct reward for manufacturers who actively invest to avoid future shortage." The same paper added that the need for ratings "does not, however, indicate that substandard drug products are on the market." Meeting current good manufacturing practice is the legal floor. Maturity is meant to describe how far above it a site operates.

Two pilots and a unanimous vote

FDA announced both pilots in the Federal Register on October 16, 2020. The finished dosage form pilot⁴ was open to domestic drug product makers and the active ingredient pilot⁵ to foreign facilities. Each would take up to nine participants, accept requests through November 30, 2020, and run through December 31, 2021. A third-party contractor would conduct the assessment, accompanied by FDA staff.

Both notices were candid about the commercial logic. A rating system "would allow a cross-sectional comparison of manufacturers," and sites that chose to disclose their ratings "could benefit from a competitive advantage, as knowledge of QMM ratings would enable health systems and other purchasers and payers of medications to differentiate among drug manufacturers."

Seven domestic and eight foreign sites took part. Many of them told FDA the assessments found strengths, weaknesses and areas for improvement "which they had not previously identified through internal audits or CGMP inspections," the AAPS Journal paper² reported.

FDA then took the program to its Pharmaceutical Science and Clinical Pharmacology Advisory Committee, which met on November 2, 2022, to weigh its effect on industry, shortages and supply chain resiliency, according to the meeting notice⁶. By a vote of 9 to 0, the committee said CDER should establish the program, FDA recounted in a September 2023 notice⁷ that opened a public docket through December 14, 2023. Among its questions: "what are your thoughts about making outcomes public?" and would the answer change if results were descriptive rather than "a numerical rating"?

What an assessment looks at

CDER's protocol groups its questions into five practice areas, described in an August 2023 white paper⁸ and in the program's Federal Register notices. The examples below are the ones FDA itself lists.

• Management commitment to quality: management review and resource management.
• Business continuity: supply planning and demand forecasting.
• Advanced pharmaceutical quality system: the corrective and preventive action process, later broadened to continual improvement.
• Technical excellence: data governance and process optimization.
• Employee engagement: rewards and recognition.

The white paper draws a line that matters for anyone hoping a score will say something about a specific pill. "QMM assesses manufacturing establishments; QMM does not evaluate product quality," it says. It also warns that a well-funded site with the newest equipment "may not be highly mature" if that equipment is not fit for purpose and controlled. Business continuity work, in FDA's description, includes qualifying backup suppliers and setting inventory levels, the kind of planning that bears directly on why shortages happen.

Three rounds of volunteers

In 2024 the program moved from pilots to a standing prototype. Its notices form a short paper trail.

Under the January 2024 notice⁹, trained assessors would work onsite or in a hybrid format. Each assessment could take up to five business days, and the assessments "are distinct from FDA's regulatory inspections." A year later, the April 2025 notice¹⁰ reported that the rubric "effectively differentiated the maturity of quality management practices across the nine establishments assessed in 2024," while participants found parts of the protocol repetitive.

FDA's February 2026 notice¹¹ fills in who took part and what they received. The 2024 group included generic drug manufacturers, a contract testing laboratory and brand manufacturers. To qualify for the third round, a site needed at least one human drug surveillance inspection and a current classification of No Action Indicated or Voluntary Action Indicated, the two outcomes short of official action described in our guide to FDA inspections. The assessment team is made up of CDER staff and excludes FDA's inspection office. Each site gets a report with "their score in each practice area," plus two or three strengths and two or three opportunities for improvement in each area.

The business case, and what the shortage list shows

FDA's July 2025 economic white paper¹² argues that quality management pays for itself through fewer defects, recalls and lost sales. One example it describes is a site that cut product defects by more than 50 percent and waste by 75 percent and redirected a quarter of its staff to other work.

The shortages the program was built to prevent have not gone away. FDA's list showed 69 current shortages as of November 3, 2026, 71 percent of them injectables, with a median age of 1,710 days, according to GxRadar's analysis of the openFDA drug shortages data¹⁴. The reason FDA records for each entry rarely points at quality.

Only three entries cite good manufacturing practice, and 37 say "Other" or nothing at all. That makes the list a weak tool for tracing root causes, a gap our piece on shortage reasons in FDA data looks at more closely. The task force's 62 percent figure came from FDA's own case-by-case review, which the public list does not reproduce. Quality problems do show up in recalls. Of 18,076 drug recall records from 2012 through October 28, 2026, 2,299 fall in GxRadar's CGMP-deviation category, including 142 so far in 2026, based on openFDA enforcement data¹⁵ summarized on our recalls page.

What to watch

CDER's program page¹³, last updated in July 2026, states four goals, the last being to "minimize risks to product availability to assure reliable market supply." The third round's request window closed on April 13, 2026. The 2026 notice describes a report that goes to the participating site. It says nothing about publishing scores, which was the step the 2019 task force said would let hospitals and other buyers pay more for a plant that runs better.