The FDA issued a White Paper titled CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, designed as the next step in the evaluation of key quality assessments designed to identify a high level of commitment to quality management at a manufacturing firm. In the document, the FDA cautions that “Information from QMM assessments is not intended to evaluate compliance with CGMP or support regulatory actions,” but it rather provides an assessment of a deeper commitment by a firm’s management to total quality or (if you will) a mature view of how the firm approaches its quality obligation.

The FDA contends that many shortages are tied to quality issues and reports “[t]he Drug Shortage Task Force identified that one of the contributing factors to drug shortages is the failure of the market to recognize and reward manufacturers with mature quality management systems that promote the early detection of quality problems and the proactive optimization of business operations.” This program is targeted to assess just that!

The Agency has been promoting this program for quite a while and now, with drug supply chain interruptions causing 62% of drug shortages in 2019 (according to the FDA White Paper), it may be a great time for it to get more traction in the industry, especially if firms can see a benefit in terms of fewer compliance issues and fewer inspections.

The White Paper discusses that the “QMM of a drug manufacturing establishment may be best evaluated by a team of assessors using a standardized protocol. The use of teams and a standardized protocol is intended to minimize bias and individual subjectivity in the assessment.” Exactly how the Agency will reward those firms that can demonstrate a high commitment to quality is not exactly clear, but if the number of recalls decrease, the firm’s quality issues lessen the need for OOS investigations, and batch failures are fewer, the payoff in terms of reduced cost will be more than evident.

Have a look at the White Paper here as it will walk you through the FDA’s current thinking and approach. “The next critical step in implementing this program is developing the protocol that assesses the QMM of manufacturing establishments.” This prototype assessment protocol will be tested and refined during the 2024 calendar year so now is certainly a good time to get familiar with it and get ready for participation in the program.