Drugs

More Info on Quality Manufacturing Maturity

FDA is providing additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturity (QMM) Prototype Assessment Protocol Evaluation Program, which is described as the next phase in CDER’s QMM program. A 1/25 Federal Register announcement said the agency was seeking nine drug companies to volunteer to test the program, which will be used to evaluate an establishment’s level of QMM.

FDA says the program will allow drug establishments to gain experience with the prototype assessment protocol and permit the agency to evaluate whether using it as designed will enable a meaningful assessment of the establishment’s quality management practices, while providing useful feedback for the establishment.

In 2022, FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee 11/2 voted 9 to 0 to recommend that CDER move forward with developing and implementing the long-planned QMM program. “QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement,” the Center said at the time. It has proposed using a rating system to help incentivize drug makers to adopt more mature quality management practices at their facilities that will reduce drug shortages and improve supply chain resiliency.

In 2021, CDER director Patrizia Cavazzoni outlined the principles (see story) behind the Center’s push toward QMM. At the time, she said the agency needs to make sure that manufacturers have more mature quality management systems that “really proactively focus on performance and outcomes that affect the patient, rather than only being focused on ticking boxes, and process metrics…”

An earlier agency white paper said that “(c)hanging the course of pharmaceutical quality by using a QMM rating system is a move toward performance-based regulation of the pharmaceutical industry.” The agency said that a root cause of many drug shortages is the absence of incentives for manufacturers to strive for more than simply meeting GMP regulations and to develop mature quality management systems.

The white paper hinted that QMM ratings will go beyond GMP inspections to “measure how far a site’s pharmaceutical quality system (PQS) rises above the minimum requirements. Simple adherence to GMP standards does not indicate, for example, that a firm is investing in improvements to prevent supply disruptions.”

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