FDA proposes to assess pharmaceutical manufacturing facilities

According to a new white paper. Ratings would be publicly available.

“QMM ratings are part of a move towards performance-based regulatory practice and as such may cause some concern,” according to the white paper. “Public transparency is often a necessary driver for industry improvements. Pharmaceutical executives, for example, may not like the fact that a poor QMM rating can affect their stock price. However, public knowledge of installation issues and product recalls is already having a serious negative impact on stock prices.

QMM’s assessments and ratings would be considered oversight functions and “separate from determining compliance with regulatory standards,” according to the FDA.

The FDA first discussed plans for a rating system in 2019 to incentivize the pharmaceutical industry to improve product quality and reduce drug shortages. (RELATED: FDA pitches idea of ​​scoring system for drugmakers, regulatory guidanceOctober 25, 2019).

An agency report in October 2019 found that up to 60% of drug shortages are caused by quality issues. (RELATED: Drug quality: FDA officials discuss perception, Regulatory guidanceFebruary 3, 2020).

The white paper characterizes QMM as “the state achieved by having robust, reliable, and robust business processes to meet quality objectives and promote continuous improvement.”

Such a rating system “could inform buyers of the level of QMM on the sites from which they buy drugs. In the absence of transparency generated by QMM’s ratings, there is a risk that price competition and cost minimization will continue to be the main market drivers, particularly for generic drugs, with no direct rewards for manufacturers who are actively investing to avoid a future shortage.

The document does not present any specific proposal for the rating system, but rather describes a general policy framework. The FDA said implementing a QMM scoring program would require collaboration with industry and other stakeholders. The agency has already formed multidisciplinary and multicenter working groups to develop a program.

For such a scoring system to work, the market would have to reward products from facilities with higher QMM scores, the FDA said. “Using QMM ratings in purchasing decisions should incentivize long-term continuous improvement, but not push manufacturers out of the market and/or dramatically increase short-term purchasing costs.”

Yet one of the challenges of a rating system is convincing buyers to use it to make decisions. “The current perception among stakeholders who are not already using some type of supply chain assessment in purchasing decisions is that quality of all kinds basically exists if the drug has been approved by the FDA. Some do not consider the maturity of quality management in their decisions.

The agency will hold two workshops on the maturity of quality management, on May 24 and 25. The first workshop will address the CDER QMM program and the second will discuss quality ratings.

The article also follows up on two pilot projects to measure QMM at a pharmaceutical and active pharmaceutical ingredient (API) site (RELATED: CDER Launches Quality Management Maturity Pilot Projects for APIs and Finished Dosage Forms Regulatory Focus, October 16, 2020).

The program would also complement the FDA’s Quality Metrics Proposal released in early March (RELATED: Quality Indicators: FDA Seeks Feedback on Streamlined ProgramRegulatory guidanceMarch 8, 2022).

white paper