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Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)

The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.

Alignment 90 Sep Oct 2018

FDA continually looks at ways to uphold long-term quality and may one day offer incentives to those who demonstrate Quality Management Maturity (QMM). FDA is currently soliciting feedback on this topic through a survey open until October.

As Dr. Douglas Throckmorton, deputy director for FDA regulatory programs, explained at the virtual 2020 PDA/FDA Joint Regulatory Conference this week, QMM is a collection of business processes needed to consistently implement and maintain quality in the marketplace.

While QMM is built on current Good Manufacturing Practices (cGMP) compliance, it's more than that. “You're building a culture to build in a larger business case for sustained and consistent high quality manufacturing,” said Throckmorton. He added that the focus is on stronger quality management systems that are proactively focused on performance, especially those that reduce adverse events, reduce shortages, and ultimately become more efficient in manufacturing.

(Editor's note: If you're already familiar with QMM, jump to Incentives, below.

QMM

Steps

Throckmorton offered a stair-step graphic that encapsulates the pieces. “A critical first step is the cGMPs. Those are standards that we've all applied for decades. We understand them, our inspectorate understands them. They’re the bedrock of what we need to build on,” he said.

The next step is cooperation and consolidation of those recommendations into an international standard, in this case, ICH Q10, which lays out a model for an effective quality management system in manufacturing.


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