Drugs

CDER Continuing QMM Program Development

The CDER Office of Pharmaceutical Quality (OPQ) says two Quality Management Maturity (QMM) pilots provided insights into how to design and implement a future QMM assessment protocol. Writing in the APPS Journal, OPQ staff say the program will continue to be developed with stakeholder input. “CDER is committed to providing stakeholders with additional information on the QMM program as it develops,” they say, “including the implementation timeline, how ratings will be determined, and the measures of program success that track year-to-year progress on a continual improvement journey.”

The authors say that mature quality systems promote proactive detection of vulnerabilities, prevent problems before they occur, and foster a culture that rewards process and system improvements. “A CDER QMM program may help to advance supply chain resiliency and robustness and mitigate drug shortages,” they write.

The pilots evaluated seven U.S.-based establishments that produce finished drugs and eight establishments outside the U.S. that produce active pharmaceutical ingredients.

“Many of the participating establishments reported that the QMM pilot assessments helped to identify their strengths, weaknesses, and new areas for improvement which they had not previously identified through internal audits or CGMP (current good manufacturing practice) inspections,” the report says.

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