Seeking Participation in a Quality Benchmarking Study
FDA is seeking participation from pharmaceutical manufacturers in a study on the current state of pharmaceutical quality management systems. Manufacturers would participate through a standardized Quality Benchmarking Study questionnaire or an onsite interview conducted by researchers. There will be no cost to the firms. The study will run May through December 2020. It will be conducted by Dun & Bradstreet and the University of St.Gallen in Switzerland.
This is not an audit or site inspection, and the agency will not take regulatory action using the information it obtains. Once data analysis and comparison are complete, manufacturers will receive a customized report with an assessment of each establishment’s current state of quality and a spotlight of where to focus continual improvement efforts. The report also includes an assessment of the manufacturers’ key performance indicators against their peers.
FDA will receive an anonymized report with an assessment of the global understanding of what quality management practices are most effective. This will enable the agency to better evaluate quality management maturity (QMM) and identify critical attributes of effective quality systems.
This research project will help integrate the QMM assessment into the Office of Pharmaceutical Quality’s comprehensive surveillance of site and product quality programs. Data about institutional QMM will inform FDA which key performance indicators, attributes of quality culture, and management practices drive robust quality systems among global manufacturers.
Learn more on FDA’s Pharmaceutical Quality Resources page and sign up at the Quality Benchmarking Study page.
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