The FDA’s Center for Drug Evaluation and Research (CDER) announced Oct. 15 two pilot programs designed to gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an agency rating system. The idea is that such a rating system would offer incentives to maintain quality manufacturing. Manufacturers who opt to disclose their facility ratings could benefit from a competitive advantage, as knowledge of quality management maturity (QMM) would enable drug product manufacturers to differentiate among facilities when purchasing active pharmaceutical ingredients. Access to ratings would also enable health systems and other purchasers and payers to differentiate among drug manufacturers.
CDER’s programs include one for domestic manufacturers – the Quality Management Maturity for Finished Dosage Forms Pilot Program (QMM FDF) – and one for foreign manufacturers – the Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program (QMM API). The FDA will accept requests to participate in each program through Nov. 30, with the programs to run through Dec. 31, 2021.