The US Food and Drug Administration Center for Drug Evaluation and Research (CDER) is announcing two new pilot programs to gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system.
- The Quality Management Maturity for Finished Dosage Forms Pilot Program (QMM FDF Pilot Program) is for domestic drug product manufacturers of prescription and over-the-counter (OTC) drug products.
- The Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program (QMM API Pilot Program) is for foreign manufacturers of active pharmaceutical ingredients (APIs), including drug substance intermediates used to produce APIs used in FDA-regulated prescription and OTC drug products.
A rating system would characterize quality management maturity (QMM) and incentivize investments in quality manufacturing. Manufacturers who choose to disclose their facility ratings could benefit from a competitive advantage, as knowledge of QMM ratings would enable drug product manufacturers to differentiate among facilities when purchasing APIs Knowledge of the ratings would also enable health systems and other purchasers and payers of medications to differentiate among drug manufacturers. For additional information on QMM, see FDA’s Report: Drug Shortages: Root Causes and Potential Solutions from October 2019.