CDER launches quality management maturity pilots for APIs and finished dosage forms
Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).The agency’s Center for Drug Evaluation and Research (CDER) is hoping to “gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system,” according to CDER’s announcement to industry of the new pilot programs.
One pilot program will characterize quality management maturity (QMM) for finished dosage forms from domestic manufacturers of prescription and over-the-counter (OTC) drug products. The second pilot will look at QMM for active pharmaceutical ingredients (APIs), including drug substance intermediates, from foreign manufacturers and destined for use in FDA-regulated prescription and OTC products.
“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,” said FDA in announcing the voluntary pilot programs.
The rating system that FDA hopes to develop from the pilot programs would better allow an apples-to-apples comparison of facilities, which could be of benefit to a variety of stakeholders including healthcare facilities and consumers.
The initiative is part of the broader FDA effort to shift to risk-based pharmaceutical quality assessment systems. “The desired goal has been described as a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight,” according to the agency’s Federal Register announcements of the pilots.
Some of the topics anticipated to be assessed in the pilot program, said FDA in the announcement, include
- supply chain management;
- manufacturing strategy and operations;
- safety, environmental, and regulatory compliance;
- inventory management;
- performance management and continual improvement;
- risk management;
- management review and responsibility;
- planning;
- workforce management;
- quality culture; and
- customer experience.
The announcements of the pilots detail selection criteria for each pilot program, which include a clean FDA inspection record over the past 5 years, being agreeable to third-party QMM assessment, collecting specified metrics and providing the data to FDA, and being available to consult with FDA and any contractors involved in the pilot. The announcements also specify the information that must be provided in applying to participate in the pilot programs.
QMM Pilot for FDFs
QMM Pilot for APIs