USA – FDA proposes rating system for pharmaceutical QMM

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM)  as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper. The ratings would be publicly available.

“QMM ratings are a part of an evolution towards performance-based regulatory practice and, as such, they may raise concern for some,” according to the white paper. “Public transparency is often a necessary driver for industry improvements. Pharmaceutical executives, for example, may not like the fact that a poor QMM rating could affect their stock price. However, public knowledge of facility issues and product recalls already has severe negative consequences to stock price.”