Economics and risks of FDA’s Quality management maturity rating programme

Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to firms adopting quality management best practices – including greater operational efficiency, lower costs and better productivity. The introduction of pharmaceutical manufacturing quality ratings by the FDA under its Quality Management Maturity (QMM) programme has the potential to reduce drug shortages and improve pharmaceutical company financial performance. Here, Dr Clifford Rossi of the University of Maryland explains.