Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.
Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include: (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies.
Office of Pharmaceutical Quality, CDER, FDA, United States.
Thomas F
TF
O'Connor
Office of Pharmaceutical Quality, CDER, FDA, United States.
Lawrence X
LX
Yu
Office of Pharmaceutical Quality, CDER, FDA, United States. Electronic address: Sau.Lee@fda.hhs.gov.
Sau L
SL
Lee
D004345:Drug Industry / Q000379:methods* / Q000592:standards*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards*; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations
Emerging technologies; Innovation; Pharmaceutical manufacturing; Product quality; Regulatory science