Wu H.,U.S. Food and Drug Administration |
Kurtyka B.,Office of Process and Facilities OPF |
Wu G.,Office of Lifecycle Drug Products OLDP |
Maguire J.A.,Office of Process and Facilities OPF |
And 11 more authors.
European Pharmaceutical Review | Year: 2015
Process analytical technology (PAT) is a groundbreaking approach for pharmaceutical innovation in the 21st century, representing a new dimension of pharmaceutical manufacturing and quality regulation. It provides unprecedented opportunities for the pharmaceutical sector to monitor, understand and assess pharmaceutical manufacturing processes and ensure product quality. In this article, we briefly discuss the history of PAT. A critical scientific review and technological analysis is conducted in three areas: scientific excellence achieved by the global PAT community; enabling technology available for PAT development; and current industry trends in utilising PAT for materials characterisation, process/product development and understanding, and manufacturing. It is hoped that these three areas together provide the necessary science and technology to support future PAT development. Finally, some of the future challenges and opportunities for PAT progress are discussed in the spirit of further stimulating the development and adaption of PAT in the pharmaceutical and academic communities from both pharmaceutical engineering and public health perspectives. © 2015 Russell Publishing Limited.