
This article reviews the development of FDA's PAT Initiative along with CPAC's ANSI/ISA-76.00.02 (2002) (NeSSI) development. The intent is to show how the NeSSI components could contribute to the PAT philosophy and physical requirements.

This article reviews the development of FDA's PAT Initiative along with CPAC's ANSI/ISA-76.00.02 (2002) (NeSSI) development. The intent is to show how the NeSSI components could contribute to the PAT philosophy and physical requirements.

Published: January 2nd 2005 | Updated: