Regulatory process analytical technology

This guidance is intended to describe a regulatory framework that the FDA chooses to call process analytical technology, or PAT. It is the FDA s hope that this will... 

CASE FOR PROCESS ANALYTICAL TECHNOLOGY REGULATORY AND INDUSTRIAL PERSPECTIVES... 

D Sa, A. (2005), Process analytical technology (PAT) regulatory process, review and inspection, paper presented at the 19th International Forum on Process Analytical Technology—IFPAC 2005, Arlington, VA. 

Robert P. Cogdill, Duquense University Center for Pharmaceutical Technology, Pittsburgh, Pennsylvania, Case for Process Analytical Technology Regulatory and Industrial Perspectives... 

The current regulatory climate of QbD places an emphasis on clinically relevant specifications and methods for in vitro dissolution.20 Development scientists should identify dissolution methodology that has been closely examined for its relevance to in vivo performance, as well as for mechanistic information. In other words, the release mechanism of the product should be understood and the dissolution test should be able to detect changes reflecting deviation of the mechanism. There is also the quality control (QC) side of dissolution testing, which, until the process analytical technology (PAT) develops beyond the current capabilities, is very important for stability and end-product release testing. 

Science-based formulation is nowadays a good strategy for the development of a pharmaceutical formulation. The new regulatory environment (process analytical technology) will transform science-based formulation in the next years. 

Royal Pharmaceutical Society and American Association of Pharmaceutical Scientists (2003), The Key for Achieving New Standards of Manufacturing Excellence and Regulatory Compliance Process Analytical Technology, Eighth Arden House European Conference, March 24—26, London. 

Regulatory Leeway sought for process analytical technology. Gold SheetFebruary 2002, 36 (2), 1-19. 

---