Process and Automation

The process analytical technology (PAT) initiative has been percolating at the US Food and Drug Administration for a long time, explained FDA's John E. Simmons at the AAPS Annual Meeting and Exposition on Wednesday. "If you think of PAT as an isolated set of applications, I think you are missing the point," Simmons said. "The FDA would like PAT to become commonplace?not to be an initiative, but common practice."

"The better we understand the relationship between process parameters and product attributes, the better control we'll have over product quality," said Beth Fowler, PhD, during Tuesday?s session on process monitoring at the AAPS Annual Meeting.

To implement process analytical technology systems into the current information technology landscape, manufacturers will need to adopt continuously available systems and infrastructures.

The authors propose a strategy for classifying and validating inprocess testing methods.

The C-SOC team must develop a network of committed industrial partners who will participate in the direction, execution, and evaluation of research and educational activities.

ISA-88 Automation Standard Gains IEC PAS Status

Emerging high-tech solutions prepare to cater to industrial automation with promises of increased efficiencies, faster communications, and custom applications.

The author describes the efforts of the standards committees to establish guidelines for PAT implementation and the impact of the guidelines on the industry.

From data acquisition to enterprise resource planning, software systems operating at all levels of pharmaceutical manufacturing prepare for the seemingly inevitable implementation of process anlytical technology.

The author brings attention to the connectivity problems among various data-gathering systems and discusses the drivers and benefits of change, including PAT.

This article outlines the key concepts that define process analytical technology and emphasizes the relevant theory and applications of chemometrics.

A limited number of container sizes, dispensing lanes, computerized tracking, and polyethylene mailing bags are just a few of the new elements of packaging launched at one company's automated pharmacy facility.