About 35 of us have gathered at ISA Headquarters in North Carolina to discuss PAT.
Mike Nager started off by talking about the Food and Pharmaceuticals Division, which has (suddenly, so far as I know) become one of the largest ISA divisions (technical interest groups) with over 1600 members.
Nager pointed out that the world Pharma market is huge, with over $170 billion in NA, and $101Billion in Western Europe.
What is needed, according to Nager, is to reduce time-to-market, reduce scrap and waste of product, increase overall utilization rate, increase manufacturing efficiencies, and improve compliance to regulation.
Enter the PAT initiative. Why Process Analytical Technology? The goal of PAT is, according to Nager and the FDA, to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.
Here’s the FDA resource website!
Nager introduced Alex Habib.
BlackBerry service provided by Nextel