Displaying 1–25 of 518 results for PAT
What can a PAT program bring to the packaging party?
Pharmaceutical processing & engineering: Pfizer has launched an industry-wide initiative to develop open IT interfaces for PAT, and diminished profitability this year has only underscored the importance of the companys PAT efforts, says PAT leader Steve Hammond.
Pharmaceutical processing & engineering: Last year at the IFPAC conference, NIR guru Emil Ciurczak bemoaned the fact that PAT was being promoted by geeks for geeks. Now, however, he notes that an upcoming summit may lead the charge toward a new emphasis on convincing corporate and financial ...
A PAT consultant discusses how many pharmaceutical manufacturers miss the boat when they fail to appreciate the opportunity that PAT offers them to achieve systematic improvement in manufacturability and reap significant business benefits.
Attention, corporate bean counters: PAT is not a magic bullet for reducing QC headcounts. In fact, it may require hiring more people, but the efforts will pay off in improved efficiencies and lower costs.
Ziggy Waraszkiewicz, one of AstraZeneca's key PAT stewards, gave the “industry perspective” on PAT implementation and exploitation at the recent Pittcon show. He and his colleague Nils-Erik Andersson share their views.
In her keynote address at IFPAC 2007, FDA's Chief Medical Officer, Dr. Janet Woodcock, discussed the Critical Path Initiative, and PAT's role in improving the overall drug development and manufacturing process.
Pharmaceutical processing & engineering: Look at FDA's process analytical technology (PAT) pre-op reviews as opportunities, suggests PAT expert David Radspinner. Focus on risk, and get FDA involved early.
Pfizer's Jeff Miller, Martin Warman and Lou Pillai participated in a PAT Roundtable panel at AutomationXchange and hosted by Control magazine. Their mission, in large part, was to discuss how PAT differs from simply using process analyzers. They identified three paradigms of use: 1) establishing ...
FDA’s involvement has convinced the pharmaceutical industry to embrace Process Analytical Technology, but new recruitment and validation issues have arisen as PAT moves into its next phase.
Pharmaceutical processing & engineering: Talecris Biotherapeutics has a clear PAT mission and firm management support, but takes a measured, case-by-case approach to make process analytical technology work where it will.
A relative whos who in the world of Process Analytical Technology (PAT) gathered for a roundtable discussion at an IFPAC pre-conference on Sunday in Baltimore, Maryland.
Pharmaceutical processing & engineering: Typically, Ph.D.s from R&D have led pharmaceutical PAT efforts, and results have been decidedly mixed. At Novartis, process engineer Jim Cheney is driving the companys global initiative from a manufacturing perspective.
Results suggest that concerns about time and cost are dampening pharma's enthusiasm for PAT and QbD: Experts examined these issues in a July webcast.
Process Analytical Technology: Weak FDA support and a dearth of adequate sensor technology are holding back adoption of PAT in biopharmaceutical manufacturing, says Xcellerex President Galliher.
FDA's PAT team aims to take compliance and manufacturing from art to science.
Aprils Induniv conference in San Juan and Interphex in New York City focused on Process Analytical Technology (PAT) to an unprecedented degree.
Pharmaceutical processing & engineering: A consultant ponders the question, as it relates to NIR and pharmaceutical process analytical technology (PAT) projects that require a high level of hard-to-find technical expertise.
When is an aspirin tablet like a yacht? According to Jack Carroll, the answer to this riddle lies in five S-factors: Staff, Select, Strategize, Spend and finally, Supplant a GMP-tested product line with its parallel PAT counterpart.
In this interview with Emil Ciurczak during IFPAC, Dr. Chris Watts discusses pharma PAT and where it is going, within FDA and the industry.
Leveraging PAT and QbD promises significant environmental dividends
Manufacturers are reporting fewer batch failures, adopting PAT and other quality initiatives, and stepping up supply chain quality control.
Although PAT and technologies like NIR are important, there still are things that they cannot do, concedes NIR expert Emil Ciurczak. Are advocates within the industry suspending rational and much needed skepticism, he asks, when they talk about eliminating final product stability testing altogether?
Drug manufacturers are tapping a wealth of new spectroscopic tools and techniques for PAT and Quality by Design. Heres a primer and review on how they work and where theyre most useful
Many pharmaceutical manufacturers have been dragging their heels on adopting PAT techniques for years, but now the pressure is on according to this article from Control magazine.