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Posts Tagged ‘critical quality attributes’

Implementing Process Analytical Technology and Continuous Process Verification

Posted in Life Sciences & Medical on Tuesday, August 12th, 2014. One comment so far
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In the 4:42 video, Life Science Drug Process Development and Manufacturing, Emerson’s Gary Mitchell highlights the changes occurring for pharmaceutical and biotech manufacturers. Gary opens noting how these manufacturers are challenged to respond to new methods for drug process development and manufacturing. The U.S. Food and Drug Administration (FDA) is driving manufacturers in the Life […]

Implementing Quality by Design

Posted in Life Sciences & Medical on Thursday, February 20th, 2014. 2 comments so far
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Many manufacturers in the Life Sciences industry are challenged to respond to a new paradigm for process development and manufacturing. The FDA’s cGMP for the 21st Century initiative is driving the industry to change its development and manufacturing to be based on process understanding and a risk based approach. This new paradigm uses terminology such […]

Continuous Manufacturing for Solid Dose Form Pharmaceuticals

Posted in Life Sciences & Medical, Operations & Business Management on Thursday, December 19th, 2013. 2 comments so far
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Emerson’s Jonathan Lustri explores the trend towards continuous manufacturing for solid dose pharmaceuticals and the technologies and practices that make this possible. This past year I have become aware of a very big change that is coming to the pharmaceutical industry in the area of manufacturing solid dose form pharmaceuticals. The manufacturing of pharmaceutical tablets […]

Fluidized Bed and Bin Blender PAT Applications

Posted in Life Sciences & Medical, Operations & Business Management on Thursday, October 24th, 2013. No comments yet
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In the early 2000s, a Wall Street Journal article, New Prescription For Drug Makers: Update the Plants, shared the news: The FDA [U.S. Food and Drug Administration] has concluded that the industry needs to adopt manufacturing innovations, partly to raise quality standards. The agency is overhauling its elaborate manufacturing regulations for the first time in […]