Tag Archive | "process understanding"

QbD-Based RTR: A Systems Engineering Approach


by Jose Menezes, 4TUNE Engineering

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Baxter: Modeling for Real-Time Release of Device Components


By Paul Thomas, Senior Editor

At the 2012 Umetrics Users Meeting today in Chicago, Lee Hutson, Senior Principal Engineer for Baxter Healthcare in Mountain Home, Arkansas, presented on “Achieving Real-time Release of Medical Device Components.” In particular, Hutson elaborated on Baxter’s work in improving processes for the manufacture of injection-molded components.

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Ajaz Hussain on the State of Pharmaceutical Manufacturing


By Agnes Shanley, Editor in Chief

PharmaQbD: Has drug manufacturing advanced in the last decade?

A.H.: I’ve probably kept up more on the regulatory side and what’s happening with different companies. The progress seems to be slow when one looks at news reports on shortages, recalls and other quality issues. Prevention of such issues was, in part, the motivation for FDA to launch the PAT and then the CGMP for the 21st Century Initiative.

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Rethinking Time to Market


Now that QbD is firmly entrenched within our industry (could we have said that confidently a year or two ago?), manufacturers, regulators, and assorted thought leaders have their sights set on next steps for the movement:

  • continuing to build the collection of case studies to serve as models for industry to follow, and fleshing out the literature on the topic

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QbD Tools: Process Control Software with a Chemometric Engine


Editor’s Note: We regularly spotlight new tools that are enabling drug manufacturers’ QbD efforts. Let us know if you have a tool that the industry should know more about.

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Get Engineers and Chemists Talking, or Face the Black Box Syndrome


Another video from this week’s Emerson Global Users Exchange (apologies for the inundation):

Why do key members of drug development teams struggle to work together? Claus Weisemann, VP Quality & Regulatory Compliance for Grifols Biologicals, speaking this week in San Antonio, says that automation engineers and chemists/biologists are not speaking the same language, and this needs to change.

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