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Pharmaceutical Manufacturing and Packing Sourcer

Lean Machine

Pharmaceutical manufacturing costs the industry approximately $90 billion each year and represents twice the expenditure of R&D (1). A 2001 study conducted by the MIT Pharmaceutical Manufacturing Initiative (PHARMI) indicated that significant time was spent conducting quality control (QC) testing and documenting QC results during the manufacturing process (2). Eroding profit margins from stiff competition, increasing product defects, and the FDA’s focus on a ‘quality by design model’ has led the industry to reevaluate manufacturing efficiency (1,3). The industry has recently begun adopting both lean manufacturing and Six Sigma to achieve the efficiency and quality gains achieved by other industries (4-6). IT solutions will play a significant role in managing QC standard operating procedure (SOP) documentation during the focus on lean and Six Sigma to eliminate waste, improve...

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Chris Stumpf joined Waters in 2001 after earning his PhD in Analytical Chemistry and Mass Spectrometry from Purdue University in 2000, and held a post doctoral position at the University of Cincinnati Medical School conducting proteomics research. During his doctorate and post-doctorate education, he became keenly interested in informatics solutions to manage and mine analytical data.

Phil Kilby joined Waters in 1998. He received a degree in Chemistry from Greenwich University while working in drug metabolism at Rhone Poulenc in London. He is now responsible for worldwide business and partnership development of Waters’ suite of informatics solutions. Email: phil_kilby@waters.com

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Chris Stumpf
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Phil Kilby
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