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Users Conference 2005

Does Manufacturing in the Pharmaceutical Industry Lag Far Behind Potato Chip Makers?

In The Wall Street Journal, the capabilities of manufacturing in the pharmaceutical industry were claimed to lag significantly behind potato chip makers. After calming one’s nerves, an honest self-assessment would suggest that as an industry we do tend to be risk-averse, and installation of available technology is often hampered by perceived regulatory hurdles (i.e., paperwork). In this talk, we discuss the technology in our pilot plant; in particular, plug-n-play equipment utilizing Bus technologies and at-line Process Analytics, and the Instrument Society of America’s Batch Control Methodology (ISA S88.01). The installed system provides electronic execution of batches, more flexible use of portable equipment, and a data architecture that allows desktop access of process data to enhance the creation of the development history for regulatory filings and technology transition.

Company
Bristo-Myers-Squibb

Speaker
Paul McKenzie

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