Pharmaceutical manufacturing technology has been depicted as outdated and inadequate for optimal quality and control. While the industry remains highly reliant on batch processing, there has been a focused effort to apply six sigma and lean principles to manufacturing operations. Currently, Quality by Design principles are broadly used across the pharmaceutical industry in product development. Product quality and compliance are key pillars to successful business, and when there are lapses in keen attention to one or both, serious consequences follow, not only to the business, but more importantly, these occurrences present a most serious failure to the patients the industry is meant to serve. With presence of smart equipment across the end-to-end process for manufacture, extensive amounts of data are generated, some of it effectively used and some of it inaccessible resulting in a waste of potential value. The next frontier for pharmaceutical processing from development through commercialization is effective use of data.
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