Functionality and Performance of Excipients in a Quality-by-Design World Part X: Continuous Processing of Pharmaceutical Finished Products
Excipients
Chris Moreton, Ph.D. FinnBrit Consulting LLC
Introduction
In this paper, I plan to discuss excipients and Quality-by-Design (QbD) in the context of the manufacture of pharmaceutical products using continuous processing. Continuous processing is not new; it has been around for many decades. It is just that the pharmaceutical industry has been even more reluctant to consider it than they have QbD. (QbD has only been around as a concept since the mid 1980s [1]; continuous processing has been around for a lot longer.) The reasons for this slowness to adopt new technologies and concepts in general are worth exploring because, in my opinion, they may provide some understanding of how long it could take for QbD to become generally accepted. (But hopefully it will be much quicker because continuous processing can bring real benefits to the pharmaceutical industry.)
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