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Are “Green” PAT and QbD Taking Root?

    Are “Green” PAT and QbD Taking Root?

    The cover story of Pharmaceutical Manufacturing’s May issue—“Green Processes: PAT and QbD Take Root”—looks at how drug manufacturers are beginning to leverage PAT, as well as QbD, to green their processes—that is, to reduce waste, save energy, cut back on solvent use, and so on. (The article was a follow-up to last fall’s “Pharma’s Green Evolution“, which focused on how manufacturers are going green at the facility level.) The piece explores how GSK, Allergan, DSM, and the industry in general are looking at PAT and QbD with an eye towards sustainability, and cites survey data from our readers.

    GSK’s Darryl Ertl discussed the green potential of PAT with us last fall (see “Is It Time for PAT to Go Green”). Just six months later, as the cover story notes, Ertl has seen a dramatic difference within his own company in terms of its acceptance of PAT as a tool for energy and cost savings, and meeting corporate sustainability objectives.

    That PAT/QbD can serve sustainability and help to green processes is not new, of course. As “PAT and Green Chemistry: The Intersection of Benign by Design and Quality by Design,” by Julie Manley, Buzz Cue, and John Berridge points out (ISPE registration required), there are a lot of synergies between PAT/QbD and green chemistry. Principle #11 of the well-established 12 Principles of Green Chemistry, for example, emphasizes “Real-time Analysis for Pollution Prevention”: “Analytical methodologies need to be further developed to allow for real-time, in-process monitoring and control prior to the formation of hazardous substances.”

    It still may not be easy to go green in pharma, but increasingly manufacturers are using the ideals of PAT and QbD to their advantage.

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