Green Pharmaceutical Manufacturing on a Foundation of PAT & QbD

This is a guest blog post by Paul Thomas.  Paul is Senior Editor of Pharmaceutical Manufacturing magazine, PharmaManufacturing.com, and PharmaQbD.com.

Next week, METTLER TOLEDO is hosting a webcast on using Process Analytical Technology (PAT) and Quality by Design (QbD) for the greening of drug manufacturing operations. I’ll be kicking off the program by discussing the potential of the industry to leverage PAT/QbD to meet corporate sustainability objectives such as reducing energy usage and cutting carbon emissions. It’ll be a big-picture look at the elements of PAT and QbD that overlap with sustainable manufacturing. PAT Qbd Pharmaceutical ManufacturingNext, technical experts from METTLER TOLEDO will discuss how specific PAT technologies are already being used within the pharmaceutical industry to meet green objectives.  A Q&A session will follow our talks.

The question of whether or not PAT (and QbD) can be used to leverage sustainability efforts at drug manufacturers seems a bit of a no-brainer. If you’ve got a well-designed process, and you’ve got tight control of that process, it stands to reason that there will be less waste and optimized production. Last spring, we at Pharmaceutical Manufacturing surveyed our readers about their green manufacturing habits, and I like this quotation that one reader sent back: “Process control is environmental control.” It has a nice ring to it.

In writing an article based on that survey, I spoke with many experts about the link between PAT and QbD and sustainability. Everyone I spoke to recognized the PAT connection. Fermentation operations, for example, stand to be much less wasteful, and require much less energy, if endpoints can be determined using PAT, and thus equipment shut down hours or days sooner than it might have been before.

A connection between Quality by Design (QbD) and green operations might not be such a no-brainer. The need to develop products more efficiently and get them to market faster can run counter to efforts to reduce waste, save energy, etc. QbD and sustainability considerations are “two different variables,” one expert has told me.

Nevertheless, the synergies between the pharmaceutical PAT and QbD movements and the drive for more environmentally friendly production are there, and we’ll explore them in more depth in next week’s web event: Building Green Pharmaceutical Manufacturing on a Foundation of PAT and QbD.

Paul Thomas can be reached at pthomas@putman.net, and followed on Twitter @PaulThomasPharm.

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