Author Archives: Paul Thomas

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. Continue reading

Is Quality by Design (QbD) Stuck, Struggling, or Just Slow to Mature?

This is a guest blog post by Paul Thomas.  Paul is Senior Editor of Pharmaceutical Manufacturing magazine, PharmaManufacturing.com, and PharmaQbD.com. He can be reached at pthomas@putman.net, and followed on Twitter @PaulThomasPharm.

There has been a lot of discussion within pharmaceutical circles of late as to what’s ailing the Quality by Design (QbD) movement. There are those who say that nothing is. There have been some “striking success stories on how Quality by Design can reduce defects and variability,” noted FDA CDER’s Janet Woodcock at the DIA annual meeting in June. QbD is “a success story that is evolving,” she added.
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