Quality by Design: A Regulatory Initiative No More?

A speaker at last week’s AIChE annual meeting joked about the nitty-gritty, technical nature of the conference’s Quality by Design topical track. QbD talks at some shows are a bit like Las Vegas, he said—more superficial than substantial—whereas at AIChE they were “more like M.I.T.”

A cheap dig at other conferences, perhaps, but he had a point. The breadth and depth of QbD-related presentations at AIChE in Minneapolis were impressive—four days of back-to-back, detailed presentations by academic researchers and by chemical engineers and experts from Merck, Pfizer, BMS, Lilly, GSK, and other major manufacturers on their latest QbD projects and practices.

Unlike those at other pharma conferences, these speakers didn’t feel the need to introduce their presentations with an obligatory review of key FDA/ICH definitions and documents, nor refer to QbD as a “regulatory initiative.” (Well, okay, a few did.)

FDA was there, too, as an event co-sponsor, with Christine Moore, deputy director at the Office of New Drug Quality Assessment, taking the podium several times to share how the Agency is adapting to QbD, field questions, and wave the FDA flag. She was joined by several colleagues (and former ones like Moheb Nasr, who recently left the Agency for a job with GSK), who all spent ample time in the audience absorbing the PowerPoints and proceedings. Their attitude was much more participatory than prescriptive.

As is evidenced by AIChE, cool things are happening under the Quality by Design umbrella. Some of the projects shared would have gone on with or without the QbD movement, but it sure hasn’t hurt. The AIChE sessions show there’s reason to be excited about QbD, FDA’s Moore told me. I think she means it. And I agree.

QbD, finally, no longer seems like a regulatory initiative but an “industry initiative supported by regulators.” It seems to have a life of its own, at least among larger, established companies. Merck says that it intends to use a QbD approach for all small-molecule development and manufacturing programs. Let that sink in for a minute. Now only if small- and mid-sized manufacturers can get on board as well.

Unlike Vegas, what happens in Minneapolis does not stay in Minneapolis. For more on the events of AIChE, we’ve posted summaries of several of the better talks on PharmaQbD.com:

QbD for Analytical Methods: FDA and Industry Perspectives

Merck’s Integrated QbD Approach: Patient-Focused and Bringing Manufacturing Closer to Development

Envelope Please: AIChE Hands Out QbD Awards

Snippets from AIChE: Navigating QbD’s Shades of Gray

 

-- Paul Thomas

 

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