Where Lies QbD's Competitive Advantage?

I've had the good fortune of speaking this week with Volker Eck, senior director of science and technology at PDA, and a day later with Graham Cook, Wyeth's senior director for process knowledge/Quality by Design. Both men were integral participants in late September's workshop in Frankfurt,  hosted by PDA, to unveil and discuss EFPIA's mock examples of Quality by Design implementation.

By all accounts, the mock examples were well received and the meeting was an important step toward helping manufacturers not just interpret ICH guidances but grasp how QbD might look for their products and processes. The mock examples are now being finalized, following input from the Frankfurt meeting and one earlier with EMEA in London, and are expected to be made public later this year.

You can read my summary of Eck's take on the meeting here, and I hope to have a podcast of my interview with Cook available within a week or two. Eck was insightful in that he said that many manufacturers at the Frankfurt meeting were still clearly struggling to "translate" the ICH documents, and the mock examples, to their own operations. With QbD, manufacturers can only truly learn by doing and thus will have to dive in
without being completely comfortable with how they're approaching Quality by Design. And regulators are encouraging that manufacturers get serious about QbD in the early rather than late stages of development.

Also interesting: Eck believes that pharmaceutical manufacturers in the U.S., or those who market products in the U.S. and thus work closely with FDA, have a competitive advantage over those who do not. FDA aggressively drives QbD and maintains open (and productive) lines of communication with industry to keep the initiative moving ahead, whereas the mandate of European regulators for QbD is not as strong and thus their support is by nature more passive. Manufacturers working with FDA on Quality by Design will understand it and reap its benefits more quickly than others, was Eck's point.

Cook isn't so sure. He believes that any manufacturer that commits itself to Quality by Design will be able to get regulatory support (and regulatory relief) from authorities worldwide, and reap QbD's myriad benefits. If this is true, the competitive advantage would go to those companies who do QbD right.

Thanks to both men for sharing their thoughts, and for their enthusiasm about communicating and explaining QbD to the masses.

--Paul Thomas