Pfizer’s assessment of its data on the impact of implementing quality by design indicates that QbD is “a very large value proposition,” Global Manufacturing Network Performance Senior VP Gerald Migliaccio reported at DIA’s Annual Meeting in Washington, DC on June 16.
The “real benefits” seen by Pfizer, Migliaccio stressed, have included enhanced process understanding, higher process capability, better product quality, and increased flexibility to implement continuous improvement changes with less regulatory encumbrance.
“We have found that as you get more mature in quality by design and you get more mature in your risk assessments, you are doing a lot more work around what is critical, but a lot less non-value-added work around what is not critical,” he said. QbD and the risk assessments associated with it “really allow you to focus on what is important.”
Pfizer has found that, while there is some incremental cost during the development phase, the value proposition is significant when looked at across the development/manufacturing spectrum. “You have to look at this of course across the enterprise,” Migliaccio pointed out. “The investment occurs in research and development, and those of us on the commercial side get the payback. So we have to play nice with each other.”
More from Migliaccio on the positive impact QbD has had on his firm’s operations is provided for subscribers here. Pfizer’s findings complement those provided by Novo Nordisk at an ISPE conference a week earlier (see IPQ “In the News,” June 10, 2010).
