Quality by design is a critical tool in navigating the complex manufacturing and supply chain shoals through which pharma is now moving, expert John Berridge reaffirmed at the ISPE Washington Conference in June.
A key player in the ICH quality guideline development process including that for Q8 during his career at Pfizer, Berridge offered a strong defense of the need for and proven value of QbD in meeting the current industry challenges.
“Our manufacturing world has suffered a dramatic discontinuous shift over the past few years,” Berridge pointed out in his concluding remarks at the Q8-10/PQLI track of the conference. “When I was at Pfizer, which was not that long ago, everything that was made under GMP – if you think of Q7, the start of GMP – everything from that step onward we made in house. And we were very proud of it.”
However, for Pfizer as for other of the big pharma companies, that paradigm is changing – the supply chain is more geographically diverse and there is more contracting and outsourcing. “Using the principles of quality by design,” he stressed, “gets you the understanding, the knowledge that you are going to need, to manage these processes.”
[Berridge’s further analysis of the QbD manufacturing imperatives, including the flexibility it provides in adjusting to market demand, is provided for subscribers here. Nonsubscribers can purchase the story for $95 by contacting Peter Blachly (firstname.lastname@example.org). For subscription/license information, click here.]