Quality By Design, Should Pharma & Biotech Suppliers Be Ready?
Quality by design, oh my … is it salvation or mere vexation for manufacturing and other suppliers to pharma and biotech companies — or something else entirely?
I came out of a USP (United States Pharmacopeial Convention) meeting last October with the strong impression that QbD was surging across the globe as the ultimate solution in risk management for the bio/pharma supply chain. Now I’m not so sure. Despite declarations, conventions, and even extensive guidelines from regulators who want to see it happen, QbD is not quite the tidal wave I first envisioned. The innate conservatism of Big Pharma and the persistence of Byzantine regulatory disincentives are two key reasons; another, the lack of a clear payoff for smaller companies. Because it largely comes down to a productby-product decision, the case for more universal adoption of QbD over conventional QA remains at least equivocal.