By Daniel O'Regan and Cliff Campbell

Published in: IVT Jr GXP Compliance Vol 26, Issue 3

Published on: June 25, 2020

Abstract: This paper highlights the practical benefits to the industry, of adopting the concept of the ‘Spectrum of Importance’ (SOFI) as proposed by O’Keeffe which presented an alternate approach to understanding and prioritizing process parameters. Their approach represented a move away from the current binary critical/non-critical one that is widely used by many companies today; instead, it involved positioning process parameters (and material attributes also) on a spectrum which reflects the relative importance of those parameters and attributes.

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