Forging certainty: A novel framework for the specification of combination products.

Abstract

The specification for a combination product represents a critical covenant of its quality. Too often, the current intellectual framework for forging this covenant remains a fragmented patchwork of legacy pharmaceutical and medical device paradigms. This paper argues that significant product failures are not random accidents but predictable consequences of these historical limitations. We therefore propose a novel, deductive framework-Quality by Design in Specification (QbD-S)-that complements ex