ABSTRACT

Promoting innovation through Quality-by-Design in the pharmaceutical sector

Two decades have passed since the quality expert Dr. Joseph Juran coined the term Quality-by-Design (QbD) to define the idea that quality is an intrinsic property of a product and therefore it shall be planned from early stages of process and product development. The concept has been embraced by the pharmaceutical sector as its main innovation paradigm, and its application is embedded in the sectorial regulatory frameworks, which are harmonized across most developed countries. This has led to a worldwide diffusion of the QbD literature, although from its start it seems almost exclusive for experimental scientists and technical practitioners. Thus, the literature on QbD from the lens of management is still missing. Based on a bibliometric and content analysis of the most influential papers amongst the identified topics, we develop the mechanisms that seem to promote the adoption of QbD, as well as its main innovation benefits. This paper has several implications both for practitioners and policy makers to promote the internalization and diffusion of QbD, shedding light on its potential application beyond the pharmaceutical sector.