Quality by design

Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design.[1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes.[2] Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned.

While quality by design principles have been used to advance product and process quality in industry, and particularly the automotive industry, they have also been adopted by the U.S. Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs.[3][4][5][6]

  1. ^ Juran, J.M. (1992). Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. Free Press.
  2. ^ Juran, J.M. (1986). "The Quality Trilogy: A Universal Approach to Managing for Quality". Quality Progress.
  3. ^ Yu, Lawrence X. (2008). "Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control". Pharmaceutical Research. 25 (4): 781–791. doi:10.1007/s11095-007-9511-1. PMID 18185986. S2CID 11700550.
  4. ^ Rathore, Anurag S. (September 2009). "Roadmap for implementation of quality by design (QbD) for biotechnology products". Trends in Biotechnology. 27 (9): 546–553. doi:10.1016/j.tibtech.2009.06.006. PMID 19647883.
  5. ^ Lebrun, Pierre; Govaerts, Bernadette; Debrus, Benjamin; Ceccato, Attilio; Caliaro, Gabriel; Hubert, Philippe; Boulanger, Bruno (2008). "Development of a new predictive modelling technique to find with confidence equivalence zone and design space of chromatographic analytical methods". Chemometrics and Intelligent Laboratory Systems. 91: 4–16. doi:10.1016/j.chemolab.2007.05.010. S2CID 124129813.
  6. ^ Schweitzer, Mark; et al. (February 2010). "Implications and Opportunities of Applying QbD Principles to Analytical Measurements". Pharmaceutical Technology. 34 (2): 52–59.