Examining the basic principles of quality by design (QbD) approach in analytical studies

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MESUT B., Onal C., Aksu B., ERGİNER Y.

ISTANBUL JOURNAL OF PHARMACY, vol.51, no.2, pp.271-276, 2021 (ESCI) identifier

  • Publication Type: Article / Review
  • Volume: 51 Issue: 2
  • Publication Date: 2021
  • Doi Number: 10.26650/istanbuljpharm.2020.0087
  • Journal Indexes: Emerging Sources Citation Index (ESCI)
  • Page Numbers: pp.271-276
  • Keywords: Analitycal quality by design, risk assesment, process analytical technology, analytical target profile, critical quality atrributes
  • Istanbul University Affiliated: Yes


Although the first application of Quality by Design (QbD) concept started for product development studies, the number of studies regarding its application to analytical development has been increased recently. Basically, QbD strategy in both formulation development and analytic studies are identical logically and conceptually, but they have some differences in terms of its terminology and application. Essential terminology and approach differences in this concept are; the determination of the analytic target profile, critical method characteristics, critical process parameters, and the determination of the method study area. However, the risk evaluation method which is necessary for the appropriate application of quality by design is also an inseparable part of the analytical quality by design. Despite those terminological differences, developing a quality-based method with the analytical design that contributes to research with an appropriately applied risk-based design quality approach and provides multiple advantages that will be noticed each and every time, will be useful both for researchers and authorities who investigate license documentation and changes. Therefore, the terminology which is used for analytic quality by design and appropriate risk evaluation approaches are explained in this study.