Journal of Pharmaceutical Innovation

, Volume 7, Issue 3–4, pp 195–204 | Cite as

Pharmaceutical Engineering Strategy for Quality Informatics on the IDEF0 Business Process Model

  • Hirofumi KawaiEmail author
  • Hiroya Seki
  • Tetsuo Fuchino
  • Yuji Naka



Intricate modern pharmaceutical business activities strive to achieve lean development for the desired quality level by applying the quality by design (QbD) approach.


To engineer suitable information flows for quality development by this approach, a business process model written in the type 0 method of integrated definition language (IDEF0) was created for biopharmaceuticals development activities by analyzing actual company activities.

Results and Discussion

The model comprises engineering activities of product quality design, recipe development, process engineering, and production. In the QbD approach, the activities are hierarchized into five stages. Information flows that trigger plan–do–check–action (PDCA) cycles beyond the stages (vertical PDCA) as well as those in the same stage (horizontal PDCA) are defined.


With the model as reference, it becomes possible to design an extensive information sharing system applying the QbD approach to the activities necessary for a series of functions.


Quality by design Informatics Engineering activity model Pharmaceutical product development IDEF0 



The authors would like to thank Kyowa Hakko Kirin Co. Ltd. for providing instances of change controls, which were applied to enhance the information flows in our activity model.


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Copyright information

© Springer Science+Business Media New York 2012

Authors and Affiliations

  • Hirofumi Kawai
    • 1
    Email author
  • Hiroya Seki
    • 1
  • Tetsuo Fuchino
    • 2
  • Yuji Naka
    • 1
  1. 1.Chemical Resources LaboratoryTokyo Institute of technologyYokohamaJapan
  2. 2.Chemical Engineering DepartmentTokyo Institute of TechnologyMeguro-kuJapan

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