Advertisement

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
Perspective

Abstract

Introduction

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

Methods

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.

Conclusion

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.

Keywords

Quality by design Informatics Engineering activity model Pharmaceutical product development IDEF0 

Notes

Acknowledgment

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.

References

  1. 1.
    Ministry of Economy, Trade and Industry. The Industrial Structure Vision 2010 (outline), June 5, 2010. http://www.meti.go.jp/english/policy/economy/industrial.html. Accessed 15 Nov 2011.
  2. 2.
    Pharmaceutical Research and Manufacturers of America (PhRMA). 2010 Industry Profile. 2010.Google Scholar
  3. 3.
    Suresh P, Basu PK. Improvement pharmaceutical product development and manufacturing: impact on cost of drug development and cost of goods sold of pharmaceuticals. J Pharm Innov. 2008;3:175–87.CrossRefGoogle Scholar
  4. 4.
    International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8(R2) Step 4, Aug 2010.Google Scholar
  5. 5.
    Nasr MM. Quality by design (QbD)— a modern system approach to pharmaceutical development and manufacturing—FDA perspective. North Bethesda: IFPAC; 2007. Feb 28 2007.Google Scholar
  6. 6.
    Hallow DM, Mudryk BM, Braem AD, Tabora JE, Lyngberg OK, Bergum JS, et al. An example of utilizing mechanistic and empirical modeling in quality by design. J Pharm Innov. 2010;5:193–203.CrossRefGoogle Scholar
  7. 7.
    Potter C. PQLI application of science- and risk-based approaches (ICH Q8, Q9, and Q10) to existing products. J Pharm Innov. 2009;4:4–23.CrossRefGoogle Scholar
  8. 8.
    Zomer S, Gupta M, Scott A. Application of multivariate tools in pharmaceutical product development to bridge risk assessment to continuous verification in a quality by design environment. J Pharm Innov. 2010;5:109–18.CrossRefGoogle Scholar
  9. 9.
    Rathore AS, Mhatre R. Quality by design for biopharmaceuticals—principles and case studies. 1st ed. New York: Wiley; 2009.CrossRefGoogle Scholar
  10. 10.
    McKenzie P, Kiang S, Tom J, Rubin AE, Futran M. Can pharmaceutical process development become high tech? AICHE J. 2006;52(12):3990–4.CrossRefGoogle Scholar
  11. 11.
    Instrument Society of America, ANSI/ISA-S88.01-1995 (R2006), Batch control part 1: models and terminology, 2006.Google Scholar
  12. 12.
    Fuchino T, Shimada Y, Kitajima T, Takeda K, Batres R, Naka Y. A business process model for process design that incorporates independent protection layer considerations. Comput Aided Chem Eng. 2011;29:326–30.CrossRefGoogle Scholar
  13. 13.
    Fuchino T, Miyazawa M, Naka Y. Business model of plant maintenance for lifecycle safety. Comput Aided Chem Eng. 2007;24:1175–80.CrossRefGoogle Scholar
  14. 14.
    Fuchino T, Shimada Y, Miyazawa M, Naka Y. Business process model for knowledge management in plant maintenance. Comput Aided Chem Eng. 2008;25:955–60.CrossRefGoogle Scholar
  15. 15.
    Fuchino T, Shimada Y, Kitajima T, Naka Y. Management of engineering standards for plant maintenance based on business process model. Proceedings of 20th European Symposium on Computer Aided Process Engineering, 2010, pp 1363–1368.Google Scholar
  16. 16.
    Shimada Y, Kumasaki M, Kitajima T, Takeda K, Fuchino T, Naka Y. Reference model for safety conscious production management in chemical processes. Proc Int Symp Loss Prev Saf Promot Process Ind. 2010;1:629–32.Google Scholar
  17. 17.
    Venkatasubramanian V, Zhao C, Joglekar G, Jain A, Hailemariam L, Suresh P, et al. Ontological informatics infrastructure for pharmaceutical product development and manufacturing. Comput Chem Eng. 2006;30:1482–96.CrossRefGoogle Scholar
  18. 18.
    Zhao D, Jain A, Hailemariam L, Suresh P, Akkisetty P, Joglekar G, et al. Toward intelligent decision support for pharmaceutical product development. J Pharm Innov. 2006;1:23–35.CrossRefGoogle Scholar
  19. 19.
    Hailemariam L, Venkatasubramanian V. Purdue ontology for pharmaceutical engineering: part I. Conceptual framework. J Pharm Innov. 2010;5:88–99.CrossRefGoogle Scholar
  20. 20.
    Hailemariam L, Venkatasubramanian V. Purdue ontology for pharmaceutical engineering: part II. Applications. J Pharm Innov. 2010;5:139–46.CrossRefGoogle Scholar
  21. 21.
    The National Institute of Standards and Technology. Integration definition for function modeling (IDEF0). Federal Information Processing Standards Publication 183. 1993.Google Scholar
  22. 22.
    Barkmeyer EJ. SIMA reference architecture part 1: activity models. NISTIR 5939, National Institute of Standards and Technology. 1996.Google Scholar
  23. 23.
    Fuchino T, Shimada Y. IDEF0 Activity model based design rationale supporting environment for lifecycle safety. Lect Notes Comput Sci. 2003;2777:1281–8.CrossRefGoogle Scholar
  24. 24.
    Sugiyama H, Hirao M, Mendivil R, Fischer U, Hungerbuhler K. A hierarchical activity model of chemical process design based on life cycle assessment. Process Saf Environ Protection. 2006;84(B1):63–74.CrossRefGoogle Scholar

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

Personalised recommendations