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The Concept of Quality-by-Design

  • Mark A. StaplesEmail author
Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

Abstract

In 2002, the FDA introduced a major initiative, recognizing that regulation of pharmaceutical manufacturing and product quality needed to be enhanced and modernized. In 2003, the International Conference of Harmonization (ICH) workshop participants proposed a new vision of pharmaceutical development – “The Desired State.” The basic concepts of Quality by Design (QbD) as expressed in the ICH Q8 Guidance are described, as applied to pharmaceutical product development. QbD will ideally lead to better-understood products and manufacturing processes that will be subject to less variability in quality. ICH and FDA hope that the implementation of QbD will increase regulatory flexibility, creating an easier path for the manufacturers to introduce process and product improvements.

Perspectives are provided on how QbD may affect design, implementation and reporting of pharmaceutical stability testing in the global marketplace.

Keywords

Design Space Product Configuration Product Lifecycle Stability Program Pharmaceutical Manufacturing 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Chen C-W and Moore C (2006) FDA/Industry Statistics Workshop, Washington DC, Role of statistics in pharmaceutical development using quality-by-design approach – an FDA perspectiveGoogle Scholar
  2. De Palma A (2006) PharmaManufacturing.com, QbD takes Biopharma by stormGoogle Scholar
  3. FDA (2004a) Pharmaceutical CGMPs for the 21st Century – a risk-based approach (SEP04) Google Scholar
  4. FDA (2004b) Pharmaceutical CGMPs for the 21st Century – a risk-based approach; ICH Q8 EWG reference to The Desired State, p. 13 (SEP04)Google Scholar
  5. FDA (2004c) ONDC’s new risk-based pharmaceutical quality assessment system (29 Sep 2004)Google Scholar
  6. FDA (2007) Pharmaceutical CGMPs for the 21st Century – a risk-based approach: Progress Report, Appendix 19 (May 07) Google Scholar
  7. ICH Harmonized Tripartite Guideline (2000) M4Q: The CTD – Quality (NOV2000) Google Scholar
  8. ICH Harmonized Tripartite Guideline (2005a) Pharmaceutical development Q8 (Nov 2005)Google Scholar
  9. ICH Harmonized Tripartite Guideline (2005b) Quality risk management Q9 (Nov 2005)Google Scholar
  10. ICH Draft Consensus Guideline (2007a) Pharmaceutical Development. Annex to Q8 (Nov 2007)Google Scholar
  11. ICH Harmonized Tripartite Guideline (2007b) Pharmaceutical Quality System Q10 (May 2007)Google Scholar
  12. Hussein A (2005) PharmaManufacturing.com, The Desired State: PAT and the Road to EnlightenmentGoogle Scholar
  13. Kozlowski S (01 Oct 2007) Protein therapeutics and the regulation of quality: a brief history. Int BiopharmGoogle Scholar
  14. Nasr MM (2006) FDA/Industry Conference, risk-based CMC review and quality assessment: what is Quality by Design (QbD)?Google Scholar
  15. Nasr MM (2007) FDA quality initiatives workshop, Quality by Design (QbD) – a modern system approach to pharmaceutical development and manufacturing – FDA perspectiveGoogle Scholar
  16. Poochikian G (2005) PQRI Workshop: Leachables and Extractables, Best Practices Recommendations: Regulatory Science StrategiesGoogle Scholar
  17. Power M (2007) Insight (BearingPoint) quality by design: life sciences companies need to step up nowGoogle Scholar
  18. ICH Steering Committee Press Release, Brussels (2003) Step 4 for the ICH6 Program (JUL03)Google Scholar
  19. Winkle HN (2007) PDA/FDA Joint Regulatory Conference, Implementing Quality by Design; related press release (26OCT2007) in The MQN Weekly Bulletin, Biotech QbD Pilot Program to Start Within Two MonthsGoogle Scholar
  20. Woodcock J (2005a) The concept of pharmaceutical quality. Industrial Pharmacy, pp. 2–9, (Mar 2005)Google Scholar
  21. Woodcock J (2005b) AAPS Workshop –Pharmaceutical quality assessment – a science and risk-based CMC approach in the 21st century, Pharmaceutical quality in the 21st century – an integrated systems ApproachGoogle Scholar
  22. Rathore AS, Branning R, Cecchini, D (01APR2007) BioPharm Int, Quality: Design Space for Biotech ProductsGoogle Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Cusp PharmaTech ConsultingCambridgeUSA

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