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Pharmaceutical Stability Testing to Support Global Markets pp 101–106Cite as

The Concept of Quality-by-Design

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Part of the book series: Biotechnology: Pharmaceutical Aspects ((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.

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References

  • 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 perspective

    Google Scholar 

  • De Palma A (2006) PharmaManufacturing.com, QbD takes Biopharma by storm

    Google Scholar 

  • FDA (2004a) Pharmaceutical CGMPs for the 21st Century – a risk-based approach (SEP04)

    Google Scholar 

  • 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 

  • FDA (2004c) ONDC’s new risk-based pharmaceutical quality assessment system (29 Sep 2004)

    Google Scholar 

  • FDA (2007) Pharmaceutical CGMPs for the 21st Century – a risk-based approach: Progress Report, Appendix 19 (May 07)

    Google Scholar 

  • ICH Harmonized Tripartite Guideline (2000) M4Q: The CTD – Quality (NOV2000)

    Google Scholar 

  • ICH Harmonized Tripartite Guideline (2005a) Pharmaceutical development Q8 (Nov 2005)

    Google Scholar 

  • ICH Harmonized Tripartite Guideline (2005b) Quality risk management Q9 (Nov 2005)

    Google Scholar 

  • ICH Draft Consensus Guideline (2007a) Pharmaceutical Development. Annex to Q8 (Nov 2007)

    Google Scholar 

  • ICH Harmonized Tripartite Guideline (2007b) Pharmaceutical Quality System Q10 (May 2007)

    Google Scholar 

  • Hussein A (2005) PharmaManufacturing.com, The Desired State: PAT and the Road to Enlightenment

    Google Scholar 

  • Kozlowski S (01 Oct 2007) Protein therapeutics and the regulation of quality: a brief history. Int Biopharm

    Google Scholar 

  • Nasr MM (2006) FDA/Industry Conference, risk-based CMC review and quality assessment: what is Quality by Design (QbD)?

    Google Scholar 

  • Nasr MM (2007) FDA quality initiatives workshop, Quality by Design (QbD) – a modern system approach to pharmaceutical development and manufacturing – FDA perspective

    Google Scholar 

  • Poochikian G (2005) PQRI Workshop: Leachables and Extractables, Best Practices Recommendations: Regulatory Science Strategies

    Google Scholar 

  • Power M (2007) Insight (BearingPoint) quality by design: life sciences companies need to step up now

    Google Scholar 

  • ICH Steering Committee Press Release, Brussels (2003) Step 4 for the ICH6 Program (JUL03)

    Google Scholar 

  • 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 Months

    Google Scholar 

  • Woodcock J (2005a) The concept of pharmaceutical quality. Industrial Pharmacy, pp. 2–9, (Mar 2005)

    Google Scholar 

  • 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 Approach

    Google Scholar 

  • Rathore AS, Branning R, Cecchini, D (01APR2007) BioPharm Int, Quality: Design Space for Biotech Products

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Cusp PharmaTech Consulting, Cambridge, MA, USA

    Mark A. Staples

Authors
  1. Mark A. Staples
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Corresponding author

Correspondence to Mark A. Staples .

Editor information

Editors and Affiliations

  1. Pharmalytik Consulting Services, Forest Ridge 32, Newark, 19711, U.S.A.

    Kim Huynh-Ba

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© 2010 American Association of Pharmaceutical Scientists

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Staples, M.A. (2010). The Concept of Quality-by-Design. In: Huynh-Ba, K. (eds) Pharmaceutical Stability Testing to Support Global Markets. Biotechnology: Pharmaceutical Aspects, vol XII. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-0889-6_14

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