Building a Framework for Quality by Design - Pharmaceutical Technology

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Building a Framework for Quality by Design
The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

Pharmaceutical Technology
Volume 33, Issue 10


1. J. Wechsler, "FDA Moves to Streamline CMC Review, Promote Drug Quality," Pharm. Technol. 29 (12), 36–42 (2005).

2. ICH, Q8(RI) ICH Harmonized Tripartite Guideline: Pharmaceutical Development, (Geneva, Switzerland, Nov. 10, 2005).

3. R.A. Fisher, Design of Experiments (7th edition, Oliver and Boyd, London, 1960).

4. G.E.P. Box, J.S. Hunter, and W.G. Hunter, Statistics for Experimenters—Design, Innovation, and Discovery (John Wiley and Sons, New York, 2005).

5. J.M. Juran, Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services (Free Press, New York, 1992).

6. S.R. Covey, The 7 Habits of Highly Effective People (Simon and Schuster, New York, 1989).

7. R.D. Snee, "Quality by Design: Four Years and Three Myths Later," Pharma Processing 26 (1), 14–16 (2009).

8. FDA, PAT—A Framework for Pharmaceutical Development, Manufacturing and Quality Assurance (Rockville, MD), 2004.

9. P. Alaedini, R.D. Snee, and B.W. Hagen, "Technology Transfer by Design—Using Lean Six Sigma to Improve the Process," Contract Pharma 9 (4), 4–9 (June 2007).

10. R.D. Snee, "Lean Six Sigma and Outsourcing—Don't Outsource a Process You Don't Understand," Contract Pharma 8 (8), 4–10 (2006).

11. R.D. Snee, W. J. Reilly, and C.A. Meyers, "International Technology Transfer By Design," Int. Pharm. Ind. 1 (1), 4–10 (2008).

12. R.D. Snee and R.W. Hoerl, Six Sigma Beyond the Factory FloorDeployment Strategies for Financial Services, Health Care, and the Rest of the Real Economy (Prentice Hall, New York, 2005).

13. M.H. Hulbert et al., "Risk Management in Pharmaceutical Product Development—White Paper Prepared by the PhRMA Drug Product Technology Group," J. Pharm. Innov. 3 (1), 227–248 (2008).

14. C.G. Pfeiffer, "Planning Efficient and Effective Experiments," Mater. Eng, 35–39, May 1988.

15. Product Quality Research Institute (PQRI) Robustness Workgroup, "Process Robustness—A PQRI White Paper," Pharm. Eng. 26(6), 1–11 (2006).

16. R.D. Snee et al., "Quality by Design—Shortening the Path to Acceptance," Pharma Processing, 25 (3), 20–24, 2008.

17. J.P. Kotter, ForClientReviewOnlyLeading Change (Harvard Business School Press, Bos.AllRightsReserton, 1996).

18. P. Holman, T. Devane, and S. Cady, The Change HandbookThe Definitive Resource on Today's Best Methods for Engaging Whole Systems (Berrett-Koehler Publishers, San Francisco, 2007).

Additional reading on design of experiments

N.A. Armstrong and K.C. James, Pharmaceutical Experimental Design and Interpretation (Taylor and Francis, Bristol, PA, 2006).

G.E.P Box, J.S. Hunter, and W.G. Hunter, Statistics for ExperimentersDesign, Innovation and Discovery (2nd ed., John Wiley and Sons, New York, 2005).

P.D. Haaland, Experimental Design in Biotechnology (Marcel–Dekker, New York, 1989).

R.W. Hoerl and R.D. Snee, Statistical Thinking: Improving Business Performance (Duxbury Press, Pacific Grove, CA), Ch. 7 and App. E, 2002).

G.A. Lewis, D. Mathieu and R. Phan-Tan-Luu, Pharmaceutical Experimental Design (Marcel–Dekker, New York, 1999).

R.D. Moen, T.W. Nolan, and L.P. Provost, Improving Quality Through Planned Experimentation (McGraw–Hill, New York, 1991).

D.C. Montgomery, Design and Analysis of Experiments (4th ed., John Wiley and Sons, New York, 1997).

R.D. Snee, L.B. Hare, and J. R. Trout, Experiments in Industry—Design, Analysis and Interpretation of Results (Quality Press, Milwaukee, WI, 1985).


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