Quality by design: Four years and three myths later

Pharmaceutical Processing

Volumn 24, Issue 2, 2009, Pages 14-16

  Snee, Ronald D ^a  

^a Tunnell Consulting   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG DESIGN; DRUG INDUSTRY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; PROCESS CONTROL; PROCESS DESIGN; QUALITY CONTROL;

EID: 77953413391     PISSN: 10499156     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (9)

1. Alaedini, P.R.D. Snee and B. Hagen (2007) "Technology Transfer by Design - Using Lean Six Sigma to Improve the process" Contract Pharma, June 2007, 4-9.
2. Heilman, C. (2008) "Coming to a Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals"; "Part 2: Design Space in Development and Manufacturing (with J. Kamm)". International BioPharm, May 2008, July 2008.
3. ICH (2005) "ICH Harmonized Tripartite Guideline: Pharmaceutical Development, Q8," Current Step 4 Version, November 10, 2005.
4. ICH (2007) "Pharmaceutical Development Annex To Q8," November 1, 2007.
5. Juran, J.M. (1992) Juran on Quality by Design, Free Press, New York, NY.
6. Snee, R. D., L. B. Hare and J. R. Trout (1985) Experiments in industry - Design, Analysis and Interpretation of Results, Quality Press, Milwaukee, WI
7. Snee, R. D. (2006) "Lean Six Sigma and Outsourcing - Don't Outsource a Process You Don't Understand", Contract Pharma, October 2006, 4-10.
8. Snee, R. D., P. Cini J. J. Kamm and C. Meyers (2008) "Quality by Design - Shortening the Path to Acceptance", Pharma Processing, Febuary 2008.
9. Snee R. D.and R. W. Hoerl (2005) Six Sigma Beyond the Factory Floor - Deployment Strategies for Financial Services, Health Care, and the Rest of the Real Economy, Financial Times Prentice Hall, NY, NY.