Eight steps to PAT: Using the design for lean six Sigma toll-gate process as best practice

Pharmaceutical Engineering

Volumn 27, Issue 2, 2007, Pages 8-20

  Chatterjee, Bikash ^a   Green, Jeremy ^a  

^a Pharmatech Associates   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; COMPUTER ANALYSIS; COST BENEFIT ANALYSIS; DRUG INDUSTRY; HEALTH CARE ORGANIZATION; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; LABORATORY TEST; MEDICAL EXPERT; MEDICAL INFORMATION; MEDICAL LITERATURE; PROCESS DESIGN; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; VALIDATION STUDY;

EID: 34247473521     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. Maes, I. and B. Van Liedekerke, "The Need for a Broader Perspective if Process Analytical Technology Implementation is to be Successful in the Pharmaceutical Sector," Journal of Pharmaceutical Innovation, Volume1, Number 1, September/October 2006, pp. 19-21.
2. Kourti, T., PhD, "Process Analytical Technology and Multivariate Statistical Process Control: Wellness Index of Product and Process - Part 1," PAT Journal, Volume 1, Issue 1, September/October 2004, pp. 13-19.
3. Kourti, T., PhD, "Process Analytical Technology and Multivariate Statistical Process Control: Wellness Index of Product and Process - Part 2," PAT Journal, Volume 2, Issue 1, January/February 2005, pp. 24-29.
4. Kourti, T., PhD, "Process Analytical Technology and Multivariate Statistical Process Control: Wellness Index of Product and Process - Part 3," PAT Journal, Volume 3, Issue 3, May/June 2006, pp. 18-24.
5. Harry, Mikel and R. Schroeder, Six Sigma: The Break-through Management Strategy Revolutionizing the World's Top Corporation, Doubleday, 2000.
6. Pyzdek, T., The Six Sigma Handbook: A Complete Guide for Green Belts, Black Belts and Managers at All Levels, Revised and Expanded, McGraw-Hill, 2003.
7. Brue, G., Design for Six Sigma, McGraw-Hill, 2003
8. GAMP 4: The Good Automated Manufacturing Practice Guide for the Validation of Automated Systems, International Society for Pharmaceutical Engineering (ISPE), Version 4, December 2001.