Statistical thinking and knowledge management for quality-driven design and manufacturing in pharmaceuticals

Pharmaceutical Research

Volumn 28, Issue 7, 2011, Pages 1465-1479

  Korakianiti, Evdokia ^a   Rekkas, Dimitrios ^b  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b UNIVERSITY OF ATHENS   (Greece)

Author keywords

design of experiments; knowledge management; process analytical technologies; process variability; quality; quality by design; statistical process control and analysis; statistical thinking

Indexed keywords

ANALYTIC METHOD; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG RESEARCH; MEDICAL SOCIETY; PATENT; PHARMACEUTICS; PRACTICE GUIDELINE; PRINCIPAL COMPONENT ANALYSIS; PRIORITY JOURNAL; PROCESS DESIGN; PROCESS MONITORING; PROCESS TECHNOLOGY; PRODUCTIVITY; PUBLICATION; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; STATISTICS;

DRUG INDUSTRY; KNOWLEDGE MANAGEMENT; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79959885083     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-010-0315-3     Document Type: Review

References (117)

1. Abboud L, Henslye S. New prescription for drug makers: update the plant. Wall Street J. September 3, 2003.
2. Smith A, Martin R. Pharmaceutical quality: build it into the process. AMR research report. May 12 (2004) http://www.pharmamanufacturing.com/articles/ 2007/119.html (accessed on 01/18/2010).
3. FDA Pharmaceutical Quality for the 21st century a risk-based approach Progress Report May 2007 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ ucm128080.htm#intro (accessed 01/18/2010).
4. FDA Guidance for Industry AT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance, September 2004 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070305.pdf (accessed 01/18/2010).
5. ICH Q8(R2): Pharmaceutical Development November 2005, http://www.ich.org/LOB/media/MEDIA4986.pdf (accessed 01/18/2010).
6. ICH Q9 Quality risk management 9 November 2005, http://www.ich.org/LOB/ media/MEDIA1957.pdf (accessed 01/18/2010).
7. ICH Q10 Pharmaceutical quality system, June 2008, http://www.ich.org/LOB/ media/MEDIA3917.pdf (accessed 01/18/2010).
8. Pirsig RM. Zen and the art of motorcycle maintenance. New York: William Morow; 1974.
9. Hoyer RW, Hoyer BY. What is quality? Qual Prog. 2001;53-62.
10. Feigenbaum AV. Total quality control. 3rd ed. New York: McGraw-Hill; 1991.
11. Montgomery DC. Introduction to statistical quality control. New Jersey: Wiley; 2001.
12. Deming WE. Out of the crisis. Cambridge: MIT Press, Center for Advanced Engineering Study; 1988.
13. Garvin DA. Competing on the eight dimensions of quality. Harvard Bus Rev. 1987;101-9.
14. ICH Q6A. Specifications: test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances. October 1999. http://www.ich.org/LOB/media/MEDIA430.pdf (accessed 01/18/2010).
15. ASQ Glossary http://www.asq.org/glossary/q.html (accessed 01/18/2010).
16. Ishikawa K. Introduction to quality control. Japan: 3A Corporation; 1991.
17. LR Smith 2001 Six sigma and the evolution of quality in product development Six Sigma Forum Mag 1 1 28 35
18. Shewhart WA. Economic control of quality of manufactured product. New York: D. Van Norstrand Co; 1931.
19. Juran JM. Juran on quality by design: the new steps for planning quality into goods and services. New York: Free; 1992.
20. Blomquist HJ. A missing step to better quality. Deming Electronic Network Website. http://deming-network.org/deming-blomquist1.htm (accessed 01/05/2010).
21. ASQ. The history of quality-overview. http://www.asq.org/learn-about- quality/history-of-quality/overview/overview.html (accessed 01/05/2010).
22. Georgaki T, Kouroupi K, Politis S, Rekkas DM. Total quality management. Athens: Sideris; 2010.
23. VE Kane 1986 Process capability indices J Qual Technol 18 1 41 52
24. Bohte D. Measuring process capability. New York: McGraw-Hill; 1997.
25. Deming WE. The new economics-for industry, government, education. Cambridge: MIT; 1993.
26. Oakland JS. Total quality management. 2nd ed. Oxford: Heinemann; 1993.
27. C Roethlen P Mangiameli M Ebrahimpour 2002 Quality in US manufacturing industries: an empirical study QMJ 9 3 48 66
28. A Gunasekaran SK Goyal T Martikainen P Yli-Olli 1998 Total quality management: a new perspective for improving quality and productivity Int J Qual Reliab Manage 15 8/9 947 68 10.1108/02656719810199033 (Pubitemid 128150492)
29. Dooley K. The paradigms of quality: evolution and revolution in the history of the discipline. In: Fedor D, Ghosh S, editors. Advances in the management of organizational quality, vol. 5. JAI Press; 2000. p. 1-28.
30. Hooper JH. The process approach to QMS in ISO 9001 and ISO 9004. Qual Prog. 2001;70-3. (Pubitemid 34061695)
31. L Von Bertanlaffy 1950 An outline of general system theory Br J Philos Sci I 2 134 65 10.1093/bjps/I.2.134
32. J West 2002 ISO 9001: 2000's process approach Qual Prog 35 103 4 (Pubitemid 34799608)
33. Prevette S. Systems thinking an uncommon answer. Qual Prog. 2003;32-5.
34. R Ackoff 1971 Towards a system of systems concepts Manage Sci 17 11 661 71 10.1287/mnsc.17.11.661
35. MA Mohammed 2004 Using statistical process control to improve the quality of health care Qual Saf Health Care 13 243 5 15289621 10.1136/qshc.2004.011650 1:STN:280:DC%2BD2czos1ektA%3D%3D (Pubitemid 39070887)
36. Assaf AF, Schmele JA. The textbook of total quality in health care. Florida: St. Lucie; 1993.
37. Lewis RG, Smith DH. Total quality in higher education. Florida: St Lucie; 1994.
38. ST Foster LW Howard P Shannon 2002 The role of quality tools in improving satisfaction with government QMJ 9 3 20 31
39. Pyzdek T. The Six sigma handbook. New York: McGraw& Hill; 2003.
40. Goldratt EM, Fox J. The goal. Great Barrington: North River; 1992.
41. D Nave 2002 How to compare six sigma, lean and the theory of constrains Qual Prog 35 3 73 8 (Pubitemid 34916954)
42. J Kovach P Stringfellow J Turner BR Chao 2005 The house of competitiveness: the marriage of agile manufacturing, design for six sigma and lean manufacturing with quality considerations JIT 21 3 2 9
43. T Kourti 2004 Process analytical technology and multivariate statistical process control, wellness index of product and process-Part1 Process Anal Technol 1 1 13 9
44. Shanley A, Thomas P. Flexible Pharma: puzzling out the plant of the future. Pharma Manufacturing.com http://www.pharmamanufacturing.com/articles/ 2009/170/html (accessed 01/08/2010).
45. Pselk PE. Creativity, innovation and quality. Wisconsin: ASQ Quality; 1977.
46. MP Brocklebank J Lam P Mehta 2006 A hub layout concept for oral solid dosage facilities Pharm Eng 26 1 1 8
47. Shanley A. Lurching towards agility. PharmaManufacturing.com http://www.pharmamanufacturing.com/articles/2009/179.html (accessed 01/26/2010).
48. LX Yu 2008 Pharmaceutical quality by design: product and process development, understanding and control Pharm Res 25 4 781 91 18185986 10.1007/s11095-007-9511-1 1:CAS:528:DC%2BD1cXkt1Sntrg%3D
49. J Antony T Taner 2003 A conceptual framework for the effective implementation of statistical process control Bus Process Manag J 9 4 473 89 10.1108/14637150310484526
50. TN Goh 2002 The role of statistical design of experiments in Six Sigma perspectives of a practitioner Qual Eng 14 4 659 71 10.1081/QEN-120003565 (Pubitemid 34741115)
51. DeFeo JA. The tip of the Iceberg. Qual Prog. 2001;29-37.
52. JC Benneyan PE Pselk 2003 Statistical process control as a tool for research and healthcare improvement Qual Saf Health Care 12 458 64 14645763 10.1136/qhc.12.6.458 1:STN:280:DC%2BD3sngtlOntw%3D%3D (Pubitemid 37542026)
53. Liberatore R. Teaching the role of SPC in industrial statistics. Qual Prog. 2001;89-94. (Pubitemid 32690769)
54. Rys R, Abel J. PAT: gateway to advanced control for operational excellence. Pharma Manufacturing.com http://www.pharmamanufacturing.com/ articles/2006/061.html (accessed 01/20/2010).
55. BL Joiner MA Gaudard 1990 Variation, management, and W. Edwards Deming Qual Prog 23 12 29 37
56. Prahalad CK, Krishnan MS. The new meaning of quality in the information age. Harvard Bus Rev. 1999;109-18.
57. Morris K. Making the most of drug development data. PharmaManufacturing. com http://www.pharmamanufacturing.com/articles/2005/399.html?page=full (accessed 01/25/2010).
58. Rockwell Automation. White paper. Making sense of e-manufacturing: a roadmap for manufacturers. May 2001. http://www.instrumentation.co.za/article. aspx?pklArticleId=1201 (accessed 01/20/10).
59. FDA Innovation and continuous improvement in pharmaceutical manufacturing. Pharmaceutical cGMPs for the 21st century. http://www.fda.gov/ ohrms/dockets/ac/04/briefing/2004-408b1-01-manufSciWP.pdf (accessed 01/24/10).
60. FDA Pharmaceutical cGMPs for the 21st century-A risk-based approach-final report: Executive Summary: Key Accomplishments. http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/Manufacturing/ QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/ucm137175. htm (accessed 01/19/2010).
61. T Burr 1990 The tools of quality. Part IV: Pareto charts Qual Prog 23 11 59 61
62. Lucas JM. The essential six sigma. How successful implementation can improve the bottom line. Qual Prog. 2002;27-31.
63. Macher J, Nickerson J. Pharmaceutical Manufacturing research project. September 2006. http://apps.olin.wustl.edu/faculty/nickerson/results/ PMRPFinalReportSept2006.pdf (accessed on 01/19/2010).
64. Maes I, Van Liedekerle B. The need for a broader perspective if process analytical technology implementation is to be successful in the pharmaceutical sector. J Pharm Innov. 2006;19-21. (Pubitemid 46795702)
65. Economist Intelligence unit. Quality manufacturing: a blockbuster opportunity for pharmaceuticals. September 2005 ( http://graphics.eiu.com/files/ ad-pdfs/eiu-oracle-pharma-wp.pdf ).
66. Marcher and Nickerson. Pharmaceutical Manufacturing Research Project. Sep. 2006 http://apps.olin.wustl.edu/faculty/nickerson/results/ PMRPFinalReportSept2006.pdf (accessed 12/10/2009).
67. M Makrymichalos J Antony F Antony M Kumar 2005 Statistical thinking and its role for industrial engineers and managers in the 21st century Manag Audit J 20 4 354 63 10.1108/02686900510592043 (Pubitemid 40640344)
68. F Bjerke M Hersleth 2001 Introducing statistical thinking to the food industry, facilitating and inhibiting factors QMJ 8 3 49 59
69. WH Woodall DC Montgomery 1999 Research issues and ideas in statistical process control J Qual Technol 31 4 376 86 (Pubitemid 129585019)
70. Griffith GK. Statistical process control methods for long and short runs. Milwaukee: ASQC Quality; 1996.
71. Swift JA. Introduction to modern statistical quality control and management. Florida: St Lucie; 1995.
72. Okes D. Organize your quality tool belt. Qual Prog. 2002;25-9. (Pubitemid 34799601)
73. W Woodall DJ Spitzner D Montgomery S Gupta 2004 Using Control charts to monitor process and product quality profiles J Qual Technol 36 3 309 19
74. B Blankenship P Petersen 1999 W. Edwards Deming's mentor and others who made a significant impact on his views during the 1920s and 1930s J Manag Hist 5 8 454 67 10.1108/13552529910290511
75. AT&T Hanbook. Statistical quality control handbook. USA: AT&T Technologies; 1956.
76. LS Nelson 1984 Technical aids: the Shewart control charts tests for special causes J Qual Technol 16 4 237 9
77. JS Hunter 1986 The exponentially weighted moving average J Qual Technol 18 4 203 10
78. SJ Wiklund 1995 Process adjustment when using the EWMA charts Int J Qual Reliab Manage 12 2 8 27 10.1108/02656719510080587
79. Jackson J. A user's guide to principal components. New York: Wiley; 1991.
80. S Wold K Esbensen P Geladi 1987 Principal components analysis Chemom Intell Lab Syst 2 37 52 10.1016/0169-7439(87)80084-9 1:CAS:528: DyaL1cXjtVyjsw%3D%3D
81. Abdi H, Wiliams LJ. Principal component analysis. Wiley Interdisciplinary Reviews: Computational Statistics. 2010;2:in press.
82. Abdi H. Partial Least Square Regression. In: Salkind NJ, editor. Encyclopedia of measurement and statistics. Thousand Oaks: Sage; 2007. p. 740-4.
83. Eriksson L, Johansson E, Kettaneh-Wold N, Wold S. Multi- and megavariate data analysis- principles and applications. Umea: Umetrics Academy; 2001.
84. Wold S. PLS for multivariate linear modeling QSAR. In: van de Waterbeemd H, editor. Chemometric methods in molecular design. Methods and principles in medicinal chemistry. Verlag-Chemie; 1994.
85. P Geladi BR Kowalski 1986 Partial least squares regression: a tutorial Anal Chim Acta 185 1 17 10.1016/0003-2670(86)80028-9 1:CAS:528: DyaL28XmtVahs7c%3D
86. P Wehrlé A Stamm 1994 Process control and quality improvement in the pharmaceutical industry Drug Dev Ind Pharm 20 2 141 64 10.3109/ 03639049409039081 (Pubitemid 24069261)
87. JV Kresta JF MacGregor TE Marlin 1991 Multivariate statistical monitoring of process operating performance Can J Chem Eng 69 35 47 10.1002/cjce. 5450690105 1:CAS:528:DyaK3MXhsVKitLg%3D
88. J MacGregor 1996 Using on-line process data to improve quality; Youden Address ASQC Stat Div Newslett 16 2 6 13
89. T Kourti JF MacGregor 1995 Process analysis, monitoring and diagnosis, using multivariate projection methods Chemom Intell Lab Syst 28 1 3 21 1:CAS:528:DyaK2MXlt1Squr4%3D
90. T Kourti P Nomikos JF MacGregor 1995 Process analysis, monitoring and diagnosis, using multivariate projection methods Chemom Intell Lab Syst 28 3 21 1:CAS:528:DyaK2MXlt1Squr4%3D
91. P Nomikos JF MacGregor 1995 Multivariate SPC charts for monitoring batch processes Technometrics 37 41 59 10.2307/1269152
92. T Kourti 2003 Abnormal situation detection, three-way data and projection methods; robust data archiving and modeling for industrial applications Annu Rev Control 27 2 131 9 10.1016/j.arcontrol.2003.10.004
93. T Kourti 2006 Process analytical technology and multivariate statistical process control, Part 3 Process Anal Technol 3 3 18 24 1:CAS:528: DC%2BD28XlvFaqsL8%3D
94. G Box T Kramer 1992 Statistical process monitoring and feedback adjustment-A discussion Technometrics 34 3 251 67 10.2307/1270028
95. GP Box JF MacGregor 1974 The analysis of closed-loop dynamic-stochastic systems Technometrics 16 3 391 8 10.2307/1267669
96. DG Montgomery JB Keats GC Runger WS Messina 1994 Integrating statistical process control and engineering process control J Qual Technol 26 2 79 87
97. W Tucker F Faltin SV Wiel 1993 Algorithmic statistical process control: an elaboration Technometrics 35 4 363 75 10.2307/1270270
98. SV Wiel F Faltin N Doganaksoy 1992 Algorithmic statistical process control: concepts and an application Technometrics 34 3 286 97 10.2307/1270035
99. S Bisgaard 1992 Industrial use of statistically designed experiments: case study references and some historical anecdotes Qual Eng 4 4 547 62 10.1080/08982119208918936
100. Lewis GA, Matieu D, Phan-Tan-Luu R. Pharmaceutical experimental design. New York: Marcel Dekker; 1999.
101. Montgomery DC. Design and analysis of experiments. 4th ed. New York: Wiley; 1997.
102. J Lepore J Spavins 2008 Product quality lifecycle implementation (PQLI) innovations. PQLI design space J Pharm Innov 3 79 87 10.1007/s12247-008-9034-2
103. CM Anderson-Cook HB Goldfarb CM Borror DC Montgomery KG Canter JN Twist 2004 Mixture designs and mixture-process variable experiments for pharmaceutical applications Pharm Stat 3 247 60 10.1002/pst.138 (Pubitemid 40011919)
104. Bhote KR. World class quality. New York: Amacon; 1991.
105. S Blake RG Launsby DL Weese 1994 Experimental design meets the realities of the 1990s Qual Prog 27 10 99 101
106. Chatterjee B. Embracing risk. PharmaManufacturing.com. http://www.pharmamanufacturing.com/articles/2007/175.html (accessed 01/24/10).
107. Stamatis DH. Failure mode and effect analysis: FMEA from theory to execution. WI: ASQ Quality; 1995.
108. N Bhuiyan A Baghel 2005 An overview of continuous improvement: from the past to the present Manage Decis 43 5 761 71 10.1108/00251740510597761 (Pubitemid 40815181)
109. Pearson A. Measurements and the knowledge revolution. Qual Prog. 1999;31-7.
110. Buckman RH. Building a knowledge driven organization. NY: McGraw-Hill; 2004.
111. Mohan P, Glassey J, Montague GA. Pharmaceutical operations management: manufacturing for competitive advantage. New York: McGraw-Hill; 2006.
112. Lapre MA, Van Wassenhove LN. Learning across lines. The secret to more efficient plants. Harvard Bus Rev. 2002;107-11.
113. Womack JP, Jones DT, Roos D. The machine that changed the world. New York: Free; 2007.
114. H Czarnecki BJ Schroer M Adamas MS Spann 2000 Continuous process improvement when it counts most Qual Prog 33 5 74 80
115. Whitney D. Agile pathfinders in the aircraft and automobile industries-a progress report. MIT 1995. http://web.mit.edu/ctpid/www/agile/atlanta.html#r1 (accessed 01/24/10) part of Fast and Flexible communication projects at MIT http://web.mit.edu/ctpid/www/agile (accessed 01/24/10).
116. LM Sanchez R Nagi 2001 A review of agile manufacturing systems Int J Prod Res 39 16 3561 600 10.1080/00207540110068790 (Pubitemid 35165502)
117. Tolve A. How lean manufacturing can cut costs. Eye for Pharma. http://social.eyeforpharma.com/story/how-lean-manufacturing-can-cut-costs (accessed 01/27/2010).