The History of OPEX in the Pharmaceutical Industry
The History of Operational Excellence in the Pharmaceutical Industry is still short. Serious initiatives were only launched around 10 years ago. This chapter provides some background on how and why OPEX became a topic of serious interest in this industry.
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The History of OPEX in the Pharmaceutical Industry Thomas Friedli and Ju¨rgen Werani
The History of Operational Excellence in the Pharmaceutical Industry is still short. Serious initiatives were only launched around 10 years ago. This chapter provides some background on how and why OPEX became a topic of serious interest in this industry. As pharmaceutical manufacturing evolves from an art to a science and engineering based activity, application of this enhanced science and engineering knowledge in regulatory decision-making, establishment of specifications, and evaluation of manufacturing processes should improve the efficiency and effectiveness of both manufacturing and regulatory decision-making.1 . . ., industry’s hesitancy to broadly embrace innovation in pharmaceutical manufacturing is undesirable from a public health perspective. Efficient pharmaceutical manufacturing is a critical part of an effective U.S. health care system. The health of our citizens (and animals in their care) depends on the availability of safe, effective, and affordable medicines.2
Compared to other industries, the pharmaceutical industry was rather slow to adopt programs to increase Operational Excellence and strive for Continuous Improvement. By the late 1990s, only a few actions with rather limited scope had been taken. In the first decade of the 2000s, OPEX then gained momentum. Since then, OPEX has become a priority not only for the top management and workforce of almost every major pharmaceutical manufacturer, but also for small and
1 FDA, Final Report “Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach”, September 2004. 2 Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, FDA, September 2004, Page 3.
T. Friedli (*) Institute of Technology Management, University of St.Gallen, St.Gallen, Switzerland e-mail: [email protected] J. Werani Schuh & Co, Komplexita¨tsmanagement AG, Langgasse 13, 9008, St.Gallen, Switzerland e-mail: [email protected] T. Friedli et al. (eds.), Leading Pharmaceutical Operational Excellence, DOI 10.1007/978-3-642-35161-7_3, © Springer-Verlag Berlin Heidelberg 2013
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T. Friedli and J. Werani
Direction of Highest Leverage
Strategic Role of Manufacturing
Minimal Expectation
Beat Practice 1 (Non Pharma)
Stage 4 „Manufacturing based competitive advantage“
Best Practice 2 (Non Pharma)
Stage 3 „Provide credible support to business strategy“
Stage 2 Average Pharma Company
„Keep up with other pharma company‘s manufacturing“
Stage 1 „Just don‘t screw up“
1s
2s
3s
4s
5s
6s
Underlying Process Capability
Fig. 3.1 Current status of the pharmaceutical industry (Source: Raju (2003) cited by Kickuth and Friedli 2006)
medium-sized contract manufacturers. Even so, the industry still has a lot to do to catch up with excellence levels of other industries that have been working towards continuous improvement for decades. According to G. K. Raju, in 2003 the sigma level of the pharmaceutical industr
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