Application of Lean Sigma In Pharmaceutical Industry - A Practitioners review

Authors

  • Shelly Senior Manager, Department of Regulatory Affairs, Pharm Hawk Consultant, New Delhi (110018), India;

Keywords:

Lean, Six sigma, Pharmaceutical Industry

Abstract

LEAN thinking and Six Sigma have been utilized by manufacturing industries to decrease cost and improve quality and productivity by reducing variation and production defects. Because of the dramatic successes in manufacturing, there is rising interest among companies in the pharmaceutical industry, which choose to implement LEAN in order to accomplish such goals as decreased wait time to release product to the market, reduce production waste, improve communication with end users and raize quality level both in the production and in testing laboratories. In this article, basics of LEAN and Six Sigma are presented and suggestion was given for application of their concepts in pharmaceutical industry together with harmonization with legal regulation represented by requirements Good Manufacturing Practice (cGMP) , in order to work “smarter”, more cost-effectively and avoid wasting time and other resources.

References

An Introduction to Lean, Deborah Blecker-Shelly and Joel E. Mortensen, Continuing Education Topics & Issues, August 2008

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John E. Danese, Dennis Constantinou, Life Sciences

Lean Manufacturing practice in cGMP environment, Oct 1, 2006, Anne Greene, Dermot O Rourke, Pharmaceutical Technology Europe, Vol 18, Issue 10

S. Spear and H. K. Bowen, Decoding the DNA of the Toyota Production System (Harvard Business Review, Boston, MA, USA, 1999)

H. Thomas, Transforming the Pharma Industry: Lean Thinking Applied to the Pharmaceutical Manufacturing, Section 2, World Congress of Chemical Engineering (WCCE7), Glasgow, UK, July 2005

US Food and Drug Administration (5600 Fishers Lane, Rockville, MD 20857–0001, USA), Pharmaceutical cGMPs for the 21st Century — A Risk-Based Approach, September 2004.

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Published

2018-03-30

How to Cite

Shelly. (2018). Application of Lean Sigma In Pharmaceutical Industry - A Practitioners review. Universal Research Reports, 5(1), 290–299. Retrieved from https://urr.shodhsagar.com/index.php/j/article/view/525

Issue

Section

Original Research Article