Six Sigma in the Pharmaceutical Industry


Posted by: meikah | 18 July 2006 | 10:44 pm

Many in the healthcare industry are now going into Six Sigma. Shouldn’t the pharmaceutical industry do the same—especially that both industries concern people’s health, people’s lives?

PharmaLive says that pharmaceuticals will benefit a lot if they implement Six Sigma. The methodology will allow them to reduce the time needed to get their drugs on store shelves and cut costs by eliminating variations in many processes and trimming waste.

To me what’s more important is the state of processes when these companies manufacture these drugs. How often do we hear about defective drugs that have ruined lives?

iSixSigma features “Breakthrough: Do Clinical Research the Six Sigma Way,” which basically emphasizes improved process workflows. The article also suggests how Six Sigma methodology can help pharmaceutical companies improve clinical trial performance.

The following key strategies are suggested to launch a Six Sigma effort within this industry:

  1. Begin to change the traditional ways of conducting clinical trials by campaigning for the implementation of needed integration initiatives through the use of Six Sigma with a commitment from top down leadership.
  2. Focus on the integration of technology and workflow improvement in meeting challenges and extend new ventures not possible using conventional isolated implementation of technology or homegrown process improvement methodologies.
  3. Provide tested research approaches for the quantitative evaluation of clinical development and process improvement strategies, the integration of which highly correlates with strong financial performance.

The author, Elliott W. Liu, concludes, “In the highly regulated pharmaceutical industry, documenting processes is a critical element in the demonstration of quality and is considered concrete evidence for regulatory approval in marketing new drugs. However, if defects and inefficiency exist from the continued use of traditional clinical research methods, documented evidence will continue to carry defects and inefficiencies.”

I agree!

Incidentally, there’s a Lean Six Sigma for Pharmaceutical and Biotech Manufacturing Excellence conference on July 24 - 26, 2006 at Park Hyatt Philadelphia, Philadelphia.

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 Filed under: Manufacturing, Deployment | |






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