Here is a News article about implemantation in pharma sector.

Click here to read the article.

Do follow up with your comments and ideas.

The number of drug recalls has risen sharply in recent years - three-quarters of which are attributed to manufacturing defects. The reject percentage in the pharmaceutical industry ranges from 5 percent to 10 percent (<2 Sigma), compared to 0.0001 (6 Sigma) in the semiconductor industry. This reject-percentage costs the industry between US$ 4.5 billion and US$ 9 billion per year based on US$ 90 billion/year spent on manufacturing.

Several years ago Dowpharma followed parent company Dow's lead and

adopted Six Sigma and got huge benefits. There are possible improvement projects that involve determining the cost of unplanned events, or one-off occurrences that cannot be traced to systemic problems. For example, misloading a batch, temperature controls drifting out of range, or someone accidentally turning off process machinery during operation.

Since it is impossible to reconfigure or re-blend a batch, significant unplanned events are always very costly in pharmaceutical manufacturing. In another successful Six Sigma project in pharma, yield improvement from 40% to 87% by more tightly controlling two process variables and increased the capacity of a plant by a factor of 7.5 through an add-on investment, amounting to just 3% of the cost of the facility.

The average cycle time for manufacturing, including formulation, packaging, and quality activities, is about 60 days and average inventory turns are currently less than two per year. Cycle time can be reduced by 75% in many cases to the two-three week range and inventory turns increased to four. The combination of reduced inventory and the tremendous efficiency gains in manufacturing justify running a process more frequently.

Formulation and quality operations are two areas ripe for Lean/Six Sigma improvement. Currently, these activities take about two months per batch, 90% of that time is wasted waiting for a piece of equipment to free up for signatures on various records or for changing the status of a computer from working to completed. Streamlining these non core operations through strategies as simple as better scheduling makes a huge dent in cycle time.

Ref : http://www.pharmafocusasia.com...igma_manufacturing.htm

Dear All,

This article appeared in 2005 where efforts of some of the Pharma Companies were highlighted. I highlighted at that forum that it is a mistake to consider GMP as the greatest achievement.

Without revealing the names of companies, I am happy to say that our association has paid some rich dividends in this sector.

Click Here to Read an Article about Six Sigma in Pharma