Lean Six Sigma Transparency and Patient Focus - Take Home Message from Interphex 2012

I had the fortune to attend Robert Lechich's session entitled "Deploying Lean Six Sigma in Global Manufacturing Networks"at the Interphex 2012 Conference on May 3rd. 

The biggest take home message for me was when he painted a picture of the future of the Pharma Industry which includes  an era where technical transfers will be more common.  Companies will then choose CMO's based on similarities to their own organizational culture.  Evolution of Lean Six Sigma, transparency and patient focus are the top items that will drive these partnerships. 

Further development and growth of these areas are at the forefront of the Pillar5 Pharma culture.

Pillar5 Completes Successful FDA Audit

Pillar5 Pharma Successfully Passes FDA Inspection

Pillar5 Pharma Inc. recently received notice that they have successfully passed a cGMP  and pre-approval inspection (PAI) for a New Drug Application (NDA) by the U.S. Food and Drug Administration to manufacture a solid dose product on behalf of one of its clients.  The acceptable rating was received after full inspection by the FDA of the Quality, Facility and Equipment, Materials, Laboratory, Production, Packaging and Labeling Systems, and a PAI, with no 483 observations.

“I am very pleased that Pillar5’s high quality standards and expertise were reflected in the outcome of this inspection” notes John Carkner, President and CEO of Pillar5. “This is a significant milestone for our client partnership and brings this important product one step closer to market.”