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EZ Pass Testing, Coercion and Buck Passing: A Tale of Broken Pharma QA and QC. Sound familiar?


Just read Mina Kime's enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's. 

From 'On Pharma'

Ranbaxy, Wishful Thinking and the Fudge Factor


FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."

But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?

From 'On Pharma'

Pharma Leads the Way in Help for Haiti


The drug industry is usually out front in assisting disaster relief, and many manufacturers have already come forth with major donations of money and supplies to Haiti in the aftermath of this week's earthquake.

Abbott will donate $1 million and says it has donated drugs that are already "on the ground" in Haiti. 

From 'On Pharma'

FDA Cites "Shadow" Heparin Manufacturing Plants in China


Some of those in favor of relaxed reimportation often argue that the drug industry is fear mongering when it points to potential safety problems with drugs or ingredients sourced from abroad. "Be afraid, be very afraid. "  Well, recent events have shown that there is reason for fear....or at least for extreme caution when ensuring the pedigree of any raw materials  sourced from abroad. 

From 'On Pharma'