Ever see the old Abbott and Costello "who's on first" baseball routine? "I don't know" was on third base.
Pharma is not the only industry that suffers from less-than-perfect supply chain risk management, as Juran Institute CEO Joe De Feo pointed out in a recent audio interview.
As the heparin tragedy has pointed out, many companies may not be aware of who their second- and third-tier suppliers are, especially when there are shortages of raw materials and a first-tier supplier opts to buy material on a spot basis or to work, temporarily, with a new source.
How well does your company know its business partners---all of them? Drug industry professionals, please take a few minutes to respond to a new survey we've developed with experts from Marsh Consulting Group, to benchmark drug company supply chain risk management. Results will be kept strictly confidential---and, besides, you can also use an alias and your hotmail address for an additional layer of security.
Marsh will interpret results in September's issue.
Established compendial tests are inadequate (topic for an upcoming article) for assessing intentionally adulterated material ---just as we never factored in the potential for suicide bombers in national security plans, we may never have suspected that so many people would intentionally profit from counterfeit drugs. USP and FDA have been meeting for the past few months to change that, and to specify the use of advanced analytical techniques---USP is also developing standards for process analytical technologies (PAT) and incorporating PAT into its framework.
(Recent news reports find that drug counterfeiting is dramatically on the rise, and Nigeria's brave Dr. Dora Akunyili , head of FDA-equivalent NAFDAC has reportedly asked for life prison terms for offenders (read on for more). Stiff penalties are allegedly on the books in India. Even Peru has reportedly instituted 10-year prison sentences for offenders---more here.) .
AMS
