Recent postings in the WSJ blog and elsewhere have asked the troubling question: Does Lean Manufacturing, by definition, lead to quality control problems? Click here for an interesting read. (For something that doesn't require registration, click here.)
Genzyme Corp. has had numerous regulatory problems at its Allston, Mass. Facility of late—viral contamination issues last summer, and recently FDA warnings and production shutdowns related to metal and other contaminants found in products manufactured in Allston. The Agency has posted a redacted version of its inspectional observations chronicling specific violations.
Mylan Labs has reportedly filed a second lawsuit against the Pittsburgh Post-Gazette, in the wake of an ongoing feud between the two over an article the paper published alleging that Mylan operators systematically ignored alarm warnings. "
At the USP science meeting in Toronto, I met Janeen Skutnik of Pfizer, currently chair of IPEC Americas, and former IPEC chair, Colorcon's David Schonecker. (Also met incoming chair, William Dale Carter of JM Huber, who will start his new role next year).
I spent the first part of this week in Toronto, Canada (light years away from the staid, dull town I remember visiting as a kid----with rush hours that easily rival New York’s. I almost missed my flight home!) to attend USP’s annual science meeting.
In the latest installment of a continuing saga, Mylan Labs is suing the two reporters from the Pittsburgh Post-Gazette who alleged Quality violations at the manufacturer's Morgantown, West Virginia facility.
FDA Commissioner Margaret Hamburg, whose speech on enforcement objectives and public health was just videocast live by the FDLI., appears to be the kind of leader this Agency has needed for a long time, one who communicates equally effectively to the public, politicians, industry and to colleagues within the Agency.
Every so often, one gets a major reminder of the strategic importance of manufacturing and the largely invisible "CGMP set" to the drug industry and, yes, its bottom line. Former FDA chief Mark McClellan gave pharma a good one years ago with his famous "potato chips and soap flakes" comment,...