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FDA Expert Martin Browning on Outsourcing
Everything can be outsourced - except responsibility. That's a rule the U.S. FDA lives by, and one you should embed in your policies, SOPs, and corporate culture.
Last year, the deaths associated with contaminated heparin - followed by the ensuing FDA investigations and embarrassing (and expensive) product recalls - underscored the importance of ensuring your suppliers comply with the regulations and conform to your manufacturing specifications at all times.
It's not surprising that pharmaceutical leaders have compliance concerns. If the $875 million fine leveled against TAP Pharmaceuticals back in 2001 didn't open eyes, the public's declining opinion of the drug industry - along with regular headlines about lawsuits, safety problems and generics squabbles - provide regular wake-up calls.
On September 30, 2008 the FDA website listed 44 warning letters for the Bioresearch Monitoring (Bimo) Program's GCP inspection programs. These include inspections of clinical investigators, sponsors/CROs, and institutional review boards (IRBs). The federal fiscal year ends on September 30 and FDA maintains warning letters on their website for one year. A review of these warning letters sheds light on three new developments.
David Linnemeyer's own blood bank's ISBT implementation was not quick or easy. How would he improve the process if he could? A review of his "own mishaps," according to Linnemeyer, will help you plan your own ISBT implementation more effectively.
Did you know that the European recast of the Medical Device Directives has been put on hold but that the revision of the directives and new approach revision are coming?
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