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U.S. Nabs $83 Million in Fake Devices and Drugs in 2012, Down From 2011
The number of counterfeit medical devices seized at the border in 2012 dropped by roughly a third from 2011, a Department of Homeland Security report shows. Devices and drugs seized U.S. Customs & Border Protection (CBP) during fiscal 2012 were worth about $82.9 million. The 2,350 medical product shipment seizures represented 9 percent of the total seizures. . . .
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ISO Anti-Counterfeit Standard Strengthens Lifecycle Product Verification Processes
In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the life-cycle integrity of products. While not a cure-all or substitute for track-and-trace programs, ISO 12931:2012 assists device- and drugmakers in defining and generating risk-based, user-defined authentication elements for integrating into products and packaging. It suggests numerous ways in which authentication programs can be tailored to meet the needs of a product's physical characteristics, processing and storage requirements and resistance to attack. . . .
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Tougher USP Heparin Standard No Substitute for Stringent Supplier Controls, FDA Says
While an impending update to the U.S. Pharmacopeia's (USP) reference standard for heparin sodium will sharpen the drug's monograph, there is no substitute for solid supplier quality control to prevent contaminants in heparin and other active pharmaceutical ingredients (API), FDA officials say. The revised monograph that USP will propose in November looks strong, but it's unlikely it will actually help manufacturers and API purchasers detect all contaminants in heparin, Ali Al-Hakim, a branch chief at CDER's Office of New Drug Quality Assessment and USP's heparin expert, said at an August heparin workshop in Rockville, Md. hosted by USP. USP scientist Anita Szajek agreed, saying the compendium's monographs would run a mile long if they included methods for detecting every kind of contaminant. The organization did update its heparin sodium standard in 2009 with a more potent assay method for detecting over-sulfated chondroitin sulfate (OSCS) in response to the 2008 heparin crisis. . . .
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Revised PIC/S Adds GDP to Help Stem Device Counterfeiting
The international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its charter to include language promoting global harmonization of good distribution practices (GDP) and confidentiality in data sharing. . . .
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