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Washington Letter: New Drug Pedigree Rules A Paper Chase?
, and all along the distribution chain. FDA is requiring a pedigree because drug manufacturers have been too slow to implement radio frequency identification (RFID) track and trace technology, which the Agency considers the "gold standard" for supply chain security. Pfizer has been tagging some packages...
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Drug Pedigree Standard Established
chains, has announced the approval of the EPCglobal Electronic Pedigree Document specification. A drug pedigree is a record of each distribution of a prescription drug from its sale by a manufacturer through acquisition and sale by any wholesale distributor until final sale to a pharmacy or other...
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Drug Makers Fight Back!
. Current issue. Issue Archive. Training & Cert. Subscribe. Drug Makers Fight Back!. New Technology, Packaging and Distribution Are Helping in the Battle Against Counterfeits. To cast your vote, log in or become a member. This quick, one-time registration gives you access to members-only site benefits...
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Drug Makers Fight Back!
in counterfeiting, given a labyrinthine distribution system where a drug may change hands 10 times before it's sold. It now requires a paper pedigree for pharmaceutical distributors ( In the meantime, pharmaceutical manufacturers and the FDA are addressing weaknesses through Product Surety and other collaborative...
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Drug Makers Fight Back!
. Community. Login. On Pharma Blog. Twitter. LinkedIn. Facebook. YouTube. Calendar of Events. E-News. Experts. Webcasts. Magazine. Current issue. Issue Archive. Training & Cert. Subscribe. Drug Makers Fight Back!. New Technology, Packaging and Distribution Are Helping in the Battle Against...
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Drug Delivery and QbD: A Collision of Lifecycles
guidance, but have made great strides in identifying a path forward within the product development and quality infrastructure. Over the last 10 years, however, a new market segment has made conforming to these guidelines more challenging than ever: drug delivery systems developed for new and innovative...
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Drug Security Gets (Nano-) Granular
As the drug product security landscape broadens, many manufacturers are looking beyond packaging-level security features and looking for ways to secure the actual drug product itself. Advances in "on-dosage" technologies have made them feasible complements to tamper-resistant packaging, barcoding...
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Covert Ops: In- and On-Product Drug Security
As the drug security landscape broadens, many manufacturers are looking beyond packaging-level security features for ways to mark, and verify, the actual drug product or materials. Advances in on- and in-dosage technologies have made them feasible complements to tamper-resistant packaging, RFID...
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Purdue Pharma Blazes a Trail for Drug Security
Operational Excellence & Lean Six Sigma Wal-Mart s mandate that, by scheduled dates, all products being shipped through its key distribution centers must have RFID verification, at least at the case level; FDA s backing of RFID as a preferred means for drug manufacturers, especially those producing...
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FDA, Industry Redouble Efforts To Foil Drug Counterfeiters
, Amgen and Ortho Biosciences, have also developed strategies of their own, including new packaging designs and controlled distribution. To increase cooperation between industry and the Agency, a new voluntary program has been set up where drug manufacturers notify FDA within five days if they have...