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informatica_template_sep2003 “turning integration into - fda.ppt

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informatica_template_sep2003 “turning integration into - fda

Technology options for RFID in pharma How best to enable a cost-effective electronic pedigree? Summary RFID should provide tremendous benefits to the US pharmaceutical supply Provide electronic pedigree Enable improved track-and-trace Efficiencies in supply chain HF RFID is a mature technology with several suppliers and products available today Tremendous investment is occurring in EPC UHF RFID, promising lower cost with equivalent or better performance compared to HF RFID Additional study is warranted before one type of RFID is selected for wide scale implementation for pharmaceutical items Passive Tag RFID Operation HF and UHF RFID tag construction HF RFID tag Metallic coil antenna Multi-layer due to loop crossover EPC UHF RFID Market Drivers Wal-Mart and U.S. Dept. of Defensemandates to suppliers: supply RFID tagged cases and pallets as of January 2005 Others retailers following fast: Target, Tesco, Metro, Albertsons, BestBuy Enterprise software solutions withRFID capability from Microsoft, SAP,IBM, Manhattan Associates, and others Single global spec for UHF RFID: Gen 2 Strong interest from other markets (transportation, for example) Readers are likely to become ubiquitous and available to consumers EPC UHF Global Product Availability HF and UHF comparison table HF and UHF comparison table Value of market data is recognized From COMBATING COUNTERFEIT DRUGS A Report of the Food and Drug Administration (February 2004) “In the long term, after there is significant market place experience with RFID, FDA plans to propose or clarify, as necessary and appropriate, policies and regulatory requirements relating to the use of RFID. Labeling, electronic records, product quality, and Current Good Manufacturing Practices (cGMP) requirements are issues that have arisen in connection with RFID. However, regulatory or policy determinations regarding these, or other, issues should not be made until they can be informed by sufficient data and significant marketplace experienc