New e-pedigree alliance forms up to address serialization implementation

The last time pharma manufacturers and distributors made preparations for mass serialization of item-level pharma packages—in 2007 and 2008, leading up to a deadline that had been imposed by the California Board of Pharmacy, but then postponed to 2015—one of the hallmarks of the effort was the need to coordinate activities of diverse solution providers and equipment vendors. Putting tags or unique marks on each unit coming down a packaging line required complex interaction between the packaging and labeling machinery and the software that managed the process.

Now, as at least some pharma manufacturers renew their efforts, both to meet near-term requirements in Turkey and Brazil, and to prepare for the 2015 deadline, industry vendors are regrouping. The latest is 4 Serialization, announced at this week’s Pack Expo in Chicago. The alliance comprises Acsis Inc. (Marlton, NJ), an IT solution provider; Cognex Corp. (Natick, MA) a machine-vision systems vendor, Nosco (Waukegan, IL), a contract provider of labels and folding cartons, and Omega Design Corp. (Exton, PA), a packaging machinery vendor.

The group says that it will design serialization and traceability systems compliant with GS1 industry standards (which continue to be under development by the GS1 organization), using either 2D barcode or RFID technology. It will support both pilot programs and fullblown commercial installations.

Item-level serialization started as an effort to combat diversion and counterfeiting in pharma distribution—problems that have only worsened since the mid-2000s, although many industry organizations still resist the resource burdens of implementing a track-and-trace system. In the interim, industry standards have evolved, technology (at least for 2D barcode) has become more standardized, and pharma manufacturers are beginning to recognize the value to better supply chain efficiency by having trackable shipments moving through distribution channels.