Benefits beyond compliance
The goal of pedigree efforts and laws is to ensure a safe supply chain free from counterfeit product. Some companies only
seek compliance. Others view pedigree implementation strategically. Indeed, once product serialization and pedigree record-keeping
are in place, previously unavailable supply-chain data can be used in many beneficial ways. For example, one manufacturer
increased revenue by halting a parallel trading operation that was diverting product sold overseas into the United States.
Serialization also offers the potential for faster, more precise, and less costly recalls than are currently possible. Recalls
tend to be a largely manual process. "You never know if you're done," says Peter Spellman, senior vice-president of products
and services at SupplyScape. "A pedigree system can immediately tell you how much of an affected lot was on hand and where
it was sent," he explains. "What normally takes days can be accomplished in 15 minutes," he concludes.
Other advantages of serialization include improved inventory management, particularly expiration-date management, expedited
payment, and efficient processing of returns.
Although members of the pharmaceutical supply chain can assemble their own systems, some suppliers have collaborated to offer
a turnkey solution. Products include the "California Express Solution," which consists of enterprise software from HP (Palo
Alto, CA), preserialized packaging from Nosco (Waukegan, IL), ePedigree software from SupplyScape, a packaging-execution system
from Systech International (Cranbury, NJ), the "PharmaTrack" serialized distribution solution from Acsis (Marlton, NJ), and
serialization strategy and services from VeriSign (Mountain View, CA).
Solutions for electronically capturing pedigree data at various supply-chain points are being brought to the market. One system
that supports linear barcodes, 2D barcodes, and RFID tags is available in tabletop, conveyor-mounted, and mobile-cart configurations.
The system creates the initial ePedigree; aggregates items into cases, totes, pallets, orders, and shipments; verifies the
ePedigree and completeness of incoming goods; updates the pedigree of items being shipped; and provides quarantine or special
handling ("Blue Vector Serialization Station," Blue Vector Systems, Palo Alto, CA).
Decisions about suppliers must be made soon to ensure timely delivery and implementation. Waiting 8, 12, or 16 months to place
an order could easily double or triple lead times because of order volume.
Although counterfeit prevention is the goal of pedigree requirements, it should be noted that serialization and tracking must
be supplemented by physical authentication features because it is "inevitable that serial codes from legitimate product will
be copied and used on counterfeit product. The capability to authenticate both the serial code and the physical item quickly,
definitively, and in the field will be a critical component of a complete product surety initiative" (2).
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com
.
References
1. "Identification and Coding of Pharmaceutical Products in Europe," position paper, European Federation of Pharmaceutical
Industries and Associations, Brussels, June 2008.
2. J. Rittenburg, "Authentix Comments to the European Commission, Enterprise and Industry Directorate-General, Pharmaceuticals,"
European Commission, Brussels, May 7, 2008.
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