Pedigree Like It's 2009
You have serialization options to meet the California ePedigree law.
By Joe Tenhagen, VP Marketing and Gregg Metcalf, Industry Manager
Nosco (Waukegan, IL)
The deadline to meet California’s ePedigree Law is approaching fast. Companies that have engaged in pilots well understand what it will take to develop and implement a successful infrastructure for ePedigree and serialization. If you have not yet begun to prepare your organization and define interoperability with trading partners, start now. As we know, major wholesalers expect to begin receiving serialized inventory in 2008.
The California Board of Pharmacy is considering a delay of the ePedigree Law to 2011. Even so, wholesalers would need serialized product by 2010, roughly 30 months away. When manufacturers begin to fully understand the scope of the initiative within their own organizations, most wish they had started earlier and are rapidly deploying pilot programs, or implementing directly on selected SKUs.
One challenge that producers face is defining serialization technology. By working with several pharmaceutical and biotechnology product manufacturers, Nosco has defined two primary technologies to implement: 2-D Data Matrix serialized codes, available at the case and item level, and high-frequency (HF), ultra-high-frequency (UHF), and UHF near-field (NF) options at the case and item level, with proven read rates in the field.
To select, understand the basic differences between radio-frequency identification (RFID) and 2-D barcodes. Both can help the pharmaceutical industry comply with mass serialization and ePedigree, but each has distinct differences.
The real difference comes down to line of sight and data storage. RFID reading requires no line of sight. With the size of the pharmaceutical industry, this could be practical at the wholesale level (or others) as a long-term solution. With the RFID tag, you can add information throughout the supply chain. Security or encryption-based technology also can protect the data on the tag. With respect to data storage, the 2-D variable bar code is, in effect, static after the code is first created, so information can’t be added.
Still, 2-D codes can serialize biologic drug products until RFID can emerge as a viable alternative, or as a way to begin. The advantage of the 2-D bar code is cost. The implementation hardware and software costs may be slightly less than RFID, but even more appealingly, the consumable can cost a good deal less. The RFID tag is more expensive than printing variable 2-D Data Matrix codes.
Consider what will be mass serialized before choosing what to deploy. EPCglobal has developed its Pedigree Messaging Standard, which has been ratified for use. This ePedigree works with a Serialized Global Trade Item Number (SGTIN) 96-bit code. This 24-character code encompasses such items as manager number, item number, and a serialized code. This serial number, when embedded into either an RFID tag or a 2-D code, is key to tracking and tracing the product through the pharmaceutical supply chain. It is included in the ePedigree, which contains additional information about the chain of custody.
Options exist for blending the two technologies. Each can employ either RFID or 2-D Data Matrix codes, or a combination, at the item and/or case level. The sidebar on page 24 examines three options.
Making it Happen
Many drug makers believe that serialization and ePedigree will happen on a national scale. They’ve begun investing in infrastructure with high-risk drugs to not only start to comply, but also to learn what it will take to fully enable 2-D and/or RFID integration throughout their operation as the standard order of business.
To move forward, create a detailed plan for a compliance and serialization strategy that you can closely follow. Many companies seek to demonstrate best effort and intent to comply by targeting a particular brand or group of commodities, and taking a risk-based approach.
Starting can be difficult and confusing. Many issues and mass serialization suppliers, exist. Coordinating this effort vendor by vendor can be daunting. Consider the options within your company and collaboratively with trading partners to establish a plan. This should include steps at the case, pallet, and item levels for all drug products. For biologic drug products, or as a way to start a “bridge or redundancy” to full RFID implementation, 2-D codes can be the right fit.
Nosco offers preserialized 2-D Data Matrix codes with HP Security Publishing Solution, and RFID-enabled printed packaging with data certification under cGMP/QSR-based processes.