As deadlines for meeting electronic pedigree (ePedigree) requirements approach, a growing number of technology choices help
deliver supporting data. The foundation of a drug ePedigree, serialization, is the application of a unique code at the item
level. These unique codes can be used to authenticate products and enable tracking and tracing.
In a March 2010 guidance document, Standards for Securing the Drug Supply Chain—Standardized Numerical Identification (SNI) for Prescription Drug Packages, the US Food and Drug Administration recommended that each sellable unit carry a unique serial number. In most cases, according
to FDA, this identification could consist of the National Drug Code for the product plus a unique serial number with a maximum
of 20 characters, printed in both machine- and human-readable forms.
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The SNI format is compatible with global standards that call for a serialized Global Trade Item Number (GTIN) for item-level
identification. Normally, manufacturers would apply the SNI. If a manufacturer's package is to be broken down for sale, however,
the repackager would apply an SNI to each sellable unit and link this number to the manufacturer's SNI.
Creating an ePedigree takes item-level serialization several steps further and affects all partners in the supply chain. "It
also requires a lot more integration between equipment and packaging lines and packaging lines and upper level systems," says
Robb Roebles, principal product marketing manager at Cognex (Natick, MA), a supplier of machine-vision hardware and software.
Once applied and recorded, item-level codes must be linked to the unique code applied to each bundle, carton, case, and pallet
to create parent–child relationships. Serial numbers also must be captured, recorded, and certified at each stop in the supply
chain, and these data must be stored in a centralized system that's accessible to all supply-chain partners.
Serialization begins on the packaging line with the application of a two-dimensional DataMatrix code or a radio-frequency
identification (RFID) tag. Since a DataMatrix code is easy and inexpensive to apply, it's now more commonly used than RFID.
Many processes reproduce DataMatrix codes, including inkjet, thermal-transfer, and laser coding.
A pedigree solution needs...
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After code printing or tag application, a camera or RFID reader and software confirm the correctness of the code and the print
quality. As the product moves down the packaging line, a unique code is applied to each level of packaging. These codes are
not only verified as correct and readable, but also aggregated to create parent–child relationships. With this data stored
in a database, drugmakers and other supply-chain partners can determine that Product A was shipped in Carton X in Case Y on
Pallet Z.
The hardware and software associated with code capture and recording also must accommodate events on the line such as rejects
or quality-assurance sampling to ensure that no discrepancies occur between the products and the data.
Line-management software sends serialization data, including all good numbers (i.e., commissioned products), bad numbers (i.e.,
decommissioned products), and parent–child relationships to higher level systems. "Ultimately, this data goes into a system
of record that becomes the master historian," says Joe Ringwood, chief operating officer at Systech International (Cranbury,
NJ).
Implementing serialization requires hardware such as printers and vision systems as well as software for the line, site, and
historian levels. Integration is required to make everything work together. The complexity of the integration depends on what
systems are already in place and the approach taken by the manufacturer.
In general, commercial, configurable serialization software will take less time to implement than line, plant, and enterprise
systems that must be customized to perform serialization functions. Choosing specific, standard devices also simplifies implementation,
particularly if multiple lines or locations are involved. It's also helpful to specify device-neutral software that is compatible
with virtually any brand or model of equipment.
"Serialization means you have to know what happens to each serialized package and requires new workflows and processes,"
says Ringwood. "So the better job done assessing current workflows and defining 'to-be' workflows, the smoother the implementation,"
he predicts.
Ringwood also advises looking at the total cost of ownership instead of focusing solely on the expenses associated with implementation.
"Many decisions have implications down the road," he explains.
Implementing serialization requires months of planning to identify software needs, qualify vendors, perform pilot projects,
and integrate hardware and software. Serialization teams should include representatives from automation, information technology,
engineering, and plant-floor teams. In fact, says Roebles, the most successful implementations involve and train the plant-level
personnel who work with the system daily. Actual implementation schedules vary, but vendors agree that an 18-month validation
process is common. "Companies that haven't started planning better start soon or they won't be ready when FDA or a country
they sell to sets [ePedigree] rules," warns Roebles.
