Developing the implementation plan
Pharmaceutical manufacturers, distributors, wholesalers, and retailers must begin the process of implementing solutions that
support ePedigrees, incorporate serialization down to the item level, and generate ePedigrees at each point of shipment. For
organizations that have already begun the implementation process or have yet to start, the key is to understand where and
how serialization impacts processes once the product leaves the manufacturing line and enters the supply chain.
Although the to-do list may seem overwhelming, it doesn't have to be. A solid serialized distribution plan is the first important
step. When implementing a serialization strategy, many companies primarily focus on the finished product on the manufacturing
packaging line, and, why not? The California requirement basically stipulates this. Many, however, do not realize that it
is equally important to successfully manage the distribution of serialized product. By doing so, regulatory compliance can
be realized more quickly.
There are three fundamental objectives and capabilities required for serialization within an organization's distribution
operations as outlined below:
- Serialization of drug product, typically at the item, case, and pallet level, and management of the associated parent-child
relationships of these levels to the saleable unit
- Tracking all product movement events such as receiving, putaway, picking, packing, and shipping of serialized product, for
which data is integrated with the existing business processes and systems
- Tracking the associated serialized product with a shipment to trigger the generation of the ePedigree.
Barcode versus RFID
The industry vision is that all pharmaceutical products will be serialized at the item, case, and pallet levels during the
manufacturing process. To do so, manufacturers need to consider designing the capability to serialize product during the packaging
process. The question arises, should pharmaceutical companies embrace radio frequency identification (RFID) technologies or
use less costly barcodes? The answer to both questions is "yes."
EPCglobal, the governing body leading the development of industry-driven requirements for the Electronic Product Code, defined
and ratified a number of serialization standards that offer direction for pharmaceutical companies implementing such solutions.
Yet, industry still lacks a consensus on data-carrier technology. For simplicity, and to minimize costs, many manufacturers
are leaning toward a 2D-barcode solution at the saleable item level and also at the case and pallet level. A barcode solution,
however, makes the distribution process extremely difficult because each packed item requires a manual scan. Using barcodes
does not generate the benefits of automatic identification RFID technology. Many distributors demand that manufacturers begin
using the ultrahigh frequency RFID standard at the case level to minimize the complexity of the distribution process.
If the lack of industry consensus on technology and data constructs has been an impediment to starting a company's implementation,
there is reason to reconsider. There are several standards already ratified and more on the way covering the fundamental components
of the serialization architecture such as tag data formats, data filter and collection, Electronic Product Code Information
Services (EPCIS), and ePedigree. Many companies are effectively working with their trading partners to agree on interoperability
standards in lieu of a final word from the industry. For example, in the consumer packaged goods (CPG) industry, brands such
as Wal-Mart and Sam's Club adopted standards that suppliers must meet.
The key to a quick implementation is starting small while developing a business foundation for scaling up in the future. Early
adopters' experiences have shown that companies are more successful in rolling out new pedigree and serialization technologies
and business processes when they phase in implementation. It is important to work closely with partners to determine the best
strategy and to ensure that processes are aligned. Be careful when jumping into a pilot serialization implementation project
without considering how the entire enterprise will be affected by the change. As with most things, it's important to define
a strategy and then execute. Consider the business implications of counterfeiting, diversion, and pedigree compliance, and
how they relate to the organization.
Full pedigree and serialization compliance affects all products. Companies previously planning a risk-based approach to serializing
products in a phased manner over time must think strategically about encompassing all products, including pipeline products.
It will also be important to take other regulations into account and develop a single approach for nationwide full compliance
Understanding the technologies to use—and for what products—in a pragmatic and cost-effective manner is crucial to developing
a cohesive product-security program. Until the industry ratifies standards, companies along the pharmaceutical supply chain
will employ a wide range of data-collection technologies. Although a company may be starting with fewer stock-keeping units
(SKUs), serialization solutions will need to use and support multiple technologies and data constructs. A serialization solution
that uses both barcode and RFID technologies requires varying types of hardware. RFID technology requires tags and fixed-mount
readers, and barcode technology uses fixed-mount or handheld scanners. Thus, the ideal serialization solution would allow
for the capability to manage and orchestrate both types of data-carrier technologies.
Once a strategy is developed and understood, the company is better prepared to define the appropriate initial implementation,
its timeline, and plan for the cost of the overall solution.