Piloting Traceability with GS1 Standards AmerisourceBergen teams with Johnson & Johnson Supply Chain for significant learnings “The key to success in meeting
any instance of regulatory
The Food and Drug Administration (FDA) regulation requires that the
pharmaceutical industry implement end-to-end traceability by 2023. Trading
down to collaboration. It all rests on the willingness of our
partners in the supply chain have chosen to implement and test GS1 Standardsbased solutions in real-world pilots to meet the deadline for interoperability.
industry partners across the
supply chain to work toward
While GS1 Standards have created a hierarchy that reaches down to the
consensus and then drive to adoption. This pilot with JJSC has been a stunning example of true partnership as we move to establish a meaningful standard that serves our industry and protects patients.” —H EATHER ZENK, Vice President, Secure Supply Chain, AmerisourceBergen
product level for serialization, several industry entities have voluntarily chosen to use GS1 EPCIS even as this standard evolves to fully meet the intent of the regulation. EPCIS allows trading partners to exchange data, in concert with the products as they move through the supply chain. An industry pilot between Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) did just that with actionable and repeatable results.
BENEFITS In addition to assuring compliance and continued product access for patients and customers, serialization can potentially enable the investigation of counterfeit and diverted products, affording brand owners additional supply chain integrity and security. End-to-end visibility means that recalls, where necessary, can be executed more efficiently. As the foundational standard, the Global Trade Item Number® (GTIN®) helps to automate all processes and minimize errors, ultimately increasing patient safety.
A prescription for a clearer vision If the subject is pharmaceutical traceability, ABC is in the thick of it as the wholesaler positioned between more than 450 pharmaceutical manufacturers and more than 60,000 customers, including pharmacies and healthcare providers. The company is a private label manufacturer, re-packager, 3PL service provider and specialty pharmacy, effectively placing it at the origin, middle and end of a vast global supply chain. With this breadth, it’s no wonder ABC was eager to lead a unit-level traceability pilot with trading partner, JJSC. A traceability pilot that involved serialization of individual products was sure to be instructive for the industry. “Our collaboration with AmerisourceBergen highlights the importance of having a robust, well-implemented serialization platform—one that opens up a host of future supply chain and commercial capabilities enabling the delivery of a reliable supply of high-quality products and other services to our customers,” says Mike Rose, vice president of Supply Chain Visibility, JJSC.
In fact, all three industry associations played a critical role in helping Congress draft and enact the FDA’s Drug Supply Chain Security Act (DSCSA), which was signed into law on November 23, 2013. The DSCSA requires the industry to institute an electronic, interoperable system to identify and trace by 2023 certain prescription drugs distributed in the United States. Both ABC and JJSC are also long-term members of the GS1 Healthcare US Standards Initiative, the voluntary user group implementing global standards to address patient safety and deliver supply chain efficiencies. With “the global language of business” supplied through GS1 Standards, traceability mandated by DSCSA is exceedingly easier. To enable serialized product identification and end‑to‑end traceability, manufacturers like the Janssen companies of Johnson & Johnson have opted to leverage GS1 Standards. At the saleable level, a GTIN with a serial number is encoded in a GS1 DataMatrix barcode to establish global uniqueness. Per the HDA standard, both a GS1-128 linear barcode and a DataMatrix barcode is
“This pilot was an opportunity to not only help develop
leveraged by trading partners to share information about
the industry solution, but also provide insights that may
the physical movement and status of products as they
help our patients and customers use it and leverage
travel throughout the supply chain.
it beyond just compliance,” says Matt Sample, senior director for Secure Supply Chain at ABC.
Let the pilot begin ABC and JJSC decided on a four-week pilot program in a
“Our collaboration with AmerisourceBergen highlights the importance of having a robust, well-implemented serialization platform—one that opens up a host of future supply chain and commercial capabilities enabling the delivery
live production setting, excluding the several months of planning that preceded it. Beginning at the point of manufacture, a DataMatrix barcode was applied that contained a serialized GTIN, batch/lot number and expiration date to each lowest saleable unit. The lowest saleable units were packed into
of a reliable supply of high-quality products
cases, and a logical relationship between the “children”
and other services to our customers.”
and “parent” was established via aggregation.
—M IKE ROSE, Vice President of Supply Chain Visibility,
Product cases were then loaded onto a pallet or other
Johnson & Johnson Supply Chain
Naturally, compliance is a critical issue for the pharmaceutical industry, which is why ABC and JJSC are active in industry associations like the Pharmaceutical Distribution Security Alliance (PDSA), the Healthcare Distribution Alliance (HDA and formerly the Healthcare Distribution Management Association) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
logistics units, establishing yet another level of the aggregated hierarchy. At supply chain points downstream from packaging, automated vision systems or manual barcode scanners read the DataMatrix barcode to capture the GTIN, serial number, batch/lot number and product expiration date. GS1 EPCIS—Electronic Product Code Information Services—was used to record business events associated with the serialized GTIN at various critical points along the supply chain, including commissioning, packing and shipping, followed by receiving and unpacking by the buyer.
Key members of the JJSC pilot team include (left to right): Rebecca Hehnly, Thomas Pizzuto, Rosemary Hampton and Chris Reed.
As in the past, product was moved from manufacturing to
“We have a solid playbook on how to run a pilot with
distribution with the addition of the serialized information.
more than just one manufacturer and more than just one
After the wholesaler placed an order and the truck
product. We have a good repeatable process for future
departed, JJSC issued an EPCIS message containing
pilots,” Sample says.
the serialized GTINs and hierarchies contained in the shipment. This provided the ABC distribution center with the details of the specific products that were on their way. When the shipment arrived, the EPCIS events and inference of the contents allowed ABC to confirm
“Using EPCIS message standards provides for a more streamlined process, in that systems are established with similar data file expectations
receipt—without opening a single case—of every single
across the supply chain. Most failures
item that had begun its journey at the manufacturing site.
experienced during past pilots are avoidable
“Using EPCIS message standards provides for a more
if manufacturers provide DSCSA-compliant
streamlined process, in that systems are established with
EPCIS v1.1 files that include master data
similar data file expectations across the supply chain,” explains Jeffery Denton, senior director of ABC’s Global
for material attributes as well as valid GLNs
Secure Supply Chain. “Most failures experienced during
(Global Location Numbers) and GTINs.”
past pilots are avoidable if manufacturers provide DSCSA-
— JEFFERY DENTON, Senior Director,
compliant EPCIS v1.1 files that include master data for material attributes as well as valid GLNs (Global Location
Global Secure Supply Chain, AmerisourceBergen
Numbers) and GTINs.”
“We continue to discover ways to improve our design and processes through pilots. The pilot with ABC enabled us to validate and challenge our end-to-end business processes and architecture that grew since our last round of EPCIS exchange.” — ROSEMARY HAMPTON, IT Manager, Supply Chain Business Systems, Johnson & Johnson Information Technology
“We have a solid playbook on how to run a pilot with more than just one manufacturer and more than just one product. We have a good repeatable process for future pilots.” — MATT SAMPLE, Senior Director, Secure Supply Chain, AmerisourceBergen
Instructive indeed, interactive in deed JJSC is a strong believer in conducting pilots. “We continue to discover ways to improve our design and processes through pilots. The pilot with ABC enabled us to validate and challenge our end-to-end business processes and architecture that grew (significantly more internal and external manufacturing sites, regional requirements, and IT complexity) since our last round of EPCIS exchange,” remarks Rosemary Hampton,
Benefits beyond compliance
IT manager, Supply Chain Business Systems, Johnson & Johnson Information Technology.
Serialization and traceability can bring value to the
“To facilitate just this relatively small pilot, our resource
respective businesses, beyond compliance.
planning instance, warehouse management system and
“We see this as more than just a regulatory compliance
traceability processes needed to perform in unison,” says
effort,” says Chris Reed, JJSC’s lead for Product Serialization and Traceability. “Leveraging GS1 Standards also is intended to improve patient safety and helps provide a means to investigate counterfeit and diverted products. It improves our internal and external supply chain integrity.” “With the implementation of serialization and traceability,
Reed. “We found that products were arriving on ABC’s loading docks before product data arrived, because of the way we had batched our data transmissions between these three large systems. This led us to challenge and reconfigure our old way of thinking. The pilot was a reminder of how many processes and IT systems we have in play.”
we will have the opportunity to trace a serialized product from a specific wholesaler to the end customer,” continues Reed. “We can use these capabilities to further ensure that our patients and customers receive quality, genuine products. We also believe that they will provide additional
“With the implementation of serialization and traceability, we will have the opportunity to trace a serialized product from the specific
benefits to our business such as being able to more
wholesaler to the end customer. We can use
effectively manage and verify returns.”
these capabilities to further ensure that our
He adds, “With GS1 Standards, specifically the use of
patients receive quality, genuine products.”
GLNs and GTINs, identification of a product and its unit
— CHRIS REED, Lead, Product Serialization and Traceability,
of measure will become clearer to the entire supply chain. In the future, there’s also immense value in utilizing GTINs
Johnson & Johnson Supply Chain
for ordering processes.”
Lessons learned “A missing element of data—whether it’s a dosage form or a letter in the description of the product—may seem
“Don’t treat this as a side IT project; it’s not a casual exercise. It’s a business transformation
trivial, but it can drastically impact the efficiency of
project, so don’t underestimate it.”
the pharmaceutical supply chain, potentially leading
— MATT SAMPLE, Senior Director, Secure Supply Chain,
to disruption for our patients. I strongly recommend a profound emphasis on cleansing existing master data
and establishing robust data governance going forward,” says Reed. “Data formatting issues—how others were encoding data using GS1 Standards—is important,” Sample agrees. “You have to test it thoroughly with the right amount of volume in production.” Something as seemingly simple as labeling requires careful consideration. A case displays multiple labels— an HDA label, a 2-dimensional (2D) matrix label, another put on by transport and logistics, among others. This can be a source of confusion at stops along the supply chain. Glare resulting from shrink wrap and flashing lights can also impede automated code capture; damage to cases can compromise label readability.
The Carnegie Hall approach JJSC’s Reed, who is involved with several other pilots, recommends: “Practice, practice, practice. This and other pilots have confirmed that our technological and business process implementations are sound, but the exchange of data business-to-business takes some massaging in the real world. Start now.” “It may take 25 percent more time to receive serialized cases, and about 30 percent more time to pick serialized products,” Sample says, pointing to a need for a better understanding of exceptions—how often they occur, how to deal with them and what will be deemed acceptable by the FDA. “Exceptions are a reality, especially with niche
“We found we were putting the 2D barcodes in the most
products, and we need to know how to deal with them.”
vulnerable spot on the packaging, so we had to change
ABC’s Sample is a strong proponent of transparency. “It’s
that,” says Sample.
a unique situation: You’ve got all of these manufacturers
As a result of the pilot, participants are working with both
and wholesalers and we’re all competitors. But it’s
GS1 US and HDA to update labeling guidelines.
nice we have an opportunity to collaborate to work on
“Don’t treat this as a side IT project; it’s not a casual exercise,” warns Sample. “It’s a business transformation project, so don’t underestimate it.”
“For this initiative to be successful, trading partners up and down the supply chain must collaborate and communicate. We found that collaboration with our customers was critical to helping us align on objectives and resolve issues. If we keep the lines of
standardization of these traceability issues.” He goes one step further: “We had fun bringing manufacturers into our distribution center, and us visiting theirs; walking the shelves together.” Reed also recommends robust communication. “For this initiative to be successful, trading partners up and down the supply chain must collaborate and communicate. We found that collaboration with our customers was critical to helping us align on objectives and resolve issues. If we keep the lines of communication open and continue to develop and refine industry standards together, we will all be prepared for the DSCSA requirements and continue to
communication open and continue to develop
provide safe and effective medicines to our patients.”
and refine industry standards together, we will
Heather Zenk, vice president of ABC’s Secure Supply
all be prepared for the DSCSA requirements
Chain, sums up the companies’ pilot in this way. “The key to
and continue to provide safe and effective medicines to our patients.” — CHRIS REED, Lead, Product Serialization and Traceability, Johnson & Johnson Supply Chain
success in meeting any instance of regulatory compliance— really comes down to collaboration. It all rests on the willingness of our industry partners across the supply chain to work toward consensus and then drive to adoption. This pilot with JJSC has been a stunning example of true partnership as we move to establish a meaningful standard that serves our industry and protects patients.”
Revelations of the pilot The natural order of things. The GS1 GTIN is not only
Not trivial, transformational. Treat this as the business
foundational, but has tremendous value to enhance
transformation that it is. Assign proper resources in
ordering processes and unit of measure ambiguity in
time, investment and decision-makers.
the future. The devil is in the details. What may seem like an inconsequential piece of data can actually derail communications between trading partners. Clean, quality data is imperative. Timing is everything. Make sure data transmissions precede product arrivals.
The Carnegie Hall approach. Start now and practice, practice, practice. Take the chance. This industry transformation presents the unusual opportunity of sharing best practices among partners, customers and and even competitors. Everyone wins. Bask in the benefits. End-to-end traceability also helps
Too much information. With multiple labels on a case,
trace counterfeit and diverted products, and delivers
be sure to follow labeling guidelines of those who have
supply chain integrity and safe medicines for patients.
gone before--industry leaders share their expertise through the GS1 community.
Key members of the ABC pilot team include (left to right): Matt Sample, Alex Philips, Josh Sutherland, Pat Burress and Girish Sethuram (scanning).
About the Companies ABOUT AMERISOURCEBERGEN AmerisourceBergen maintains partnerships with global manufacturers, providers and pharmacies to provide product access and efficiency throughout the healthcare supply chain. AmerisourceBergen is part of the largest global generics purchasing organization, the leading specialty pharmaceutical services provider, and the partner with more community and health system pharmacy relationships than any other. From product commercialization and distribution to pharmacy, provider and manufacturer solutions, AmerisourceBergen is a leader patient care. www.amerisourcebergen.com
ABOUT JOHNSON & JOHNSON SUPPLY CHAIN Johnson & Johnson Supply Chain encompasses four segment supply chains (Pharmaceuticals, Consumer Products, Medical Devices, and Diabetes & Vision Care) that cover planning, sourcing, internal and external manufacturing, Customer Logistics Services and the Supply Chain Strategy and Deployment. Additional enterprise-wide functions that are part of Johnson & Johnson Supply Chain include Quality & Compliance, Environment, Health, Safety & Sustainability and Engineering & Technical Operations. www.jnj.com
ABOUT GS1 US® GS1 US, a member of GS1®, is an information standards organization that brings industry communities together to solve supply-chain problems through the adoption and implementation of GS1 Standards. More than 300,000 businesses in 25 industries rely on GS1 US for trading-partner collaboration and for maximizing the cost effectiveness, speed, visibility, security and sustainability of their business processes. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, barcodes, Electronic Product Code (EPC®)-based Radio Frequency Identification (RFID), data synchronization, and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code® (UNSPSC®). www.GS1US.org
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