Global biopharmaceutical company AstraZeneca is using a track-and-trace solution from Axway to enhance patient safety and protect brand integrity through serialization of medicine packs, as part of its comprehensive product security strategy.

AstraZeneca has taken a multi-faceted approach to combating counterfeiting and ultimately improve patient safety:

♦Improve security to prevent counterfeit products from entering the supply chain.
♦Make it easier to identify counterfeit products.
♦Raise awareness among law enforcement agencies and other stakeholders.
♦Investigate suspected cases and seeking prosecution of counterfeiters.
♦Lobby for stronger anti-counterfeiting regulations and penalties.

Implementing standardized item level serialization-in combination with tamper-evident packaging-was identified early on as a powerful approach to respond to the challenges of counterfeiting and patient safety. Axway's Track & Trace solution was chosen as the unique product number repository to achieve these goals.

Using the solution from Axway, AstraZeneca has increased product safety by securely collecting product security data for every pack of medicine of an increasing number of its brands in a global repository, which can be verified against packs within the supply chain. The Axway Track & Trace repository is now handling close to 100 million serialized product data records, from the three global sites where item-level serialization was first implemented. By the end of 2010, 10 sites and a total of 33 production lines will be feeding serial numbers into the system, with further sites and lines planned to be connected in 2011.

"We needed a solution that would be flexible and adaptable to fit with our approach. At the time, there was nothing on the market that met our requirements, but Axway had modules that provided a solid foundation for the solution AstraZeneca wanted to build. It really was a co-development project," says Christoph Krähenbühl, IS program manager, pack coding and product security at AstraZeneca Global Operations Information.

Security and stability are important to AstraZeneca, especially in view of the fact that large volumes of codes are continually added. Axway Track & Trace is now a central component of AstraZeneca's global systems-based product security approach, and is used as an object-event repository of unique serial numbers.

By enabling product traceability with Axway Track & Trace, AstraZeneca is achieving best practice in tackling counterfeiting and diversion, while complying with new regulations.

"As Axway's solution has evolved, the new version enables us to benefit from moving to the GS1 standards-based system EPC Information Services (EPCIS) that reduces the cost and complexity of complying with regulations," Krähenbühl adds. "As part of our global program, we have staff dedicated to monitoring all of these requirements, whether they are legal, regulatory or supply chain driven. Even though we have recently seen a surge of such requirements, we have not yet met a requirement that our adaptable, standards-based solution, built on Axway Track & Trace, cannot handle."

Axway Track & Trace provides end-to-end transparency, supply chain logistics management and product authentication services across even the most complex supply chains. As a GS1-certified implementation of the EPCIS open standard, Track & Trace:

♦Securely captures, retrieves, transfers and manages key product and serialized event data. The event repository supports EPCIS queries to retrieve commissioning, packaging and product movement events. In addition, it captures change-of-ownership and other financial events to provide a complete picture of the product lifecycle.
♦Centrally manages serial number generation and allocation.
♦Easily integrates with third-party systems, including SAP's EPCIS system, allowing internal and external trusted parties to access product identification, location, and event data at any point in the supply chain.
♦Fully supports global trade identification numbers (GTIN) and global location numbers (GLN) for product and location identification.
♦Manages global compliance regulations for numerous countries, including emerging mandates in Turkey, Brazil, Israel and the United States.

Source: Axway