HDA said Monday that the GTIN Repository Service, prompted by the enactment of the Drug Supply Chain Security Act (DSCSA), will be created via a new, long-term partnership with ValueCentric LLC, a provider of channel data management and analytic solutions for the health care industry.
The GTIN is a unique 14-digit number used to identify trade items, products or services. The GTIN coding system was developed by the GS1 System, which manages a global standardized system for product traceability.
Along with further DSCSA compliance, GTIN Repository Service is slated to provide a user-friendly central GTIN repository for the efficient and accurate exchange of pharmaceutical product master data between manufacturers and their supply chain partners, HDA said. The self-service, cloud-based portal will provide real-time access for manufacturers to upload, update and share product information quickly with their downstream partners.
Also, the service creates a foundation for using product serialization data to advance industry logistics planning, analysis and reporting, HDA added.
“HDA is committed to developing products and services that support the industry’s ability to deliver medicines efficiently and quickly, while also enhancing the safety of the pharmaceutical supply chain,” HDA presient and chief executive officer John Gray said in a statement. “A repository with up-to-date GTIN information, readily available to all stakeholders, will help ensure end-to-end system accuracy and heightened productivity.”
Plans call for the GTIN Repository Service to go live in the third quarter of 2017. HDA noted that the DSCSA is being implemented in phases for tracing product movement in the pharmaceutical supply chain. Begun in 2013, DSCSA’s staged milestones culminate in November 2023, when all packaged product will be serialized and traced from the manufacturer to the patient, the association said. The repository service is expected to be widely used by manufacturers and wholesalers.
“As we move toward the DSCSA serialization requirements, access to a GTIN database with real-time, reliable information will be crucial to meeting regulatory demands and to ensure pharmaceutical products move through the supply chain efficiently,” stated Heather Zenk, vice president of global secure supply chain operations at AmerisourceBergen Corp. “We are confident that our partnership with HDA combined with ValueCentric’s dedication to quality and reliability will make this service an exciting endeavor for companies working across the pharmaceutical supply chain. We are all committed to patient safety and continued access to life-saving treatments. This service is a step to ensuring we provide both.”
Product specifications will be overseen by a committee appointed by HDA’s member community. Subscriptions will be solicited in the first half of 2017.
At its recent Traceability Seminar in Washington, D.C., HDA released results from its Pilot Study for Saleable Returns, designed to inform manufacturers and distributors in their efforts to comply with upcoming DSCSA requirements.
“Recent pilot activity to support DSCSA requirements has outlined the importance of maintaining accurate product master data to facilitate serialized data exchange,” commented Shaun Kirkpatrick, manager, of track-and-trace operations for GlaxoSmithKline. “Ongoing efforts to seek solutions to address these types of industry challenges is welcomed by GSK.”