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GS1 Healthcare US publishes new serialization guideline

The GS1 Healthcare US Secure Supply Chain Task Force, consisting of more than 50 members from throughout the supply chain, developed a guideline to identify and serialize pharmaceutical products using GS1 identification numbers.
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The GS1 Healthcare US Secure Supply Chain Task Force, consisting of more than 50 members from throughout the supply chain, developed a guideline to identify and serialize pharmaceutical products using GS1 identification numbers. Entitled, “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support Serialization, Pedigree and Track & Trace,” the guideline enables pharmaceutical companies to trace the movement of products through the U.S. pharmaceutical supply chain.


Available for download www.gs1us.org/RxGuideline, the guideline focuses primarily on best practices and methodologies for product serialization and sharing pedigree and traceability data to support implementation for pending state regulations. Implementing GS1 Standards will contribute to increased supply chain security, visibility, and control, and help the industry prepare for pending government serialization, pedigree, and traceability requirements.

“This guideline will help organizations take an active role in the transformation of the healthcare system, meeting the goals of patient safety and regulatory compliance while making the supply chain more efficient,” saya Siobhan O’Bara, senior vice president of industry engagement, GS1 US. “This new guideline should be the ‘first stop’ for all organizations that are preparing their pharmaceutical supply chain systems and business processes to meet pending improved supply chain security regulatory requirements.”

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The first phase of the California drug pedigree requirements will become mandatory in 2015, marking the beginning of product serialization and visibility in the healthcare supply chain. In addition, the U.S. Food and Drug Administration is developing track-and-trace initiatives.


“The guideline will help companies leverage their existing technology investment and move forward with effective implementation strategies,” says Michael Ventura, serialization and security manager (Americas), GlaxoSmithKline. “Working on this initiative has given me a much greater appreciation for the importance of non-proprietary, standards-based solutions and trading partner collaboration.”


“To have true security in the supply chain, there needs to be consistency in terms of how the standards are implemented by individual trading partners to support collaborative supply chain solutions like pedigree and traceability,” says Ron Bone, senior vice president, distribution support, McKesson Pharmaceutical. “The guideline takes the best of what we know and puts that against real implementation activities.”


Leading manufacturers, wholesalers, healthcare providers, government agencies, and industry associations analyzed business processes and post-2015 business requirements. They also evaluated results from industry pilots to provide a clear path to how the GS1 Standards should be applied. The GS1 Healthcare US Secure Supply Chain Task Force will now focus its efforts on developing formal test criteria that will ultimately serve as the basis for certification against the guideline.


The guideline covers product serialization, supply chain data exchange for pedigree and traceability, as well as pilot learnings and best practices.

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