TRACEABILITY
Pharma Supply Chain: Master Data Exchange in 2021 KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. The global GS1 standard, EPCIS, offers a common information exchange language.
2. EPCIS onboarding takes time and requires immediate action from pharma manufacturers.
3. To avoid product holdups, it’s critical that manufacturers have processes in place for exceptions in data exchange.
I
n order to arrive at the unit-level traceability sought by the Drug Supply Chain Security Act (DSCSA) by its 2023 deadline, the pharmaceutical industry as a whole must tackle the issue of interoperable systems to share data with trading partners. The overall goal of DSCSA legislation is to verify product legitimacy, make recalls more efficient, and enhance detection of illegitimate products in the supply chain. A major component of this is the requirement of serialization, the practice of assigning a unique serial number linked to product data—product origin, batch number, and expiration date—to each saleable unit of each prescription drug product. “But the exchange of master data today is a manual process,” explained Allison Sheldon, Senior Manager, Pfizer Digital Serialization, Pfizer Inc. at a recent Healthcare Distribution Alliance (HDA) Traceability Webinar event. Serialization data is manually pulled from internal systems, and spreadsheets are maintained and emailed back and forth to trading partners. Part of what manufacturers are trying to sort out now is how their trading partners are managing data on their end. “Are they taking HDA’s forms and applying changes that are required in their systems? How do we keep that data up to date? We’ll see that
↑ Get the links the panelists offered at hcpgo.to/gs1. (Credit: HDA)
Related Stories at HealthcarePackaging.com + Serialization 101 Fraud is a serious issue for drug manufacturing, and pharmaceutical and medical device regulations using serialization have been mandated to defend against counterfeiting. hcpgo.to/s101 + [Video] MIT PhD on Supply Chain Resiliency in the Face of COVID-19 MIT’s Dr. David Simchi-Levi visited with Keren Sookne, Healthcare Packaging, to re-examine how life science companies think about their supply chains. hcpgo.to/resilience + 3 EPCIS Data Exchange Issues in Pharma Traceability Conformance testing services emerged to cut down on wasted back-and-forth between manufacturers and trading partners to get efficient data exchange up and running. hcpgo.to/3epcis + The Logistics of Supply Chain Visibility Tive and project44 team up to deliver the Open Visibility Network, a way to provide transparency between shippers, logistics service providers, brokers, and customers. hcpgo.to/visibility
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