3 EPCIS Data Exchange Issues in Pharma Traceability

Keren Sookne | Healthcare Packaging | Jun 16th, 2020

Conformance testing services have emerged to cut down on wasted back-and-forth between manufacturers and trading partners to get efficient data exchange up and running.

Gary Lerner, president at Gateway Checker Corporation, presented at GS1 Connect.

Pharma companies continue to make inroads to meet the DSCSA 2023 requirement for unit-level traceability at each change of ownership between trading partners. “Capturing and exchanging information at this level of specificity requires a common information framework,” explained Gary Lerner, president at Gateway Checker Corporation, at the GS1 Connect: Digital Edition (virtual) conference this week.

“This information framework captures what happens in the physical world with an electronic twin, essentially an information encoded representation of packing and shipping events that can be exchanged with trading partners. What’s needed to accomplish that is a common vocabulary and structure that enables trading partners to then share and exchange essential trading information in a consistent, accurate and interoperable manner,” said Lerner. Without a common standardized approach, there will be considerable waste in time and effort with trading partners negotiating the structure and content in each point of connection.

EPCIS

Lerner pointed to the value of the global GS1 standard EPCIS (Electronic Product Code Information Services), which enables the common information exchange language that can be shared. “However, EPCIS is a general purpose exchange standard. Application-specific standards are therefore necessary to tailor EPCIS to suit a specific industry and application. In 2015, the GS1 US Healthcare working group recruited more than 50 companies representing a cross section of the pharmaceutical industry to adapt EPCIS to address DSCSA specific requirements. And in 2016, the application standards governing DSCSA traceability were published. Adopting these standards therefore helps different businesses within the drug supply chain to more efficiently and effectively connect and share information,” he said.

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Healthcare Packaging | Jun 16th, 2020

https://www.healthcarepackaging.com/issues/traceability-serialization/article/21137492/3-epcis-data-exchange-issues-in-pharma-traceability

Join Jeff Denton (AmerisourceBergen) and Gary Lerner (Gateway Checker) as they discuss how to bridge the gap to US Drug traceability at the GS1 Connect Digital Conference, June 16 and 17.

GS1 Connect: Bridging the Gap to Pharmaceutical Traceability

FDA regulations mandates interoperable, electronic tracing of medicines at the item level to enhance the security of the US Drug supply chain by 2023.

Establishing traceability requires accurate and complete data sharing among trading partner within the drug supply network.

Closing the gap to traceability is essential for major US pharmaceutical wholesalers. See the challenges AmerisourceBergen faces as they prepare to onboard more than 500 drug manufacturers and accept serialized electronic transactions from nearly 25,000 drugs   Learn how they utilize new tools and technology from Gateway Checker to test, evaluate and certify conformance to GS1 US traceability standards.

Conformance to the GS1 Electronic Product Code Information Services (EPCIS) standards specific to the Drug Supply Chain Security Act allows trading partners within the supply chain to enable compatible connections: first-time, every-time.

Register for complimentary attendance to the GS1 Connect Digital conference.