3 EPCIS Data Exchange Issues in Pharma Traceability
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.
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.
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.
Healthcare Packaging | Jun 16th, 2020