Using EPCIS to Attain Lot Level Traceability
The latest EPCIS Implementation Guideline details how GS1 Standards can best be applied to meet lot-level and item-level traceability requirements as stipulated in the US FDA DSCSA regulation.
What is the EPCIS Standard?
Electronic Product Code Information Services (EPCIS) is a GS1 Standard for capturing and communicating data about the movement and status of objects in the supply chain (e.g., products; logistics units; returnable assets; etc.). It enables supply chain partners to capture event information about objects as they move through the supply chain (e.g., shipped; received; etc.), and to share that information with their trading partners securely and in near real-time.
EPCIS defines technical standards for a data-sharing interface between applications that capture EPC-related data and those that need access to it. EPCIS also provides data standards for how to express what business process was operating on the object and the status of the object upon exiting the process. For the data standards, EPCIS makes use of a second standard named the Core Business Vocabulary (CBV), which offers a predefined vocabulary for a large set of business events and scenarios.
Why consider EPCIS as an Exchange Method?
In the United States, the government established the Federal Drug Supply Chain Security Act (DSCSA) drug traceability requirements to establish a national, uniform approach to distributor licensing and drug supply integrity.
The DSCSA establishes a Federal system for tracking prescription drug products through the pharmaceutical distribution supply network. In order to comply, the US Pharmaceutical industry will begin lot-level transaction management and reporting no later than January 1, 2015. Subsequent compliance dates will require increasing levels of supply integrity and traceability including item-level serialization and item-level traceability.
EPCIS provides the industry with a standardized approach to serialized information interoperability. The EPCIS is a GS1 Standard that enables supply chain partners to capture event information about supply chain events (e.g., shipped; received; etc.), and to share that information with their trading partners securely and in near real-time. The healthcare industry is widely adopting the Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability to comply with the US supply integrity mandates.
The EPCIS is a flexible standard that can be leveraged for a wide variety of business needs. There are numerous options for how the standards can be implemented in order to accommodate different applications, work processes, and environments. However, consistency of application by the supply network is required to enable a collaborative and interoperable exchange. The EPCIS 1.2 Implementation Guideline resulted from the efforts of more than fifty U.S. pharmaceutical supply organizations including leading manufacturers, wholesalers, retail pharmacies, healthcare providers, government agencies and industry associations.
The EPCIS standard revision 1.2 was ratified by GS1 in September 2016. It is fully backward compatible with revision 1.1.
EPCIS and Core Business Vocabulary (CBV) – GS1 Landing Page
Access the Document: EPCIS-Standard-1.2-r-2016-09-29