Track-and-trace in pharmaceuticals refers to the ability to follow a medicine's journey from manufacturer to patient and to trace it back through the supply chain if needed. EPCIS (Electronic Product Code Information Services) is the global standard for pharmaceutical track-and-trace event reporting.
EPCIS Standard
EPCIS (GS1 standard) defines a common data model and interface for sharing supply chain event data. EPCIS events capture: What (which products); When (timestamp); Where (location); and Why (business step and disposition). Key EPCIS event types for pharmaceuticals include: commissioning; shipping; receiving; decommissioning; and aggregation/disaggregation.
DSCSA Interoperability
The DSCSA requires electronic interoperability between trading partners using EPCIS or an equivalent format from November 2023. The FDA has published guidance on EPCIS implementation for DSCSA, specifying required EPCIS event types and data elements. Trading partners must be able to exchange EPCIS data directly or through a third-party interoperability network.
Repository Architecture
EPCIS data can be stored in: centralised repositories (single database for all trading partners); federated repositories (each trading partner maintains their own EPCIS repository); or hybrid architectures (combination of centralised and federated). The choice of architecture affects data sovereignty, query performance, and compliance with national data localisation requirements.