In November 2023, item-level traceability introduces significant complexity and industry-wide challenges compared with current lot-level traceability.
- Trade partners must ensure that Transaction Information (TI) with serialized product identifiers and Transaction Statements (TS) are provided for each unit of product that they receive, with such data exchanged in an electronic, interoperable manner.
- Trade partners must be able to exchange this information electronically in the event of a suspect product investigation or verification request.
- While the law doesn't specify an electronic format, the pharmaceutical supply chain is adopting the Electronic Product Code Information Service (EPCIS) standard to encode and communicate transaction data, replacing ASNs primarily used today for lot level data exchange.
- This will require new network connectivity tools to establish digital connections with direct suppliers/trade partners, and often with indirect trade partners as well under certain business conditions.
- These new requirements add an additional burden on companies to ensure the identity and authorized trade partner status of the suppliers and trade partners with which they do business.
Traceability, Verification, and Serialization