Table of contents
Overview
The Serialized Shipments transaction (Transaction Code: EPCIS 1.2) is an XML-based message used to record the shipment of serialized pharmaceutical products in compliance with global serialization regulations such as DSCSA (US), and EU FMD (Europe). Used in conjunction with MINT, it can help companies achieve compliance with Indonesia, Saudi Arabia, UAE, Bahrain and other countries. This transaction provides a standardized, traceable record of serialized product movement from one supply chain partner to another.
Triggered at the point of physical shipment, this transaction captures essential details such as product identifiers, event time, shipment location, and destination. It ensures that serialization repositories, regulatory systems, and trading partners are accurately updated with the serialized shipment data.
Executed through TraceLink’s Enterprise Serialization Management (ESM) platform, the transaction adheres to GS1 EPCIS 1.2 standards and supports interoperability across global supply chain networks.
Key Use Cases
- Record the physical shipment of serialized products between supply chain partners.
- Ensure compliance with DSCDA mandates for the exchange of serialized shipment information between a buyer and a seller.
- Facilitate exchange between MAH, CMO, and 3PLs when performing shipping operations on behalf of or in conjunction with the manufacturer.
- Assist when MAH sells product to a customer, exchange shipment data to facilitate compliance requirements of their customer.
- Maintain traceability of serialized units across the supply chain.
- Enable downstream receipt, verification, and decommissioning of serialized products.
- Provide audit-ready documentation of product movement.
- Integrate seamlessly with ERP, WMS, and partner systems via TraceLink.
Data Elements Included
An EPCIS 1.2 – Serialized Shipments transaction includes:
- Event Type: ObjectEvent with business step "shipping" and action "observe" to indicate product movement.
- Serialized Product Identifiers (EPCs): Serialized GTINs (SGTINs) or container codes (SSCCs) being shipped.
- Event Time and Time Zone: Timestamp when the shipment event occurred, including time zone offset.
- Read Point: Physical or logical location where the shipment was recorded (e.g., shipping dock, ERP system).
- Business Location: GLN or internal code of the facility initiating the shipment.
- Destination Party: GLN or identifier of the receiving partner or customer.
- Disposition: Typically "in_transit" or "shipped" to denote the movement status.
- Parent-Child Aggregation (optional): Hierarchical relationships such as cases or pallets containing serialized units.
- Shipment ID (optional): Unique identifier for the shipment (e.g., ASN, delivery number).
- Carrier and Tracking Info (optional): Logistics provider and tracking number for shipment monitoring.
- Transaction ID (optional): Unique identifier for the EPCIS event for traceability.
- Digital Signature (optional): Ensures data integrity and compliance in regulated environments.
- Comments or Notes (optional): Free-text field for additional shipment context or logistics notes.
Benefits of EPCIS 1.2 – Serialized Shipments
- Enables serialized product traceability from manufacturer to end customer.
- Ensures regulatory compliance across multiple global markets.
- Automates shipment reporting to partners, regulators, and serialization repositories.
- Provides audit-ready records for product movement and compliance checks.
- Enhances supply chain visibility and reduces risk of diversion or counterfeiting.
Business Process: EPCIS 1.2 – Serialized Shipments
The Serialized Shipments transaction can fit into the outbound logistics and compliance workflow as follows (other use case scenarios may apply):
- Serialized products are commissioned and optionally aggregated.
- A shipment is created and prepared for dispatch.
- EPCIS 1.2 – Serialized Shipments transaction is triggered at the point of shipment.
- Serialized data is transmitted to TraceLink, regulatory authorities, and trading partners.
- The receiving party uses the data to verify, receive, and decommission the products as needed.
How TraceLink Supports EPCIS 1.2 – Serialized Shipments
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure and compliant serialized shipment processing by:
- Capturing EPCIS 1.2-compliant shipment events from ERP, WMS, or shop floor systems.
- Transmitting shipment data to partners, regulators, and serialization repositories.
- Providing real-time dashboards and audit logs for shipment visibility.
- Managing aggregation hierarchies and serialized container relationships.
- Ensuring secure data communication with optional digital signatures and encryption.
Explore More Serialization & Compliance Capabilities
- EPCIS Serialization: Record and share commissioning events at unit, case, or pallet level for regulatory compliance.
- SOM Product Release: Confirm SOM evaluation clearance before releasing serialized products for shipment.
- SOM Sales Shipment: Record serialized sales order shipments after SOM approval.
- SOM Receipt: Confirm serialized product receipt and reconcile against shipment records.
Need Help Implementing EPCIS 1.2?
Contact us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate serialized shipments, ensure regulatory compliance, and achieve end-to-end traceability across your global supply chain.
