Pharmaceutical Manufacturer Use Cases

TraceLink Roles

TraceLink API Guides group messages by application. Each API Guide contains all messages available within that application. Your company's business type (e.g. CMO, Wholesale Distributor, 3PL) and role in the TraceLink Network (Owner or Partner1) determine which of these messages to develop (i.e. not all messages within this guide may fulfill your business or compliance needs).

See below to confirm which messages you should develop based on your role in the supply chain and/or the TraceLink Network.

Configure and exchange (send or receive) each message separately as a best practice.

Serialized Operations Manager Owners

Pharmaceutical Manufacturers receive the Deactivate message from the CMO communicating uncommissioned or unused serial numbers.
"Deactivated" is a terminal state that cannot be undone and therefore cannot move to any of the other states.
Pharmaceutical Manufacturers receive the Destroy message from 3PLs to destroy products if:
  • Damage happens to the product while in the warehouse.
  • The 3PL or CMO receives instructions to destroy returned goods.
A destroy event is a permanent termination of that number/the product (i.e. destroy event cannot be undone).
Pharmaceutical Manufacturers receive the Destroy message from 3PLs to destroy products if:
  • Damage happens to the product while in the warehouse.
  • The 3PL or CMO receives instructions to destroy returned goods.
A destroy event is a permanent termination of that number/the product (i.e. destroy event cannot be undone).
The End of Batch message fulfills two purposes:
  • Pharmaceutical Manufacturers receive an End of Batch message from the CMO reporting an end of production which triggers an Serial Number Exchange End of Batch process in the Pharmaceutical Manufacturer's repository.
  • Allows Pharmaceutical Manufacturers to process a successful End of Batch event in their repository and send commission and aggregation data to their external system prior to shipment.
Pharmaceutical Manufacturers receive the Receipt Event message from the CMO or 3PL communicating the purchase, transfer, and return receipts. The message supports the following events associated with receiving:
  • Aggregation event (optional)
  • Receiving event (mandatory)
Pharmaceutical Manufacturers receive the Receive Event message from the CMO or 3PL communicating the purchase, transfer, and return receipts. The message supports the following events associated with receiving:
  • Aggregation event (optional)
  • Receiving event (mandatory)
Pharmaceutical Manufacturers send the Shipment Event message to a 3PL communicating the serial numbers and information corresponding to the product shipped by the Pharmaceutical Manufacturer and received by the 3PL.
Pharmaceutical Manufacturers send the GS1 USHC Shipment message to a 3PL communicating the serial numbers and information corresponding to the product shipped by the Pharmaceutical Manufacturer and received by the 3PL.
Pharmaceutical Manufacturers receive the Shipment Eventmessage from a CMO or 3PL who is communicating the commission, aggregation, repackaging, and shipping data using GS1 EPCIS events. When a CMO transfers goods to the Pharmaceutical Manufacturer, or a 3PL delivers to the downstream trade partner, it triggers the initial communication of all serialized data to the Pharmaceutical Manufacturer.
Pharmaceutical Manufacturers receive the Shipment Event message from a CMO when a shipment is sent from the CMO to a Pharmaceutical Manufacturer, which communicates the commission, aggregation, repackaging, and shipping data using GS1 EPCIS events.
Pharmaceutical Manufacturers receive the Product Release Event message from a CMO to exchange commission, aggregation, and product release data. This message supports the following use cases:
  • Commission + Aggregation + Product Release events: Does not report Decommission/Destroy.
  • Commission + Product Release events: Does not aggregate the product and does not report Decommissioning/Destroy.
  • Commission + Product Release + Decommission/Destroy events: Does not aggregate the product.
Pharmaceutical Manufacturers use the Take Product Sample message to update item status to "Sampled" when quality personnel remove serialized product for sampling purposes. This enables a Serialized Operations Manager Owner to:
  • Disaggregate items from the container if already packed.
  • Trigger government reporting for the sampling of serial numbers.
Pharmaceutical Manufacturers receive the Update Serial Number Status message from a CMO or 3PL, which details a status update to one or more serial numbers. This can be used to correct mistakes or indicate certain state changes.

Serialized Operations Manager Partners

The End of Batch message fulfills two purposes:
  • Pharmaceutical Manufacturers receive an End of Batch message from the CMO reporting an end of production which triggers an Serial Number Exchange End of Batch process in the Pharmaceutical Manufacturer's repository.
  • Allows Pharmaceutical Manufacturers to process a successful End of Batch event in their repository and send commission and aggregation data to their external system prior to shipment.
Pharmaceutical Manufacturers use the Product Release Event message from a CMO to exchange commission, aggregation, and product release data. This message supports the following use cases:
  • Commission + Aggregation + Product Release events: Does not report Decommission/Destroy.
  • Commission + Product Release events: Does not aggregate the product and does not report Decommissioning/Destroy.
  • Commission + Product Release + Decommission/Destroy events: Does not aggregate the product.