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

Serialized Operations Manager Owners use all of the messages within this API Guide to communicate with internal warehouse systems.
Only Serialized Operations Manager Owners should use the Serialized Operations Manager SOAP API to perform real-time integration into their Serialized Operations Manager application. Owners should never allow partner access to the SOAP API messages in order to avoid unintended manipulation of serial numbers within the system.

Delivery Functions

Pharmaceutical Manufacturers use Change Delivery Number to update the delivery number that uniquely identifies the shipment for a receipt or order.
Pharmaceutical Manufacturers use Delete Order to remove an erroneous order from the system for a receipt or order. A deleted order:
  • Requires a delivery number.
  • Cannot be restored.
  • Disassociates "picked" serial numbers from the delivery.
Pharmaceutical Manufacturers use Find Delivery Numbers to provide a list of orders and order receipts based on optional parameters for delivery number, sales order, and/or open. If no parameters are provided, all delivery numbers are returned.
Pharmaceutical Manufacturers use Get Order to provide details of a delivery number (SoldFromParty, ShipFromLocation, SoldToParty, and ShipToLocation), as well as serial numbers and sales information about the order.
Pharmaceutical Manufacturers use List Open Orders and Receipts to provide a list of a delivery's open orders and receipts that are not yet marked as "complete."
Pharmaceutical Manufacturers use Update Order Receipt to:
  • Create receipts.
  • Report the transfer, purchase, and/or return receipt confirmation.
  • Set the status of all serial numbers to "Available."
Pharmaceutical Manufacturers use Update Order Shipment to communicate shipment details and mark all serial numbers as either "Shipped" for sales/returns or "Pending Receipt" for transfers when no change of ownership occurs, such as between warehouses or with a CMO/3PL.

Upon shipment confirmation, the system communicates the products that are picked/packed for the shipment using the delivery number to link order details to the picked items. The message may also be used to correct a voided shipment.

Pharmaceutical Manufacturers use Void Shipment to void a "Submitted" outbound delivery and to update the status of serial numbers from "Shipped" to "Available." Serial numbers already received may be transferred back to the original location.

A voided delivery is still accessible as either "Voided - Canceled" or "Voided - Not Corrected." If corrected, the status updates to "Voided - Corrected."

Pack and Unpack Functions

Pharmaceutical Manufacturers use Aggregate to record the serial number of a container along with the serial numbers of its contents (e.g. item to existing container, inner pack to case, case to pallet). New aggregation requests keep existing child serial number associations in the main container.
Pharmaceutical Manufacturers use Disaggregate to remove products or containers from a parent container (e.g. item or inner pack from case or case from pallet). The serial numbers of the contained product or container are disassociated from the parent.
Pharmaceutical Manufacturers use Aggregation Update to report aggregation and disaggregation actions in a single message to account for warehouse packing activities (e.g. removing an item from container and then placing that item back into the container, the inner pack to case, and the case to pallet). Each message can contain multiple aggregations or disaggregations.
Pharmaceutical Manufacturers use Reset Aggregation to reduce scans by disaggregating commissioned child serial numbers from a container and then aggregating new items to that container. This is often done as a way of managing exceptions after packaging is complete. Updating aggregation requires access to the container serial number and any child serial numbers.

Query Functions

Pharmaceutical Manufacturers use Get Lot Quantity to query the repository for data on a product code and lot, including packaging codes, expiration date, quality release status, repackaging details, and quantity of commissioned serial numbers associated with the lot.
Pharmaceutical Manufacturers use Get Lot Status to query the repository for data about a product code and lot, including packaging codes, expiration date, quality release status, repackaging details, and quantity of serial numbers associated with the lot. The Get Lot Status query response also includes the product recall and market withdrawal status of the lot and if applicable, relevant recall and market withdrawal information.
Pharmaceutical Manufacturers use Fetch Lot Status Result to provide the lot status of high-volume lots containing 100,000 or more serial numbers. The RequestId value returned in the original Get Lot Status request supports this asynchronous operation.
Pharmaceutical Manufacturers use Get Receipt to retrieve receipt details for SOM sales, transfers, and returns.
Pharmaceutical Manufacturers use Get Serialized Entity to provide the integrating system with full visibility of a serial number, including state, attributes, status, and aggregation, to perform warehouse operations. If applicable, the query response also includes a list of Target Markets in which the requested serial number is in a recalled or withdrawn state.
Pharmaceutical Manufacturers use Get Serialized Hierarchy during rework to provide the hierarchy data of a serial number, such as a list of all child serial numbers within a specific container. By redoing the entire hierarchy, the system can reset aggregation.
Pharmaceutical Manufacturers use Fetch Serial Number Hierarchy Result to provide the hierarchy data of 100,000 or more serial numbers. The RequestId value returned in the original Get Serialized Hierarchy request supports this asynchronous operation.

Serial Number Update Functions

Pharmaceutical Manufacturers use Commission to associate a serial number (or a list of serial numbers) and its attributes to a product or container using a 2D barcode.
Pharmaceutical Manufacturers use Registration to record the serial number and attributes in their Serialized Operations Manager repository, and then perform serialized operations against the serialized product.
Pharmaceutical Manufacturers use Set Serial Number Status to update the status of the serial number, item, and attributes. This enables a Serialized Operations Manager owner to:
  • Manage exceptions.
  • Correct a serial number status that is incorrect or out of sync (e.g. a case is reported as shipped but later found in the warehouse, for example).
  • Change the status from "Shipped" to "Available."
Changing a serial number status does not undo triggered operations, such as reports sent in Government Reporting or Product Track.
Pharmaceutical Manufacturers use Release Product to:
  • Trigger government reporting workflows for commissioning serial numbers after a quality hold is released from a specified lot.
  • Verify serial numbers for pick/ship operations to ensure that product on quality hold is not picked for shipment.
Line management systems must send commission data to TraceLink before communicating the sampled status.
Pharmaceutical Manufacturers use Take Sample 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 use Destroy to disassociate a serial number from a product or container that is physically destroyed so that it is no longer tracked. Destroyed serial numbers cannot be reused, whereas decommissioned serial numbers can be reused.
Pharmaceutical Manufacturers use Decommission to disassociate a serial number from a product or container so that it is no longer tracked. Decommissioned serial numbers can be reused, whereas destroyed serial numbers cannot be reused.
Pharmaceutical Manufacturers use Market Release to designate that a full or partial lot of imported product is released for circulation and that all required registration is complete.