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Frequently Asked - Find answers to common questions about Track & Trace

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Data 10

Lot number: Identifies production batch (many units share same lot)
Serial number: Unique identifier for each unit

  • Both required for full traceability
  • Lot = quality tracking
  • Serial = individual tracking
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A verification response confirms product authenticity:

  • GTIN + Serial + Lot + Expiry verified
  • Response: Valid/Invalid/Unknown
  • Required at point of dispense
  • Real-time query to repository
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Master data is reference information:

  • Product data (GTIN, description)
  • Location data (GLN, address)
  • Trading partner data
  • Must be synchronized across systems
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Key difference:

  • Master data: Static reference data (product info, locations)
  • Event data: Dynamic transaction records (what, when, where, why)

Both needed for complete traceability.

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Data synchronization keeps data consistent:

  • Between internal systems
  • With trading partners
  • With regulatory portals
  • Critical for EPCIS accuracy
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Exception handling manages serialization issues:

  • Rejected units on line
  • Failed submissions to portal
  • Verification failures
  • Data discrepancies

Requires documented procedures.

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Batch traceability tracks products by production batch:

  • Same lot number = same production run
  • Enables batch-level recalls
  • Links to quality records
  • Part of GMP requirements
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A transaction ID links business transactions:

  • Purchase order number
  • Invoice number
  • Delivery note number
  • Required in EPCIS transaction events
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Data retention requirements:

  • Keep records for specified period
  • Typically 1 year after expiry + buffer
  • Country-specific requirements
  • Must be retrievable for audits
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Compliance reports demonstrate regulatory adherence:

  • Serialization status by product
  • Event submission statistics
  • Error rates and resolution
  • Required for audits
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EPCIS 10

EPCIS stands for Electronic Product Code Information Services. It is a GS1 standard for sharing event data between trading partners in the supply chain.

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EPCIS defines four event types:

  • ObjectEvent: Observation of objects (commissioning, shipping, receiving)
  • AggregationEvent: Parent-child relationships (packing/unpacking)
  • TransactionEvent: Links objects to business transactions
  • TransformationEvent: Input/output relationships (manufacturing)
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An ObjectEvent captures observations about objects at a point in time. Common uses:

  • Commissioning (serial number activation)
  • Shipping (products leaving a location)
  • Receiving (products arriving)
  • Dispensing (products given to patient)

Action types: ADD, OBSERVE, DELETE

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An AggregationEvent records parent-child relationships between containers and their contents:

  • ADD: Items packed into a container
  • DELETE: Items unpacked from a container
  • OBSERVE: Confirmation of aggregation

Essential for case and pallet tracking.

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Common bizStep values in pharmaceutical track and trace:

  • commissioning: Serial number activation
  • packing: Items packed into container
  • shipping: Products shipped
  • receiving: Products received
  • dispensing: Given to patient
  • destroying: Product destruction
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CBV (Core Business Vocabulary) defines standard values for EPCIS fields:

  • Business steps (commissioning, shipping, receiving)
  • Dispositions (active, inactive, recalled)
  • Business transaction types
  • Source/Destination types

Using CBV ensures interoperability between systems.

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EPCs (Electronic Product Codes) in EPCIS follow URN format:

  • SGTIN: urn:epc:id:sgtin:CompanyPrefix.ItemRef.Serial
  • SSCC: urn:epc:id:sscc:CompanyPrefix.SerialRef
  • GLN: urn:epc:id:sgln:CompanyPrefix.LocationRef.Extension
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EPCIS 2.0 is the latest version of the standard with new features:

  • JSON-LD support (in addition to XML)
  • REST API bindings
  • Sensor data integration
  • Digital link URIs
  • Enhanced CBV 2.0

EPCIS 2.0 was released in 2022.

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Disposition indicates the business state of objects after an event:

  • active: Normal, sellable state
  • inactive: Not available for sale
  • recalled: Subject to recall
  • expired: Past expiry date
  • destroyed: Physically destroyed
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An EPCIS Repository is a system that stores EPCIS events and provides:

  • Capture interface (to receive events)
  • Query interface (to retrieve events)
  • Event persistence and management

Regulatory portals like TATMEEN and RSD act as EPCIS repositories.

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