FAQs answered for you.

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

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

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.

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.

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

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.

Two different timestamps in EPCIS:

• eventTime: When the physical event actually occurred
• recordTime: When the event was recorded in the EPCIS repository

eventTime should reflect real-world timing; recordTime is system-generated.

EPCIS supports two data formats:

• XML: Traditional format, widely supported, verbose
• JSON-LD: Added in EPCIS 2.0, more compact, better for web APIs

Choose based on your system capabilities and regulatory requirements.

A TransactionEvent associates objects with business transactions such as:

• Purchase orders
• Invoices
• Shipment notifications

Links physical product movement to business documents.

Source and destination identify the parties involved in a transaction:

• Source: Where objects came from (owning_party, possessing_party)
• Destination: Where objects are going

They provide context for shipping and receiving events.

A TransformationEvent records when inputs are transformed into outputs, such as:

• Manufacturing (raw materials → finished product)
• Repackaging
• Kitting

Links input identifiers to output identifiers.

Track and trace is a system that allows the monitoring of products throughout the supply chain from manufacturing to the end consumer. In pharmaceuticals, it involves:

• Assigning unique identifiers (serial numbers) to each product unit
• Recording events as products move through the supply chain
• Enabling verification of product authenticity
• Supporting recalls and preventing counterfeiting

EPCIS (Electronic Product Code Information Services) is a GS1 standard that enables trading partners to share information about the physical movement and status of products throughout the supply chain.

In pharmaceutical track and trace, EPCIS is used to record events like commissioning, packing, shipping, and receiving of serialized products.

Learn more about EPCIS

Pharmaceutical serialization is the process of assigning a unique serial number to each saleable unit of a medicine. This enables:

• Individual product tracking throughout the supply chain
• Authentication and verification at any point
• Protection against counterfeiting
• Efficient recall management

Serialization is now mandatory in most regulated markets including the MENA region.

GS1 serialization is the process of assigning a unique identifier to each individual product unit, following GS1 standards.

For pharmaceuticals, this typically means assigning an SGTIN (Serialized Global Trade Item Number) to each saleable unit, which combines the GTIN (product identifier) with a unique serial number.

Read more about GS1 identifiers

Track and trace is critical for pharmaceuticals because:

• Patient Safety: Ensures medicines are authentic and safe
• Anti-Counterfeiting: Makes it difficult to introduce fake medicines
• Recall Efficiency: Enables rapid, targeted product recalls
• Supply Chain Visibility: Provides real-time inventory visibility
• Regulatory Compliance: Meets legal requirements in most countries

Tracking and tracing are complementary but different:

• Tracking (Forward): Following a product from origin to destination - 'Where is my product now?'
• Tracing (Backward): Identifying the path a product took from current location back to origin - 'Where did this product come from?'

Together, they provide complete supply chain visibility.

GTIN (Global Trade Item Number) is a unique identifier for a product type, assigned by GS1. It identifies the product but not individual units.

Common GTIN formats include GTIN-14 (14 digits), GTIN-13 (EAN-13), and GTIN-12 (UPC-A).

Example: GTIN-14: 00614141123452

Unit-level serialization means assigning a unique identifier to each individual saleable unit (e.g., each box of medicine). This is the most granular level of serialization and is required by most pharmaceutical regulations.

Each unit gets a unique combination of GTIN + Serial Number (SGTIN).

Case-level serialization involves assigning a unique SSCC (Serial Shipping Container Code) to each shipper case containing multiple product units.

Through aggregation, the case SSCC is linked to all the unit-level SGTINs packed inside it.