FAQs answered for you.

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

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

Links input identifiers to output identifiers.

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

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

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).

SSCC (Serial Shipping Container Code) is an 18-digit GS1 identifier used to uniquely identify logistics units such as cases and pallets.

SSCCs are essential for aggregation - linking individual product units (SGTINs) to their shipping containers.

Example: SSCC: 006141411234567890

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.

Pallet-level serialization assigns a unique SSCC to each pallet. Through hierarchical aggregation:

• Pallet SSCC links to Case SSCCs
• Case SSCCs link to Unit SGTINs

This creates a complete parent-child relationship enabling efficient logistics.

The DSCSA is a US federal law establishing requirements for pharmaceutical product tracing. Key requirements include:

• Product identification with unique identifiers
• Product tracing through transaction information
• Verification of product authenticity
• Detection and response to suspect/illegitimate products

Full enforcement began in November 2023.

GLN (Global Location Number) is a 13-digit GS1 identifier used to identify physical locations (warehouses, factories) and legal entities (companies).

GLNs are used in EPCIS events to specify where events occurred (readPoint and bizLocation).

The EU FMD is European Union legislation to prevent falsified medicines from entering the legal supply chain. Key requirements:

• Unique identifier on each pack (2D DataMatrix)
• Anti-tampering devices on packaging
• Verification through connected European databases (EMVS)

Active since February 2019.

A serialization solution provider offers software and systems to implement pharmaceutical track and trace, including:

• Serial number generation and management
• Line-level systems for printing and verification
• Enterprise software for aggregation and reporting
• Connectivity to regulatory portals

Examples include TraceLink, SAP, Antares Vision, and Optel.

GS1 is a global non-profit organization that develops and maintains supply chain standards. Key GS1 standards for pharmaceuticals include:

• GTIN - Product identification
• GLN - Location identification
• SSCC - Logistics unit identification
• GS1 DataMatrix - 2D barcode
• EPCIS - Event sharing

Visit gs1.org for more information.

Application Identifiers (AIs) are GS1 prefixes that define the meaning and format of data elements in barcodes. Common pharmaceutical AIs:

• AI 01: GTIN (14 digits)
• AI 10: Batch/Lot number
• AI 17: Expiry date (YYMMDD)
• AI 21: Serial number

Example: (01)00614141123452(17)251231(10)ABC123(21)12345

GTIN-14 is a 14-digit Global Trade Item Number used in pharmaceutical serialization. It consists of:

• Indicator digit (packaging level)
• GS1 Company Prefix
• Item reference
• Check digit

Example: 00614141123452

SGTIN (Serialized GTIN) is the combination of a GTIN and a unique serial number that identifies a specific individual product unit.

Format: GTIN + Serial Number

Example: GTIN 00614141123452 + Serial 12345ABC = SGTIN

SGTINs are used in EPCIS events to track individual products.