FAQs answered for you.

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

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

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.

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.

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 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.

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.

A GS1 Company Prefix is a unique number assigned to your company by GS1. It forms the basis for creating:

• GTINs for your products
• SSCCs for your logistics units
• GLNs for your locations

Contact your local GS1 Member Organization to obtain a prefix.

The GTIN check digit is calculated using the Modulo 10 algorithm:

1. Multiply alternate digits by 3 and 1 (starting from right)
2. Sum all results
3. Check digit = (10 - (sum mod 10)) mod 10

Use our Barcode Decoder to verify check digits automatically.

A batch/lot number identifies products manufactured under the same conditions. In GS1 barcodes:

• Encoded with AI 10
• Variable length (up to 20 alphanumeric characters)
• Critical for recalls and quality control

Example: (10)BATCH123

GS1-128 (formerly UCC/EAN-128) is a linear barcode symbology used primarily for:

• Shipping labels
• Case and pallet identification
• Encoding multiple data elements

It uses Application Identifiers and is commonly seen on logistics labels alongside 2D DataMatrix codes.

Expiry date is encoded using AI 17 in YYMMDD format:

• YY = Year (00-99)
• MM = Month (01-12)
• DD = Day (01-31, or 00 for end of month)

Example: (17)251231 = December 31, 2025