FAQs answered for you.

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

Different GTIN lengths serve different purposes:

• GTIN-8: Small items (rare in pharma)
• GTIN-12: North American retail (UPC)
• GTIN-13: International retail (EAN)
• GTIN-14: Trade items and cases (standard for pharma serialization)

All can be converted to GTIN-14 by adding leading zeros.

GS1 Digital Link is a web URI structure that combines product identification with web addresses. It enables:

• QR codes that link to product information
• Consumer engagement through smartphone scanning
• Multiple data sources from one scan

Format: https://id.gs1.org/01/00614141123452

A GS1 Member Organization (MO) is a local GS1 office that:

• Issues GS1 Company Prefixes
• Provides training and support
• Offers local implementation guidance

MENA MOs include: GS1 UAE, GS1 Saudi Arabia, GS1 Egypt, GS1 Jordan, GS1 Bahrain.

FNC1 (Function Code 1) is a special character in GS1 barcodes that:

• Indicates the barcode follows GS1 standards
• Acts as a separator between variable-length data elements

In human-readable text, FNC1 appears as GS (Group Separator, ASCII 29) or is shown as parentheses around AIs.

GRAI (Global Returnable Asset Identifier) is used to identify reusable assets like:

• Pallets
• Containers
• Crates
• Totes

GRAI helps track returnable assets through the supply chain.

AI 240 encodes an additional product identification, often used for manufacturer's internal item number or customer-specific product code. It allows up to 30 alphanumeric characters.

Common challenges include:

• Line speed impact
• Print quality consistency
• System integration complexity
• Data management
• Staff training
• Multi-market compliance

Typical implementation timeline:

• Planning: 2-3 months
• Equipment installation: 3-6 months
• Testing and validation: 2-3 months
• Pilot production: 1-2 months

Total: 6-12 months depending on scope.

Training requirements:

• Operators: Line equipment, scanning
• IT: System administration, integration
• Quality: Compliance, documentation
• Management: Reporting, oversight

Key vendor selection criteria:

• Experience in pharma industry
• Integration capabilities
• Regulatory expertise for target markets
• Support and maintenance
• Scalability

Line qualification validates packaging line:

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification

Required for GMP compliance.

A pilot is a limited production run:

• Test serialization on selected products
• Validate equipment and processes
• Train operators
• Identify issues before full rollout

ROI from serialization includes:

• Reduced counterfeiting losses
• Improved supply chain visibility
• Better recall management
• Enhanced brand protection
• Regulatory compliance (avoiding penalties)

CMO (Contract Manufacturing) transfer considerations:

• Serial number pool management
• System access and credentials
• Training for CMO staff
• Integration with CMO systems

SOP (Standard Operating Procedure) documents processes:

• Serialization workflow
• Exception handling
• System operations
• Compliance requirements

Required for GMP.