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

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GS1 6

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.

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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

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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.

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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.

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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.

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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.

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Implementation 10

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.

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Common challenges include:

  • Line speed impact
  • Print quality consistency
  • System integration complexity
  • Data management
  • Staff training
  • Multi-market compliance
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Key vendor selection criteria:

  • Experience in pharma industry
  • Integration capabilities
  • Regulatory expertise for target markets
  • Support and maintenance
  • Scalability
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Line qualification validates packaging line:

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

Required for GMP compliance.

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A pilot is a limited production run:

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

  • Operators: Line equipment, scanning
  • IT: System administration, integration
  • Quality: Compliance, documentation
  • Management: Reporting, oversight
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SOP (Standard Operating Procedure) documents processes:

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

Required for GMP.

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CMO (Contract Manufacturing) transfer considerations:

  • Serial number pool management
  • System access and credentials
  • Training for CMO staff
  • Integration with CMO systems
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ROI from serialization includes:

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

  • Document all changes
  • Impact assessment
  • Testing and validation
  • Regulatory notification if required
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Platform 3

Our EPCIS Analyzer tool helps you:

  1. Upload your EPCIS XML or JSON file
  2. View a summary of all events
  3. Validate against country-specific requirements
  4. Identify errors and get fix recommendations

Simply drag and drop your file or paste EPCIS content to get started.

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Use our Barcode Decoder tool:

  1. Enter the barcode data string (e.g., from a scanner)
  2. The tool will parse and display all encoded data
  3. View GTIN, serial number, batch, expiry, and other fields
  4. Validate the check digit automatically
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Visit our Regulation Hub for comprehensive information on:

  • Country profiles and requirements
  • Authority contacts and portal links
  • Onboarding guides and timelines
  • Technical specifications

Select a country to view detailed regulatory information.

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Technical 1

Common reasons for EPCIS file rejection:

  • Schema validation errors: Check XML/JSON syntax
  • Invalid identifiers: Verify check digits
  • Missing required fields: Ensure all mandatory elements are present
  • Unregistered products/locations: Register master data first

Use our EPCIS Analyzer to identify specific issues.

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