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

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All Categories 221 Country-Specific 106 Technical 37 General 15 GS1 15 EPCIS 15 Technology 10 Data 10 Implementation 10 Platform 3
GS1 1

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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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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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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Training requirements:

  • Operators: Line equipment, scanning
  • IT: System administration, integration
  • Quality: Compliance, documentation
  • Management: Reporting, oversight
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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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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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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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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 6

TATMEEN integration steps:

  1. Register your company on the portal
  2. Obtain API credentials
  3. Implement EPCIS message generation
  4. Configure secure connection (HTTPS)
  5. Test in sandbox environment
  6. Go live after certification
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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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RSD integration steps:

  1. Register with SFDA
  2. Obtain RSD portal access
  3. Implement EPCIS capture interface
  4. Configure API authentication
  5. Complete testing phase
  6. Receive production approval
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A duplicate serial number error occurs when the same serial is used twice. Causes:

  • System generating non-unique serials
  • Re-using previously commissioned serials
  • Data synchronization issues

Solution: Implement proper serial number management and validation.

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To print GS1 DataMatrix barcodes:

  1. Use a printer capable of 300+ DPI resolution
  2. Ensure proper quiet zones around the barcode
  3. Follow GS1 size recommendations (minimum X-dimension)
  4. Verify print quality with a barcode verifier

Consider using Continuous Ink Jet (CIJ), Thermal Inkjet (TIJ), or laser marking.

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The typical EPCIS events required for pharmaceutical track and trace are:

  • ObjectEvent (Commissioning): Serial number assignment
  • AggregationEvent: Packing/unpacking
  • ObjectEvent (Shipping): Products leaving a location
  • ObjectEvent (Receiving): Products arriving at a location
  • ObjectEvent (Dispensing): Products given to patients

Specific requirements vary by country.

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