Master data is reference information:

• Product data (GTIN, description)
• Location data (GLN, address)
• Trading partner data
• Must be synchronized across systems

A verification response confirms product authenticity:

• GTIN + Serial + Lot + Expiry verified
• Response: Valid/Invalid/Unknown
• Required at point of dispense
• Real-time query to repository

Lot number: Identifies production batch (many units share same lot)
Serial number: Unique identifier for each unit

• Both required for full traceability
• Lot = quality tracking
• Serial = individual tracking

Data synchronization keeps data consistent:

• Between internal systems
• With trading partners
• With regulatory portals
• Critical for EPCIS accuracy

Key difference:

• Master data: Static reference data (product info, locations)
• Event data: Dynamic transaction records (what, when, where, why)

Both needed for complete traceability.

Batch traceability tracks products by production batch:

• Same lot number = same production run
• Enables batch-level recalls
• Links to quality records
• Part of GMP requirements

Exception handling manages serialization issues:

• Rejected units on line
• Failed submissions to portal
• Verification failures
• Data discrepancies

Requires documented procedures.

A transaction ID links business transactions:

• Purchase order number
• Invoice number
• Delivery note number
• Required in EPCIS transaction events

Compliance reports demonstrate regulatory adherence:

• Serialization status by product
• Event submission statistics
• Error rates and resolution
• Required for audits

Data retention requirements:

• Keep records for specified period
• Typically 1 year after expiry + buffer
• Country-specific requirements
• Must be retrievable for audits

EPCIS stands for Electronic Product Code Information Services. It is a GS1 standard for sharing event data between trading partners in the supply chain.

EPCIS defines four event types:

• ObjectEvent: Observation of objects (commissioning, shipping, receiving)
• AggregationEvent: Parent-child relationships (packing/unpacking)
• TransactionEvent: Links objects to business transactions
• TransformationEvent: Input/output relationships (manufacturing)

An ObjectEvent captures observations about objects at a point in time. Common uses:

• Commissioning (serial number activation)
• Shipping (products leaving a location)
• Receiving (products arriving)
• Dispensing (products given to patient)

Action types: ADD, OBSERVE, DELETE

An AggregationEvent records parent-child relationships between containers and their contents:

• ADD: Items packed into a container
• DELETE: Items unpacked from a container
• OBSERVE: Confirmation of aggregation

Essential for case and pallet tracking.

Common bizStep values in pharmaceutical track and trace:

• commissioning: Serial number activation
• packing: Items packed into container
• shipping: Products shipped
• receiving: Products received
• dispensing: Given to patient
• destroying: Product destruction

CBV (Core Business Vocabulary) defines standard values for EPCIS fields:

• Business steps (commissioning, shipping, receiving)
• Dispositions (active, inactive, recalled)
• Business transaction types
• Source/Destination types

Using CBV ensures interoperability between systems.

EPCs (Electronic Product Codes) in EPCIS follow URN format:

• SGTIN: urn:epc:id:sgtin:CompanyPrefix.ItemRef.Serial
• SSCC: urn:epc:id:sscc:CompanyPrefix.SerialRef
• GLN: urn:epc:id:sgln:CompanyPrefix.LocationRef.Extension

Disposition indicates the business state of objects after an event:

• active: Normal, sellable state
• inactive: Not available for sale
• recalled: Subject to recall
• expired: Past expiry date
• destroyed: Physically destroyed

EPCIS 2.0 is the latest version of the standard with new features:

• JSON-LD support (in addition to XML)
• REST API bindings
• Sensor data integration
• Digital link URIs
• Enhanced CBV 2.0

EPCIS 2.0 was released in 2022.

An EPCIS Repository is a system that stores EPCIS events and provides:

• Capture interface (to receive events)
• Query interface (to retrieve events)
• Event persistence and management

Regulatory portals like TATMEEN and RSD act as EPCIS repositories.

Two different timestamps in EPCIS:

• eventTime: When the physical event actually occurred
• recordTime: When the event was recorded in the EPCIS repository

eventTime should reflect real-world timing; recordTime is system-generated.

A TransactionEvent associates objects with business transactions such as:

• Purchase orders
• Invoices
• Shipment notifications

Links physical product movement to business documents.

EPCIS supports two data formats:

• XML: Traditional format, widely supported, verbose
• JSON-LD: Added in EPCIS 2.0, more compact, better for web APIs

Choose based on your system capabilities and regulatory requirements.

Source and destination identify the parties involved in a transaction:

• Source: Where objects came from (owning_party, possessing_party)
• Destination: Where objects are going

They provide context for shipping and receiving events.

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

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

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

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.

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.

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.

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.

Common challenges include:

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

A pilot is a limited production run:

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

Line qualification validates packaging line:

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

Required for GMP compliance.

Key vendor selection criteria:

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

Training requirements:

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

Change management handles system modifications:

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

SOP (Standard Operating Procedure) documents processes:

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

Required for GMP.

CMO (Contract Manufacturing) transfer considerations:

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

ROI from serialization includes:

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

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.

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

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.

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.

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

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

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.

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.

Check digit errors occur when the last digit of a GTIN or SSCC doesn't match the calculated value:

1. Use the GS1 Modulo 10 algorithm
2. Recalculate the check digit
3. Compare with the actual last digit
4. Correct the barcode or data entry

Use our Barcode Decoder to validate check digits.

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.

When EPCIS events fail:

1. Check error response from portal
2. Validate XML/JSON syntax
3. Verify all identifiers (GTIN, GLN, SSCC)
4. Ensure master data is registered
5. Check business rules compliance
6. Retry after fixing issues

A parent-child mismatch occurs when aggregation data is inconsistent:

• Child already in another parent
• Parent doesn't exist
• Unpacking before packing was reported

Solution: Ensure proper event sequencing and aggregation management.

Common reasons for barcode read failures:

• Poor print quality (low contrast, defects)
• Wrong scanner type (laser vs imager)
• Scanning angle or distance issues
• Damaged or dirty barcode
• Inadequate lighting

Use a barcode verifier to check quality.

Master data is foundational reference data required before sending events:

• Product master: GTIN, description, NDC
• Location master: GLN, address, type
• Trading partner: Company information

Master data must be registered before transactional events.

A product not found error means the GTIN is not registered in the portal master data. Solution:

1. Verify GTIN format and check digit
2. Register product master data first
3. Wait for approval before sending events

A location not found error means the GLN is not registered. Solution:

1. Verify GLN format and check digit
2. Register location master data
3. Ensure GLN is approved before use

Serial number validation involves:

1. Format validation: Check length and character set
2. Check digit validation: Verify GTIN check digit using Modulo 10
3. Uniqueness check: Ensure no duplicates exist
4. Database lookup: Verify against regulatory portal

Use our Barcode Decoder tool to validate barcodes.

Barcode verification is the process of grading barcode quality using ISO standards. Verification checks:

• Symbol contrast
• Modulation
• Decodability
• Defects

Grades range from A (best) to F (fail). Grade C or better is typically required.

API (Application Programming Interface) enables system-to-system communication. In track and trace:

• Submit EPCIS events to portals
• Query product status
• Retrieve master data

REST and SOAP APIs are common.

A schema validation error means the EPCIS message doesn't match expected format:

• Invalid XML/JSON structure
• Missing required elements
• Incorrect data types

Use an EPCIS validator to check message format before submission.

A sandbox environment is a testing system that mimics production without affecting real data. Use it to:

• Test EPCIS message format
• Validate integration
• Train users
• Debug issues

Always test thoroughly in sandbox before production.

Disaggregation is the reverse of aggregation - breaking parent-child relationships:

• Unpacking cases from pallets
• Unpacking units from cases
• Reported with AggregationEvent action DELETE

Required when products are repackaged or split.

GS1 DataMatrix is a 2D barcode format used for pharmaceutical serialization. It can encode the GTIN, serial number, batch/lot number, and expiry date in a small space.

DataMatrix barcodes are required on pharmaceutical packaging in most regulated markets.

Learn about DataMatrix requirements

For pharmaceutical serialization:

• Unit level: GS1 DataMatrix 2D barcode
• Case level: GS1-128 linear barcode or GS1 DataMatrix
• Pallet level: GS1-128 linear barcode

The barcode must encode: GTIN (AI 01), Serial (AI 21), Batch (AI 10), and Expiry (AI 17).

DataMatrix size depends on the application:

• X-dimension: Minimum 0.254mm recommended
• Module size: Based on scanning distance
• Overall size: Varies with encoded data

Follow GS1 General Specifications for exact requirements.

Decommissioning removes a serial from active status:

1. Send ObjectEvent with action DELETE
2. Set appropriate disposition (destroyed, sample, etc.)
3. Include reason code if required

Decommissioned serials cannot be used for further transactions.

Common authentication methods:

• OAuth 2.0: Token-based authentication
• Certificate-based: Digital certificates
• API Keys: Unique access keys
• Username/Password: Basic authentication

Check specific portal documentation for requirements.

For product returns:

1. Receive products with receiving event
2. Verify serial numbers against expected data
3. Update disposition (returned, sellable, destroyed)
4. Report appropriate events to portal

Returns workflow depends on country regulations.

Aggregation is the process of recording parent-child relationships between packaging levels - for example, which unit-level products are packed into which case, and which cases are on which pallet.

Aggregation is recorded using EPCIS AggregationEvents with ADD (packing) or DELETE (unpacking) actions.

Read aggregation best practices

Key differences between EPCIS versions:

• EPCIS 1.2: XML format, widely adopted, CBV 1.2
• EPCIS 2.0: Adds JSON-LD support, sensor data, CBV 2.0

Most MENA portals currently accept EPCIS 1.2, with 2.0 support being added progressively.

In EPCIS events:

• readPoint: The specific location where the event observation occurred (e.g., a scanner at dock door 3)
• bizLocation: The business location where objects are after the event (e.g., the warehouse)

Both are typically identified by GLN.

A barcode scanner reads and decodes barcode data. Types include:

• Handheld: Portable, manual operation
• Fixed mount: Automated line scanning
• Camera-based: 2D barcode capability

For DataMatrix, you need an imager (2D scanner), not a laser scanner.

A line-level system manages serialization on the production line:

• Serial number assignment
• Barcode printing
• Verification and inspection
• Aggregation at packaging

It interfaces with enterprise systems for data exchange.

An enterprise serialization system manages track and trace at the company level:

• Serial number pool management
• Aggregation data storage
• EPCIS event generation
• Regulatory portal connectivity
• Reporting and analytics

EPCIS queries retrieve event data from repositories:

• SimpleEventQuery: Search events by criteria
• SimpleMasterDataQuery: Retrieve master data

Query parameters: eventTime, GTIN, serial number, location, etc.

To obtain a GS1 Company Prefix:

1. Contact your local GS1 Member Organization
2. Complete the membership application
3. Pay the membership fee
4. Receive your unique Company Prefix

MENA GS1 offices: GS1 UAE (gs1.ae), GS1 Saudi Arabia (gs1sa.org), GS1 Egypt (gs1eg.org)

For product recalls:

1. Identify affected serial numbers
2. Query EPCIS repository for current locations
3. Send ObjectEvent with disposition 'recalled'
4. Track return/destruction events
5. Report to regulatory portals as required

EPCIS provides full traceability for efficient recall execution.

Aggregation inference means deducing child contents from parent events without explicit disaggregation:

• Scan pallet → infer all cases and units inside
• Reduces scanning requirements
• Requires accurate aggregation data

Not all portals support inference.

No. While technically the SGTIN (GTIN + Serial) would be unique, best practice is to use unique serial numbers across all products to avoid confusion and simplify tracking.

Most serialization systems generate globally unique serial numbers.

EPCIS events should be reported in chronological order. Reporting out of order may cause:

• Validation errors on some portals
• Inconsistent product status
• Failed aggregation relationships

If events arrive late, ensure eventTime reflects actual occurrence time, not submission time.

Serialization software manages serial number lifecycle:

• Generates unique serial numbers
• Manages number pools
• Interfaces with packaging lines
• Reports to regulatory systems

Key vendors: SAP, TraceLink, Antares Vision.

Level 4 in serialization architecture is the enterprise level:

• ERP integration (SAP, Oracle)
• Business process management
• Cross-site visibility
• Regulatory reporting

Part of the ISA-95 hierarchy.

Level 3 is the site/plant level:

• Local serialization management
• Line-level coordination
• Serial number pooling
• Production scheduling

Examples: TraceLink, SAP ATTP.

A vision system verifies printed codes:

• Camera-based inspection
• Reads barcodes and text
• Verifies print quality
• Rejects non-compliant items

Critical for serialization quality.

Print and verify is the serialization process:

• Print unique code on each unit
• Immediately verify with camera
• Reject if verification fails
• Record successful serialization

An aggregation station creates parent-child relationships:

• Scans units going into cases
• Scans cases going onto pallets
• Creates aggregation hierarchy
• Prints parent labels

API integration connects systems programmatically:

• REST or SOAP protocols
• Exchange serial/event data
• Automate reporting
• Enable system interoperability

Level 2 is the line controller level:

• Controls packaging line equipment
• Manages printers and cameras
• Real-time code verification
• Aggregation station control

A handheld scanner reads barcodes manually:

• 2D barcode scanning capability
• Used in warehouses and pharmacies
• Verification at point of dispense
• Wi-Fi or Bluetooth connected

Cloud-based serialization uses cloud infrastructure:

• Centralized serial number management
• Multi-site visibility
• Easier regulatory reporting
• Lower infrastructure costs

Examples: TraceLink, SAP ICH.