GXPTrace™
End-to-End Pharmaceutical Track & Trace Solutions

In today’s highly regulated pharmaceutical environment, securing the supply chain is no longer optional — it is essential.

With the World Health Organization estimating that approximately 10.5% of medicines worldwide are substandard or falsified, pharmaceutical companies must adopt robust, technology-driven safeguards. GXPTrace™ by GXPWAY delivers advanced track and trace solutions that create a secure, transparent, and fully compliant supply chain — from manufacturing to patient dispensing.

What is Pharmaceutical Track & Trace?

Track and trace systems ensure the integrity, authenticity, and traceability of medicinal products across the entire product lifecycle.

As pharmaceutical supply chains expand globally, every transfer point — from manufacturer to distributor, wholesaler, pharmacy, and hospital — represents a potential vulnerability. GXPTrace™ eliminates blind spots by creating an unbroken digital chain of custody, ensuring:

  • Protection against counterfeit medicines

  • Real-time product visibility

  • Regulatory compliance across multiple jurisdictions

  • Faster recall management

  • Enhanced patient safety

Beyond regulatory compliance, track and trace technology strengthens operational performance across the entire pharmaceutical ecosystem.

Benefits Across the Pharmaceutical Ecosystem

For Manufacturers

  • Product serialization and aggregation

  • Enhanced brand protection

  • Improved inventory accuracy

  • Reduced recall impact

  • Global regulatory compliance

For Distributors & Wholesalers

  • Automated shipment verification

  • Reduced liability exposure

  • Real-time supply chain visibility

  • Efficient recall processing

For Pharmacies & Healthcare Providers

  • Instant authentication verification

  • Automated expiration tracking

  • Improved stock management

  • Reduced dispensing errors

For Patients

  • Protection against counterfeit or falsified medicines

  • Increased trust in medication safety

How GXPTrace™ Works

GXPTrace™ integrates three core components to ensure seamless compliance and supply chain transparency:

1. Pharmaceutical Serialization

Each product pack is assigned a unique identifier, including:

  • Product code

  • Unique serial number

  • Batch/lot number

  • Expiry date

High-precision packaging equipment and advanced barcode labeling systems apply secure DataMatrix codes, ensuring each pack is individually traceable.

2. Real-Time Traceability Platform

GXPTrace™ software monitors product movement across the supply chain.

  • Each scan generates a secure digital transaction record

  • Data updates in real time

  • Pharmacists and hospitals can instantly verify product authenticity

  • Automated alerts notify stakeholders of recalls or status changes

This creates a secure digital audit trail accessible across authorized stakeholders.

3. Global Regulatory Compliance Framework

Track and trace systems are driven by international regulatory requirements, including:

  • Falsified Medicines Directive (EU FMD)

  • Drug Supply Chain Security Act (U.S. DSCSA)

GXPTrace™ is designed to support multi-market compliance, enabling pharmaceutical companies to operate efficiently across the UK, EU, U.S., and other global markets while maintaining continuous regulatory alignment.

Applications in Pharmacies, Hospitals & Healthcare Facilities

Pharmacies

  • Instant verification upon product receipt

  • Automated recall and expiration alerts

  • Simplified regulatory audits

  • Improved inventory control

Hospitals

  • Full visibility of medication movement within the facility

  • Optimized inventory across satellite pharmacies

  • Reduced emergency orders

  • Integration with electronic health record (EHR) systems

When integrated with clinical systems, barcode scanning before administration ensures the right patient receives the right medication — significantly reducing medication errors.

Measurable Impact

Healthcare facilities implementing track and trace systems report:

  • Faster recall processing

  • Reduced stock discrepancies

  • Improved reimbursement documentation

  • Decreased medication waste

Challenges in Pharmaceutical Track & Trace — and How GXPTrace™ Addresses Them

Implementing serialization and traceability systems presents several challenges:

  • Fragmented global regulatory frameworks

  • Evolving compliance requirements

  • Complex system integration

  • Increasingly sophisticated counterfeit methods

GXPTrace™ provides a flexible, scalable architecture capable of adapting to evolving regulations while maintaining operational efficiency. Continuous security updates and advanced authentication features help protect against emerging counterfeiting techniques.

Why Choose GXPWAY GXPTrace™

  • Designed for GMP & GDP regulated environments

  • Multi-market regulatory compliance capability

  • Seamless ERP and MES integration

  • Scalable for manufacturers, distributors, and healthcare providers

  • Supports inspection readiness and audit traceability

GXPTrace™ transforms compliance from a regulatory obligation into a strategic advantage — delivering transparency, operational efficiency, and enhanced patient safety across the pharmaceutical supply chain.