Serialization versus Track & Trace in the Pharmaceutical Industry

What sets Serialization apart from Track & Trace?

In the realm of pharmaceutical logistics, the terms Serialization and Track & Trace often dance in tandem, presenting a unified front against the infiltration of counterfeit drugs into the hands of patients. However, beneath the surface, these seemingly synonymous terms reveal nuanced differences that contribute to their shared mission of enhancing the safety of medicine distribution.

Serialization: Unveiling the Unique Identity

Serialization, a cornerstone in the battle against counterfeit pharmaceuticals, revolves around the individual identification of each manufactured drug. This involves assigning a distinct serial number, creating a digital fingerprint that goes beyond conventional barcodes. The ultimate aim is to streamline the identification of authentic products and detect those lacking a valid serial number.

While national standards for serialization vary, adherence to GS1 criteria is common, ensuring international standardization. The process of serialization extends beyond mere labeling, with the overarching goal of achieving aggregation—a hierarchical serialization scheme involving parent-child interactions across various packaging layers.

Serialization’s journey doesn’t end with the creation of serial numbers. The maintenance of these identifications is imperative for enhancing supply chain visibility. To seamlessly monitor and record data as products traverse from manufacturers to distributors and then to dispensing sites, the integration of the entire supply chain becomes essential.

Track & Trace: Orchestrating Transparency

Enter Track & Trace, a broader concept that extends beyond the individualized approach of Serialization. While Serialization focuses on the unique identity of each unit, Track & Trace paints a comprehensive picture of the entire product journey through the supply chain. It involves the aggregation of serialized data, facilitating a holistic view at various levels—batches, cases, pallets, and beyond.

Tracking entails locating a product within the supply chain, while tracing involves identifying all entities the product has encountered. Serialization forms the bedrock for these processes to unfold. Together, they weave a complex system, enabling stakeholders to monitor product progress and enhance traceability, especially in the event of product returns.

Bridging the Gap: Integration for Comprehensive Security

The integration of Serialization and Track & Trace emerges as a symbiotic alliance, fortifying the pharmaceutical supply chain comprehensively. While Serialization brings individualized identification, Track & Trace broadens the narrative, providing a panoramic view of the entire product journey. This integration not only enhances security against counterfeiting but also empowers stakeholders with actionable insights for operational efficiency and regulatory compliance.

The End Goal: Collective Benefits

Serialization vs. Track & Trace, despite their distinctions, converge on a common purpose—to establish a chain-wide system that makes introducing counterfeit medications into the pharmaceutical supply chain nearly impossible. Special serial numbers assigned to each product become visible to all supply chain participants, safeguarding patient safety and offering numerous collective benefits:

• Easier tracing of complaints to individual packaging
• Long-term improvements in operational profitability and efficiency
• Demonstration of commitment to patient safety
• Standardization of customs and regulations in local and global markets
• Facilitation of crucial market analytics

While the implementation of serialization may take time, it paves the way for aggregation, streamlining the data entry process into the database. In conclusion, the dynamic interplay between Serialization and Track & Trace signals a new era of transparency, security, and efficiency in pharmaceutical logistics. If this exploration prompts a desire to accelerate the implementation of these systems, tailored services provided by Evoltrace stand ready to assist pharmaceutical companies on this transformative journey. For further inquiries, feel free to contact us.