The Pharmaceutical Industry’s Track-and-Trace Test

Shipment tracking and tracing has been a boon for every consumer who has ever bought anything online with the hope of getting it tomorrow, or even today.

In the pharmaceutical industry, patient safety and ensuring timely access to medicines are paramount. And that means track and trace carries safety and accountability components, says Upender Solanki, CEO at Novatio Solutions, an AI-driven technology solutions company with operations across the U.S., Europe and India.

The industry is subject to rigorous regulatory requirements in the U.S. as well as around the world. It’s also under constant pressure to modernize systems while maintaining reliability across global networks.

That’s why having interoperable track-and-trace standards and systems across the global pharmaceutical supply chain makes such a difference, he says.

“Supply chain leaders need to move beyond viewing operations as a set of controlled processes and instead recognize them as interconnected ecosystems designed to deliver outcomes to end users and consumers,” Solanki wrote in the May/June issue of Inside Supply Management^®. Track and trace is part of that interconnected ecosystem.

The Age of Track and Trace

Unique identifiers — typically represented through a combination of a unique global trade item number (GTIN), serial number, lot number and expiration date — are critical to pharmaceutical track and trace, enabling products to be identified and traced from manufacturing through distribution, Solanki says.

The unique identifier not only ensures traceability; it also indicates compliance with extensive U.S. regulations, Solanki says. “In the life sciences supply chain, somebody can’t build a system, do some coding, do some testing and then start using it,” he says. The process requires validation at every step.

The pharmaceutical industry increasingly relies on globally recognized identification standards, although regulatory requirements vary by market. “Whether it is a contract manufacturer producing or packaging drugs for distribution in America — that contract manufacturer could be in Europe, the Asia-Pacific region or elsewhere — it needs to comply with U.S. law and the same standards,” Solanki says.  

The U.S.’s Drug Supply Chain Security Act (DSCSA) regulation was implemented over a 10-year process in several phases, including establishing lot-level identification and verifying saleable returns. “The final phase, in 2023, was the full transfer interoperability or full track and trace for pharmaceutical products,” Solanki says.

“What it meant was as the manufacturer shifts the product to the wholesaler, the data travels along with the product,” he says. So, akin to ordering from an online retailer, a tracking ID is created, which follows the product — in this case, the pharmaceutical — through shipping, receiving, shipping and so on, tracking all movements. This occurs for every saleable unit, he says.

The volume of pharmaceuticals can make the process complicated. “The manufacturer cannot do it alone,” Solanki says. “There needs to be common agreement on the interpretation of the law and how this will be managed across the industry as well as the common language,” such as GS1 Electronic Product Code Information Services (EPCIS).

Ultimately, GS1 and the Healthcare Distribution Alliance played roles in bringing together manufacturers, distributors and pharmacies to agree on data exchange standards and interpretation of regulations, enabling interoperability and common language for serialization data.  

Potential Complications

Think about pharmaceutical track and trace from a wholesaler’s perspective, Solanki says. If a wholesaler receives a shipment from a manufacturer that doesn’t have complete track-and-trace identifier data, it cannot accept that product, he says.

In the past, wholesalers would quarantine such products, contact the manufacturer and ask them for the complete data to scan, he adds. “But now, when full traceability is enforced, wholesalers may be getting many shipments and many exceptions,” he says. “They don’t have space to quarantine those products, so they end up back to the manufacturers.

“Imagine the cost — and it goes beyond cost, because some patient is waiting for those drugs,” and the delay could have adverse consequences.

Expanding Serialization

Unique identifiers and other track-and-trace technologies and processes are not just common to pharmaceuticals. They can be found throughout the supply chain, including in high-tech manufacturing for critical components.

While many things can still be improved, Solanki says, advances include:

Aggregation. To manage complex packaging hierarchies, the industry developed data aggregation or parent-child relationships, linking unique identifiers across different packaging levels. For example, individual bottles can be aggregated into bundles, bundles into cases, and cases onto a pallet.

Each serialized level has its own unique identifier, while the aggregation data electronically maintains the relationship between the parent and its children. This enables the entire hierarchy to be identified, tracked and traced without physically opening every case or pallet.

Barcode and data matrix scanning. Manufacturers have upgraded packaging lines to print and verify 2-D data matrix barcodes containing product identifiers, serial numbers, lot numbers and expiration dates. Across warehouse and distribution operations, these codes can then be scanned during receiving, picking, packing and shipping, enabling unit-level identification, verification and traceability throughout the pharmaceutical supply chain.

How Technology Can Help

Advanced tools and technologies, including AI, are making it easier to manage such supply chain track-and-trace processes as barcode scanning, ensuring GS1 standards, process optimization and real-time communication between partners, Solanki says.

Additionally, AI can move pharmaceutical track and trace from reactive exception management toward proactive exception prevention. It can identify patterns across transactions, determine probable root causes and recommend or automate corrective actions before an exception results in a delayed shipment, he says.

Nevertheless, while AI and automation can optimize processes in the pharmaceutical and other industries, humans remain responsible for oversight, validation and decision-making, Solanki says. “Accountability is always important,” he says.

(Photo credit: Getty Images/Guteksk7)