Introduction to Serialization, Track and Trace – June 12, 2025

Serialization and track and trace are critical components in the pharmaceutical industry, designed to enhance the safety and integrity of the supply chain. Serialization refers to the process of assigning a unique identifier, typically a serial number, to each saleable unit of a product. This identifier allows for the precise tracking of individual items throughout the supply chain, from manufacturing to distribution and ultimately to the point of sale. Track and trace, on the other hand, encompasses the broader system that enables the monitoring of a product’s journey through the supply chain, ensuring that it can be traced back to its origin and verified for authenticity. Together, these processes help to curb distribution of substandard, falsified and counterfeit medical products safeguarding patient safety.

The session on Serialization and Track and Trace, held on June 12, 2025, was hosted by the Regulatory Affairs Professional Society of Kenya (RAPSK) and the Kenya Association of Pharmaceutical Industry (KAPI). The event featured presentations from key industry players, highlighting the critical role of GS1 standards in enhancing traceability and product safety within the healthcare supply chain. Led by Ms. Nuran Idris from GS1 Global Office and Mr. Nelson John Uyirwoth from GS1 Kenya, the session began with an overview of GS1 standards, emphasizing their importance in improving supply chain operations and patient safety. The GS1 DataMatrix was identified as a vital tool for accurate product identification, incorporating key data elements such as GTIN, serial number, expiry date, and lot number.

The distinction between traceability—tracking product movement—and verification—ensuring product authenticity—was discussed, with the European Union’s verification process cited as a model. The global adoption of GS1 standards was highlighted, noting that over 70 countries, including Kenya, Nigeria, and Ethiopia, are considering integrating these standards into their serialization, track & trace processes. The speakers acknowledged the costs associated with implementation and stressed the importance of collaboration among stakeholders to share these burdens. Successful case studies from Turkey and Nigeria illustrated practical compliance steps with GS1 standards. The session concluded with a call for continuous improvement and adaptation of systems to meet evolving regulatory and supply chain environment.

Ms. Merryl Riley from the National Bioproducts Institute (NBI) South Africa presented their track and trace solutions. NBI, a nonprofit organization focused on manufacturing human plasma-derived medicinal products, underscored the necessity of effective track and trace systems for product safety. Merryl detailed NBI’s approach, emphasizing the importance of understanding GS1 terminology and the need for both human-readable and non-human-readable information on packaging. The discussion included the complexities of managing Global Trade Item Numbers (GTIN-14) and regulatory considerations for printed information on products.

Mr Shaun Pillay, from Pyrotec Company, provided insights into serialization and traceability in the pharmaceutical industry. He emphasized the significance of applying unique identifiers to retail units per GS1 standards and detailed the processes of authentication and traceability. Shaun discussed the integration of custom-designed serialization systems with NBI’s ERP system, SAP, and the role of camera systems equipped with Optical Character Recognition (OCR) and Optical Character Verification (OCV) technologies in ensuring data accuracy and compliance. He also highlighted the potential of RFID technology for product tracking and authentication.

The final presentation by Mr Gedion Murimi from the Pharmacy and Poisons Board of Kenya focused on the proposed pathway for implementing a track and trace system in Kenya. Mr. Murimi outlined the initiative’s history, status, and what is to be expected in the future. He highlighted that a draft blueprint for traceability had been created, and batch traceability had begun, with integration into the Kenya Trade Authority’s (KENTRADE) system. Kenya is proposing a phased implementation consisting of three phases: the first phase (12-48 months) aimed at establishing basic visibility and record capabilities for tracking products, including data capturing and a central batch repository; the second phase (48-72 months) focused on unique level traceability with serialized numbers for high-risk health products and event-based reporting; and the third phase (72-120 months) that will implement universal serialization and advanced analytics, including AI for data-driven regulation.

Overall, the session underscored the importance of serialization and track and trace systems in enhancing product safety and integrity within the healthcare supply chain. Its implementation requires collaboration between the regulator and industry stakeholders, gradual roll-out with continuous improvement, and adherence to GS1 standards.

Authors of executive summary are; Dr. John Mwangi and Dr. Peter Odhiambo

For more information about the executive summary; please click on the links below for presentations and meeting recording;