In the context of Track & Trace Pharma, digital systems are used to uniquely identify, serialize, and trace medicinal products throughout the pharmaceutical supply chain. Track & Trace systems document every relevant step – from manufacturing and packaging through storage and distribution to dispensing to patients. As part of serialization, each saleable unit receives a globally unique identifier, typically encoded in a two-dimensional Data Matrix code on the packaging, which contains information such as the product code, serial number, batch or lot number, and expiry date.
The particular importance of Track & Trace systems in the pharmaceutical sector arises from the specific function of medicines. Medicines can and are intended to save lives and maintain health. However, if misused, incorrectly composed, or counterfeited, the opposite can occur: they themselves can become significant risk factors for life and health.
For the quality of pharmaceutical products as well as their manufacturing and distribution, special legal regulations and documentation requirements apply. In addition to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), these include serialization and traceability requirements such as the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA).
What does the term Track & Trace mean?
The basic principle of Track & Trace is similar to shipment tracking in logistics: products are uniquely identified and their path is recorded at defined process steps. In an industrial environment, Track & Trace systems are used not only to track shipments in transit but also for location tracking, status monitoring, and traceability within the company – for example, between individual production stages, warehouse areas, and external logistics partners.
Why are Track & Trace systems critical in the pharmaceutical industry?
Within the pharmaceutical supply chain, Track & Trace systems ensure that individual pharmaceutical products are uniquely identifiable and traceable at any time from production to the point of dispensing.
In many markets, they are a prerequisite for complying with national or international regulations such as the U.S. Drug Supply Chain Security Act (DSCSA) or the EU Falsified Medicines Directive (FMD), which require a unique serial number and electronic traceability at the pack level.
Furthermore, they reduce the risk of counterfeit and diverted medicines, support the detection of stolen or tampered products, and facilitate targeted product recalls.
They also enable near real-time transparency across the entire supply chain – from filling and packaging to dispensing in a pharmacy, doctor’s office, or hospital.
Integration of Track & Trace into aseptic production processes
In Blow-Fill-Seal (BFS) systems, traceability plays a crucial role because primary packaging and filling take place in a single automated aseptic process step. Track & Trace systems can be directly integrated into production and documentation processes to ensure complete batch and component traceability.
By connecting to Manufacturing Execution Systems (MES) or Enterprise Resource Planning (ERP) systems, production data, test records, and material batches can be automatically linked and made available centrally.
This enables seamless, GMP-compliant documentation – from filling and sealing through in-process controls to secondary packaging, aggregation, and serialization.
What are the advantages of Track & Trace Pharma?
Track & Trace systems increase overall safety by preventing or at least significantly hindering theft, diversion, and the distribution of counterfeit medicines.
They improve patient safety by ensuring that only verified and quality-approved products reach consumers and that suspect packs can be identified and blocked quickly.
In addition, Track & Trace Pharma solutions enable the streamlining of supply chain processes through automated data capture, monitoring, and analysis, thereby increasing the operational efficiency of pharmaceutical companies.
Moreover, they help pharmaceutical manufacturers and suppliers comply with international traceability and serialization requirements, support audit and inspection readiness, and adapt more quickly to changing legal regulations.