Traceability in the pharmaceutical industry is an essential aspect of ensuring patient safety and complying with industry regulatory requirements. Through proper coding and the implementation of control systems, companies can track each medicine throughout its lifecycle, from production to the point of distribution.
That's why in this article, from United Barcode Systems,manufacturers of labelling, coding and marking equipment with over 30 years of experience,we talk to you about what pharmaceutical traceability involves, the current challenges and the benefits of efficient management.
What is traceability in the pharmaceutical industry?
Definition of the concept and its importance
Traceability in the pharmaceutical industry is the process of tracking and monitoring every step in the life of a medicine, from its manufacture until it reaches the final consumer. It ensures that products are safe, authentic and of high quality , by providing accurate information on their origin, composition and distribution. Its main objective is to avoid risks to patients by ensuring that the medicines administered are legitimate and meet the required standards.
The importance of traceability in this sector lies in its ability toprevent errors, identify defective batches and respond quickly and efficiently to potential product recalls. In an industry where safety and accuracy are priorities, implementing a reliable traceability system is essential to protect both patients and pharmaceutical brands.
Tracks and monitors every step in the life of a medicine
Current challenges in pharmaceutical traceability management
Despite technological advances, medicines traceability faces several challenges. One of the main challenges is the complexity of global supply chains, which involve multiple actors and jurisdictions, making it difficult to maintain unified and efficient control.
Another major challenge is the integration of technology systems. Many companies still operate with outdated infrastructures or infrastructures that are not compatible with new serialisation requirements, limiting their ability to ensure efficient traceability. In addition, the emergence of counterfeit medicines and the rise of e-commerce have added pressure on pharmaceutical companies to implement more advanced solutions to protect their products and consumers.
Benefits of efficient traceability in the pharmaceutical sector
Ensuring patient safety
An efficient traceability system allows each medicine to be traced from its origin to its final destination,ensuring that it is safe and meets established quality standards. . This level of control helps to quickly identify and recall defective or contaminated products, minimising the risk to patients. It also provides an additional level of confidence, as consumers can verify the authenticity of the medicines they purchase.
Patient safety is also enhanced by the ability of traceability systems to prevent errors in the administration of medicines. For example, by providing accurate, real-time information on each product, traceability systems help to avoid confusion between similar medicines or batches with specific problems.
Prevention of counterfeit medicines
Counterfeit medicines are a global problem that puts public health at risk. Traceability of pharmaceutical products is an essential tool to combat this problem, as it allows each product to be identified with a unique code,making it more difficult to counterfeit. In addition, serialisation systems make it easier to verify the authenticity of medicines at any point in the supply chain.
Thanks to technologies such as 2D codes and digital verification systems, companies can track each unit of medicine, ensuring that it reaches the consumer in perfect condition. This not only protects patients' health, but also strengthens trust in the healthcare system and pharmaceutical companies.
Key technologies to improve traceability in the pharmaceutical industry
Advanced coding and labelling systems
Advanced coding and labelling systems are the basis for ensuring efficient traceability in the pharmaceutical industry. They allow each product unit to be uniquely identified, from the primary level to the end of the supply chain, in compliance with regulations such as serialisation and GS1-128 codes.
For pallet labelling in the final stages of production, the APL 60 and APL 80 Series from United Barcode Systems are an ideal solution. These automated systems allow the printing and application of labels on one, two or three sides of the pallet, even on pallets with variable heights or overlapping. Their ability to operate at high speeds and comply with international standards ensures accurate and legible coding on every pallet, improving traceability and reducing logistical errors.
When it comes to product coding, the TJX Series printers excel in their ability to print directly onto a variety of substrates, including porous and non-porous surfaces such as glass, plastics, painted materials, paper, cardboard, wood or metal.
Thethermal inkjet technology (TIJ) used in these printers enables crisp, high-resolution printing, ideal for batch, expiry dates and 2D codes that facilitate drug traceability at the primary level. In addition, their compact design and easy integration make them a versatile tool for pharmaceutical production lines.
Management software and centralised databases
Specialised software is essential to manage traceability in the pharmaceutical industry. These systems centralise and automate coding, labelling and registration processes, ensuring that each product is accurately identified and complies with international regulations.
In addition, reliable software facilitates real-time monitoring of movements in the supply chain, detecting irregularities and enabling rapid responses to problems such as defective batches or distribution errors. In a highly regulated pharmaceutical environment, software-based management systems not only improve operational efficiency, but also enhance patient safety by ensuring that each medicine reaches its final destination with complete integrity.
In our case we have UBS LABMAN, , an advanced software specifically designed to manage and control all labelling and coding equipment on the production line. This software stands out for its ability to fully automate processes, eliminating the need for human intervention and significantly reducing the margin of error. UBS LABMAN can generate 18-digit pallet number plates (SSCC), monitor the status of the equipment in real time and reprint labels if necessary, ensuring continuous and accurate operation.Gracias a su integración con sistemas ERP y MES, UBS LABMAN permite una comunicación instantánea con toda la línea de producción, optimizando el flujo de datos y asegurando que cada producto esté correctamente etiquetado y codificado.
Thanks to its integration with ERP and MES systems, UBS LABMAN enables instant communication with the entire production line, optimising data flow and ensuring that every product is correctly labelled and coded.
Real-time traceability with IoT and blockchain
The implementation of technologies such as the Internet of Things (IoT) and blockchain is revolutionising traceability in the pharmaceutical industry. IoT devices, such as sensors and readers, allow real-time data to be collected during all stages of the supply chain. This ensures continuous tracking of products, improving visibility and detecting any anomalies immediately.
The blockchain, on the other hand, provides a decentralised and secure platform for storing and sharing traceability data. By recording every transaction or movement in an immutable chain, it ensures the integrity of information and reduces the risk of counterfeiting or tampering with medicines.
Strategies for implementing effective traceability
Integrating traceability at all stages of the supply chain
To ensure efficient traceability, it is crucial to integrate traceability into all stages of the supply chain, from initial production to final distribution. This involves adopting standardised coding systems and ensuring that every actor in the chain has access to relevant product information. Full integration allows for early detection of irregularities, such as incorrect shipments or defective products, minimising the impact on the end customer.
Collaboration between the different links in the chain is essential. By implementing interconnected systems, companies can share data in real time, optimising logistics and ensuring that each product complies with specific regulations at each stage.
Staff training in new technologies and regulations
The success of any traceability system depends on staff preparation and training. As technologies evolve, it is important that operators and managers understand not only how to use the equipment and software, but also the regulations with which they must comply. This includes knowing the latest serialisation standards, labelling regulations and coding technologies.
Continuous training not only reduces the margin for error, but also ensures that employees can adapt quickly to regulatory or technological changes, keeping traceability a strategic priority in the organisation.
Staff training is key to the smooth running of the project.
Establishment of internal quality control audits
Internal audits are a key tool to ensure compliance and quality of the traceability system.These regular assessments identify process failures, ensuring that products are correctly coded and comply with international standards.
In addition, audits help to identify areas for improvement, such as the need to upgrade equipment or implement new technologies. By maintaining constant monitoring, companies can stay ahead of potential problems, protecting both consumers and their reputation.
As you have seen, traceability in the pharmaceutical industry is not only a regulatory obligation, but an essential tool to ensure patient safety, prevent counterfeit medicines and optimise logistical processes.
In an environment where safety and accuracy are paramount, adopting strategies that integrate traceability at all stages of the supply chain is key to maintaining consumer confidence and strengthening competitiveness in the marketplace.
At United Barcode Systems we offer end-to-end solutions for labelling, coding and marking in the pharmaceutical sector. Contact us today to find out how our equipment can help you comply with international regulations and improve the safety and efficiency of your operations.
