Discover Pharma speaks with Max van Heeswijk, IT Manager at Tjoapack, about the evolving role of serialisation, how digital infrastructure enhances supply chain security, and what the future holds for pharmaceutical traceability.

Why is serialisation no longer just a regulatory checkbox but a strategic necessity for pharma companies today?

For pharmaceutical companies today, serialisation has gone far beyond a simple regulatory box-ticking exercise; it’s now a crucial strategic imperative.

Initially, serialisation was driven by legislation like the EU Falsified Medicines Directive (FMD), focused on combating counterfeit drugs and boosting patient safety. Companies prioritised compliance deadlines, often viewing it as a pure cost. However, the industry has matured, and serialisation’s true value is becoming increasingly clear.

Beyond compliance, serialisation provides real-time supply chain visibility, allowing companies to optimise inventory, respond quickly to recalls, and gain insights into product movement. It protects brands from falsified products and enhances patient safety. The data generated informs market analysis, forecasting, and investigations—transforming serialisation into a competitive advantage that improves product integrity and operational efficiency.

What are some of the key risks facing supply chains without adequate serialisation, particularly in light of increasing global counterfeiting?

Without serialisation, pharmaceutical supply chains are highly vulnerable to counterfeit medicines infiltrating the legitimate network. Without unique identifiers, fake products are difficult to detect and remove, putting patient safety at risk.

A lack of serialisation also hampers targeted recalls. Identifying and isolating affected products becomes difficult, often resulting in large-scale recalls that disrupt supply and damage public trust. It also hinders investigations into contamination or diversion.

Poor visibility makes it harder to track inventory and respond to changing demand, increasing waste and vulnerability to theft or diversion. Ultimately, inadequate serialisation undermines patient safety and the financial stability of pharmaceutical businesses.

How have global regulatory requirements, like the EU Falsified Medicines Directive and the US DSCSA, shaped industry approaches to serialisation?

The FMD in the EU and the US DSCSA transformed serialisation from an optional process into a mandatory one, prompting major investments in IT systems and process redesign.

These frameworks standardised product identification using 2D DataMatrix barcodes, enabling granular tracking. While both regulations aim for secure supply chains, the EU uses a central verification system decommissioned at the point of dispensing, while the US focuses on electronic tracking and verification of suspect products.

These differing approaches mean companies must navigate dual-compliance models and maintain interoperable systems across markets. Despite the increased operational complexity, these requirements have helped drive digital transformation and foster greater collaboration in the pharma supply chain.

In practice, how does serialisation data get used across the supply chain, and what happens when discrepancies are detected?

Serialisation data includes serial numbers, batch info, and expiry dates, generated during manufacturing. This data travels with the product, scanned at each handover—manufacturer to wholesaler to dispenser.

Each scan validates the product’s authenticity and location, creating a transparent audit trail. In the EU, pharmacies decommission packs at dispensing, preventing re-entry into the supply chain.

When discrepancies occur—duplicate or invalid serial numbers—products are quarantined and investigated. These issues may stem from scanning errors, shipment mistakes, or potential fraud. Swift resolution is key to maintaining patient safety and avoiding disruption.

What are the biggest technical or operational hurdles companies face when implementing digital serialisation, especially in multi-market supply chains?

A major challenge is integrating older legacy IT systems with modern serialisation requirements. These systems often weren’t designed for real-time, granular data exchange.

Managing the huge volume of data and ensuring compliance across varied markets is another hurdle. Differences in reporting and verification rules require custom workflows and add complexity.

Operationally, aligning practices across packaging sites and training staff on new technologies requires sustained effort. Exception handling—resolving scanner failures or mismatched data—also demands robust protocols and coordination.

What role does serialisation play in recall management and pharmacovigilance?

Serialisation enables precise product tracking, allowing companies to conduct targeted recalls rather than withdrawing entire batches. This reduces waste and ensures faster removal of affected packs.

In pharmacovigilance, serialisation aids the tracing of adverse event reports to specific batches and distribution routes. This enhances root-cause investigations and accelerates safety signal detection, ultimately protecting patient health.

Can serialisation data be used for more than compliance, for example, in improving inventory efficiency or patient safety?

Yes—serialisation data greatly improves inventory visibility and control. It allows accurate stock monitoring, helps manage expiry dates, and reduces the risks of overstocking or shortages.

This real-time tracking supports demand forecasting and logistics planning. The detailed unit-level data also provides a foundation for process optimisation, from distribution to product returns.

Beyond inventory, it informs market intelligence and improves responsiveness across the supply chain.

Serialisation also contributes to broader operational control. For example, detailed tracking helps identify inefficiencies and bottlenecks, enabling companies to fine-tune processes. It also facilitates better returns management and helps flag unauthorised product movement, further supporting brand protection.

How do you ensure data integrity and cybersecurity when managing vast amounts of serialised product information across partners and platforms?

A secure technical framework is essential. This includes strong encryption for data in transit and at rest, robust cloud infrastructure with backup, and secure network designs.

Strict access controls—role-based permissions and multi-factor authentication—help safeguard data. Regular audits and monitoring are also critical.

Standardised protocols such as secure APIs enable secure data exchange with partners. Continuous threat assessments and penetration testing help identify vulnerabilities. Creating a culture of security is key to ensuring data resilience.

Additionally, consistent data validation routines and automated alerts help ensure accuracy across systems. By embedding these checks into daily operations, companies can respond swiftly to anomalies and avoid data corruption or loss.

What impact do you think serialisation has had on counterfeit prevention so far, and where are the gaps that still remain?

Serialisation has made counterfeiting harder by enabling traceability down to the unit level. Unique identifiers and audit trails discourage fraud by closing gaps in the legitimate supply chain.

However, challenges remain in unregulated channels like illicit online pharmacies, where serialisation offers limited protection. Global inconsistencies in enforcement and data exchange can also create vulnerabilities.

To strengthen anti-counterfeiting efforts, the industry must continue improving interoperability, compliance consistency, and vigilance across the supply chain.

Moreover, education and public awareness are critical. Encouraging consumers and healthcare providers to verify products via smartphone apps or packaging tools can add an extra layer of security to the ecosystem.

Looking ahead, how might technologies like blockchain or AI influence the next phase of serialisation and supply chain transparency?

Blockchain could enhance transparency by creating tamper-proof records shared securely across stakeholders. This would reduce data manipulation risks and improve accountability.

AI can analyse serialisation data to detect anomalies, predict disruptions, and optimise logistics. It supports predictive maintenance, smarter demand planning, and faster issue resolution.

These technologies also enable more proactive approaches to quality control and compliance monitoring. For instance, blockchain-enabled smart contracts could automate verification at customs or trigger alerts when supply chain standards are not met.

Together, AI and blockchain can elevate serialisation from traceability to intelligence—enabling a more agile, secure, and efficient pharmaceutical supply chain.