Packaging Serialisation: Enhancing Traceability and Compliance across Regulated Industries

Packaging serialisation is a crucial element for compliance and supply chain transparency, especially in highly regulated sectors such as the pharmaceutical industry. It enhances product traceability and ensures safety from production to end users.

While serialisation is vital in pharmaceuticals, it’s increasingly important across various other industries. Many sectors are now adopting serialisation to combat counterfeiting, improve traceability, and enhance logistics efficiency.

So, which sectors rely most on serialisation? How does it benefit them—and what challenges exist in implementing it?

What is Packaging Serialisation and Why it Matters

Serialisation is the process of creating and assigning a unique identity to each product so it can be tracked throughout the supply chain. By enabling traceability, serialisation allows for end-to-end visibility empowering monitoring from upstream production to after-sales service.

• From Batch Codes to Unique Product Identifiers (UPIs)

Before serialisation, product tracking in regulated industries relied on batch codes meaning products were traced at the batch level. Today, the process has evolved: each product package is assigned a Unique Product Identifier (UPI).

With a UPI, every unit can be individually tracked and verified from factory to consumer. In other words, serialisation enables full transparency revealing where the product came from, who produced it, and whether it’s authentic. This level of visibility not only strengthens consumer confidence but also empowers regulators and manufacturers to respond faster to safety or quality issues.

Read About: Lot and Batch Code: The Differences and How to Track

• How Serialisation Works on Primary and Secondary Packaging

Serialisation is applied differently on primary and secondary packaging. On primary packaging, it’s typically applied directly using a vial label but only if the unit is intended for individual sale.

Conversely, serialisation is mandatory on secondary packaging. Each unit must be assigned a UPI to support rapid verification and traceability during shipment.

Industries that Rely on Serialisation for Compliance and Safety

Industries ranging from pharmaceuticals to high-value consumer goods depend heavily on packaging serialisation particularly to ensure safety and regulatory compliance.

• Pharmaceutical and Healthcare Supply Chains

The pharmaceutical and healthcare sectors rely heavily on serialisation to manage supply chains. It’s essential for compliance with global regulations and for preventing counterfeit or expired drugs from reaching consumers. Serialisation also streamlines product recalls in the pharmaceutical sector, reducing risks to patient safety and minimizing operational disruptions.

• Food and Beverage Safety and Recalls

In the F&B industry, serialisation supports safety and speeds up product recalls. It helps mitigate allergen risks and enables faster traceability back to suppliers for effective recall management.

• Personal Care and High-Value Consumer Goods

Personal care and high-value consumer goods are frequent targets of counterfeiting. Serialisation helps prevent such incidents and also enables precise recalls of defective product units when needed.

Benefits of Serialisation in Modern Packaging Operations

While packaging serialisation offers major benefits to regulated industries, it also provides valuable advantages across modern packaging operations, including:

• Improved Traceability and Inventory Accuracy

Serialisation enables complete traceability tracking products from raw materials through every stage of distribution.

It also improves inventory accuracy, helping manufacturers, distributors, and suppliers collaborate more effectively. Better collaboration across the supply chain ultimately leads to cost savings, reduced waste, and improved delivery performance.

• Brand Protection and Anti-Counterfeiting

Each unit’s unique identifier makes counterfeiting extremely difficult. In short, serialisation ensures product authenticity and protects brand reputation.

• Support for Regulatory and Customs Compliance

Serialisation helps industries like pharmaceuticals, personal care, and F&B comply with global regulations. This prevents penalties, reduces legal risks, and ensures access to international markets.

Challenges in Implementing Serialised Packaging Systems

Despite its benefits, implementing serialisation, comes with challenges particularly around integration, print durability, and choosing the right system.

• Print Speed, Line Integration, and Code Durability

Implementing serialisation in high-speed production lines presents challenges in maintaining speed, quality, and code durability. Without seamless system integration, operations can be error-prone, suffer downtime, and compromise overall compliance.

• Choosing the Right Coding Technology for Your Packaging Line

Choosing the right coding technology is essential for smooth serialisation. However, the decision isn’t always straightforward due to the wide range of factors to consider.

Markcom’s Approach to Smart Serialisation Printing

The wrong coding technology can disrupt or even break your production and traceability flow. That’s where Markcom Global comes in, offering smart serialisation printing to meet your evolving needs.

• Flexible Printers for Individual Unit Coding

Markcom Global offers a smart solution with thermal inkjet technology, a flexible printer that works seamlessly across various packaging types. It delivers sharp, consistent unit-level coding to help ensure compliance with regulatory standards.

• Seamless Integration with MES and Cloud Tracking Systems

Our advanced thermal inkjet printers integrate effortlessly with MES, ERP, and cloud-based tracking systems. This allows for real-time printing while meeting compliance and readability standards.

Elevate Your Quality Results with Our Smart Printing!

Smart printing technology is the foundation of effective packaging serialisation. With Markcom Global solutions, every product unit is marked clearly and uniquely. Future-proof your operations with our fast, reliable, and adaptable printing systems today! By adopting the right serialisation strategy now, businesses can secure long-term competitiveness while meeting evolving global regulatory standards.

References:

https://www.gs1.org/standards/epcis

https://www.domino-printing.com/en-us/products/serialisation/serialisation.aspx

https://blog.nbs-us.com/how-serialization-is-used-in-pharmaceutical-packaging

https://www.weber-marking.com/blog/what-is-serialisation/