Need to know: pharmaceutical labelling

Posted on 21 October 2022 by Thomas Glendinning

The pharmaceutical industry is unforgiving and has extremely high demands. With patient safety and adherence front and centre,  100% accuracy is required 100% of the time for labelling and packaging.

As regulators and markets push harder on serialisation, traceability, anti-counterfeiting, and patient-centric information, manufacturers of labelling and sleeving equipment must deliver systems that are accurate and future-proof.

Why labelling matters for pharma

A correct, legible label that carries the right data (product identifier, lot, expiry, serial number, handling instructions, etc) directly benefits patient safety. Beyond use instructions, modern pharmaceutical labels are the primary mechanism for serialisation, verification and recall management. This means labelling lines are essential to safeguarding the supply chain from counterfeits and errors.

Pharma is one of the most regulated markets. In the US, for example, unit-level identification and electronic traceability of prescription drugs is required under the Drug Supply Chain Security Act (DSCSA). The DSCSA’s aim is an interoperable, electronic system to identify and trace certain prescription drugs at the package level throughout the supply chain. Manufacturers must be prepared to apply unique identifiers and to support downstream verification and data exchanges.

Additionally, FDA’s 21 CFR Part 201 specifies what must appear on labels and how information must be presented to avoid misleading claims and to ensure safe use. These rules drive the need for consistent, auditable label application processes and change-control on printing data.

In Europe, the EU’s Falsified Medicines Directive has obligations for safety features (a unique identifier and an anti-tampering device) on the outer packaging of many medicinal products, to prevent fake medicines entering the legal supply chain. This Is just one of the Directive’s measures.

Trends shaping the future of pharma

The above require the following of labels and their content for pharmaceutical products and packs:

• Serialisation & 2D barcodes (as standard)
  GS1-aligned 2D barcodes are the de-facto carrier for GTIN, batch/lot, expiry and serial numbers, supporting both regulatory traceability and faster automated inspection. High-density DataMatrix codes must be printed reliably and be read at high speeds.
• Track-and-trace integration
  Serialisation has moved beyond printing and manufacturers must provide secure serialisation data capture, aggregation, and systems that integrate with ERP/MES and national repositories for real-time verification.
• Anti-counterfeiting and smart labels
  Adoption of NFC/RFID and other smart label technologies is growing to enable consumer verification, cold-chain monitoring, and enhanced anti-tamper features, especially for biologics and high-value medicines. Hybrid labels that combine a printed DataMatrix with NFC/RFID chips and temperature-sensitive inks are increasingly popular.
• Sustainability
  Pressure is growing to lower the footprint and impact of packaging and use recyclable/bio-based materials. This affects labelstocks, adhesives, and sleeve choice (where applicable). Equipment must be able to handle a broader range of substrates without sacrificing quality or verification.
• Automation, inspection and AI
  Vision systems and machine-learning inspection are rapidly evolving to detect print defects, code quality issues, and tamper evidence automatically, reducing false rejects while improving safety.
• Market growth and investment
  The serialisation and secure-labelling market is expanding quickly as mandates roll out globally and companies retrofit lines to comply and add anti-counterfeiting features.

The role of labelling equipment

To ensure compliance with the evolving needs of the pharmaceutical market, labelling lines need to be able to offer some of, if not all of the following:

• The ability to print and apply high-quality 2D DataMatrix and human-readable information, inline at the required line speeds.
• Capture and log serialised data in an auditable, tamper-evident way and integrate with serialisation repositories and enterprise systems.
• Verify every code with inline vision/readers and reject or divert non-conforming items automatically.
• Meet hygiene and material-compatibility requirements (stainless construction, cleanroom-friendly designs where required).
• Support electronic records and access controls consistent with regulatory audit expectations (e.g., validation documentation, secure user management).
• Be modular and upgradable to accommodate NFC/RFID, temperature sensors, or future changes in regulatory data requirements.

Using our deep experience and appreciation for the challenges facing the pharmaceutical market, we provide systems that are bespoke and built with pharmaceutical production realities in mind.

For example, working with OEMs and third-party suppliers, serialisation-ready print engines can be integrated to deliver crisp, machine-readable codes at line speeds, with automatic print-quality monitoring.

Similarly, inline verification and vision inspection tool check and confirm code integrity, with automatic rejection/segregation workflows.

Our machines feature a pharma-grade mechanical design and use stainless steel or enclosed designs for low particle shedding, easy washdown, and few crevices.

Being modular by design, they can be upgraded with any number of additional options and features that are required as needs change and markets evolve.

These capabilities and more make our systems a strong fit for pharmaceutical manufacturers who must blend high throughput with uncompromising quality, compliance, and validation

This is important as pharmaceutical labelling is a rapidly evolving landscape and demands fully integrated, data-centric control points for safety, authenticity, and compliance. Regulatory mandates plus commercial drivers mean manufacturers should, nee must invest in reliable, verifiable, and upgradeable labelling systems.

View our labelling options suited for pharmaceutical labelling and contact us to discuss your specific requirements.