Pharmaceutical serialisation and traceability


pharmaceutical serialisation and traceability


With the threat of counterfeit or faulty products, being able to track and trace items during manufacture is more important than ever. Industrial traceability is vital for a number of industries and in many cases, it is essential for compliance within the industry.

Serialisation and traceability in the pharmaceutical industry  is arguably some of the more stringent considerations in regards to monitoring the production and distribution of products. Industrial traceability for the pharmaceutical and medical industry is life critical and the need for reliable and accurate machinery is vital. In this article, we’ll explore how full traceability is achieved and why it’s so important in this growing market sector.

The global pharmaceutical traceability market

Over the years, the global drugs market has continued to expand. Alongside the rise in the use of the internet and the introduction of the dark web (amongst other reasons), the rise in counterfeit drugs has meant that regulations around traceability continue to tighten in the interest of consumer safety. Tracking the manufacture of medicine throughout the supply chain ensures consistency in quality, verifying that the product is processed in a compliant environment, by a fully legal company. In addition to this, the ability to trace a drug back to its source dramatically decreases the chances of prescription drugs being sold on the black market and acts as a deterrent for illegal activity.

Why is traceability so important?

Quality control

Serialisation and traceability help to isolate contaminated pharmaceutical products and prevent them from reaching consumers in the event of a product recall. Reputable organisations must prioritise product traceability in order to be able to trade. The lack of an effective traceability procedure can be a serious public health issue. In addition, a company can benefit from a robust recall management plan by being able to return back to business with minimal interruption as soon as possible.


Appropriate tracking procedures allow organisations to keep a database of production, finding efficiencies (or inefficiencies) in the supply chain and improving internal processes and profits. Without this database of information, organisations would not be able to make informed decisions.

EU serialisation requirements

The EU has strict constraints on the quality of the medicine that can be legally distributed in the EU marketplace. Providing safe, compliant healthcare products is of paramount importance and there are a number of requirements that ensure the safety of these member countries. This legal framework sees traceability as a vital part of the process. We have identified some of the key areas surrounding these important directives.

  • Medicine authenticity
  • Dosage
  • Toxicity
  • Strengthened record-keeping requirements for wholesalers
  • Good manufacturing practice (GMP)
  • Supplier website compliance

For further information on the EU’s fight against the falsification of drugs, click here.

NCB Marking understands the importance of traceability in the pharmaceutical and healthcare industry and provides accurate, reliable and state-of-the-art traceability machinery for businesses across the EU and the globe.