Serialization and the fight against counterfeit medicines

Counterfeit medicines are a growing problem on a global scale. It is an issue affecting the whole of the pharmaceutical industry as it concerns patient safety, business ethics and financial impact.

To combat the problem, regional and national authorities are implementing new regulatory requirements. Some are already in place, while the majority will come into force during the coming years.

Primarily, protection against counterfeit medicines covers four areas:

  • Serialization – All pharmaceutical packaging needs to be market with unique information (product-related information and a unique random serialization number).
  • Aggregation – The ability to read a single code on a transport unit in order to identify which products are included.
  • Tamper evident packaging – To show if the packaging is intact.
  • Verification – Uploading and checking serialization numbers on an information database, to ensure each unit is only sold/prescribed once.

Meeting requirements

To meet the new regulatory requirements, pharmaceutical companies face a major challenge. In most cases, implementing a ‘track & trace’ solution will require a company-wide change program, including:

1. Indentifying requirements

2. Anchoring change internally and ensuring stakeholder buy-in

3. Selecting the right supplier and the right system solution

4. Installing the new solution on the production line

5. Establishing a data management solution

6. Adapting routines to ensure the new system works in day-to-day operations

7. Managing change, learning and improving

New opportunities

It is a complex journey affecting many different functions and levels within the organization. But it is also an opportunity to modernize and improve operational performance.

To be successful requires a holistic approach and an integrated strategy taking in the need for specialist expertise, for example, knowledge of applicable regulations, change management, system installation, validation activities, and administration of both automation and IT systems.

Linda Pell
Linda PellSenior Consultant & Team Leader
Tel: +46 (0)8 503 045 92