What is the impact of the latest regulations and recommendations?

Counterfeiting of medicinal products is an increasing threat to public health and safety. The World Health Organisation estimates that in industrialised countries up to 1% of medicines are likely to be counterfeit. To combat counterfeiting in the fragmented EU pharmaceutical market, the EFPIA (European Federation of Pharmaceutical Industries and Associations) is working on an end-to end product verification system, based on mass serialisation. Zetes Globe asked Pascal Longchambon, Manager of Unattended Automated Systems at ZetesInterscan, what the impact is of the latest regulations and recommendations.

The concept of EFPIA is based on serialisation. What should we understand by this?

Pascal Longchambon: In this context, serialisation means affixing unique product identification codes on the secondary packaging of all pharmaceutical products. Two-dimensional barcodes or Datamatrix are being used to uniquely identify each pack. The final goal is to enable authentication throughout the entire supply chain, from point of manufacture to point of dispensation, through a standardised and interoperable system throughout the EU.

What is the impact of the EFPIA’s recommendations on drug manufacturers today?

Pascal Longchambon: Although not yet imposed, their recommendations are already having an impact on production lines across Europe. With Turkey and France (as of January 2011) adopting the Datamatrix identification for secondary packing, companies in other countries are being pushed to be compliant with their new system. Several countries are currently considering implementing Datamatrix identification and serialisation, so we expect a serious boost in the very near future.

Does this mean customers need to implement a whole new identification system at their production line?

Pascal LongchambonNot necessarily. At Zetes, we offer 2 possibilities: we can implement an entirely new system, but we also work ‘retrofit’. This means that we make the necessary adaptations to the existing packaging machines that have already been installed at the customer’s production line.

Will the speed of the production line be affected when implementing a serialisation or codification solution?

Pascal Longchambon: When the system is solidly integrated with the ERP system and well tuned to the characteristics of the production line, the performance of the production line will not be affected. To give you an example: Zetes’ solution offers a capacity of up to 500 packages/minute.

The codification of secondary packaging involves not only printing, but also verification and storage of the data. Can one provider guarantee all these elements are well integrated?

Pascal Longchambon: This type of system requires a lot of integration work indeed, as it combines various software and hardware components that all need to be tuned to each other. In addition, it is important to offer customers a complete and flexible solution, that may consist of tamper evident sealing and/or labelling with pre-printed or inline-printed labels (as required by the social security system in France). Selecting a proven system integrator is therefore key in this type of projects.

You said it is important to select a flexible solution. What do you understand by this?

Pascal Longchambon: It is important to offer customers the most open architecture possible, both in terms of hardware and software. In a world where technology evolves extremely quickly, this approach guarantees a bigger independence towards manufacturers and hence ensures a robust and perennial solution. In these type of projects, it would be a risk to be halted by a proprietary equipment.

What about the identification of other levels of packaging?

Pascal Longchambon: An efficient serialisation solution is only possible in a broader perspective that also includes logistics containers such as boxes and pallets. This requires robust software programmes with a data model that allows the gathering of container and content information as well as the connection with all necessary hardware (marking, labeling, data capture via scanner or camera).

In addition, end-to-end traceability solutions allow optimising other processes in the logistics chain, such as order preparation, shipment verification, proof delivery, etc. By investing in the identification process at the production line, customers can thus benefit from optimised traceability across the entire supply chain.

Many drug manufacturers are global players. Imagine they would wish to optimise their production lines across various sites in Europe?

Pascal Longchambon: Managing multi-site and/or multi-country projects is an increasing challenge for multinational customers in the supply chain. Thanks to its EMEA network of subsidiaries and centralised Competence Centres, Zetes is well positioned to offers these companies an answer to their problems. Our solutions for the pharmaceutical sector are developed by the 3i Print & Apply Competence Centre, a dedicated team of experts with extensive expertise in the print & apply and labelling sector. They design and build the solutions, which are in turn implemented by the local country specialists. This allows us to offer customers a consistent approach across EMEA, while ensuring local service and support.