Tackling the Challenge of Serialisation and Traceability

Pharma IQ

As counterfeit drug sales become increasingly costly to both pharmaceutical manufacturers and patients, companies are attempting to address the challenges of serialisation and traceability to reduce the burden on health services across the world.

There is already a great degree of activity in the industry to help boost supply chain security, reduce counterfeiting and ultimately protect patient safety and companies' bottom lines, and one company which is aiming make a difference in the sector is Belgian firm Zetes.

The coding systems company has already is predicted a "very good financial year" after revenues rose by almost six per cent in the first half of 2010, largely due to sales in its Goods ID division, which focuses on technologies used to manage products through the supply chain using barcodes, RFID and voice recognition systems.

In its interim results statement, the firm revealed that although much of Zetes Goods ID division sales come from the food sector, it has begun to make forays into the pharmaceutical sector and has ambitious plans with regards to serialisation and traceability.

"From a sector perspective, the distribution sector and the pharmacy sector are the ones supporting the growth," the company stated.

At the start of the month, Zetes' expanded its activities in the pharmaceutical sector by launching a new datamatrix marking, control and serialisation solution which it claims will "help drug manufacturers across Europe comply with new and incoming legislation regarding the identification of secondary packaging of medical goods".

The solution ensures the accurate affixing of datamatrix codes, either directly on the package (coding or marking) or via real-time printed labels, which is designed to minimise the chances of counterfeiting occurring. In addition, the tool also handles serialisation, tamper-evident sealing, and labelling with pre-printed labels, with Zetes claiming it has been designed to integrate with high speed production lines, which will ensure secure marking and inspection and the storage of data of up to 500 packs per minute.

Alain Wirtz, chief executive of Zetes, said that improving traceability is an "increasing challenge" for many manufacturers, with one drug manufacturer in France already utilising the news system to print the datamatrix codes needed to comply with the country's CIP13 batch-level coding requirements.

He explained: "Our solution has been developed based upon our extensive experience with designing, building and implementing print and labelling systems, which are already used by many drug manufacturers at the end of their production lines."

Mr Wirtz said that the counterfeiting of medicinal products is an "increasing threat to public health and safety", and pointed out that the European Federation of Pharmaceutical Industries and Associations is working on an end-to-end product verification system, based on mass serialisation.

By identifying each individual product, he noted that the industry may be able to combat counterfeiting, reduce theft and derivations, and thus ensure improved patient safety.

With industry leaders keen to identify the best way of achieving a smooth transition to mass serialisation and keep apace of the rapidly-evolving authentication, serialisation and track and trace systems in order to reduce counterfeiting and remain competitive, developments such as those being made by Zetes are likely to continue to increase in volume in the coming months and years.

Cost-effective supply chain security and compulsory safety features are industry buzzwords and both will play a key role in serialisation and traceability in the near future.

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