The serialisation landscape: Challenges and opportunities for a CDMO

Erik Haeffler, vice president of manufacturing services, Recipharm, examines the challenges and opportunities for a CDMO in the landscape of serialisation that contract partners must overcome.

With growing concerns surrounding counterfeit medicines and the threat they pose to patient safety, the pharmaceutical industry is introducing varying serialisation mandates across the global market.

Serialisation goes far beyond the ability to apply barcodes to products at the packaging line level and implementing a robust process can be both time consuming and costly. As a result, it is imperative that contract manufacturers are well prepared for the introduction of the European Falsified Medicines Directive (FMD) and its counterparts across the rest of the world.

Challenges for CDMOs

Serialisation represents a significant challenge for CDMOs; particularly those with manufacturing facilities and customers across the globe. While equipping packaging lines with new technology may seem relatively simple, managing the complexity associated with packing several companies’ products on the same line, as well as meeting the varying regulations of multiple markets, is not without its challenges.

Failing to meet the required regulations on time can not only mean costly downtime and product shortages, but potentially a loss of business in key markets. Now is the time for CDMOs, particularly those serving the European market, to rise to the challenge and differentiate their offering by demonstrating proactivity in their preparations.

Geographic and market requirements

Data requirements vary depending on the market that the drug product is supplied to. A CDMO must therefore implement a flexible solution that can be adapted to varied customer and market requirements.

For example, if production lines need to serialise products for more than one customer supplying to more than one market it may be beneficial to use the most complex data matrix (i.e., containing the most information) as standard. Some markets also require aggregation as part of their serialisation mandates and so this must be factored into the serialisation solution.

Technical challenges

In addition to the geographic complexities, there are numerous technical considerations that CDMOs need to address. Firstly, software and hardware selection is critical. In particular, the chosen software should offer the flexibility to adapt to future track and trace demands.

In addition to the line level software, CDMOs also need to consider how to generate and manage serial numbers, particularly if they’re supplying to a market, like the EU, where the varying requirements call for randomised serial numbers and in both the EU and US, where the responsibility falls on manufacturers. They should also consider how the data will be securely exchanged with customers and the relevant authorities. Using a cloud storage system can help CDMOs to simplify the data exchange process by connecting to a large global network and provide the scalability that is necessary to cater to a diverse and growing customer base.

An opportunity: good practice for CDMOs

While serialisation brings a number of challenges, it also creates the opportunity to improve business processes and establish your business as an industry leader. So, what does good practice look like? And, what should pharmaceutical companies be looking for in a contract partner? First and foremost, it is imperative that CDMOs have factored in enough time to plan, implement and agree on a solution that meets their customers’ requirements. If the CDMO has a dedicated taskforce it should be a sign that it has prioritised its serialisation preparations and allocated sufficient resources to the cause.

It is the responsibility of CDMOs to have a detailed understanding of the complexities of serialisation and the various markets in which their customers operate, which makes previous experience of delivering serialised batches desirable. However, perhaps most importantly, CDMOs should have a standardised solution which simplifies the serialisation process, while also being flexible enough to cater for the required markets and adapt to future changes to regulations.

Final thought

Introducing a comprehensive solution that will meet the varying serialisation requirements across the globe is no small task and the complexities associated with developing a robust process mean a thorough understanding of the global market is essential.

Failure to comply with the new legislation on time could lead to product shortages and a potential impact on patients, as well as wastage, costly downtime and a possible loss of business due to reputational damage.

The potential impact of being under-prepared is vast and CDMOs should be working closely with their customers to ensure they can cater for their individual requirements. As the saying goes, those who fail to prepare should prepare to fail.

Erik Haeffler will be leading a speaking session on serialisation from a CDMO perspective at NEXUS '17, taking place in Barcelona, 7-8 June.