The clock is ticking: Steps to success for serialisation

Are you preparing for serialisation? Carlos Machado, serialisation director at SEA Vision US, explores some of the challenges and opportunities companies are facing when preparing for serialisation and outlines some steps to success for those that are yet to make a start.

The upcoming serialisation deadlines in the US and EU should be one of the top business priorities for pharmaceutical manufacturers today. However, new industry research conducted by SEA Vision and Zenith Technologies, has highlighted that more than one third of companies in this space are not currently preparing for global serialisation requirements.

Companies need to turn their attention to meeting the demands of the US Drug Supply Chain Security Act (DSCSA) in 2017 and the European Falsified Medicines Directive (FMD) in 2019, if they are to achieve compliance in sufficient time. Of course, this is a complex task that requires both internal and external systems and processes across the entire supply chain to be adapted, meaning time is very much of the essence.

Never under-estimate impact

Companies that fail to comply with the new regulations risk production downtime and loss of business in key markets. Our recent research revealed that 15% of companies believe it is too early to begin preparations, while over half said that they don’t have enough internal resource to dedicate to serialisation.

It is important that companies recognise the enormity of the task at hand, particularly if a lack of resource is delaying their preparations. Identifying a suitable partner to assist in implementing serialisation can help but remember, the clock is ticking.

Think long-term

While compliance is the main driving force behind the need to implement a serialisation solution, it is possible to achieve wider business benefits by taking a long-term view. The regulatory changes provide the opportunity to review business processes, improve productivity and in some instances, provide a competitive advantage. The huge amounts of data that will be generated also creates the potential to increase visibility and information sharing across the supply chain. Despite this, only 44% of companies surveyed intend to use serialisation to benefit the wider business.

It is likely that global track and trace requirements will evolve over time, therefore implementing a scalable and flexible solution that accounts for this will save time and money in the future. For example, consider upcoming global regulations and the potential need for aggregation in the future. Preparing for this now will mean you are ahead of the curve.

A well-considered strategy can be a differentiating factor between a good and a great serialisation programme. So how can companies who are yet to make a start guarantee success? Below are some tips that can help keep you on the right track:

1. Consider your geographical reach — serialisation requirements differ across countries, therefore it is important to consider all of the markets you operate in or that you might want to enter in the future. Make sure you understand the various regulations to ensure you remain compliant.
2. Choose the right technology — a full serialisation set-up requires packaging, printing, data storage and transfer technology. It is not a one size fits all solution and requires a comprehensive strategy that is tailored to your individual needs. When choosing serialisation solutions, flexibility and scalability should be key, guaranteeing they are fit for purpose for the long-term.
3. Identify a suitable partner — companies that have identified a lack of internal resource to dedicate to serialisation may find external support useful. A third-party implementation partner can assist with the planning and roll-out of your solution. It can also help support seamless integration across multiple sites.
4. Establish a realistic timeframe — there are various complexities involved when implementing serialisation. As a result, it is important that time is built into your strategy to allow for test pilots to identify potential operational hurdles and rectify these before the upcoming deadlines.
5. Think ahead — take the time now to consider how future requirements will affect your business. Implementing a flexible solution will make it easier to adapt as legislation evolves.

With less than two years to go until the EU FMD enters into force, pharmaceutical manufacturers need to make serialisation a priority. It is not a task that can be completed overnight and the repercussions of failing to prepare can have a detrimental impact to the longevity of your business. Start now and you can ensure that you are on the right path to serialisation success.