As the EU Falsified Medicines Directive (FMD) draws closer, there remains a lack of readiness industry-wide. With many pharmaceutical businesses still yet to tackle the task of serialisation, Dexter Tjoa, Director Corporate Strategy at Tjoapack, talks about the role outsourcing will play in the months ahead and how best to engage a contract packaging organisation (CPO). 

What do you find is the most common misunderstanding when it comes to the upcoming EU FMD regulations?

Most misconceptions stem from a lack of understanding of the complexities involved in serialization. Serialization can, indeed, be a very simple process, but only if you have a team of experts to guide you through your onboarding and implementation. We should not underestimate the scale of the challenge for those who try to achieve this independently, failing to recognise the time and resource required for implementing a compliant solution. This situation has led many companies to consider outsourcing serialization to contract service providers who have a tried and tested solution in place. However, it’s important that companies recognise the time scales involved in integrating new products onto packaging lines. Realistically, at least four months are needed for a new customer to allow for sufficient communication and approval cycles. And, of course, compliance does not have a one-size-fits-all solution, meaning more time will be needed when managing multiple market requirements and ensuring system integration across supply chain partners.  

 What advice would you give a company which is yet to begin its serialisation journey?

At this stage in the countdown to the FMD deadline, outsourcing is probably the only realistic option. Time is simply too tight to start developing an in-house solution that will guarantee compliance before the February 2019 deadline. Serialization itself is not an entirely new concept, with some CPOs having been involved in serialization projects for decades. These experienced CPOs are ideal partners for companies looking to outsource their requirements. Pairing market knowledge with a tried and tested solution can be invaluable in terms of implementing serialization as quickly and efficiently as possible. 

Outsourcing can offer a level of flexibility and access to expert knowledge that may not be available in-house. The right contract partner will be able to find the best solution and work through challenges, providing the expertise and resource required at a pivotal time ahead of regulatory enforcement. 

Why would a company that would not usually outsource their packaging requirements look to a CPO for assistance?

Nothing disrupts ‘business as usual’ more than pressure and distractions. Enlisting the support of a CPO can help businesses to effectively manage the challenges they might encounter through serialization.If a company has not yet started preparations, it is unlikely it will have the capacity to deliver a compliant solution before EU FMD enforcement. The time pressures and requirement for specialist knowledge has meant that some companies, even those that would have previously regarded packaging as one of their core competencies, have started to turn to partner organisations instead. 

Outsourcing can help to reduce investment costs and prevent unnecessary disruption to production lines. In addition, it allows access to expert knowledge which can help to avoid costly ‘trial and error’ during the implementation process. It’s important to appreciate how much experience matters when it comes to serialization. Although in-house training is part of the process, avoiding the need to hire or train existing employees allows projects to start sooner. 

When should a company look to engage a CPO in its serialization preparations?

Experienced and well-prepared CPOs are already in high demand, so it’s imperative that businesses approach potential partners as soon as possible.  Standard implementation involves more than redesigning packaging artwork to incorporate a barcode. It involves creating new packaging protocols such as product master data management and master packaging records. Software integration, data exchange and connecting to the EU and national hubs are difficult processes that require proficiency to achieve smooth onboarding processes. Managing the data involved is often the most daunting task for customers, so the sooner a partnership is established the sooner both teams can work through any challenges together. Finally, test runs, training and validation are a vital part of the implementation process and should begin well ahead of the February deadline. 

If a company were to delay contacting a CPO, what affect would it have on the implementation process?

They run the risk of delays and depletion of stock. Whilst at least four months is required to implement a compliant solution, this does not mean that mid-October is the time to act. As the deadline gets closer, it is likely we will start to see a bottleneck situation as CPOs get busier with companies looking for last minute solutions. Serialization requires people, power and capital, and once a CPO reaches capacity, it will inevitably have to start pushing projects back. Resource needs to be forecasted early on so that companies can return to ‘business as usual’ as promptly as possible. Any further delay to engaging a CPO may mean companies run the risk of failing to comply altogether.