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The value of serialisation

Being innovative and flexible by making smart investments early on can help set the stage for moving beyond compliance.

As we draw ever nearer to the time that compliance with the European Falsified Medicines Directive (FMD) is required, we discuss the value of serialisation beyond compliance and outsourcing with six leading solutions providers.

Value beyond compliance

While investment in serialisation is being driven by compliance — businesses should look to add value to their operations by implementing hardware and software solutions that offer multiple processes.

Aggregation may not be a condition of FMD but most global regulations require it, and many pharmaceutical businesses desire it of their partners. Adding aggregation capabilities to a packing line after, instead of in conjunction with a serialisation solution will be costly.

Paolo Landriani, technical department director — SEA Vision

As the legal landscape for drug serialisation continues to evolve, companies must look beyond short-term compliance requirements and the next major deadline to consider how this will adapt to future legislation, both in the markets they currently cater for, markets they intend to enter in the future and relevant markets that are not yet regulated.

Future-proofing solutions can be more easily achieved when outsourcing as a partner contract packaging organisation (CPO) can look beyond the day-to-day and will be more versed in the potential future requirements.

Colin Newbould, director of regulatory affairs and QP services at The Wasdell Group

At FutureLink 2018, industry leaders from across the sector discussed the ways they plan to drive increased business value from their serialisation solution in a series of polls.

When asked in which areas they would use predictive analytics to inform their decision making:

Attendees were also asked what areas of the supply chain would most benefit from serialisation data, 35% said supply chain services including recall management.

Dan Walles, VP Solution Marketing, TraceLink

Outsourcing: before it’s too late

The FMD is likely to push many CDMOs away from packaging altogether, as some don’t have adequate resources to continue this while also delivering serialisation. The outcome of this will likely be CDMOs partnering with CPOs, which should be better prepared for the new regulations. This will allow them to deliver the services that their clients require while meeting FMD compliance.

For CDMOs large enough to operate from multiple sites, centres of excellence for the implementation of serialisation may become necessary.

Staffan Widengran, director corporate projects, Recipharm

Time is simply too tight to be able to tackle the challenge of serialisation independently. Many companies are now considering external serialisation solutions simply because they have underestimated the scale of the challenge. Many are either still struggling to understand what is required, do not have the in-house expertise or have misjudged the time and resource requirements, not to mention the upfront investment involved.

Engaging the support of a CPO can help to minimise these hurdles, with tried and tested lines, as well as access to expert knowledge making the process more straightforward, efficient and stress-free.

Dexter Tjoa, director corporate strategy, Tjoapack

Serialisation is far more complex than just placing a barcode on a package. To ensure that all the dynamics of the equipment, the data, and the processes work as they should, implementation cannot be treated as a project for just one or a few functional areas. It requires changes and adoption of new technology and processes in almost all areas of an organisation and the supply chain. Collaboration with each functional area can help to avoid challenges and missed opportunities. Organisations should partner and leverage product solutions that are proven in serialisation and can help aid in not only meeting the minimum requirements but can be scalable to provide additional functionality and services. 

Being innovative and flexible by making smart investments early on can help set the stage for moving beyond compliance.

Lauren Catalano, technical services manager at Sharp

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