Over the next few weeks, I will be discussing important tips that are intended to help guide you while undertaking your new serialisation program or project.
While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded many lessons learnt and continues to do so. This series explains some of the key things that we wish we had known before embarking on our early projects.
We hope that this information will help you make a success of your serialisation activities and avoid some of the mistakes that were made in the past.
What is serialisation
Serialisation, or serialization as it is spelled in some regions, is a tool that can be used to improve product security, help ensure patient safety and prevent fraud. Because of the benefits, much legislation is either in place, or being developed across the world that mandates serialisation. Failure to comply with these legislative requirements will mean that pharmaceutical companies will not be able to sell products in the affected markets.
Generally, serialisation requires that every product pack is uniquely identified with some form of machine readable code and registered in an external database, together with information about the product contained in the pack. Depending on the particular serialisation model, it may also be necessary to update the external database with product movement and change of ownership information, a significantly more complex requirement. Implementing serialisation across the supply chain is a major and very costly undertaking.
It is imperative that companies have a comprehensive strategy for tackling serialisation that will ensure that any risks to product supply are adequately mitigated.
I look forward to sharing this series with you and hope you will benefit from Things we wish we had known before starting a serialisation program or project. Please check back in next week for Tip 1 – Executives need to understand that serialisation will halt sales if implemented poorly.
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