Serialization Beyond Compliance

Serialization Beyond Compliance

Edith Oyen Posted 24 March 2020

The circulation of counterfeit drugs is a genuine danger for patient safety. They might be ineffective or can cause adverse reactions, leading to major health risks and putting the life of patients in danger. Furthermore, pharmaceutical companies risk to lose tremendous amounts of revenues, and brand equity can get impaired.

In order to counteract unauthorized parallel supply chains and the circulation of falsified drugs, many countries are developing or have developed regulatory roadmaps for serialization. Over one year ago, the Falsified Medicines Directive (FMD) entered into force in the European Economic Area, which made serialization mandatory for pharmaceutical supply chain members. It includes the implementation of safety and control features, such as a unique serial number and an anti-temper evidence, to ensure recognition of product authenticity. In addition, a new European legislation for Medical Devices is on its way, with the Medical Devices Regulation (EU MDR) becoming effective in May 2020. We expect that more regulations and legislations will follow to further secure the supply chain in Life Sciences as well as in other industries.

It is important to note that the implementation of serialization should not be limited to a legislation compliance exercise (although this is the main driver). There are many benefits beyond compliance, providing opportunities for additional return on investment. Some examples are:

  1. Supply Chain Visibility
    The implementation of serialization improves Supply Chain visibility, as each product can be tracked via track & trace features while it moves along the supply chain. Inventory and lead times can be controlled better, and product losses and associated costs can be avoided.
  2. Optimization of Recall Management
    In case a product needs to be recalled, a company can react much faster with a serialization system in place. With the information of the affected product in hand, it is possible to trace in which storage locations the batch is situated.
  3. Big Data Analytics
    Serialization can be the source of Big Data to gather statistics about amongst others Sales & Marketing effectiveness, consumption behavior and geographical penetration. This can in turn be used as input for strategical projects.

Our Modis Project Managers and Subject Matter Experts have profound expertise in Industry 4.0, Serialization and Compliance & Regulatory Management. By close collaboration with your team, Modis will be your partner to successfully guide your serialization project towards success.

If you want to learn more about serialization, you can consult our Case Study.

Edith Oyen,
Project Manager Life Sciences

SOURCE: https://emvo-medicines.eu/mission/emvs/

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