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Serialization programs: overlooked business risks and pitfalls


Chuck Sailer
Serialization Solutions Expert
Princeton, USA


Mandates for unit-level serialization and aggregation are looming in both the European Union and the United States. Like any major regulation, the approaching mandates have triggered an expedited push for compliance to maintain market share and viability. But any large-scale infrastructure investment – and their resulting production process complexities – comes with risks, and the effort toward serialization compliance certainly has its share of potential pitfalls. Here are tips for avoiding these business missteps.

In the modern pharmaceutical supply chain, Serialization and Track & Trace are absolutely essential. However, implementing a new process is a complex undertaking, and with complexity comes risk and uncertainty. As mandated deadlines draw near, the window to identify issues, mitigate risks and gain clarity on uncertainties is shrinking. Having a Serialization and Track & Trace solution, or a solid strategy for it, has now become critical, as there are almost 40 different legislations on drug serialization in place, with varying deadlines and almost as many different requirements.

In Korea, for instance, all pharmaceutical products have required serialization since January 2016, per the country’s Pharmaceutical Affairs Act. In the United States, current serialization requirements are limited to marking the unit of sale with a unique data carrier; however, America’s Drug Supply Chain Security Act (DSCSA) mandates that, by 2023, a pharmaceutical product is traceable through its entire journey. In the European Union, the Falsified Medicine Directive (FMD) necessitates serialization solutions be operational by February 2019.


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