Serialization vs. Track & Trace in the Pharma Industry

Why Serialization vs. Track & Trace? 

To talk about serialization vs. track & trace in the pharmaceutical industry might seem counter-intuitive to some people. After all, these two (or three) terms are often taken to mean the same (or at least very similar) thing. Once we look under the hood, however, it becomes apparent that not only are they not the same but feature important differences between each other that all contribute to their ultimate purpose.

It should be noted, however, that despite not meaning the same thing, the reason for all three of these technologies is largely the same in the world of pharmaceutical businesses. Whether we are talking about serialization or tracking or tracing, all of these ultimately serve to make the world of medicine distribution safer for patients. A truly robust global serialization and track and trace system is necessary if we are ever to purge the world of counterfeit and dangerous drugs which make their way into the hands of patients with potentially deadly consequences.

Compared to some of our other texts, this article may seem a bit on the simpler side. Nevertheless, it is essential knowledge. Get comfortable, fetch yourself a drink or snack of your choice, and enjoy!

Serialization 

The most effective strategy to stop fake pharmaceuticals from entering the supply chain is to keep track of every drug that is made. This is where serialization comes in. It means that every manufactured item has a special serial number associated with it.

The standards for serialization vary by nation. While some nations adhere to the GS1 standards, others have their own system for product identification. The fundamental goal, however, remains the same: to make it easier to identify all authentic products and make it possible to identify those that lack a valid serial number.

When talking about serialization vs. track & trace, then, we can say that serialization refers purely to this process of association and labelling.

Since the majority of national pharmaceutical companies participate in international trade, serialization regulations typically follow the GS1 criteria to ensure standardization. As manufacturers would need to implement two different serialization systems for local and international trade, having a different serialization scheme won’t help with global trade.

Achieving aggregation is serialization’s ultimate goal. This refers to parent-child interactions between several layers of packing in a hierarchical serialization scheme.

But creating serial numbers is only the beginning of serialization. Maintaining those identifications is also necessary to improve supply chain visibility. To effectively monitor and record data as the items move from the manufacturer to the distributor and then to the dispensing site, the whole supply chain must work together.

This is where track & trace come into the picture.

Serialization vs. Track & Trace 

Getting even more granular, tracking and tracing are often both lobbed together as being the same thing. However, these are also different from each other.

When you track a product, you’re essentially finding out where it is in the supply chain.  Meanwhile, tracing means identifying all the entities that the product has previously been in contact with.

As we can see, the similarities are there, but there are also important differences. Not only that, but serialization is a prerequisite for both of these to be possible. Together, they develop a complex system that enables participants in the supply chain to track the progress of the product up until it reaches the dispensary. Additionally, it makes traceability easier in the event that a medicine is returned.

Members of the pharmaceutical supply chain need an end-to-end data reporting and management system for this system to function. Stakeholders must integrate new equipment into their manufacturing processes and grant data access to all organizations in the supply chain that are both above and below them.

The end goal of these technologies 

Although this article talks about serialization vs. track & trace, they all serve a common purpose. A chain-wide serialization and track-and-trace system, when properly implemented, might make it practically impossible to introduce counterfeit medications into the pharmaceutical supply chain. In essence, each product will be assigned a special serial number that will be visible to all supply chain participants, including producers and dispensaries. Any item with a serial number that doesn’t match a record in the database (perhaps a fake) will be rejected right away.

The many benefits they collectively provide include:

• Makes it easier to trace complaints from medical professionals, pharmacy staff, or patients back to the individual packaging
• Improves operation profitability and efficiency in the long term
• Shows that you are serious about patient safety
• Helps standardize customs and regulations in both local and global markets
• Provides an easy way to run important market analytics

One of the main concerns with serialization is that it can take a long time to implement. However, serialization will sooner or later lead to aggregation. After that, supply chain participants won’t need to scan each unit individually to enter the product data into the database. All the data related to the units inside the carton will be immediately loaded into the database once they simply scan the serial number on the parent packaging, such as a carton.

Conclusion 

You now hopefully have a better idea of the differences between serialization vs. track & trace. The very fact you are reading this article suggests that you probably did not think they are the same thing in the first place, but still perhaps had some trouble understanding truly what each of these terms referred to.

If this article has inspired you to accelerate the implementation of your own serialization and track & trace systems, then we are happy to offer you some help. If you browse our website, you will find an assortment of services tailored to pharmaceutical companies who would like help with these technologies and practices. We especially recommend Nubinno Assessment and Accelerator for these purposes.

If you have any other questions, feel free to contact us.