Track and Trace Solutions: What You Should Know

Nowadays, governments from all corners of the world are coming up with new initiatives to minimize the propagation of counterfeit drugs. They are actually using electronic systems (serialization software) to spot and trace medications during manufacturing and distribution processes. These regulatory measures apply to wholesale distributors, manufacturers, re-packagers, dispensers as well as third-party logistics providers.

How serialization software works

Products or items are assigned a serial number to every sealable unit of every prescription item using serialization software. The serial figure is then linked to a description of the item’s origin, expiration date, and the batch number. With the help of pharmaceutical track and trace system solutions, items can easily be tracked throughout the supply chain.

Importance of unique identification

Serialization also referred to as unique identification enables government or those in charge to spot those who manufactured items which have been sold to hospitals or retailers and to which buyers have been prescribed. The US Food & Drugs Administration has set some regulation to ensure safe manufacturing as well as the distribution of prescription medications. This body requires a system that documents the entire history of drugs, which have been manufactured and then sold to the ailing individuals.

The ambition of the US & Drugs Administration is to prevent drugs from being sold after expiry, misbranded, diverted, counterfeited, contaminated and/or stolen. All the wholesalers, manufacturers, repackages, OEM’s, as well as pharmacies, are required to comply with the body. They must submit accurate and up-to-date information about the subscription drugs, their source, and destination, and when drugs were prescribed to buyers.

Track and trace systems and security

Track and trace systems play an important role when it comes to improving security. They provide accurate information about the lifecycle of medications from where they were manufactured, the people doing repackaging and distribution, and when they were sold. They meet accurate and up-to-date regulatory as well as compliance requirement questions like where, what, who, and when. These prescription drugs also help in identifying the exact places where prescription drugs have been distributed.

With track and trace systems, it is possible to recall prescription drugs which were previously reported to be fake or not having met the required standards. It is also possible to identify contaminated, counterfeit, as well as stolen medications. Any good serialization software can help in supporting industry standards.

So, how can you identify the right serialization software? Well, any good serialization software meets the internationally accepted regulatory standards. This facilitates solutions, which integrates with other or external packaging facilities, central repositories, line controllers, through standards for interfaces for proper communication. This arrangement ensures there is proper information exchange within the supply chain.


The life sciences, healthcare, as well as pharmaceutical sectors experience a plethora of problems during manufacturing operations and during supply chain management procedures. Organizations such as US Food & Drugs Administration require pharmaceutical companies to make use of track and trace systems in order to enhance the security of drugs being prescribed to patients. Just like in other parts of the world, the number of counterfeit drugs is increasing day by day. This problem can only be solved with the help track and trace systems.