A Brief Guide to Pharmaceutical Serialization

The threat today for counterfeit, mislabeled, tainted or abstracted prescription drugs is increasing and persistent. Therefore, pharmaceutical executives, politicians and government leaders are striving to come up with ways to track prescription medications. On the basis of this rising threat, many countries have begun to address susceptibilities in the supply chain by requiring the use of a comprehensive system known as pharmaceutical serialization.

Understanding the Basics

It is quite easy to comprehend the basic idea behind pharmaceutical serialization. However, it is not so simple to implement into the process of manufacturing. A complicated system that tracks and traces prescription drugs throughout the complete supply chain is required.

Most of the prescription medications that patients receive are safe. However, with the large number of probable players throughout the supply chain as well as the regulation variations, there is the chance for harmful impure and counterfeit drugs to be integrated into the supply.

With a strong determination to combat this risk of tainted and bogus prescription drugs, regulators have determined the need for pharmaceutical serialization. A comprehensive serialization platform signifies the complete history of the chain of custody for a given product from manufacturing to dispensing.

A considerable amount of the early work to implement serialization solutions focused on the use of electronics. This included application terms for the management of serialization data, printed markings that are readable by humans as well as sensory technologies for verification.

While there have been many benefits to the early implementation of a pharmaceutical serialization program, there is still great confusion regarding the way the laws and regulations will progress in the future. Drug manufacturers are looking into ways to individually serialize every unit as well as register the relationships of units into large containers, cartons, cases and pallets.

The information required in a serialization program depend greatly on the many different standards and laws. While the long standing necessities regarding pharmaceutical serialization are still rather indeterminate, the capability to track an exact drug throughout the supply chain and trace the precise journey will aid in securing the reliability of the drug supply provided that accurate documentation is available at all times. Regardless of the way that pharmaceutical serialization laws are applied, all drug manufacturers, retailers and distributors have to be ready to fully comply and be prepared to address any technological challenges that may arise along the way in order for these programs to work as intended.

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