Serialization is the process of assigning predetermined codes to each unit or container of medication you manufacture. The code or serial number assigns each product item a digital identity, which you can track and trace as it progresses throughout the supply chain. Pharmaceutical serialization is a common type which is used to track and trace and provide supply chain visibility for pharmaceutical drugs. When designing a codification system, you can make your serialization codes as detailed as government regulations necessitate.
Leading solutions also provide built-in code structure flexibility that can accommodate customized application identifiers AIs. GS1 , the internationally-recognized system of standards, created a dynamic definition of AIs that gives you the freedom to include a wealth of information in your code. To adequately define serialization, we must not only consider the meaning of the term but also discuss why serializing products is a critical business management process.
Among other things, this act requires that pharmaceutical products be serialized to promote traceability and preserve product integrity. Serialization techniques may vary slightly from one nation to another. However, all labels will include some basic product information, regardless of the country of origin. For instance, a product label will typically include the following:. Performing pharmaceutical serialization reduces the risks of harm associated with counterfeit medicines seeping into the market.
Additionally, serializing medications allows regulatory authorities to hold violators accountable, preserve the integrity of the pharmacological supply chain, and protect consumers. The aforementioned laws impose harsh penalties on entities that fail to comply with labeling and serialization requirements.
Pharmaceutical serialization is an effective way of ensuring adherence to regulatory requirements and safety guidelines. Countless entities within the pharmaceutical space use serialization software for data validation and compliance purposes. That said, compliance is just one benefit of pharmaceutical serialization. It can also assist with the following:.
