![]() Now that we’ve answered the question, “What does serialization mean” and touched on the growing importance of this tracking and identification method, let’s shift our attention to the benefits of implementing a serialization strategy. Looking Beyond Compliance: The Benefits of Pharmaceutical Serialization The aforementioned laws impose harsh penalties on entities that fail to comply with labeling and serialization requirements. Additionally, serializing medications allows regulatory authorities to hold violators accountable, preserve the integrity of the pharmacological supply chain, and protect consumers.įrom your organization’s perspective, pharmaceutical serialization plays an important role in compliance. Performing pharmaceutical serialization reduces the risks of harm associated with counterfeit medicines seeping into the market. However, all labels will include some basic product information, regardless of the country of origin.įor instance, a product label will typically include the following: Serialization techniques may vary slightly from one nation to another. ![]() Among other things, this act requires that pharmaceutical products be serialized to promote traceability and preserve product integrity. While the DSCSA was passed in 2013, its final phase of provisions will come into force in late 2023. The FDA’s Drug Supply Chain Security Act (DSCSA) is the most notable of these changes. Why Is Serialization Important in the Pharmaceutical Industry? Food and Drug Administration (USFDA) have implemented significant changes to pharmaceutical regulations. Over the last several years, regulatory entities such as the European Medicine Agency (EMA) and the U.S. 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. ![]() Now that we’ve addressed the question, “What is serialization,” let’s examine why it’s important to the pharmaceutical industry and how you can tap into significant organizational benefits by adopting modern serialization software. 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. Leading solutions also provide built-in code structure flexibility that can accommodate customized application identifiers (AIs). When designing a codification system, you can make your serialization codes as detailed as government regulations necessitate.Īdditionally, you can incorporate information like the date of production, when and where the item was manufactured, a lot or batch number, the stock-keeping unit (SKU), a drug or product description, and the manufacturer’s Global Trade Identification Number (GTIN). Pharmaceutical serialization is a common type which is used to track and trace and provide supply chain visibility for pharmaceutical drugs. 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. Serialization is the process of assigning predetermined codes to each unit or container of medication you manufacture. ![]()
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