let's recap the key concepts of the FDA’s Drug Supply Chain Security Act (DSCSA) serialization laws. To comply with U.S. federal serialization laws, packaging must include new serialization information and a scannable logistics data carrier. This includes the GS1 Global Trade Item Number (GTIN), serial number, packaging lot number, expiration date, and sometimes additional details. All inventory must meet these requirements by the deadline, and existing stock cannot be traded if non-compliant.
Serialized goods can be handled more efficiently by linking serialized contents with their containers (e.g., saleable units and shipping cases). This practice, already common in industries like electronics and machine parts, is expected to become a standard requirement in the life sciences supply chain by 2024. While not yet mandatory, businesses may adopt it sooner to streamline their operations.
GS1 is a key organization in setting standards for product serialization, using symbols like the GS1 DataMatrix 2D barcode. This symbol encodes essential data, such as the GTIN and U.S. National Drug Code (NDC) and is approved for use under the law. The GTIN can also include packaging characteristics, like quantity, and tracking codes like the Serial Shipping Container Code (SSCC) for containers that do not meet established quantities. Ensuring proper handling of partial cases is crucial, as incorrect encoding can cause confusion in the supply chain.
Manufacturers need new systems to manage and share serialization data with various supply chain partners, including contract packagers, third-party logistics providers, and health authorities. Some companies are implementing multiple-tier serialization solutions to reduce risks, using advanced systems at the packaging floor, warehouse, and enterprise levels.
Advanced systems often bypass site-level systems, connecting shop floor devices directly to enterprise systems. This reduces the risk of a site-level system failure that could disrupt packaging operations. Electronic data interchange (EDI) and the emerging EPCIS standard are used to share serialization information and content-container relationships. EPCIS is gaining traction and may soon become the preferred standard for the life sciences industry.
As radio frequency identification (RFID) technology becomes more affordable, its use in tracking serialized goods is increasing. RFID is especially beneficial for identifying containers without direct line-of-sight scanning in warehouses and distribution centers. Off-the-shelf (COTS) solutions have emerged to help companies comply with serialization requirements, minimizing the need for internally developed systems.
Cloud-based, managed, and on-premises solutions are available to meet various needs, with edge-of-network systems enhancing existing warehouse operations. These solutions allow businesses to integrate new serialization workflows without overhauling their current systems.
Beyond regulatory compliance, serialization offers additional benefits. It improves supply chain control, helps manage chargebacks and incentives, prevents illegal diversion, and authenticates products. Many companies use serialization as a market differentiator to build consumer confidence. Leveraging industry expertise is crucial to avoiding common pitfalls and expediting the implementation of serialization solutions.
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