The Food and Drug Administration (FDA), under its Drug and Supply Chain Security Act (DSCSA), has established traceability requirements for companies in the Pharmaceutical Supply Chain. These requirements apply to Manufacturers, Distributors, Re-packagers, and 3PL providers, emphasizing the importance of product level tracing.
By implementing an electronic system, mandated by the act, the Pharmaceutical supply chain can enhance traceability at every stage. From the manufacturer's location to transit to 3PL warehouses, the ability to trace and recall products when needed becomes effortless, offering remarkable benefits.
To ensure compliance, packaging requirements for Pharmaceutical Products dictate the inclusion of a unique serial number on all packages. This standardized numerical identifier, represented by 2D or 3D barcodes, is essential for visibility and accountability.
The act also emphasizes the maintenance of transaction and transaction history by all parties involved. A transaction is defined as a transfer of product ownership, and the transaction history enables the identification of handlers and their respective timeframes. Ownership transfer documents and detailed packing slips and carton labels are crucial elements for tracking and maintaining the integrity of shipped items.
The use of an Electronic Data Interchange (EDI) system greatly facilitates compliance with these regulations. The EDI system generates packing slips and package labels with unique serial number identifiers, ensuring seamless traceability.
In conclusion, the FDA's Drug and Supply Chain Security Act (DSCSA) and its traceability requirements enhance the Pharmaceutical Supply Chain, promoting transparency, efficiency, and accountability. Through streamlined processes implemented across the industry, we ensure the safety and integrity of pharmaceutical products throughout their journey.
Comments