The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013. The DQSA calls for a 10 year implementation plan to track pharmaceuticals as they make their way from the manufacturer to a pharmacy.
But, there is more to the serialization regulations than compliance. Pharmaceutical companies will gain many internal benefits by adopting a serialization system.
Serialization can prove a products authenticity, which means a manufacturer can detect and combat counterfeit products and ultimately protect their company brand.
Coordination of Supply Chain Data
Manufacturers can get information about products as they move through the supply chain. Supply chain visibility can help a company control inventory and reduce costs. Manufacturers can also see the impact of supply chain disruptions.
Efficient Recall Process
Manufacturers can conduct precise recalls by pinpointing locations that received the product in question.
Reduce counterfeit activity that occurs when products are faked and diverted.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.