What is Product Serialization?
Product Serialization involves a complete system to Track & Trace the path of prescription drugs through the entire supply chain. Product Serialization could identify every product by a unique serial number in addition to the origin, shelf life, and batch number. This could allow the product’s lifecycle to be traced from production, through distribution, and finally, to the consumer.
Why is Serialization Needed?
The global pharmaceutical industry is in the middle of major changes with regulatory requirements to improve supply chain security and patient safety. By implementing serialization methods, counterfeiting can be reduced significantly. By Nov 2017, all drug manufacturers must have serializing their products at the saleable unit and case level for the U.S. market.
The US Government passed law HR 113 – 3204 Title-II to strengthen supply chain and control forfeiting products entering thru supply chain.
Pharmaceutical manufacturers need to ensure they comply with serialization legislation around the world such as US, EU, China, India, Brazil, etc. This is important to help maintain or improve your market share, sales, profitability and long-term sustainability as a company. The deadlines are approaching and pharmaceuticals companies need to start adopting this technology with a high priority.
What is required to be done for DQSA 2017 compliance?
All prescribed product saleable unit & homogenized case are required to have unique identification with 2D barcode, GTIN, Lot & Expiry date printed on each unit.