Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization.
The foundation of any tracking system is serialization, which entails affixing to finished drugs a unique serial number and barcode or radiofrequency identification (RFID) that can then be verified at the point of sale. But this basic step is fraught with complexities and variants.
Torben Vogt, life sciences expert at NNIT explains how you prepare for serialization and make use of the benefits. Read the article published online at RAPS (Regulatory Affairs Professionals Society)