By Mario Scigliano, Global Serialization Manager, CordenPharma Latina and Christian Ahlmark, Associate Director, Sales & Key Account Management, CordenPharma International
Medicines need to be packaged in a way that allows counterfeits to be quickly and easily identified, preventing their circulation and/or eliminating drug recalls. An essential element of this process is package serialization, which establishes a unique identifier that assures each member of the supply chain (from manufacturer to patient) can quickly recognize that the drug product is not counterfeit.
In November 2017 (after a one year delay of FDA policy enforcement the new date communicated is now November 26, 2018), U.S. pharmaceutical companies were required to meet new serialization compliance deadlines aimed at combatting global counterfeiting efforts. For the seven years leading up to this date, many global markets have issued various guidelines.
To navigate the myriad of guidelines and deadlines in order to safely export drug products to global markets, pharmaceutical companies need to take action immediately to align themselves with the ever-changing policy landscape and carefully choose the most efficient route to achieve compliance with these new standards. Outsourcing work with contract manufacturers is one such way to be fully prepared for serialization implementation across all production lines.