Serialization Compliance

Pharmaceutical serialization compliance will have an impact across an entire organization, including across sites and geographies. Consequently, it is important that standardized processes are put in place that can maximise effectiveness, helping with the swift rollout of new systems and technologies at different sites and ensuring a model for best practice. As part of this, ensuring that staff have an understanding of their role in achieving pharmaceutical serialization compliance will be key and investing in on-going training will help to overcome potential technical, logistical and regulatory issues that could prove to be detrimental to business performance. As serialization and track-and-trace capabilities go mainstream to meet regulatory compliance mandates, pharmaceutical companies should explore how these capabilities can improve supply chain planning and operations, elevate patient and doctor engagement, and increase sales and marketing effectiveness. High-value products, complex supply chains and dependence on multiple organizations for distribution all expose the pharmaceutical industry to threats such as counterfeiting, theft and illegal diversions. According to the Pharmaceutical Security Institute, 2,177 incidents of counterfeiting occurred worldwide in 2014 alone. To counter these threats and ensure supply chain integrity, global regulatory initiatives mandating serialization of products as well as tracking and tracing products throughout the supply chain are currently underway. Within the next five years, approximately 65 percent of the global market is expected to require serialization in the supply chain. While regulatory compliance remains a top priority, the availability of information about serialized products throughout the supply chain provides a unique opportunity to take a data- and analytics-driven approach to supply chain improvements through greater visibility and collaboration.