In March of 2010, thieves broke into a Connecticut warehouse owned by Eli Lilly and drove off with over $75 million in pharmaceutical drugs. This was a professionally planned and executed job were the thieves cut into the roof, bypassed the alarm system and spent hours packing and removing the pharmaceutical product. Further, contrary to past tactics opiate drugs were not targeted as the focus was on the branded drug product that could be moved off-shore and sold into the black market. This was just one of many thefts that have occurred around the globe.
In response, governments have continued to introduce a variety of legislation designed at securing and tracking pharmaceutical drug products as they move through the global supply chain. The pace of legislative activity continues to increase as countries such as China, Turkey,France, Argentina, Korea, Brazil and, most recently, United States have or will have legislation to ensure the safety and security of their pharmaceutical supply chain. Consequently, this rapid and expansive legislative climate continues to put extreme pressure on global pharmaceutical companies who are required to meet those standards.
Further, leading pharmaceutical companies are instituting global serialization and country specific reporting initiatives that not only allow them to meet the pervasive global mandates but also must integrate the solutions into their existing business strategies. Serialized processes must leverage the variety of product data, be tightly integrated with contract manufacturers and/or packagers, enable advanced serial number management processes that allow for a variety of scenarios including inferred serial numbers and can support the rapidly evolving country specific reporting requirements. An organization’s ability to strategically align and support their serialization processes will not only allow them to meet the global mandates but it will also provide a competitive differentiator that protects their patients and their brand.
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