The Rapidly Changing World of Serialization in Life Sciences
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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What do you think about the issues discussed here? Continue the conversation in the comments below and on Twitter @SAPlifesciences
Excellent job bringing to light this issue in a clear, concise and compelling manner. This issue is pervasive. Serialization is playing an increasingly important role across all manufacturer sectors especially in light of the ever increasing and changing global regulations. SAP's leadership in responding to the pharmaceutical sectors needs will drive innovation for other best run businesses across sector like High Tech, A&D, Industrial Equipment etc etc. On behalf of these other industries, thank you.
With the passing of DQSA in November 2013 the US finally took a step in the right direction from a federal standpoint (i.e. The US is moving towards securing the pharma supply chain to improve patient safety) but it also took a step backwards in some cases where the states, themselves, had more aggressive targets out there. California's e-Pedigree law was coming about and was based on electronic communication to maintain the Chain of Custody information whereas the DQSA has a manual / requirement until 2021 when it will be required to do the transactions electronically. There is a free virtual 1 day seminar coming up on March 12th where this topic will be discussed in more detail by industry expert Bill Fletcher. See the details at http://qdatausa.wordpress.com/about/serialization/