Serialization In Pharma: A Brief Overview
“The serialization of pharmaceuticals will lead to a more secure supply chain.”
That’s a statement that synthesizes the general feelings towards the security of pharmaceutical drugs in relation to serialization efforts in the supply chain. Over the past decade, counterfeit pharmaceuticals have come to the forefront of the major news outlets. Statistics and stories made their way out of boring CDC, WHO, and FDA reports, and settled into feature stories in the New York Times and CBS News.
The overwhelming sentiment surrounding pharma’s problem with fake drugs is that it is hard to manage: there is no one solution.
However, serialization might be the best weapon the FDA and pharmaceutical companies have against counterfeit killers.
Serialization is fundamentally the process of regulating products through a serial number, a number which can tell information about a product our batches of products. It’s an unalterable label, and one that allows companies to track a product throughout the supply chain, from production to consumption. The rise in serialization efforts coincides with regulatory standards and requirements, and usually follows their lead. Those requirements are set into place because counterfeit and stolen drugs is such a rampant (and sadly very successful) business. In addition to adhering to regulatory bodies, pharmaceutical manufacturers and distributors have found the implementation of and update of their serialization processes can lead to cost savings. Automation is king, because automation drives costs down. When your supply chain leads to a product exchanging hands over 10 times before it reaches the consumer, having a number attached to that product stating what it is, who made it, when it was made, and when it shouldn’t be consumed anymore helps limit the unknown.
Serialization standards differ from country to country, and now with California’s recent e-pedigree law, from state to state in the U.S. With rotating regulating bodies, and the choice between following protocols from organizations like the GS1 or ISO, implementing a serialization program can be a tough task for a pharmaceutical company.
But, there are general features and functions a serialization program should have, that do not vary much from Turkey to China, from California to Brazil. These features include:
Got to have them, and have them all the time. A tagging system is the home to the information network, the initial step in understanding how a company’s products move about the world. Usually scanned, these tags house key pieces of information about a product.
The GS1 calls this one “eCom,” and it is a widely accepted feature of a serialization system. You need to communicate electronically about the movement of a product. That communication needs to be secure, it needs to be documented, and it needs to be automated. Automatic alerts sent when a product reaches a particular point create a system of knowledge about all products, so that when one goes missing, you know when and where.
Very little data is “remote” anymore. You don’t want one person’s laptop in Warehouse 10B in New York to say one thing about a product, while the receiver of the item in Warehouse 14A in Chicago is reading a tablet with totally different information. The synchronization of data across all of a company’s platforms, and then into another company’s serialization system, is necessary for a complete supply chain, and it’s a focus of almost all serialization regulatory bodies and standards.
Real-time tracking is here, and it’s going to go through this pathway. I-Pass for the pharmaceutical manufacturing, packaging, and distribution worlds, and it comes with it’s own set of regulations.