In the adoption of global track and trace regulations to protect patient safety and ensure product integrity, serialization is common across most adopted regulations. This means that by 2018, the majority of the global drug supply will fall under some type of serialization requirement. Because serialization regulations will vary from country to country, Life Sciences companies face unprecedented complexity, cost and risk in how they implement strategies in different parts of the world:
While serialization will be a standard requirement for the global drug supply at the close of the decade, the serialization requirements themselves will be far from standard. Serial number formats vary widely from GS1 global standards to unique versions in China and Brazil. In most countries, the manufacturer can create the serial numbers themselves but in China, they must request the numbers from a CFDA system. Packaging hierarchies requiring serialization vary widely from solely unit level application to multi-tier relationships requiring aggregation. Uniqueness and randomization principles also vary. The key is to expect diversity and plan for it by isolating serialization diversity in your global IT architecture and identifying potential constraints it places in your global supply planning.
It's natural to start at the packaging line when planning your company's serialization program but this is a recipe for disaster! By following an "outside-in" model, you'll be able to correctly identify all of the external forces that enable or constrain your serialization program.
Start with a global scan of your commercial markets to identify and document all current and near term serialization regulations that your product supply will face. Capture the network entities that you'll have to share serialization and aggregation data with and the data exchange mechanisms (EPCIS, XML, CSV, portal) that you may use. Understand the differences between serialization regulations, especially when your internal packaging sites or external partners will be serving multiple markets from the same lines. By looking externally first, you can capture requirements and assumptions on how serialization data is formatted and shared. You don't want to serialize 20 lines only to find that you use a leading zero in your serial number while your network expects none.
TraceLink's comprehensive serialization solutions simplify your ability to meet the requirements of the evolving global regulatory and trade ecosystem, proving a single flexible platform whether you are serving patients in the United States, targeting EU expansion or preparing to enter the Brazil market.