Global Serialization

Serialization will be a global requirement by 2018, but the lack of global standards means increased complexity.

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:

  • United States: The Drug Supply Chain Security Act (DSCSA) mandates that manufacturers begin serializing all drug products at the saleable unit and case level for the U.S. market starting in Nov. 2017, with repackager deadlines beginning in 2018. Details.

  • European Union: Manufacturers serving the EU are preparing to meet serialization requirements at the package level which are expected to start in early 2018, requirements that include supporting both global and national identifiers and following strict uniqueness regulations. Details.

  • China: Drug products on the Essential Drugs Lists (2009, 2012) already need to be serialized in China following unique China requirements for serial number acquisition, serial number and product data formatting, and barcode labeling. All drug products will need to be serialized, both domestically manufactured and imported medicines, by December 31, 2015. Details.

  • Brazil: RDC 54 regulations establish very complex new serialization requirements for all registered drug products which phase in starting in Dec. 2015. Manufacturers will need to apply unique Brazilian IUM identifiers into 2D DataMatrix barcodes for each saleable unit, serialize each transport container (case) and ensure aggregation relationships. Details.

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. 

Putting barcodes on products is just the beginning.

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. 

Create a global serialization platform with the flexibility you need.

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.

  • Create reusable serial number generation profiles for all product types, logistical units (item, case, bundle, pallet) and market destinations.
  • Support global standard and country-specific formats to create GS1 standard formats (SGTIN, SSCC), generate custom formats for places like Brazil and import custom formats and lists from China.                
  • Manage and monitor allocations automatically for all packaging codes by defining serial number creation rules for request limits, minimum thresholds, uniqueness checks, randomization requirements and more.
  • Establish a common interface to capture and respond to provisioning requests from internal packaging sites and external CMO/CPO partners using dozens of diverse line management systems.
  • Manage serialized inventory operations such as product movement capture or pharmaceutical product aggregation changes across plant and warehouse operations whether they are internal locations or executed at CMO or 3PL partner locations.
  • Trigger compliance activities resulting from serialized product events to meet traceability data exchange or government reporting requirements.
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