Serialization forms the new basis for the ongoing effort to secure the supply chain—most significantly the pharmaceutical supply chain, but also increasingly in other sectors. However, it is only the foundation on which other technologies are built to add this sought-after security. Serialization goes far beyond placing a number on a box. These associated technologies, and the terms used to describe them, are explained here.
Now let’s look at some of the complications for drug manufactures when meeting the Europe's Falsified Medicines Directive (FMD), and particularly the Delegated Regulation.
Companies who market prescription drugs in any part of Europe should pay close attention to the new requirements spelled out by the Falsified Medicines Directive (FMD) and Delegated Regulation (DR). The FMD/DR spell out new and complex requirements for applying randomized unique identifiers to almost all prescription drug packages marketed in the EU by February 9, 2019. That date is now less than 18 months away. And it’s not just the EU Member States because other European countries have...
Aggregation is a technique used in conjunction with serialization that establishes and records the relationship between a serialized object and its container, which also is serialized. Aggregation is most frequently used in the supply chain to place smaller packaging units inside of larger ones, such as cartons packed into cases and cases onto pallets. The aggregation relationship directly mirrors the physical packing of the objects into their container.
In a recent article, International Pharmaceutical Industry made the point that Serialization Improves Public Health. We agree with that, up to a point. The authors point out that drugs pass “…through a complex distribution network where [their] authenticity at every level cannot be checked due to the absence of data-sharing systems.” Later in in the article they say, “…in the end serialization will help pharmaceutical companies to ensure patient safety.” And, “…reliable serialization and...
As the dust settles on the recent FDA news on the DSCSA timeline, I’m sure lots of organisations are wondering what this means to the rest of the world.
Serialization is the application of a globally unique serial number to supply-chain objects, particularly retail units. Successful serialization, particularly of mass-produced items, requires the integration of multiple systems, including enterprise software, printer or tagging technologies, reader systems, and production machinery, to apply and verify unique serial numbers.