Serialization is the unique identification of individual packs (cartons or bottles) of medications. As each batch of finished product is packaged, a globally unique code is assigned and physically marked on the packaging in the form of a two-dimensional code known as a datamatrix. At the conclusion of the packaging order, the serial numbers are electronically linked to the product’s batch number in Lilly’s global SAP environment.
To track and trace the movement of individual packs, serial numbers can be recorded and electronically linked to outbound deliveries to customers. This is a regulatory requirement in some countries, where a documented chain of custody is further established by requiring wholesalers and pharmacies to record shipments and receipts of serialized products.
Serialization not only helps secure the legitimate supply chain, but offers other potential benefits. These include automated checking of expiry dates, a way to record the batch number of specific medicines in a patient’s electronic medical records, and other tools that offer value to patients and health care providers.
Lilly is making a considerable investment in its packaging operations, distribution centers, and IT infrastructure to support this initiative, which will include new technology deployments on more than 30 packaging lines around the world. Additionally, Lilly is working closely with other organizations to advocate for unified serialization standards in the U.S. and globally. These efforts will help ensure that doctors, pharmacists and patients can be confident in the medicines they prescribe, dispense and receive.