GS1 DataMatrix applied across all cartons

From this month, all sterile injectable and oral-solid cartons manufactured at the Ergopharm Advanced Research Centre in Tandalja, Vadodara are printed with a GS1 DataMatrix (ECC200) at pack level. Each code encodes four GS1 Application Identifiers: the product GTIN (01), the expiry date (17), the batch or lot number (10) and a unique serial number (21). The same four values are printed alongside the symbol as a plain human-readable line, so a distributor, pharmacist or inspector can read the identity of a pack by eye as well as by scanner.

“A single serial on every carton, printed and recorded the same way each time, is what lets a partner anywhere verify a pack against the batch it actually came from.”

Serialisation is applied at the point of packing and captured in the Batch Manufacturing Record, so the serial printed on the carton is the serial recorded against that batch. Cases and pallets are aggregated to their contents, with pack-to-case and case-to-pallet relationships held as EPCIS events and cartons and shipping units carrying SSCC (00) identifiers. This parent-child aggregation lets a full pallet be received, and its individual packs accounted for, without opening every case.

The data structures Ergopharm has adopted are the same ones required by the major serialisation regimes: the unique identifier in a 2D DataMatrix expected under the EU Falsified Medicines Directive framework (Delegated Regulation (EU) 2016/161, applicable since 9 February 2019), and the product identifier used for the US Drug Supply Chain Security Act. Ergopharm makes no claim to any national marketing approval; the point is that a single, standards-based coding scheme on every carton lets export partners meet their own local verification and decommissioning obligations from one consistent source.

For distributors this means every inbound pack can be checked against Ergopharm's own records before onward sale, and suspect or returned units can be traced to a specific batch. For patients and dispensers at the far end of the chain, the serial and anti-tampering features together give a straightforward way to confirm a pack is genuine and unopened. For Ergopharm's register, the portfolio is now uniformly serialised: there is no longer a mixed estate of coded and un-coded cartons, which simplifies recall precision, returns handling and reconciliation.