Clinical Trials, Drug Manufacturers, Supply Chain, Technology, Therapy Area

Serialisation of Pharmaceutical Product to meet Market Regulations

By CXV Global

The key requirement for this project was the serialisation of products to meet Korean market regulations. Korean regulations mandate manufacturers to ensure secondary packaging of pharmaceutical products are printed with an item level serial number (SGTIN) in the form of a 2D barcode or RFID, as well as the capability to hold five lines of Human Readable Text (HRT).

These lines can include variable data such as lot and date codes, expiry, price, etc., and all codings must be to GS1 standards. As part of this solution, the customer also requested an off-line warehouse solution that would be capable of commissioning/ decommissioning product out of batch.

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