Our turn key track and trace system is designed in collaboration with National Instruments, and aims towards complying with the newly introduced governmental regulations to combat drugs counterfeiting.
Track and Trace regulations force all parties within the drug supply chain to comply to very strict procedures in identifying and recording transactions of drug shipments. Each container, least sellable quantity (LSQ), shall be identified with a unique serial number different from other LSQ’s in the same LOT, in addition to normal identification elements such as Batch numbers, ‘Best Before’ dates and Expiry dates. In order to accomodate all of this information on rather compact drug packages, an innovative standard, GS1 Data Matrix, is used to contain all the sufficient data.
Any shipping/selling transaction between any two parties within the supply chain should have a clear reference to the serial numbers involved, down to the level of the LSQ. Any mistake, and the parties are put under strict legal accusations.
The system is aiming towards a counterfeit-free drug market, and puts the patient health in the first priority, and the growth of the pharmaceutical industry right after. On the other hand, the new regulations pose huge challenges to all parties within the supply chain, with the most challenge being posed on the manufacturers.
The manufacturer shall install, operate and maintain a complex system of serialization, that would seamlessly integrate with it’s supply chain management ERP, in order to establish the first requirement of seriaized identification, that would enable the full traceability of the product accross the supply chain down to the patient. They have to deal with governmental databases for retireiving serial numbers and recording the actual production data for further audits. In addition, they need to maintain parent-child relationships between LSQ’s and aggregated containers, up to the level of pallets ready for dispatching from the warehouses. All this, while maintaining profitable productivity levels, and avoiding value stream disruption.
Track and Trace from itX is tailored for pharmaceutical manufacturers needs in the Middle Eastern and African markets. We ensure top quality components and systems are used, compliance is achieved, and economatics are maintained.
Feel free to ask for our ‘Track ‘n Trace’ system brochure via: email@example.com