The problem of counterfeit drugs is not a new one, but it is a growing issue and one that cannot be ignored. It has become an increasing global threat over the last few decades.
EIPICO, as a leading pharmaceutical manfacturer, was one of the first to implement a Track and Trace Program based on GS1 DataMatrix, the most widely used identification system worldwide, to ensure patient safety and enhance supply chain efficiency.
GS1 DataMatrix is a a system in which the supplier can mark items in the expectation that all trading partners will be able to read and correctly interpret the data encoded. This DataMatrix is a (2D or two-dimensional) barcode which may be printed as a square or rectangular symbol made up of individual dots or squares.
GS1 DataMatrix encodes information such as, but not limited to, the following:
■ Global Trade Item Number (GTIN), a globally unique identification number for medical products.
■ Expiration Date
■ Batch Number
■ Serial Number
GS1 defines trade items as products or services that are priced, ordered or invoiced at any point in the supply chain.
GTIN is used by a company to uniquely identify all of its trade items. It can be used to identify types of products at any packaging level (e.g. consumer unit, inner pack, case, pallet). Groups of trade items with similar production and usage characteristics such as production batches can be further identified with the help of the batch/lot number, expiry date, and similar data elements. Individual trade items can be uniquely identified using a GTIN plus serial number.
Once a company has assigned a GTIN to a trade item, it provides a common language for all of its entities and trading partners worldwide to uniquely identify the item and easily communicate information about the item.
EIPICO (being the Rank #1 Pharmaceutical Exporter in the MENA region) started to cope with the global demand to meet regulatory compliance requirements with a road map:
1- Top Management approval commitment (April 2014).
2- Establishment of Project Team Engineering, Production, IT, QC , PPM Designer, Validation (URS, Technical and price comparison for Board Approval) (August 2014).
3- Commissioning, Training and Start Up (April 2015). First production batch.
Before receiving the machine, the following points were considered:
1- Assigning secure print rooms with required utilities.
2- Development of new packaging solutions to accommodate the 2D development and serial number.
3- Successful FAT for all packs sizes.
The software functions are the most important part of the System which need a software license for printing and verification, license for serialization and a license for handed hold scanner.
Track and Trace Program is the current EIPICO's Project with the mission that all packaging lines will be provided by DataMatrix Systems. This is being worked on nowadays and will be accomplished by 2020.
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