A new era of distribution compliance and pharmaceutical manufacturing has been ushered in by the European Union and the United States. The purpose is to improve safety and remove counterfeit drugs from the supply. This is backed with advanced technologies to determine the whereabouts, identity and authenticity of specific drugs. These steps will also show authorities where in the system the counterfeit drugs are appearing. This method is referred to as a track and trace system. The system uses 2D barcodes and ePedigree technology. The basis is stamping a random serial number of every package of drugs. The authenticity is verified when the drugs are manufactured. As the package progresses through the supply chain, the repository system is checked against the unique identifier. The package must be authenticated prior to being sent to the patient.
This system will affect the members of the pharmaceutical supply chain including repackagers, drug manufacturers, dispensers and wholesale distributors. The industry has had a mixed response to the new system. Some have commended the changes while others are concerned about the increase in work and the cost for potentially minimal gains. The track and trace system was considered in the United States in 2012 by PhRMA, GPhA and HELP. There is no getting around the fact counterfeit drugs have become a worldwide issue. The European Union uses the point of dispense verification system. They believe their system is working fine. The issue of counterfeit drugs does occur much more frequently in the United States. For additional information please visit here.
The barcodes will be printed using three different types of technology. The packaging converters can choose from inkjet, laser marketing and thermal transfer or direct thermal. The inkjet system offers a high resolution with a minimum of 300 dpi. The press speed is a maximum of 1000fpm. This can be accomplished either offline or on press. Laser marketing can either cause the color to change in specific materials or ablate a coating. The advantages are character printing can be done at a high speed and the laser has fine detailing. The issue is this cannot be used for consumables and a laser mark will not be accepted by all substrates. Specific colors such as red will not work for a barcode reading. Thermal transfer is a lower speed application for off press. This method is ideal for printing labels with variable data. For some excellent information please visit https://www.rfxcel.com/solutions/regulatory_compliance_software/.
The implementation of the track and trace system is a response to issues requiring pharmaceuticals and foods to be recalled. Both software and hardware has emerged to help deal with this issue. The two most common methods for traceability are barcodes and identification by radio frequency. There are technologies designed to carry codes replacing sight reading. This technology is expected to be critical in the safety of the supply chain. Barcoding is an alphanumeric or numeric code used for the packaging label. The data is secure and can be used to correlate product quality, the time to market and production data. For additional details please visit this site.