The whole truth
New EU pharmaceutical manufacturing and distribution compliance is expected to tighten up safety within the supply chain and eliminate falsified medicines. According to Omron, companies need to factor in the importance of machine vision, to read and verify the four key data elements proposed by the European Stakeholder Model (ESM) if they are to meet the 2017 deadline
Faced with the growing and substantial threat of falsified medicines penetrating the European market, ESM has developed an end-to-end medicine verification solution, consisting of four key data elements, to combat the entry of falsified medicine. This verification system plays a pivotal role in aiding manufacturers to adhere to the 2011 EU Falsified Medicines Directive (FMD) which requires manufacturers to apply safety features to verify the authenticity and identity of individual packs of medication, which will be mandatory by 2017.
To drive implementation of the FMD, a consultation has been undertaken to define the characteristics and specifications of a unique authentic pack identifier. While these findings, which will come under a Delegated Act, are not anticipated until later in 2014, it is highly predicted that it will include the adoption of a DataMatrix barcode. Furthermore, the verification system proposed by the ESM features a DataMatrix code carrying four key data elements which will also be required in a human readable format (manufacturer product code, randomised unique serial number, expiry date, and batch number) and the definitive way to read this system is through machine vision.
Traditionally human readable code and data encoded within barcodes has remained fixed between batch runs of pharmaceutical products. The significant challenge arising from the proposed ESM, is with regard to the data management of the randomised unique serial number and the synchronisation of data between the printing device and verification solution. Omron’s flexible vision solutions are built on IPC technology, providing the flexibility to cope with a wide range of data management requirements and allowing interfacing with 3rd party devices such as printers. Omron’s vision solutions can interface with high level production management software to request the data required to verify the unique serial number, whether through database integration or simple manipulation of .csv data files.
Dan Rossek, Omron’s product marketing manager, sensing, safety and vision comments: “To ensure compliancy is met we are working with pharmaceutical manufacturers to install the appropriate software which will offer them the assurances needed. As a company we continually review our development strategy to ensure our products are optimised to meet the changing needs of manufacturers.”