From February 9 2019, according to the EU Falsified Medicines Directive 2011/62/EU, all pharmaceutical manufacturers are required to assign unique, traceable serial numbers to all of their products and packaging units. That’s why traceable data must be assigned to pharmaceutical products and medical devices during every phase of production and packaging. Serializations for the unique traceability of products as well as counterfeit-proof packaging are becoming critical requirements to ensure both quality and patient safety.
Track and Trace solution from the VINSPEC HEALTHCARE range ensures reliable serialization of pharmaceutical products. Based on a customer specific concept for existing packaging lines in combination with our comprehensive expertise in code reading, we provide a solution that ensures full traceability of all product and packaging units.
Track and Trace encodes serial numbers, checks that they are put onto products correctly, and aggregates across various packaging units.
With the Track and Trace solution, essential information such as product number, batch ID and expiry date are simultaneously placed on the product in both plain text and barcode form. Once the information has been assigned to and put onto the products, the Track and Trace system checks that the information is both correct and complete. This essential information is stored, so that products with defective barcodes can be detected and rejected.
Seamless Traceability Thanks to Aggregation
With VINSPEC HEALTHCARE Track and Trace inspection solutions, serial numbers can be encoded, put on products, inspected and captured for each individual product and at all subsequent levels of packaging, from multi-packs to shipping pallets. The data from all packaging units is transferred to a central line database, where data records are linked together logically. Based on this aggregation, the manufacturer can then accurately track the entire production history of an item. All of the data that is collected and aggregated is transferred to the existing MES and ERP systems. As a result, statutory requirements can be fulfilled, and analyses, reports and process optimizations implemented quickly and in real time.
In addition to ensuring accurate aggregation and seamless traceability of pharmaceutical products, VINSPEC HEALTHCARE Track and Trace systems are validatable according to GAMP guidelines. Optical contour, surface and dimensional inspections, plus the detection of defective packaging, can be implemented inline and at high throughput.