As stated by World Health Organization (WHO), “An estimated 1 in 10 medical products in low and middle income countries is substandard or falsified.” So, the pharmaceutical industry is facing issues of these products that are either fake or substandard. The biggest concern is the safety of patient health. Most Pharmaceutical Brand Owners & Manufacturers face problems like counterfeiting, piracy, and adulteration of products by unauthorized or illegal manufacturers, resulting in defamation and losses. With each passing day, the counterfeiting industry is growing. According to WHO reports, “Counterfeit medications yield over $10 billion annually and result in thousands of deaths.”
With that said, most counterfeiting and piracy happens in the supply chain. Supply Chain encompasses numerous manufacturing, distribution, warehousing, and consignment companies. These companies are responsible for the process from developing medicines and drugs to the transportation, sales, and marketing process. These companies also form an information network to oversee operations. Also, to avoid problems, Governments around the world are taking steps towards tracking & tracing of the goods throughout the supply chain. Hence, various countries have made it compulsory to include serialization and track & trace.
But what is serialization? Let us get into the basics of understanding the concept.
Serialization means giving a unique identification number to each saleable product whose data will be accessible to the Government. This will allow the Government to know the product’s origin and other details like batch number, expiry date, and manufacturer. Serialization is the pioneering step towards the sustainability of the supply chain process. It is a base for the track & trace systems & its implementation will reinforce the integrity of the global pharmaceutical supply chain and help it grow stronger. Let us see how the pharmaceutical products are serialized? Validated serialization equipment like Kevision’s PrintSecure installed in the production line provides high-speed printing and verification of GS1-supported 2D DataMatrix codes. The system will print and verify a GTIN, a unique serial number, expiry date, batch/lot number, and a GS1 DataMatrix 2D barcode.
The process does not end after serializing a single product. Aggregating single products in shipping boxes also is a process that needs to be tracked. Aggregation within the Track & Trace terminology means maintaining a parent-child relationship at all levels of packaging. It goes from a single packet to unit box to carton to pallet to container. At all these stages, serialization takes place. Because of this process, manufacturers will have transparent visibility of the movement of packages. The product journey starts with the manufacturer and ends with the consumers. This track & trace data is usually uploaded to the Government portal & other necessary regulatory agencies. Hence, the Government and the export/import officers can check the data and verify its authenticity at any time. This will prevent the products from being counterfeited, sold after the expiry, stolen, and diverted.
The pharmaceutical manufacturers’ requirements will differ according to the products, production capacity, and destination of shipments.
At Kevision Systems, we provide a full suite of Serialization Software, Hardware & necessary systems for Pharmaceutical Manufacturers, Brand Owners & 3PL (Third Party Logistics Providers).