Serialization has become a necessity for pharmaceutical companies and many countries like UK, USA, Italy and India have adopted different levels of serialization in their pharmaceutical supply chains. There are a host of reasons why serialization is being mandated such as: the complex and vast distribution networks in the industry, the need for product authentication and reduction of counterfeit products, current and future changing regulatory requirements (which are region specific), and to protect the brand reputation with a safer supply chain as well as to increase consumer confidence in the reliable products.
Through Serialization, it’s easier to identify counterfeit products in the supply chain and remove them in order to keep patients safer. The detailed data records businesses keep help drug manufacturers in enhancing their CMO performances, minimize losses related to product recalls and diversions, run efficient supply chain management, and support operational and marketing activities.
So what is in store for serialization in pharmaceutical companies and supply chain vendors?
1. All drugs released by manufactures will need to be serialized at an individual level with corresponding barcodes for more efficient tracking-and-tracing especially when using digital technologies such as RFID – enabled systems or blockchains. A few drug regulators, like the FDA in the US already use advanced serialization. In fact, by November 27, 2023 the US is planning to have a completely enhanced drug distribution security system that will mandate unit-level traceability (every individual container of a pharmaceutical or healthcare product will be traced). Failure to meet serialization requirements would mean that drug products cannot be sold into the relevant markets.
2. Drug distribution will change because of serialization of individual products and will affect drug demands of individual products. This will allow better distribution, exposure and visibility in the market and with the application of track and trace principles, businesses will be able to avoid counterfeit medicines from entering the supply chain.
3. Warehouses and inventories will become more visible and will be able to formulate a robust drug distribution plan. The core purpose of enforcing serialization measures is to prevent fraud and reducing changes of counterfeit medicines entering the supply chain so patient remain safe. By being able to uniquely identify every drug product pack with a machine-readable code, it will become easier for external databases to identify and trace the registered individual item.
To meet the requirements of serialization, pharmaceutical manufacturers have had to not just consider the costs of enforcing these measures but also careful planning of all operational aspects. Pharmaceutical companies will need to pay closer attention to the importance of communication in future serialization strategies. Communication within different teams (researchers, distributors, packaging department, etc.) regarding serialization involves vast amounts of data and will need constant inflow and outflow of information for each drug.
It’s important to note that for any of these to be successful for future serialization strategies, it will require manufacturers, packagers, wholesalers, dispensers, and other supply chain participants to be on the same page and have them all fulfill their responsibilities as well as to meet legislation requirements.
At CosmoTrace, we offer premium support and services that can help your business with serialization implementation. Our team of experts will make sure you are up to date with all global traceability regulations and will help in creating a successful long-term serialization strategy.
Contact us today so we can discuss how we can help.
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