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Manufacture Business Practice, Technology and Equipment, Trends & Forecasts

Wake Up to Smart Serialization

Counterfeiting is a low-risk, high-reward crime for the perpetrators, which makes it a huge challenge when it comes to many consumer products; the difference with pharmaceuticals, of course, is that counterfeit medicines can kill you. Don’t be fooled into thinking that counterfeiting affects only those buying drugs online or from a disreputable source; statistically, the likelihood is that we’ve all taken counterfeit drugs – according to the WHO, the FDA estimated in 2003 that counterfeits made up more than 10 percent of the global medicines market and were present in both industrialized and developing countries.

The advent of the global supply chain, online pharmacies, and the ease with which counterfeit drugs can now enter the market have led governments to introduce increasingly stringent regulations on track and trace. In the US, several states brought in their own legislation, ahead of the federal government deciding a single law was needed. The Drug Supply Chain Security Act has a phased roll out, with serial codes required on all products by 2017 and aggregation with product traceability by 2023. Brazil is moving faster, with full serialization, aggregation, tracking and tracing required by the end of 2016.

Most consumers are only now becoming aware of the scale of counterfeiting – and consumer demand is likely to drive change faster than regulation. If your competitor is implementing track and trace next year, you don’t want to get left behind, do you? The real challenge is aggregating serialized products for the supply chain, so that you can track every saleable unit throughout – and manage the data generated. Simply adding a unique serial code to the product is meaningless unless you are also tracking the movement of the product and the full chain of custody information that is associated with it.

But there is also a lot more that you can do with tracking data besides using it to be  regulatory compliant. By taking a holistic approach to serialization and looking at what the data can be used for, manufacturers could realize a significant return on their regulatory compliance investments. One obvious benefit is that it will make recalls faster and more efficient; rather than recalling multiple batches in nationwide or global recalls, individual products can be located and removed from the supply chain, and specific pharmacies alerted in order to remove affected products immediately and with minimum fuss. Patients who voluntarily choose to share information with the manufacturers whose products they use can benefit from direct patient care programs and direct product safety recall notifications. Manufacturers can also benefit from direct relationships with patients by improving adherence and outcomes. Companies can also offer patients loyalty programs similar to those currently offered by retailers.

But right now, many businesses are totally unprepared for the technological demands of the new legislation. Regulation, while necessary, can restrict innovation and creativity, and as a consequence pharma lags far behind other industries, for example semi-conductors, in its adoption of new manufacturing technologies. The good news is, it won’t take years to catch up – the world has changed and both regulators and the industry have recognized the need for more flexible, efficient facilities. As automation and the deployment of smart devices on the plant floor become more prevalent, we are collecting reams of data throughout the manufacturing process and beyond. The large quantity of data now being created on production floors just needs to be converted into actionable information to realize the full potential of the connected enterprise.

Everyone needs to look ahead... you’re going to collect all this data – why not use it?

Because of the new track and trace regulations, manufacturers and their supply chain partners will soon be collecting and sharing a huge amount of data about the movement of their products through the supply chain. However, many companies are thinking about serialization, track and trace strictly from a compliance perspective and implementing the minimum requirements to meet the next looming serialization milestone. Take that approach, and in four years’ time, there is a good chance that you’ll come to the next milestone, and realize that you have to re-do a lot of that work. You may realize, for example, that you now have to tie your data into the IT systems – only that wasn’t in the plan four years ago, so it’s not compatible. Clearly, such an approach is not an efficient use of resources.

Instead, everyone needs to look ahead. Don’t just think about what you have to do – think about what you can do. You’re going to collect all this data – why not use it? Decisions are always better when you have a flow of good, actionable information, so execute a holistic serialization strategy to leverage data, not just collect it.

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