We are seeing pharmaceutical supply chains digitizing across the world. It is a process that involves the implementation of AI, big data analytics, large-scale automation, digital twins and a plethora of other technological advancements that are helping to revolutionize the whole industry by breaking down siloed processes, departments and facilities.
Yet despite all the focus on digitization, many companies have not yet implemented the proper infrastructure to enable centralized, high-level computing or even ensure consumer safety with readily available technology solutions. And despite a growing interest in digitized and centralized management systems, labeling is often particularly behind the curve. Today, across many pharmaceutical manufacturers’ supply chains, there is very little control or central oversight in place.
That’s a serious concern given the plethora of challenges facing the pharmaceutical industry that modernized labeling systems can help to address. Maintaining the highest possible levels of quality is the key issue that all pharmaceutical manufacturers today are looking to address and they need to be focused on those areas where they can deliver improvements.
In this context, mislabeling is a serious concern as we have seen major recalls of pharmaceuticals that have occurred this year, like the antidepressant Mirtazapine, which was recalled due to a labeling error on declared strength – where bottles labeled 7.5 milligram may contain 15 mg tablets.
Beyond Serialization and Aggregation
Modern label management systems improve safety and efficiency by centralizing and digitizing the quality assurance process, making it more reliable, flexible and less prone to errors. Taking people out of the process reduces risk and cost and makes the process faster.
But this more automated approach also presents an opportunity for manufacturers to ensure that they achieve compliance with future regulations around aggregation in order to fight counterfeiting and ‘double sell’, for example. More broadly, in terms of business benefits, they offer pharmaceutical manufacturers and their supply chains the opportunity to achieve a competitive advantage and dramatically increase efficiency by manufacturing more.
Pharmaceutical manufacturers have had to comply with regulations around serialization but increasingly in certain countries they are also having to address rules around aggregation, where records are kept of all the serial numbers and the relationships between them. Aggregation is also important due to a need to improve supply chain visibility, without having to unpack pallets and boxes while they move through a complex system of manufacturers, wholesalers and retailers. The ability to handle aggregation, especially for contract manufacturers serving the industry, can be a point of differentiation and effectively a sales tool.
An unwieldy procedure
Often, we see semi-automated systems in place, brought in (often in haste) to address these needs, but not fully integrated or centralized in terms of their management and therefore unable to drive through process improvements. All processes and associated modifications are carried out on the production line itself. Pharmaceutical manufacturers in this situation will need to design their labels and test them out on the line. That in turn leads to downtime.
While they can achieve aggregation without a centralized label management system, they will only be able to do so by testing and verifying the production line for each specific product’s label variant individually. During this process, the line cannot run, thus this it is typically done after hours in order to not interfere with production.
It is typical for pharmaceutical products to be customer or market-specific resulting in lots of different label formats and variations even of the same product, so the challenge is a very real. The testing and verification process needs to be completed for each product and label variant separately if there is no centralized system in place. Labels will often have to be redesigned for each SKU.
Moving to centralized labeling processes
The hypothetical scenario outlined above is inevitably a cumbersome and inefficient process. However, if they could use a label management system to decouple the layout from the production line set-up, and handle the design and verification process offline, manufacturers could then then get by with a single verification run. They could also digitize their label approval workflows and automate the deployment of the right layouts for the right products to the lines automatically. In summary, such a system can make aggregation easier for manufacturers; eliminate the need to set up products and lines after hours and carry out many fewer verification runs.
So, given the benefits why have more pharmaceutical manufacturers still not moved to a more centralized label management approach? Part of the reason is that many have so far been focused mainly on serialization to the exclusion of all else. Today they are focusing more on aggregation, but manufacturers should be aware that they should not focus purely on aggregation for its own sake but instead think of it as a move to improve their packaging more generally. In this context, they should be looking to centralize and digitize as much as possible rather than having to manually check everything.
Against this backdrop, aggregation is now an opportunity not just to comply but also to streamline processes to automate and digitize their quality control – and centralized label management can play an important part in this. And by doing this, manufacturers remove the drain on productivity and cash caused by workers having to manually carry out labeling processes after hours and significantly reduce manual verification and quality control, while at the same time standing to benefit from rapid ROI.
Critically too, by reducing manual processes that are in place, they also reduce the potential for errors and the possibility of mislabeling errors taking place. Today, it is easier and faster than ever to deploy and to use this kind of solution remotely in the cloud, thanks to the advent of cloud-based label management systems, which support faster time to market and rapid return on investment (ROI). And today, these labeling solutions can be delivered in either a private or public cloud.
It is time for the industry to start moving beyond time-consuming and unproductive manual workarounds and start embracing the benefits that centralized label management, especially when carried out remotely in the cloud, can bring.
Visit https://www.nicelabel.com/pharma to learn more about the digital future of pharmaceutical labeling.