We are seeing pharmaceutical supply chains digitising 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 revolutionise the whole industry by breaking down siloed processes, departments and facilities.
Yet despite all the focus on digitisation, many companies have not yet implemented the proper infrastructure to enable centralised, high-level computing or even ensure consumer safety with readily available technology solutions.
And, despite a growing interest in digitised and centralised management systems, labelling is often particularly behind the curve. Today, throughout many pharmaceutical manufacturing supply chains, there is very little control or central oversight in place.
That’s a serious concern, especially given the abundance of challenges facing the pharmaceutical industry that modernised labelling 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 focus on those areas wherein they can deliver improvements.
In this context, mislabelling is a serious concern; we have seen major recalls of pharmaceuticals that have occurred this year, such as the antidepressant, Mirtazapine, which was recalled owing to a labelling error on declared strength (bottles labelled as 7.5 mg may contain 15 mg tablets).
Beyond serialisation and aggregation
Modern label management systems improve safety and efficiency by centralising and digitising the quality assurance process, making it more reliable, flexible and less prone to errors. Taking people out of the process reduces both 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 aggregation regulations 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 manufacturing efficiencies.
Pharmaceutical manufacturers have had to comply with serialisation regulations but, increasingly, in certain countries, they are also having to address aggregation rules, whereby records are kept of all the serial numbers and the relationships between them.
Aggregation is also important because of 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 an effective sales tool.
An unwieldy procedure
Often, we see semiautomated systems in place, brought in (often in haste) to address these needs, but not fully integrated or centralised in terms of their management and therefore unable to drive through process improvements. All processes and associated modifications are done 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.
Although they can achieve aggregation without a centralised 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 to avoid interfering 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 very real. The testing and verification process needs to be completed for each product and label variant separately if there is no centralised system in place. Labels will often have to be redesigned for each SKU.
Moving to centralised labelling 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 get by with a single verification run.
They could also digitise their label approval workflows and automate the deployment of the right layouts for the right products to the lines.
In summary, such a system can make aggregation easier for manufacturers, eliminate the need to set up products and lines after hours and do fewer verification runs.
So, given the benefits, why have more pharmaceutical manufacturers still not moved to a more centralised label management approach? Part of the reason is that many have so far been focused on serialisation to the exclusion of everything else.
Today, they are focusing more on aggregation; but, manufacturers should be aware that they can’t simply focus on aggregation for its own sake. It is one aspect of improving their overall packaging operation. In this context, they should be looking to centralise and digitise as much as possible, rather than having to manually check everything.
Against this backdrop, aggregation is now an opportunity to both comply with and streamline processes to automate and digitise their quality control — and centralised label management can play an important part in this.
By doing this, manufacturers remove the drain on productivity and cash caused by workers having to manually undertake labelling processes after hours and significantly reduce manual verification and quality control. At the same time, they stand to benefit from a rapid return on investment (ROI).
Critically too, by reducing manual processing, they also reduce the potential for errors and the possibility of mislabelling incidences taking place. Today, it is easier and faster than ever to deploy and use this kind of solution remotely, thanks to the advent of private and public cloud-based label management systems, which support faster time-to-market and rapid ROIs.
It is time for the industry to start moving beyond time-consuming and unproductive manual workarounds and start embracing the benefits that centralised label management, especially when done remotely, can bring.
