Ensure the quality and safety of temperature-controlled products during transit.
Monitor your climate-controlled warehouses, storage facilities, and cooling units.
Cold chain management, Pharmaceuticals
The pharmaceutical supply chain industry has been moving towards digitalization for quite some time now. Early adopters and supply chain leaders are moving from passive solutions with information gaps to real-time solutions providing complete visibility. This transition to real-time temperature monitoring in the pharmaceutical cold chain is no longer a question of if, but when. Those that have already made the change or are in the process of transitioning are experiencing an influx of supply chain data to which they previously did not have access. There is now the added struggle of knowing what to do with that data including how to tackle unexpected problems that are suddenly revealing themselves. How do supply chain directors and quality managers make that data work for them in order to achieve sustainable, long term improvements without being buried in information?
Companies are already adopting real-time cold chain monitoring solutions. It’s no longer a discussion of the future and where the industry is heading, but is the current situation. But one of the struggles that comes with this added data and visibility is knowing what to do with the data. The more information one has access to, the more problems those individuals become aware of and the more analysis is needed to make sense of that data.
With a passive solution using a USB logger there are often gaps in the data or missing information, but you also know from the data that you do have that there were no temperature excursions, or at least that it’s highly unlikely. There is, however, always an element of guesswork. And if there is a temperature excursion, assumptions must be made as to when and where that excursion took place based on where it should have been at that time. This means that companies are often releasing products to market based on incomplete data and investigations involving assumptions. Of course that data is quite reliable and those assumptions are educated guesses, but there is always the chance that mistakes are made.
Shed light on unknown issues
With access to real-time data there is no more guesswork. It also means, however, that issues will arise that were previously unknown to the logistics and quality leaders within the organization. Once light is shed on those issues, you are required through regulations to address the issue. An unknown issue can be ignored, but as soon as the data reveals it, it becomes a problem to be solved.
One example of this could be that issues with the processes or data provided from a receiver, supplier, or partner that was once trusted arise. In the past, pharmaceutical organizations have been reliant on the data and processes of those partners to comply with regulations and release products to market. With on-demand access to all cold chain data, that is no longer necessary. This new found freedom, however, does not come without its challenges. Once those issues surface, they must be dealt with, and depending on the gravity of the situation, it could cause a lot of headaches.
In the long term, however, once those problems have been appropriately taken care of, the benefits are exponential. Revealing an unknown issue with the processes of a supplier and fixing it can result in the continual decrease of temperature excursions, mitigate risk, increase overall ROI, and protect the quality of your products.
Not only that, but when issues do occur, there are no longer any disputes with receivers and partners about who is responsible. Not only is the proof in the data, but you no longer need to rely on the data from partners for compliance purposes.
Make decisions based on facts and not feelings
Once complete visibility over the supply chain is obtained, including over receivers, partners, and suppliers, it eventually also becomes easier to make informed decisions on spending based on hard facts. When it comes to choosing packaging, containers, blankets, and services for shipments it can be difficult to know what is appropriate. On the one hand it might be better to spend more money to ensure the product is safe, but on the other hand continuously overspending results in large amounts of wasted money and resources in the long term.
In the 2019 LogiPharma EU report supply chain leaders were asked:
“How often do you overspend or underspend on maintaining the necessary temperature for your shipments? (i.e. using too many or not enough packing, containers, blankets and services)” For 25-50% of shipments, 42% of experts said they overspend, whereas 22% say they underspend.
It’s comforting to know that professionals are prioritizing quality over cost and overspending more than they are underspending on most shipments. However, with access to the right kind of data, peace of mind that products are safe can be achieved. This means that overspending is no longer necessary without worrying about decreasing product integrity.
Zero tolerance for incomplete data
Another short-term issue that could arise from a solution dedicated to providing complete data and control is the fact that incomplete reports with incomplete data are no longer good enough. With access to new technologies and better data, a new culture of “zero tolerance” for incomplete data is formed.
Along with the adoption of more advanced cold chain monitoring technologies, the culture and mindset surrounding data must also change. Having shipments where a logger provides incomplete data is no longer acceptable, meaning that for high-value shipments it’s even more important to use multiple loggers to ensure that complete data is always provided.
Shifting the mindset to one that demands complete data is difficult. Change is always difficult, but in the long term it protects your brand and products by ensuring quality and integrity.
Complete data and data integrity is also important from a regulatory standpoint. According to the MHRA GXP Data integrity Guidance and Definitions; Revision 1: March 2019.
“3.1 - The organization needs to take responsibility for the systems used and the data they generate. The organizational culture should ensure data is complete, consistent and accurate in all its forms, i.e. paper and electronic.”
Finding value in more data
After implementing a fully validated, real-time, end-to-end cold chain monitoring solution, supply chain leaders are faced with an influx of data. Having access to more data is a good thing, but only if organizations learn to harness that data to work for them. Now that the visibility is there, it is more important than ever to know how to analyse that data in order to continuously gain value from it.
We have seen pharmaceutical companies start to shed light on three times the volume of excursions they saw before implementing a real-time solution. Just as with the problems that have now revealed themselves, this knowledge of more excursions occurring than you were aware of must be dealt with. When this starts to happen in the beginning without you expecting it, it can be a bit scary.
This data, however, can be used to learn where and how those excursions are occurring and eventually you will see ways to tackle those problems. You will learn, for example, which routes are the best to use and which airports to avoid. Not only that, but it can drastically reduce the time taken to perform summer/winter studies, risk analysis, and complete lane validation. Based on these new-found insights into your supply chain, it will become possible to implement day to day operational management changes that will result in long-term, sustainable improvements.
Controlant’s cold chain monitoring solution is fully validated for CFR Part 11 / Annex 11. It combines re-useable, IoT data loggers with an intuitive cloud platform and a suite of managed and add-on services. The Controlant hardware, software, and services are sold as a packaged subscription service. This means you always have calibrated loggers on hand, access to the user interface, and we manage your reverse logistics and our monitoring and response team is available to manage shipment alerts and respond to them 24/7, 365 days a year.