Should I invest in monitoring my shipments or in controlling them by using protective temperature controlled packaging? The question becomes even more relevant as the revised regulations apply, not only to typical cold chain shipments 2-8°C, but to all shipments, including ambient shipments. As the revised EU GDP guidelines become more and more demanding in terms of liability and protection of IMP across the supply chain, pharmaceutical and biotech companies are questioning the best approach to their supply chain strategy. When I am asked to give advice on this, I always give the same answer. It depends on three factors – historic data on the stability of the product; risk assessment & cost. There is an additional factor which is non-negotiable, that of compliance to regulations in terms of process and traceability of our actions.
Here are my first 5 tips on how to debate monitoring vs controlling of temperature sensitive supplies:
- Evaluate stability data: In terms of historical data, some biotech companies have collated stability data of their IMP’s. This data, together with information on performance of couriers and shippers, can determine that systematic monitoring may not be required for all shipments. Evaluate the true value of the data. One year-old data may not be sufficient to give this level of security, but three year’s data may give an in-depth analysis that helps determine if monitoring is really necessary.
- Consider the routes: Monitoring inner and outer temperatures of CRT shipments over three years across specific lanes may indicate that temperature controlled shippers may not be necessary for all routes.
- Determine your comfort level for risk: Even if you collect a lot of data on a high volume of shipments, the only way we can be 100% sure a shipment has not had an excursion is via continuous monitoring. This is the reason why most Biotech and pharma companies just monitor. They just do not wish to take any risk.
- Embrace technology: As technology evolves, packaging solutions that are 100% (or to be more correct 99.99%) reliable will be the norm. Although progress on high-end packaging has been slow as thermodynamics is not a simple science, I am confident that real progress will be made over the coming years. Today, many pharmaceutical companies with high volumes of cold chain shipments are adopting a reusable shipper strategy in an effort to be more environmentally friendly; to support investigator sites; and to benefit from cost efficiencies. To listen in to our recent webinar on this very topic, click here.
- Conduct a cost analysis: It is not just the cost of the monitor vs the cost of the shipper. Other factors include the software that is used by monitor manufacturers which can be a differentiator in this competitive marketplace. Your analytics to help improve processes are very much governed by the quality of the data collated. Whilst there may not be an additional charge for the software, you may have to appoint additional resources so as to gain the best use out of the system. Some monitor companies can help with the analytics but at an additional cost to you.