by Rene Tjong Tjin Tai, CEO, Dyzle
There is now a good deal of awareness of the need for proper cold chain management in the storage and transportation of temperature-sensitive products in the pharmaceutical and food industry. In particular, there is now increasing pressure on manufacturers and logistics providers alike to ensure that regulatory requirements are met, and safety or integrity of products is not compromised – especially so when the lives of patients are at stake.
According to market research firm TechNavio, the global cold chain market is set to grow at a CAGR of 15.75 percent and 10.53 percent in terms of revenue and volume, respectively, over the period 2014-2019. If defines ‘cold chain’ as supply chain management that involves storage and transportation of temperature-sensitive goods, using thermal and refrigerated packaging methods to help with the transportation and storage of those goods, and utilizing extensive logistics planning to ensure the integrity of these goods.
In order to demonstrate integrity and comply with GDP (Good Distribution Practice) guidelines, there are both monitoring and reporting requirements in the cold chain. This is provided by a variety of means – including data loggers, temperature monitors, sensors, track and trace systems and so on. Much of this reporting is provided on a historical basis (ie: at the end of a journey or on delivery), but there is also a growing trend for real time monitoring, providing alerts when a parameter such as temperature has digressed beyond a safe range.
Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP) guidelines also require mandatory reports in a standard format to demonstrate compliance. Systems are now available that automatically create these reports from real time data sent to the cloud (see image).
So what is next for the cold chain industry in 2015? Here is what we consider the top five trends to watch out for this year.
- Creation of additional capacity and capability of handling for cold chain products; there is a shortage of both at warehouses as well as 3PLs (third party logistics providers)
- Proper last mile delivery and storage; this is still an issue in many emerging economies that don’t have proper end to end cold chain infrastructure, and this also needs to include return of products.
- In air / at sea temperature monitoring; temperatures can already be monitored in the air but cannot currently be transmitted in real time as the wireless radio connection has to be switched off in air.
- GDP ‘like’ inspections by the regulators in the last-mile – for example, at pharmacies.
- Maximizing the benefits of investments in serialization, security, GS1 and temperature monitoring by integrating solutions
The last point on this list of trends to watch out for in this year, serialization, is an important one in the battle against counterfeit drugs, and ensuring supply chain security. Legislation will come on board in a number of countries, forcing multinational companies to look at effective ways of coding individual products around the world, and enabling individual item level serialization. The ability to track and record each item’s movement across borders will mean pharmaceutical companies face new challenges and requirements, and have to implement serialization standards.
In summary, we are coming to a new phase in the cold chain industry, where issues like capacity, last mile delivery, and product security become as important as the capabilities that we are currently seeing to monitor the cold chain.