Storage areas must have continuous temperature monitoring systems in place to comply with regulatory requirements and satisfy clients. This includes temperature mapping, maintenance of refrigeration equipment, and sensor calibration. Pharmaceutical products go through a complex cold chain before reaching end users, making accurate and reliable monitoring crucial at each stage. Different parties within the cold chain have varying information needs. For example, the final recipient needs to know if there were temperature excursions that would warrant rejecting the shipment, while the manufacturer and logistics service provider is interested in identifying the root cause of any excursions. Therefore, a continuous temperature monitoring system should provide relevant information to all parties involved.
The pharmaceutical industry has adopted a Quality Risk Management (QRM) approach to manufacturing and distribution, as recommended by organizations like the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Regulatory agencies and bodies like the USFDA, IATA, and the ICH create regulations and guidelines for temperature control in the cold chain. Manufacturers bear the strongest regulatory pressures and are responsible for comprehensive temperature monitoring, documented in quality agreements with downstream supply chain partners.
Temperature control regulations, as outlined in the Federal Food, Drug, and Cosmetic Act by the USFDA, specify that drugs will be deemed adulterated if the facilities or controls involved in their manufacturing, packing, processing, or holding fail to adhere to the standards set by Current Good Manufacturing Practice (cGMP). Holding refers to any form of distribution, transportation, or warehousing for distribution or transfer. Temperature control is a fundamental requirement of cGMP, and failure to maintain specified conditions throughout all stages renders the goods adulterated.
ICH guidelines, such as the Q9 ‘Guideline on Good Manufacturing Practices (GMP),’ require manufacturers to ensure appropriate transport and storage conditions are followed by product transporters.
IATA’s ‘Temperature Control Regulations’ cover the shipping of temperature-sensitive products and emphasize the importance of temperature monitoring in their ‘Guidance for Vaccine and Pharmaceutical Logistics and Distribution.’
During static stages in the cold chain, where pharmaceutical products are stored in warehouses or distribution centres, various monitoring solutions are available to reduce the risk of non-compliance with Good Practice (GxP) requirements.
Real-time monitoring with customizable reports, alarm notifications through various channels, uninterrupted monitoring during power/network outages, intuitive software, easy network connectivity, and compliance with relevant regulations are important features of an effective temperature monitoring system.
Dynamic temperature monitoring is crucial during the transport of goods in the pharmaceutical cold chain, which involves crossing borders and using different modes of transportation. The Releye RLP container, developed by Envirotainer, provides accurate and verifiable temperature control. It has features like a rechargeable power supply for autonomous operation during unforeseen delays, remote monitoring via smart devices, and customized alerts for improved process management and delivery planning.
Accurate and reliable temperature monitoring is vital throughout the pharmaceutical cold chain to ensure compliance with global regulations. While advancements in data collection and processing technologies have been significant, the usability of data and the accuracy/reliability of sensors remain crucial factors.