A cold chain can be managed by a quality management system
A cold chain can be managed by a quality management system. It should be analyzed, measured, controlled, documented, and validated.
The overall approach to validation of a distribution process is by building more and more qualifications on top of each other to get to a validated state. This is done by executing a component qualification on the packaging components, an operational qualification to demonstrate that the process performs at the operational extremes and finally a performance qualification that demonstrates that what happens in the real world is within the limits of what was demonstrated in the operational qualification limits.
Performing thermal testing can also help with validating the cold chain. Certified test labs use environmental chambers to simulate ambient profiles that a package may encounter in the distribution cycle. Thermocouple probes and separate temperature dataloggers measure temperatures within the product load to determine the response of the package to the test conditions. Replicate testing based on a qualification protocols is used to create a final qualification report that can be used to defend the configuration when audited by regulators. It is normally best to have an individual that understands the principles of validation, when defending such processes to a federal regulatory body of any nation.