Temperature Deviation During Transport – What Do You Do Now?

Temperature deviations are among the most common and costly sources of error in pharma logistics. A medicine that has been exposed to incorrect temperature conditions during transport can lose its efficacy - and if it’s not detected and handled correctly, it can, in the worst case, reach a patient.

Why temperature control is at the core of GDP

Many medicines are formulated to work correctly only within a narrow temperature range. If the temperature deviates during storage or transport, the product’s efficacy and safety may be compromised - without this necessarily being visible or detectable in the product itself. That’s why documented temperature control isn’t a formality, but a core part of ensuring patient safety, and it’s also why it carries so much weight in the GDP regulations.

Temperature mapping of warehouses and vehicles

Before you even start logging temperature in day-to-day operations, warehouses and vehicles need to be mapped - a process known as temperature mapping. The purpose is to identify whether there are “hot spots” or “cold spots” in a warehouse or a truck, where the temperature deviates from the rest of the space. Without this mapping, you risk placing temperature sensors in the wrong locations and thereby getting a false impression that conditions are fine.

OOS handling: the process from deviation to decision

When a temperature deviation is registered - a so-called Out-Of-Specification (OOS) event - it’s essential that there’s a clear, documented process for what happens next:

1. The deviation is registered automatically as soon as the temperature moves outside the permitted range.
2. A responsible person is notified immediately, not only at the next manual review.
3. An assessment is made of how long and by how much the temperature deviated, and what significance this has for the product in question.
4. The decision - release, quarantine or rejection - is documented so it can be produced at a later audit.

The faster steps 1 and 2 happen, the smaller the financial and time-related consequences of steps 3 and 4 become.

How an ERP system automates logging and alerts

Manual temperature logging - where an employee periodically records a reading - leaves gaps between measurements and depends on nobody forgetting to log one. An ERP system connected to temperature loggers can instead record data continuously and automatically generate an alert as soon as a value moves outside the acceptable range - whether that happens at two in the afternoon or three in the morning during a transport.

This means the response time to a deviation no longer depends on when someone happens to notice the problem.

Documentation that holds up to an audit

Beyond the immediate handling, it’s essential that the entire course of events - from deviation to decision - is documented in a way that can be produced if an authority asks for it. This includes temperature data, the time of the deviation and the response, who made the decision, and what the reasoning was. When this documentation arises automatically as part of the process, you avoid the stressful exercise of having to reconstruct events months after they happened.

The cold chain must not be broken - but if it is, it’s your ability to respond quickly and document correctly that determines the consequences.