A temperature excursion is a deviation of temperature outside the allowed range for a product, during storage or transport. In pharma it’s the event the cold chain is designed to prevent: a 2-8 °C medicine that rises to 12 °C, or drops below zero, has suffered an excursion.
Why it’s critical
Not every excursion compromises the product: it depends on the size and duration of the deviation and on the medicine’s stability. That’s why GDP requires every excursion to be recorded, assessed and documented, deciding whether the batch is still usable.
How it’s assessed and prevented
Assessment considers cumulative time and temperature, often via mean kinetic temperature. Prevention comes from qualified vehicles, continuous data-logger monitoring and route planning that limits exposure time — see cold chain: integrating temperature and routes.
FAQ
Does every temperature excursion make a medicine unusable?
No. The impact depends on duration, magnitude and product stability. The deviation must still be recorded and assessed under GDP procedures before deciding.
How is a temperature excursion detected?
With probes and data loggers that record temperature continuously during transport and storage, flagging any breach of the defined limits.