The cold chain is the temperature-controlled handling of a product across the whole supply chain — storage, transport and delivery — without interruption. In pharma it’s essential for vaccines, biologics and many medicines that must typically be kept between 2 and 8 °C.
Why it matters
A break in the cold chain can compromise a product’s efficacy and safety, with financial losses and patient risk. That’s why Good Distribution Practice (GDP) requires temperature monitoring, recording and management of deviations.
How it’s monitored
Probes and data loggers record temperature continuously; readings outside the limits are temperature excursions, and cumulative exposure is assessed using mean kinetic temperature. Integrating temperature and route planning is the topic of the guide cold chain: integrating temperature and routes.
FAQ
What temperature does the pharmaceutical cold chain require?
It depends on the product: many refrigerated medicines must be kept between 2 and 8 °C, others at different temperatures stated on the label. Staying within the declared range is the goal of the cold chain.
What happens if the cold chain is broken?
A temperature excursion occurs: the product may lose efficacy or fall out of compliance. The deviation must be recorded, assessed (including via MKT) and managed under GDP procedures.