Pharmaceutical cold chain9 / 9

Trace a human-medicine shipment from batch ID through handover and deviation decisions. Check that records match procedures and named owners.

GDP is a framework for processes and evidence. Link records to the product lot through receipt, storage, transport, returns and deviations.

On the wholesaler side the rules gather under three headings: suitable conditions, measured conditions, documented conditions. Two of the three are of no use without the third.

Different documents define vaccine storage, point-of-use practice and distribution records. Check requirements by product and process.

Circular 2008/14 splits vaccines into two groups by how they react to freezing. After a broken chain, the provincial commission decides by looking at the group, the temperature reached and the duration.

A thermolabile medicine is one whose structure breaks down outside a set temperature band. The damage is usually invisible, it accumulates and it cannot be undone, which is why cold chain rules exist.

Room temperature for a medicine means showing by record that it stayed in the 15-25 °C band. Mapping and a well-placed logger find the spot where the band is breached.

Infusion solutions are not fridge products, but they have a limit in both directions: product information, the USP table and the volume of ice show what to record, and at which temperature.

Unopened insulin stays in the fridge at 2-8 °C and is never frozen. The period and temperature for a pen in use come from the product information.

A thawed vial looks the same from the outside. The freeze indicator, the vial monitor and the shake test measure different things, and it helps to know what each one says.

The time is product-specific and stated in the product information: 14 days up to 25 °C for Humira, 4 weeks for Enbrel, 4 weeks below 30 °C in use for NovoRapid. For a transport excursion the decision rests on the record and the authorisation holder's data.

Cold chain medicines usually travel at +2 to +8 °C. Product condition, ice pack preparation, logger position, route and handover record are set up together in five steps.

Cold chain medicines are stored between +2 and +8 °C. Frozen and ultra-cold medicines have bands of their own; the storage statement of the product says which applies.

Vaccines, insulins, biologicals and some blood products come to mind first. Every group has exceptions; the storage statement on the pack decides the fridge question.