English to Russian Medical Medical: Pharmaceuticals

The same principle applies here as for temperature excursions.
If the alarm limits are breached and there is a regulatory or business need (i.e. building construction) then a CTF-001 must be completed – and also a non-conformance if not a brief excursion.
So if there is a one-off excursion, we don’t spend time investigating the cause.
Where humidity is not a regulatory requirement, then a humidity excursion up to 2 hours can be reported on a CTF-001 only.
Where it is a regulatory requirement (e.g. Mexico) then a non-conformance report is required for all excursions.
Therefore it is accepted that a brief excursion in air temperature, within the ranges in this table, does not adversely affect product temperature.

Where there has been an excursion QA need to put the affected stock in QA Hold until each client *confirms its disposition*.

Complete section 6 and attach a printout of the excursion from the CMS.
Depot Manager completes section 9 to make an assessment of the impact of the excursion and the final status of all the affected supplies.
This event caused an excursion so CTF-001 must be completed and clients with products in the cold room contacted.
So this event did not cause an excursion and no documentation is required.