A temperature excursion alone does not prove that a product is spoiled or usable. Assessment requires stability evidence for the specific product and batch alongside the actual exposure record; data from another product cannot substitute.
First segregate the batch under site procedure. File the logger's raw data and ID, calibration status, sensor location, excursion start and end, highest and lowest values, shipment conditions and any known prior excursions.
Obtain product-specific stability information and a written decision from the marketing authorisation holder or authorised quality owner. Logistics staff provide complete data; they do not decide release, use or disposal. Summary measures such as MKT do not replace product-specific assessment.
