What should I do when a temperature excursion is detected in cold-chain medicines during transport (Temperature Excursion)?

A temperature excursion is an urgent and serious matter that requires an investigation to be initiated immediately. Step 1: Immediately segregate the affected medicines in an “under investigation” area, clearly label them and prohibit their entry into saleable stock. Step 2: Record the excursion details, including the temperature outside the permitted range, its duration and all relevant details of the transport process. Step 3: Contact the medicine manufacturer immediately and provide complete temperature excursion data. Only the manufacturer has the medicine’s stability data and can authoritatively determine whether the excursion has had an unacceptable impact on its quality, safety and efficacy. Step 4: Decide on the final disposition of the medicines based on the manufacturer’s written assessment. If the manufacturer considers that their quality has been compromised, they must be destroyed in accordance with requirements. If the manufacturer provides data demonstrating that the excursion was within acceptable limits, the medicines may be released.