How should an incident during medicine transport, such as an interruption to temperature control, be handled?

An incident such as a break in temperature control during transport is a serious quality event, and the deviation handling procedure must be initiated immediately. First, transport personnel should immediately report the situation to the dispatching party’s (licensed wholesaler’s) quality management department and Person-in-Charge. Second, on receipt of the goods, if the recipient finds abnormal temperature-control records or suspects that medicine quality has been compromised, they have the right and responsibility to refuse the batch or immediately segregate it in an area for quarantined goods pending examination. The dispatching party must conduct a risk assessment of the affected medicines. The assessment should consider factors such as the medicine’s stability data and the extent and duration of the temperature deviation to determine whether its quality remains acceptable. If it cannot be demonstrated that quality has not been affected, or the assessment finds the batch non-conforming, the batch must be treated as non-conforming goods and handled under the destruction procedure described above; it must never be released to the market. The entire incident response, from discovery to final disposition, must be documented in detail.