GDP preparation for human-medicine distribution depends on matching records to a real shipment, not simply having a procedure file. Select one batch for a practice audit and trace its records from start to finish.
Match product and batch ID to the order, dispatch documents, carrier details, and receipt record. Identify where the current product information defining transport conditions is kept.
If a logger is used, link its ID, verification or calibration status, location, and data file to the shipment. If a record is missing, make the gap visible; do not complete it later as though data existed.
For a delay, alarm, or condition deviation, link event time, recipient of notification, investigation, quality decision, and corrective action to the same batch. Leave product release to the authorised quality process.
If transport is outsourced, compare the contract's record and notification flow with the actual receipt record. This internal check does not replace current TİTCK GDP requirements for human-medicine distribution; confirm scope against the official text.
