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including specimens of the batch coding, expiry dating and any additional overprinting; h) notes on any special problems or unusual events including details, with signed authorization for any deviation from the manufacturing
Διαδικασίες και γραπτά στοιχεία
the following information should be entered at the time each action is taken and, after completion, the record should be dated and signed in agreement by the person(s) responsible for the packaging operations: a) the name of the product; b) the date(s) and times of the packaging operations; c) the name of the responsible person carrying out the packaging operation; d) the initials of the operators of the different significant steps; e) records of checks for identity and conformity with the packaging instructions including the results of in-process controls; f) details of the packaging operations carried out, including references to equipment and the packaging lines used; g) whenever possible, samples of printed packaging materials used, including specimens of the batch coding, expiry dating and any additional overprinting; h) notes on any special problems including details for any deviation from the packaging instructions with written authorization by an appropriate person; i) the quantities and reference number or
Οι ακόλουθες πληροφορίες πρέπει να καταγράφονται κατά το χρόνο οπού λαμβάνει χώρα κάθε ενέργεια και, μετά την ολοκλήρωση.