Absence of critical production data in the batch record – intervention required for reconstruction and quality validation.
A critical anomaly was detected in Berlin: key elements of the batch record (production parameters and control readings) were missing from the documentation system.
An urgent intervention was carried out jointly by the Quality and Production teams to manually retrieve the data and secure traceability.
The batch record was completed and validated following reinforced quality review.
A preventive action plan has been initiated to avoid recurrence