The expansion of diverse modalities and therapeutic products in biopharmaceutical manufacturing has significantly increased the number of quality control (QC) tests and analytical methods. To address these changes, laboratory automation has become essential for improving efficiency in QC laboratories that traditionally rely on manual procedures. This study aimed to develop an integrated management model for laboratory automation covering the entire lifecycle, including infrastructure planning during facility construction, system implementation, operation and maintenance, system retirement, and change control related to new projects or facility expansion. A systematic review was conducted using academic literature, industry standards, and automation transition cases from other industries. Regulatory guidelines on hardware and software validation and data integrity were analyzed to define key requirements for automation systems in cGMP environments. Key elements include optimized sample flow and the establishment of logistics and network infrastructure during the design phase. In the operational phase, systematic lifecycle management including periodic calibration, system validation, and preventive and corrective maintenance is required to maintain hardware performance. This integrated model can serve as a practical guideline for the stable and efficient operation of automated QC laboratories while minimizing regulatory risks.
2026 Spring Convention