How do you maintain and calibrate critical equipment used in your manufacturing process?

Auditee: The maintenance and calibration of critical equipment within our manufacturing process are integral components of our quality assurance efforts. These practices ensure that our equipment functions accurately, consistently, and within the specified parameters, thereby contributing to the production of safe and high-quality pharmaceutical products.

Maintenance Program: Our equipment maintenance program is designed to prevent equipment failures, minimize downtime, and extend the lifespan of our critical manufacturing equipment. Here’s an overview of our approach:

Scheduled Maintenance: We establish a comprehensive maintenance schedule that includes routine inspections, cleaning, lubrication, and other preventive measures. This schedule is based on equipment manufacturers’ recommendations, industry best

practices, and our historical data.

Qualified Technicians: Maintenance tasks are carried out by qualified and trained technicians who are well-versed in the specific requirements of each equipment type.

Documentation: All maintenance activities are meticulously documented. This includes records of performed tasks, parts replaced, and any adjustments made to the equipment. This documentation supports traceability and helps identify trends in equipment performance.

Emergency Maintenance: In the event of unexpected breakdowns, we have procedures in place to address equipment failures promptly. These procedures ensure that repairs are carried out by experienced technicians using approved methods and parts.

Calibration Program: Calibrating critical equipment is crucial to ensuring accurate measurements and consistent performance. Our calibration program follows these principles:

Schedule: Equipment calibration is performed according to predetermined schedules that take into account the equipment’s usage frequency and criticality.
Traceable Standards: Calibrations are conducted using traceable standards that are regularly calibrated by accredited laboratories. This ensures the accuracy and reliability of the calibration process.
Qualified Personnel: Our calibration procedures are executed by qualified personnel who have the necessary expertise in the equipment’s operation and calibration techniques.
Calibration Records: Detailed records of calibration activities are maintained. These records include calibration dates, results, any adjustments made, and the instruments used during the process.
Out-of-Specification (OOS) Handling: If a calibration result falls out of specification, we have procedures in place to address this situation promptly. This includes investigating the cause, taking corrective actions, and re-calibrating the equipment.

Continuous Improvement: Our maintenance and calibration practices are subject to continuous improvement. We analyze maintenance and calibration data to identify trends, address recurring issues, and refine our procedures accordingly.

Through our robust maintenance and calibration programs, we ensure that our critical manufacturing equipment operates reliably, consistently, and in accordance with FDA regulations, contributing to the production of pharmaceutical products of the highest quality.