Calibration and Maintenance Procedures
1) Purpose
The purpose of this SOP is to establish standardized procedures for calibrating and maintaining equipment to ensure accurate and reliable performance.
2) Scope
This SOP applies to all equipment used in the pharmaceutical manufacturing facility that requires calibration and maintenance.
3) Responsibilities
– Maintenance personnel are responsible for performing calibration and maintenance activities.
– QA personnel are responsible for verifying the accuracy of calibration and maintenance records.
– Department managers are responsible for ensuring that their equipment is regularly calibrated and maintained.
4) Procedure
1. Calibration Schedule
1.1. Develop a calibration schedule for all equipment requiring regular calibration.
1.2. Ensure the schedule specifies the frequency and type of calibration required.
2. Calibration Procedures
2.1. Perform calibration according to the manufacturer’s instructions and established protocols.
2.2. Use calibrated reference standards traceable to national or international standards.
2.3. Record calibration results, including any adjustments made to the equipment.
2.4. Label equipment with calibration status, date, and due date for the next calibration.
3. Maintenance Schedule
3.1. Develop a maintenance schedule for all equipment
3.2. Ensure the schedule specifies the frequency and type of maintenance required.
4. Maintenance Procedures
4.1. Perform maintenance according to the manufacturer’s instructions and established protocols.
4.2. Inspect equipment for wear, damage, and proper functioning.
4.3. Replace or repair any worn or damaged parts.
4.4. Record maintenance activities, including any repairs or replacements made.
5. Verification and Documentation
5.1. Verify that all calibration and maintenance activities are performed as scheduled.
5.2. Maintain calibration and maintenance records, including dates, results, and personnel involved.
5.3. Ensure records are reviewed and approved by QA personnel.
6. Handling Out-of-Tolerance Equipment
6.1. Identify and label any equipment found to be out of tolerance during calibration.
6.2. Remove out-of-tolerance equipment from service until it has been recalibrated and verified.
6.3. Document any corrective actions taken to address out-of-tolerance equipment.
7. Training
7.1. Train maintenance personnel on calibration and maintenance procedures.
7.2. Provide regular refresher training and updates on new calibration and maintenance protocols.
7.3. Document all training activities in the training log.
8. Review and Approval
8.1. Submit calibration and maintenance records to the QA department for review.
8.2. QA will review and approve the records, ensuring all activities have been performed correctly and equipment is functioning properly.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
6) Documents, if any
– Calibration Schedule
– Calibration Record Form
– Maintenance Schedule
– Maintenance Record Form
– Training Log
7) Reference, if any
– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
8) SOP Version
Version 1.0