Standard Operating Procedure for Routine Maintenance of GMP Equipment and Facilities
1) Purpose
This SOP provides guidelines for the routine maintenance of GMP equipment and facilities to ensure optimal performance, prevent contamination, and maintain compliance with GMP standards.
2) Scope
This SOP applies to all personnel involved in the maintenance of equipment and facilities at [Company Name].
3) Responsibilities
- Operators: Perform routine maintenance and document all activities in the maintenance log.
- Maintenance Team: Responsible for overseeing equipment maintenance schedules and performing corrective actions.
- Quality Assurance (QA): Reviews maintenance logs and ensures that all equipment is functioning within GMP standards.
4) Procedure
4.1 Routine Maintenance Schedule
4.1.1 Daily Maintenance
- Inspect all equipment at the start and end of each production shift. Check for any wear or damage that may affect performance or safety. Document inspections in the equipment log.
- Perform basic cleaning and lubrication of moving parts, following the manufacturer’s guidelines. Record all activities in the maintenance log.
4.1.2 Weekly Maintenance
- Conduct a detailed inspection of all critical equipment, including motors, belts, filters, and seals. Replace any worn components and document the replacements
in the maintenance log.
Calibrate equipment as per the calibration schedule to ensure accuracy. Record all calibrations in the calibration log and submit for QA approval.
4.1.3 Monthly Maintenance
- Perform a full-system check of all GMP equipment, including HVAC systems, temperature controls, and cleanroom facilities. Address any identified issues promptly and document the maintenance in the log.
4.2 Post-Maintenance Activities
4.2.1 Cleaning and Documentation
- After performing maintenance, clean all tools, equipment, and areas involved in the process. Ensure that no debris or contaminants remain in the production environment.
- Document all maintenance activities, including inspections, repairs, calibrations, and cleaning, in the maintenance log. Submit records to QA for review.
4.2.2 QA Review and Equipment Approval
- QA must review and approve all maintenance logs before equipment is returned to service. Any deviations from the maintenance schedule must be documented in the deviation log.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
6) Documents, if any
- Maintenance Log
- Calibration Log
- Deviation Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for equipment calibration
8) SOP Version
Version 1.0
Annexure
1. Maintenance Log Template
| Date | Equipment ID | Maintenance Performed | Operator Initials | QA Approval | |
|---|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name | Maintenance Description | Operator Name | QA Name | |