Standard Operating Procedure for Preventive Maintenance of Equipment
1) Purpose
The purpose of this SOP is to establish procedures for the preventive maintenance of manufacturing equipment to ensure optimal performance and minimize equipment downtime.
2) Scope
This SOP applies to all personnel involved in the preventive maintenance of equipment at [Company Name] used for the production of intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Maintenance Personnel: Performing preventive maintenance according to the SOP.
– Quality Assurance (QA) Department: Reviewing and approving maintenance procedures and records.
– Production Department: Ensuring equipment is available for scheduled maintenance.
4) Procedure
4.1 Preparation for Preventive Maintenance
4.1.1 Identify equipment that requires preventive maintenance and the maintenance schedule.
4.1.2 Ensure that maintenance tools and spare parts are available and in good condition.
4.2 Preventive Maintenance Process
4.2.1 Perform preventive maintenance according to the manufacturer’s instructions and established maintenance procedures.
4.2.2 Inspect equipment for signs of wear, damage, or malfunction.
4.2.3 Replace or repair worn or damaged parts as necessary.
4.2.4 Lubricate moving parts and perform other routine maintenance tasks.
4.3 Verification of Maintenance
4.3.1 Verify that all maintenance tasks have been completed and equipment is functioning correctly.
4.3.2 Record maintenance activities, including the equipment ID, maintenance date, and any deviations or repairs performed.
4.4 Documentation
4.4.1 Maintain records of all preventive maintenance activities, including maintenance logs, inspection results, and any deviations or corrective actions.
4.4.2 Ensure all records are signed and dated by the responsible personnel.
4.5 Maintenance Schedule
4.5.1 Develop and maintain a preventive maintenance schedule for all equipment requiring maintenance.
4.5.2 Ensure maintenance is performed at regular intervals as specified in the schedule.
5) Abbreviations, if any
– QA: Quality Assurance
6) Documents, if any
– Preventive Maintenance Logs
– Maintenance Schedule
– Inspection Reports
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Equipment Manufacturer’s Manual
8) SOP Version
Version 1.0