Standard Operating Procedure for Laboratory Equipment Maintenance

1) Purpose

The purpose of this SOP is to establish the procedures for maintaining laboratory equipment to ensure accuracy, reliability, and compliance with regulatory requirements in the pharmaceutical industry.

2) Scope

This SOP applies to all laboratory equipment used in the pharmaceutical manufacturing process.

3) Responsibilities

The Quality Control and Maintenance Departments are responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Routine Maintenance
   1. Inspect laboratory equipment regularly to identify any signs of wear or malfunction.
   2. Perform routine calibration, cleaning, and servicing as per the manufacturer’s recommendations.
   3. Document all routine maintenance activities, including date, tasks performed, and personnel involved.
2. Preventive Maintenance
   1. Create a preventive maintenance schedule based on manufacturer guidelines and industry standards.
   2. Perform preventive maintenance tasks, such as checking electrical connections, lubricating moving parts, and verifying calibration.
   3. Document all preventive maintenance activities and update the maintenance schedule as necessary.
3. Corrective Maintenance
   1. Identify and report any issues requiring corrective maintenance immediately.
   2. Perform necessary repairs or replacements to restore equipment functionality.
   3. Document all corrective maintenance activities, including date, tasks performed, and personnel involved.
4. Performance Verification
   1. Verify the performance of laboratory equipment regularly to ensure it meets required specifications.
   2. Record verification results and take corrective actions if equipment performance is outside acceptable limits.
5. Review and Documentation
   1. Review maintenance records regularly to identify trends and areas for improvement.
   2. Update maintenance procedures and schedules based on review findings and regulatory updates.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Logs, Equipment Manuals, Calibration Records

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0