Standard Operating Procedure for Maintenance of Laboratory Equipment

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of laboratory equipment to ensure accuracy and reliability in analytical testing and research activities in the pharmaceutical industry.

2) Scope

This SOP applies to all laboratory equipment used in pharmaceutical laboratories, including but not limited to analytical instruments, chromatography systems, and spectrophotometers.

3) Responsibilities

The Quality Control Department is responsible for implementing and adhering to this SOP. The Laboratory Technicians are responsible for executing maintenance activities.

4) Procedure

1. Maintenance Schedule Planning
   1. Develop a maintenance schedule based on equipment criticality, manufacturer recommendations, and operational usage.
   2. Assign specific maintenance tasks to qualified laboratory technicians.
   3. Document the schedule and ensure it is communicated to relevant departments.
2. Preventive Maintenance Tasks
   1. Perform routine inspections of laboratory equipment according to the schedule.
   2. Check for signs of wear, calibration drift, or other abnormalities.
   3. Calibrate instruments using certified standards and procedures.
   4. Clean and decontaminate equipment surfaces and parts as needed.
3. Corrective Maintenance Procedures
   1. Address equipment malfunctions promptly to minimize impact on testing schedules.
   2. Diagnose the root cause of the issue and determine necessary repairs.
   3. Perform repairs using approved spare parts and procedures.
   4. Verify equipment performance through validation checks post-repair.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document instrument calibration certificates, maintenance logs, and any deviations from standard operating conditions.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Schedules, Calibration Certificates, Maintenance Logs, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance of laboratory equipment.

8) SOP Version

Version 1.0