Standard Operating Procedure for Laboratory Instrument Maintenance

1) Purpose

This SOP outlines the procedures for the routine maintenance of laboratory instruments to ensure their optimal performance, reliability, and longevity in pharmaceutical testing and analysis.

2) Scope

This SOP applies to all laboratory instruments used for testing, analysis, and measurement within the pharmaceutical facility, including but not limited to, analytical balances, spectrophotometers, chromatography systems, and pH meters.

3) Responsibilities

The Laboratory Manager or designated personnel are responsible for overseeing instrument maintenance procedures. Laboratory technicians and engineers are responsible for performing and documenting instrument maintenance activities.

4) Procedure

4.1 Maintenance Schedule and Plan

1. Develop a maintenance schedule based on instrument usage, manufacturer recommendations, and regulatory requirements.
2. Document maintenance procedures for each instrument type outlining maintenance tasks, frequency, and acceptance criteria.

4.2 Pre-Maintenance Checks

1. Inspect the instrument for any visible damage, wear, or abnormal operating conditions.
2. Verify availability of required maintenance tools, spare parts, and lubricants.

4.3 Maintenance Activities

1. Perform routine maintenance tasks such as cleaning, calibration verification, lubrication, and adjustment as per documented procedures.
2. Record maintenance activities including date of maintenance, tasks performed, and any observations or findings.

4.4 Preventive Maintenance

1. Implement preventive maintenance measures to prevent instrument breakdowns and ensure continuous operation.
2. Replace consumable parts and perform preventive adjustments to maintain instrument