Standard Operating Procedure for Laboratory Instrument Calibration

1) Purpose

This SOP outlines the procedures for the calibration of laboratory instruments to ensure accuracy, reliability, and traceability of measurements 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 Quality Control (QC) department is responsible for implementing and overseeing instrument calibration procedures. Laboratory personnel are responsible for performing and documenting instrument calibrations.

4) Procedure

4.1 Calibration Schedule and Plan

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

4.2 Pre-Calibration Checks

1. Ensure the instrument is clean, free from debris, and in stable operating condition.
2. Verify availability and condition of calibration standards and reference materials.

4.3 Calibration Procedure

1. Perform calibration following documented procedures and using calibrated standards traceable to national or international standards.
2. Record calibration results including instrument identification, date of calibration, standard used, and deviations (if any).

4.4 Calibration Records and Documentation

1. Maintain calibration records for each instrument, including calibration certificates, deviation reports, and adjustment logs.
2. Review and approve calibration records by authorized personnel