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 to ensure compliance with procedures.

4.5 Out-of-Tolerance Conditions

1. Define procedures for handling out-of-tolerance conditions, including investigation, root cause analysis, corrective actions, and re-calibration.
2. Implement procedures to prevent the use of instruments that are out of calibration tolerance limits.

4.6 Calibration Performance Verification

1. Periodically verify calibration performance through interim checks, correlation studies with reference laboratories, or external proficiency testing.
2. Document and review calibration verification results to ensure ongoing accuracy and reliability of instrument measurements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Calibration Schedule, Calibration Procedures, Calibration Records, Calibration Certificates

7) Reference, if any

Regulatory guidelines such as USP General Chapter 1251 Instrumental Analysis, ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories, FDA Guidance for Industry: Process Validation: General Principles and Practices

8) SOP Version

Version 1.0