Standard Operating Procedure (SOP) for Calibrating and Verifying HPLC System Accuracy

1. Purpose of Calibrating and Verifying HPLC System Accuracy

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for calibrating and verifying the accuracy of HPLC systems at [Company Name]. This procedure ensures that the HPLC system operates within defined parameters, maintaining the precision and reliability of analytical results.

2. Scope of Calibrating and Verifying HPLC System Accuracy

This SOP applies to all personnel responsible for the calibration and accuracy verification of HPLC systems within [Company Name]. It encompasses the calibration of the entire system, including pumps, detectors, and associated components.

3. Definitions involved in Calibrating and Verifying HPLC System Accuracy

3.1 HPLC System:

High-Performance Liquid Chromatography system used for the separation and analysis of compounds.

3.2 Calibration:

The process of setting and verifying the precision and accuracy of the HPLC system.

4. Responsibilities

4.1. Laboratory Manager

4.1.1 Ensure that all HPLC systems in the laboratory are calibrated and verified as per the defined schedule.

4.1.2 Allocate resources for calibration activities.

4.2. Calibration Technician

4.2.1 Perform the calibration and accuracy verification of HPLC systems as per the defined schedule.

4.2.2 Record and report calibration results.

5. Calibration and Verification Procedures

5.1. Pre-Calibration Preparations

5.1.1 Notify users about the upcoming calibration.

5.1.2 Ensure that the HPLC system is clean and free from any residues.

5.2. Calibration Equipment

5.2.1 Use calibrated standards and reference materials for calibration.

5.2.2 Ensure that calibration equipment is traceable to national standards.

5.3. Calibration Steps

5.3.1 Set up the HPLC system with the calibration equipment.

5.3.2 Calibrate the pump flow rate and verify it with standard solutions.

5.3.3 Calibrate the detector response with reference compounds.

5.3.4 Verify the temperature control accuracy.

5.4.5 Perform system suitability tests.

5.4. Calibration Report

5.4.1 Prepare a comprehensive calibration report detailing the HPLC system’s performance.

5.4.2 Include a statement of calibration and results, including deviations and adjustments made.

6. Record Keeping

6.1. Calibration Records

6.1.1 Maintain detailed calibration records for each HPLC system.

6.1.2 Include calibration certificates, reports, and system suitability test results.

6.2. Schedule

6.2.1 Establish a calibration schedule for HPLC systems.

6.2.2 Ensure that the schedule is consistently followed.

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