Service/Sales/ General Inquiries 858-202-1408

San Diego HPLC OQ

HPLC is a widelyl used analytic technique in the biopharmaceutical, pharmaceutical, and medical device industries. Operational Qualification (OQ) is an important part of the verifying the reliability, accuracy, and compliance of HPLC systems. The team at GL Technologies has a team of experienced professionals with extensive knowledge of HPLC OQ requirements. We work with organizations throughout San Diego by assessing system components, verifying performance, validating methods, and maintaining data integrity so laboratories maintain trusted analytical results.

To speak with the experts about your HPLC OQ needs, please fill out our online form or give us a call!


Understanding HPLC Operational Qualification (OQ)

Operational qualificaton (OQ) is a validation process that verifies and documents if an HPLC system is performing according to predetermined specifications. It makes sure that the system is fit for its intended use and can consistently deliver accurate and reliable results. HPLC OQ aims to evaluate critical systems such as pumps, detectors, columns, software, and operational parameters to identify possible risks and sources of errors.

Key Components of HPLC OQ

Instrument Performance Verification

Pump performance: Evaluating flow rate accuracy and precision.
Detector functionality: Assessing sensitivity, linearity, and wavelength accuracy.
Column efficiency: Verifying separation and resolution capabilities.
Autosampler reliability: Checking sample injection accuracy and precision.

Instrument performance verification makes sure the reliable functioning of the HPLC system to generate valid analytical results. The critical part of HPLC OQ includes evaluating the performance of key instrument components including the pump, autosampler’s, detector, and column oven.

System Suitability Testing

Verifying system performance using reference standards.
Evaluating parameters such as peak symmetry, resolution, and tailing factor.
Ensuring consistent and reliable chromatographic performance.

The key components of HPLC OQ system suitability testing (SST), involves a set of parameters that validates the effectiveness of the chromatographic system. The components include the evaluation of resolution, retention time, peak asymmetry, and theoretical plates. By performing a thorough assessment of these components, HPLC OQ system suitability testing verifies the accuracy of the system, providing reliable analytical results.

Method Validation

Testing the analytical method for accuracy, precision, linearity, and specificity.
Verifying the method's ability to detect impurities and quantify analytes.
Assessing robustness by evaluating the impact of small variations in experimental conditions.

After system suitability tests have been performed to verify that the HPLC system is performing as required, the calibration of detectors, including UV-Vis and mass spectrometry are carried out to verify their accuracy and linearity. The method is then assessed by evaluating the impact of small variations in parameters like mobile phase composition and flow rate on the system suitability parameters. Finally, the validation process involves establishing comprehensive validation protocol, documentation of procedures, results, and adherence to regulatory guidelines.


Verifying the accuracy, completeness, and reliability of data.
Adhering to regulatory guidelines, such as Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Implementing secure data storage and audit trails to maintain data integrity.

After testing, comprehensive documentation of OQ activities including protocols, results, and deviations are required to maintain a robust compliance framework and facilitate audit trails. All of these components create the foundation for achieving HPLC OQ compliance to maintain accuracy and reliability of the analytical process.

HPLC OQ Benefits

Reliable Results

By undertaking OQ, laboratories can make sure that their HPLC systems consistently deliver accurate and precise results, giving confidence in the reliability of the data that is being generated. With thorough testing of parameters such as system suitability, detector linearity, and precision, HPLC OQ identifies potential issues and also provides an opportunity to rectify them.

Risk Mitigation

By evaluating critical system parameters, the OQ process identifies issues early on, giving organization’s time to take corrective actions. This validation approach minimizes the risk of instrumental malfunction, sample contamination, or method failure, verifying the delivery of reliable and consistent analytical results.

Improved System Performance

With the OQ process, the performance and functionality of the HPLC system are evaluated and validated. This assessment verifies that the system operates at its optimal level, providing accurate and reliable results. By addressing any concerns, HPLC OQ improves the system’s overall efficiency and minimizes downtime. It also addresses consistent high-quality analytical data which leads to improved overall performance and laboratory productivity.

HPLC OQ Education

Improve HPLC Performance Through Operational Qualification

To speak with the experts about your HPLC OQ needs, please fill out our online form or give us a call!


GL Technologies also works with clients throughout San Francisco and Los Angeles and Orange County, covering every region throughout the state of California.  


To request a quote from GL-Tec, please fill out our online form and we will get back to you promptly.


GL Technologies Location