Operational Qualification Procedures

The LC Services Operational Qualification Procedures have been designed inline with good laboratory practise (GLP) and good manufacturing practices (GMP), which require that;

"all laboratory instrumentation shall be adequately inspected, cleaned and maintained. Instruments used for generation, measurement and evaluation of data shall be adequately tested, calibrated or standardised."

• Compliant with FDA, GLP, GMP and other accreditation bodies
• Full paper trail of all work performed and calibrated instrumentation used
• Carried out in conjunction with a PM
• Performed by dedicated OQ engineer via tamper proof software
• Final information bound and certificate paper
• Clear documentation supplied on results obtained, test information and instrument identification
• Raw data put on a CD for easy archiving

LC Services Ltd protocol (available on request) will define the methods and documentation that will be used to evaluate the instrument or system for operation in accordance with the intended use. Successful completion of this protocol will verify that the instrument or system is operating according to acceptable limits. LC Services can tailor protocols to integrate with customer’s SOPs for consistency in reporting

All preventative maintenance / repairs are completed and instrument tests carried out prior to a qualification procedure being undertaken.

All raw data collected is obtained using calibrated standards / equipment, which is traceable to nationally recognised standards. When all data is collated it is then transposed into the final certificate. This will include results obtained, information regarding the test carried out and instrumentation identification.

Qualification / Calibration Chroma Forum

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Pharmaceutical grade: GC Software OQ/PQ certification: Full certification and traceability to FDA,MRC regulations ·Temperature Accuracy and Stability of injectors,  detectors, column ovens ·Flow Rate Accuracy for Carrier, split-flow,  make-up, fuel Flow Rate ·Stability for Carrier, split-flow, make-up,  fuel gases ·Detector Linearity for FID detector. ·Auto-injector accuracy & carryover.

Pharmaceutical grade: HPLC Software OQ/PQ certification: Full certification and traceability to FDA,MRC regulations ·Wavelength Accuracy for detectors ·Response Linearity for detectors ·Pump flowrate and Gradient Proportioning  Valve Accuracy ·Temperature Accuracy for column ovens,  temperature controlled autosampler trays · Auto-injector accuracy, carryover &  injection Linearity.

Pharmaceutical grade: MS OQ/PQ certification: Full certification and traceability to FDA,MRC regulations ·Injector Precision ·Detector Linearity ·Injector Carryover ·Injector Linearity