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Laboratory instrument qualification

Qualification of laboratory equipment

To ensure the appropriate accuracy and reliability of the quality control results, it is necessary to conduct the qualification of critical lab equipment. Critical utilities that affecting quality control results must be qualified.

The following documents should be available in the quality control laboratory:

  • calibration protocols
  • qualification/requalification reports
  • records on instrument maintenance

The qualification should include the following documentation:

  • Design qualification (DQ) is a documented verification that the proposed design of the facilities, systems, and equipment is suitable for the intended purpose.
  • Installation qualification (IQ) is a documented verification that the facilities, systems, and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
  • Operational qualification (OQ) is a documented verification that the facilities, systems, and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
  • Performance qualification (PQ) is a documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.

The qualification work consists of the following stages:

  • development of qualification protocols
  • testing
  • preparation of qualification reports

We carry out the qualification of the following laboratory equipment:

  • high-performance liquid chromatographs
  • gas chromatographs
  • spectrophotometers
  • balances
  • refractometers
  • pH-meters
  • conductivity meters
  • climatic equipment (thermostats, incubators, stability chambers, medium heaters, muffle furnaces, baths)
  • sterilizers
  • disintegration tester
  • refractometers

For steam sterilizers, operational qualification is performed using biological sterilization indicators.

Test methods should be validated. A laboratory that uses the test procedure and didn`t perform its initial validation should verify the suitability of the test procedure.