Qualification of HPLC | A Complete Guide

The HPLC qualification process consists of four parts:

  1. Design qualification (DQ)
  2. Installation qualification (IQ)
  3. Operational qualification (OQ)
  4. Performance qualification (PQ)

Design Qualification (DQ)

Design qualification (DQ) describes the user requirements and defines the functional and operational specifications of the instrument. It should ensure that instruments to be purchased have the necessary functions and performance that will enable them be suitable for the intended applications.

The DQ document will be used as a basis for tests in the OQ phase. Lists elements with examples that should be included in the design qualification for the HPLC systems in the selected QA/QC laboratory.

Please note that all instruments are required to have gradient pumps, thermostatted column compartments and diode-array detectors to ensure that they all can be used for all applications.

Design elements:

  • Intended use
  • User requirement specification for the HPLC analysis

Functional specification:

  • Pump
  • Detector
  • Autosampler
  • Column compartment
  • Computer

Operational specifications:

  • Detector:Baseline noise: <5 x 10-5 AU
  • Sampler: Precision inj. volume: <0.5% RSD, sample carry over: <0.5%
  • Pump: precision of retent.time: <0.5% RSD

Installation Qualification (IQ)

  • Installation qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument.
  • Steps as recommended before and during installation.
  • IQ should include analysis of a tests ample.
  • A successful run of such a sample verifies correct installation of all modules and electrical and fluid connections
  • There are two installation qualification they are before and during installation qualifications.

Before installations:

  • Obtain manufacturer’s recommendations for installation site requirements.
  • Check the site for the fulment of the manufacturer’s recommendations (utilities such as electricity, and environmental conditions such as humidity and temperature).
  • Allow sufficient shelf space for the equipment, SOPs, operating manuals and software.

During installation:

  • Compare equipment, as received, with purchase order (including software, accessories, spare parts).
  • Check documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificates).
  • Check equipment for any damage.
  • Install hardware (computer, equipment, fittings and tubings for fluid connections, columns in HPLC and GC, power cables, data flow and instrument control cables).
  • Run test sample and compare chromatogram print-out with reference chromatogram.

Operational Qualification (OQ)

  • Operational qualification (OQ) is the process of demonstrating that an instrument will function according to its operational specification in the selected environment.
  • It verifies that the HPLC systems complies with key functional and operational requirements as specified in the design qualification.

Performance Qualification (PQ)

The performance qualification (PQ) is to verify the functions of the systems according to its design specifications and documents. Thus the HPLC system was qualified and released for use.

During performance qualification, the equipment is operated with load and all the process parameters and process deliverables are recorded.

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