Installation qualification for HPLC

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.

Before installation :

• Obtain manufacturer’s recommendations for installation site requirements.

• Check the site for the fulfillment 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)

• Switch on the instruments and ensure that all modules power up and perform an

electronic self-test

• Identify and make a list with a description of all hardware, include drawings where

appropriate.

• Run test sample and compare chromatogram print-out with reference

chromatogram

• List equipment manuals and SOPs

• Prepare an installation report