Installation Qualification (IQ)

Details

Installation qualification confirms that equipment, facilities, utilities, and systems have been installed in accordance with the approved design and specification; it is not operational testing (OQ) or performance confirmation (PQ) but asks whether what should be there is there and correctly placed. EU GMP Annex 15 §3.9 requires IQ to include verification of the installation of components, instrumentation, equipment, pipework, and utilities against engineering drawings and specifications, verification of the installation against predefined criteria, collection and collation of supplier operating and working instructions and maintenance requirements, calibration of instrumentation, and verification of materials of construction. Inspections cite instrument calibration at the IQ stage carried out only after use, installation drawings that differ from the pipework and components actually fitted yet passed without a deviation, missing evidence for product contact materials, and maintenance procedures written without the supplier's instructions.

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Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. FDA documented an unidentified (b)(4) residue, apparent rust, and unidentified liquids inside or on product contact…

   FDA · FDA Warning Letter · 2026-03-17

2. The final study report did not include all the abnormal cageside clinical observations for all 48 animals, documented between November 21, 2022, and July 13, 2023, including incidences of abnormal stool observations, such as bloody or dark-red, liquid, loose, mucoid, or unformed stools.

   FDA · FDA Warning Letter · 2026-10-13

3. You failed to perform adequate incoming testing of each component lot used in the manufacture of your over-the-counter (OTC) liquid drug products…

   FDA · FDA Warning Letter · 2025-04-29

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.