Installation qualification (IQ) is the documented proof that facilities, systems and plants, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
Definitions of installation qualification
Aide Memoire GMP
“Documented proof that the facilities, systems and plants, as installed or modified, comply with the approved design and the manufacturer’s recommendations.”
EU GMP Guide, Annex 15
“The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.”
How the IQ check works
- 1Installation statusThe basis is the status of the system’s installations and their completeness.
- 2Completeness checkComparison with the DQ design, drawings, diagrams, plans, parts lists and the requirement and functional specifications.
- 3Comparison with the systemThe test results are compared with the approved system.
- 4DocumentationCompliance with the DQ documents is documented.
The qualification process at a glance
- 1RA – Risk analysisIdentify and assess risks before the design is fixed.
- 2DQ – Design qualificationProof that the design is suitable for the intended purpose.
- 3IQ – Installation qualification (this page)Verification of the installation against the order documents.
- 4OQ – Operational qualificationVerification of the intended functionality.
- 5PQ – Performance qualificationProof of the required performance in operation.
SEEFRIED Verfahrenstechnik GmbH supports you with the documentation requirements and the verification of the installation qualification.
Frequently Asked Questions about installation qualification (IQ)
What is installation qualification (IQ)?
IQ is the documented verification that facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations (EU GMP Guidelines, Annex 15).
What is checked during IQ?
Based on the DQ, the technical documents (drawings, diagrams, plans, parts lists) and the requirement and functional specifications, the installation is checked for completeness and compared with the approved system.
What is the result of the IQ?
Documentation that the installed plant complies with the DQ documents. It is the prerequisite for the subsequent operational qualification (OQ).
How do you support us?
We support you with documentation requirements and the execution and review of the IQ.