Installation Qualification [IQ]
Pharmaceutical Guideline1 min read
installation qualification: The performance of tests to ensure that the installations (such as machines, measuring devices, utilities and manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed.
- Utilities and equipment should be correctly installed, in an appropriate location.
- There should be documented evidence of the installation. This should be in accordance with the IQ protocol, which contains all the relevant details.
- IQ should include identification and installation verification of relevant components identified (e.g. services, controls and gauges).
- Identified measuring, control and indicating devices, should be calibrated on site, unless otherwise appropriately justified. The calibration should be traceable to national or international standards. Traceable certificates should be available.
- Deviations and non-conformances, including those from URS, DQ and acceptance criteria specified and observed during installation, should be recorded, investigated and corrected or justified.
- The outcome of the IQ should be recorded in the conclusion of the report, before OQ is started.