Facility Installation Qualification (IQ)
Facility Installation Qualification establishes documented evidence that facility systems, components, and utilities are installed in accordance with the approved design and specifications. For facilities, IQ confirms that design intent has been implemented correctly and that the as-built condition is suitable to support controlled operation.
Installation Qualification does not assess how systems operate. Its purpose is to verify what was installed, how it was installed, and whether installation matches approved design documentation.
Role of Installation Qualification in the Facility Lifecycle
Within the facility qualification lifecycle, IQ serves as the link between design and operation. It provides objective confirmation that construction, installation, and configuration activities were completed as planned and documented.
IQ establishes the baseline condition against which Operational Qualification is performed. If installation is incomplete, undocumented, or inconsistent with approved design, meaningful operational testing is not possible.
Scope of Facility Installation Verification
Facility IQ typically focuses on elements that must be confirmed before systems are placed into operation, including:
- As-built drawings and layout verification
- HVAC systems and major components
- Utilities installation and distribution
- Materials of construction where relevant
- Equipment and system identification
- Critical components and instrumentation installation
The scope of IQ is limited to installation and configuration. Functional testing and performance demonstration are addressed during Operational Qualification.
Execution and Documentation
Installation Qualification activities are executed using approved protocols or controlled checklists that define acceptance criteria based on design documentation. Deviations identified during IQ must be resolved or formally justified before proceeding to OQ.
Typical IQ documentation includes:
- Installation verification records
- Approved drawings and specifications
- Vendor documentation where applicable
- IQ protocols and summary reports
The objective is to demonstrate traceability between design intent and the installed facility.
Relationship Between IQ and OQ
IQ must be completed and approved before Operational Qualification begins. Attempting to perform OQ in parallel with unresolved installation issues increases compliance risk and undermines the validity of operational testing.
A well-executed IQ simplifies OQ by ensuring that systems are complete, documented, and configured as intended.
Position Summary
For GMP facilities, Installation Qualification confirms that the facility was built as designed. It provides the factual foundation for operational testing and ongoing lifecycle control.
IQ is successful when it is thorough, objective, and limited to its intended purpose.