While the formal Qualification Process is typically a Pharmaceutical Requirement, it is a process that insures that:
Design Qualification – DQ
You Design the Project with a detailed Process
Inspection Qualification – IQ
You inspect the components, materials, equipment and assemblies to insure that they meet the Design.
Operational Qualification – OQ
This verifies the reports and tests generated in the IQ are compiled, documented, and available for inspection, that all of the items required are performing as designed.
Performance Qualification – PQ
The PQ deals with what happens when the out of the ordinary happens, such as a power failure, unit failure, etc. This allows for a verified method of bringing the Cleanrooms back into service.