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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.

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