Performance Qualifications are Total System Tests

As shown on the previous page, the IQ and OQ verify the Design Specifications and Functional Specifications. It is the PQ Tests that verify the User Specifications.

The PQ test should confirm and self-document that the HPLC components are functioning properly within the entire HPLC System. This should be done after a service person (in-house or contract organization) has left the building.

A good PQ Test should be:

• Informative and Scientifically Valid
• NIST Traceable
• Quick and Easy to perform so technicians can reliably execute them.
• Mostly self documenting
• Universal. This will help create common performance measures making Inter-Laboratory Transfers reliable, predictable and easy