The execution of the PQ protocols is again similar to that of the IQ or OQ. Trained operators are needed to run the equipment, and sufficient test material is needed for the testing. It is best to run the tests starting with the lowest concentration or speed and build up to maximum operation. This allows for conservation of materials. Also, it may minimize cleaning or set-up times between runs. The appropriate individuals (ie, those who preapproved the protocols) must carefully review all data and a final report prepared. This report can be incorporated into the IQ and OQ report or may stand alone to represent the final acceptance of the unit(s). From the CFR it is clear that the equipment and utilities need to be ready for use prior to performing the process validation.
Reports
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