Performance Qualification: Documented verification that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters, for prolonged periods.
PQ should normally follow the successful completion of IQ and OQ. In some cases, it may be appropriate to perform PQ in conjunction with OQ or process validation. This should be justified and documented in the validation master plan (or qualification protocol).
The SOP for the Operation, Cleaning, and maintenance of Equipment, system, Utility etc. shall be approved before Performance Qualification.
The Performance Qualification study depends on the Equipment, system, or Utility; e.g. The PQ study for Water System shall be carried out in three-phase to check the variability in performance due to the different seasons during the year.
PQ should include, but is not limited to, the following:
tests using production materials, qualified substitutes or simulated products are proven to have equivalent behavior under operating conditions, with batch sizes where appropriate;
tests covering the intended operating range.
Utilities and equipment should consistently perform in accordance with their design specifications and URS. The performance should be verified in accordance with a PQ protocol.
There should be records for the PQ (e.g. a PQ report), to indicate satisfactory performance over a predefined period of time. Manufacturers should justify the period over which PQ is done.
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