Performance Qualification (PQ): Protocol, Steps & Examples

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 andOQ . In some cases, it may be appropriate to perform PQ in conjunction withOQ 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 andURS . 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.