Saturday, 9 March 2013

Performance Qualification (PQ) | Instrument and Equipment

Performance Qualification

Design Qualification Installation Qualification Operational Qualification

Performance Qualification (PQ) is the part of Qualification of an Equipment or an Instrument. Let us check it out what is performance Qualification? It is the documented  collection of activities  which are necessary to demonstrate that an instrument consistently performs  according to the specifications defined by the user and is appropriate for the intended use.

Performance qualification is the documented verification that the facilities, systems and equipment, as connected together, and can perform effectively and reproducibly, based on the approved process method and product specification.

Major activities which are generally conducted during Performance qualification are:

  • Tests to include a condition or a set of conditions encompassing upper and lower operating limit.
  • Tests, using production materials, qualified substitutes or stimulated product, that have been developed from knowledge of the process and the facilities, systems or equipment.
  • Tests to include a condition or set of conditions encompassing upper and lower operation limits.
  • Tests that verify the efficacy of sterilization cycles (cleaning validation).
  • Verify that procedures describing calibration, maintenance, operation, and training are implemented. 
  • In the previous phases, it was not required that these procedure were approved, effective, and implemented , but in this phase routine operation is simulated and the procedures should be implemented.
Other terms to know about qualification of instruments and equipments are DQ, IQ, OQ and PQ