Performance Qualification (PQ)

From WikiBioPharm

Performance Qualification

The intended purpose of Performance Qualification is to demonstrate compliance with all requirements given in the User Requirements Specification document. Performance Qualification should follow on from successful completion of Operational Qualification (OQ) and should include tests designed to verify the satisfactory performance of the equipment or system in the organisations processes. Performance Qualification should be carried out using real process materials and tests intended to demonstrate satisfactory performance over the full range of expected operating conditions.

Prior to Performance qualification; all required methods and Standard Operating Procedures should have been finalised and operator training completed. Also, requirements for Calibration, Preventative Maintenance and Cleaning should have been addressed.

Performance Qualification is the last of the Qualification processes and should only commence after successful completion of Operational Qualification (OQ). Performance Qualification is best performed by the personnel who will be responsible for the routine operation of the system; the users must have received full training on the correct operation of the equipment or system prior to conducting PQ. Standard Operating Procedure (SOP)s must be written prior to start of PQ and followed at all times during the operation of the equipment or system.

Where a system is to be used in a single process, then PQ may be a single one-off exercise, manufacturing a predetermined number of product batches to demonstrate consistent correct performance. Alternatively and more usually, PQ may be a continuous ongoing activity throughout the operating life of the system, intended to show the continuing correct performance of the equipment or system as changes are made to the system or equipment or to the process or materials that interact with the system.

Equipment and systems are rarely used in isolation and very often the correct performance of an individual item or system is dependant on the continuing satisfactory performance of upstream and downstream processes. The Quality of a finished Pharmaceutical product is dependant on the continuing satisfactory performance of a long chain of distinct but interdependent processes and systems, sometimes spread across a number of sites, organisations or countries.