Performance Qualifications

This part of the validation for systems and equipment is performed after both Installation and operational Qualifications have been completed, reviewed and approved. The PQ document describes the procedure or procedures for demonstrating that a system or piece of equipment can consistently perform and meet required specifications under routine operation and, where appropriate, under worst case situations.

The PQ should include a description of the preliminary procedures required, the detailed performance test (s) to be done, and the acceptance criteria for each test. The PQ also requires that other supporting equipment used during the qualification have been validated (e.g. the steam system must be validated before the autoclave can be validated).