Performance qualification (PQ)
Performance qualification (PQ) should normally follow the successful completion of IQ and OQ. However, it
may in some cases be appropriate to perform it in conjunction with OQ or Process Validation.
PQ should include, but is not limited to the following:
– tests, using production materials, qualified substitutes or simulated product proven to have equivalent behaviour under normal operating conditions with worst-case batch sizes. The frequency of sampling used to confirm process
control should be justified;
– tests should cover the operating range of the intended process unless documented evidence from the development phases confirming the operational ranges is available.