Performance Qualification (PQ)

Performance Qualification (PQ) significantly differs from previous qualification stages. Like the Operational Qualification (OQ), the PQ stage involves testing the operational equipment, but unlike OQ, which focuses on individual system functions, PQ verifies the system's ability to operate consistently, reproducibly, and over an extended period to achieve its intended purpose. This is often done using the actual product or its simulation.

Given that PQ assesses the system's ability to function correctly over time, a wide variety of factors can change during this period, potentially affecting system performance. Depending on the type of system, these factors may include:

Gradual degradation/wear of system components (e.g., filter clogging, wear of tablet press punches, degradation of ion-exchange resin in a water softening unit, etc.)
Changes in environmental parameters (e.g., the inability of the HVAC system to maintain required environmental conditions in cleanrooms during extreme summer heat or winter cold)
Process changes (e.g., batch size, quantity of materials processed, product size/geometry, type of product, sequence of operations, etc.)
Personnel (differences in the way various operators perform tasks)

Performance Qualification is a long-term process designed to cover all possible operational periods where the system might be affected by changing factors. For example, HVAC systems must undergo qualification throughout the entire year to demonstrate proper functionality in all seasons.

PQ is often divided into several stages, differing in the frequency of testing, sampling, etc. For example, the PQ of pharmaceutical water systems (e.g., Purified Water, Water for Injection) is typically divided into three stages: PQ I, PQ II, and PQ III. If water purification systems use water from an artesian well, significant seasonal variations may also occur. In spring, during snowmelt, the water may contain higher levels of contaminants, impurities, and undesirable components.

EU GMP Guidelines Annex 15: Qualification and Validation provides the following definition of Performance Qualification (PQ):

“Performance Qualification (PQ): The documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.”

Annex 15 also defines the following requirements regarding Performance Qualification (PQ):

“…3.13. 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.

3.14. PQ should include, but is not limited to the following:

i. 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;

ii. Tests should cover the operating range of the intended process, unless documented evidence from the development phases confirming the operational ranges is available…”

The qualification is conducted based on a pre-prepared qualification protocol containing control points and pre-established acceptance criteria, typically presented in tabular form. Before the qualification process begins, the protocol must be approved for use, and no changes are allowed to the wording of the control points or the acceptance criteria during the qualification.

During the qualification process, the protocol is filled out, and upon the completion of all control point checks, a qualification report is generated. This report can either be the completed qualification protocol or a separate document that summarizes the results.

Since this is a long-term activity, unlike previous qualification stages, a multi-level documentation scheme is applied. This includes a high-level summary protocol that reviews all individual activities and provides references to the respective individual test protocols. Generally, during the preparation of the performance qualification (PQ) documentation, real production data and statistics collected during actual manufacturing processes can be used.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.