6.

G Performance qualification (PQ) Page 1 of 2

6.G Performance qualification (PQ)

Here you will find answers to the following questions:

„ What is understood by the term "PQ"?

„ What tests are carried out during PQ?
„ When must a PQ be carried out?

Figure 6.G-1 Definition of PQ

Definition of PQ (EU GMP Guideline, Annex 15)

Performance qualification (PQ)

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

During performance qualification, the correct interaction of the accessories already tested as
individual components is tested in larger units (Units Operations) such as air systems, purified
water systems, filling and packaging lines.

As in the OQ, acceptance criteria are formulated and performance tests are carried out. This
should show that the respective equipment, with the corresponding process, meets the intended
requirements. PQ requires that OQ has already been completed.

When compiling the PQ test protocols, particular attention must be paid to the representative
samples/test quantities. It should be shown that the interaction of the entire unit works properly and
that the upper and lower limits have been tested (Worst Case).

For some subject areas in qualification, there are clear regulations for PQ. PQ is required during
operation for rooms. PQs that include the first production year are required for utilities (air, water).
The classic "water tracks" for process equipment also fall in the PQ phase. Water tracks clearly
show the interaction of all components and the upper and lower control areas and partial load
behavior can be simulated cost-effectively.

Control tests that are used to define operational parameters can also be processed in PQ. This
includes, e.g. qualification batches/engineer studies, that are required to establish the process
management.

PQ can be omitted if the essential aspects, such as performance, interaction of the components
and worst case conditions are dealt with in the process validation (PV).

Summary
As part of performance qualification (PQ), the interaction of the individual components in the
equipment is tested. The performance tests carried out taking into consideration the limits after
OQ has been completed, show that the interaction of the entire unit works effectively, and is
reproducible. The PQ tests are documented in the same way as the other qualification steps. PQ
can also be carried out as part of the process validation.

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