Performance qualification (PQ) is the documented proof that premises and utilities, in harmony with the production equipment, are suitable for manufacturing the product reproducibly in the specified quality. Performance qualification is the responsibility of the user of the facility and is initiated immediately after the transfer of facility ownership from the contractor to the user.
Regarding premises and the infrastructure systems installed therein, not many surprises are to be expected at that point in time. During operational qualification, air cleanliness measurements have been performed in the at rest occupancy state. During performance qualification, they are repeated in the in operation occupancy state, i.e. with the numbers of persons present as foreseen for normal production.
During PQ, the infrastructure systems and the process equipment operate, for the first time, as an integrated entity. For the first time, all machinery and other elements contributing to the heat load are now active in parallel. Therefore, only now it is possible to assess whether the HVAC system is capable of meeting its performance requirements at the extreme thermal load conditions regarding air temperature and air relative humidity specified for summer and winter as calculation base for dimensioning.
In addition, during performance qualification the human being is present for the first time in the facility in his condition as dissemination source for microorganisms. Now, for the first time, is it possible to assess – where this is relevant – whether the limits established for microbiological monitoring are met. For sterile manufacturing, they are stipulated in Annex 1 to the EU GMP Guide (see Chapter C.6.1 and Chapter 3.C.2 GMP Requirements for Cleanrooms: Air Cleanliness Grades). In all other cases where microbiological risks have to be taken into consideration, they have to be specified case-specifically upon risk assessment considerations.
A selection of suggested PQ checks and tests is compiled in Figure 3.I-5. As now the manufacturing process and everything related to it is considered as an entity and as all interferences between the different elements of the premises, equipment, the HVAC system, process media and the human being are now fully effective, no longer a distinction is made in this table between the different infrastructure systems now acting together.
Figure 1: Checklist for performance qualification (HVAC related topics only)
What's more, you will get detailed checklists for all qualification stages!
Hans H. Schicht, PhD
Freelance, Zumikon, CH