Q7A defines performance qualification as “documented verification that the equipment and
ancillary systems, as connected together, can perform effectively and reproducibly based on the
approved process method and specifications”. One of the key phrases in this definition is “when
connected together”, because you may have done some work on the individual pieces in the pilot
plant like the reactor or centrifuge, but you haven’t run the process all the way through the entire
train. Some companies may choose to perform a solvent batch as part of the PQ.
