PQ - Process Performance
Qualification
Documentation indicating that the process
is reproducible, stable, and efficient
for all required operating circumstances. This should incorporate items
such as operating condition under maximum predictable situations and
worst-case predictable process parameters.
This should be done after the process design
phase.
Experimentation should require a minimum of
three batches or lots with a predetermined and acceptable sample
size that can be guaranteed to be statistically valid.
Also see Process,
Process improvement, Process
management, Appraisal
cost, and Process map (flowchart).
