Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing.
[1] This may include testing equipment at maximum operating capacity to show quantity demands can be met.
[4] A well trained staff and accurate, thorough records helps ensure ongoing protection from process faults and quick recovery from otherwise costly process malfunctions.
In many countries qualification measures are also required, especially in the pharmaceutical manufacturing field.
PPQ protocol is essential in defining and maintaining production standards within an organization.