Process performance qualification protocol is a component of process validation: process qualification.
This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
The Food and Drug Administration recommends the following criteria be included in a PPQ protocol:[1] Deviations from the standard operation procedures should be made within the framework of the protocol and at the approval of relevant quality control departments.
The FDA further recommends a documentation of the protocol be published internally.
The report should include: