Process performance qualification protocol


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:
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 protocol should cover all aspects of production including: equipment, personnel, raw materials, and operating environment. The FDA further recommends a documentation of the protocol be published internally. The report should include: