Follow
Conducting an operational qualification should follow an approved protocol. Critical operating parameters for equipment and systems should be identified during the OQ phase. OQ plans should identify the studies to be performed on the critical variables, the order of those studies and the measurement tools to be used, and the acceptance criteria to be met.
Studies on critical variables should include a condition or set of conditions that define the upper and lower processing and operating limits referred to as “worst case” conditions. Completion of a successful OQ allows finalization of operating procedures and operator instructions documentation for equipment. This information should be used as a basis for training operators in the requirements for satisfactory operation of the equipment.
Completion of satisfactory IQ and OQ practice validation procedures should allow for a formal “release” of equipment in the next phase of practice until calibration, cleaning, preventive maintenance, and operator training requirements have been finalized and documented.
