Process Qualification

Pre-requisite of cleaning validation

Qualifications are used to determine if an instrument, equipment, or process achieves associated specifications without deviation from its intended use. PDA Technical Report 3, Validation of Dry Heat Processes Used for Depyrogenation and Sterilization, defines process qualification as "Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment". In terms of cleaning, process qualification demonstrates that the intended cleaning effectiveness is achieved while operating within the parameters of the cleaning process.