critical variable study
- Guideline or reference source
- PIC/S006 Recommendations on validation master plan, IQ, OQ, non-sterile process validation and cleaning validation
- Definition
- A study that serves to measure variables (parameters) critical to the satisfactory operation of a piece of equipment or plant and to assure their operation within monitored and controlled limits. Examples of variables would be pressure, temperature, flow rates, time etc.
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