Relevancy of Gauge R&R in Pharma Environment
how is Gauge R&R relevant to pharma environment... !!!
typically, i have practiced/implemented the concepts of qualifications (IQ-OQ-PQ)... and method& process validations etc., and also calibrations - preventive maintenance.
viz., you do establish the precision, accuracy of equipment - methods..
whats often/mostly missing is the statistical assessment part...and even if its there its limited to RSD(standard deviations)...and seen as per compliance to requirements-specification parameters.