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Related Topic Tags
gage r&r (repeatability and reproducibility), pharmaceuticals and pharmaceutical industry
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Old 10th August 2012, 12:45 PM
v9991 v9991 is offline
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Question 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.

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Old 10th August 2012, 04:23 PM
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Re: Gauge R&R in pharma environment.
Does this Statistical Tools for Pharmaceutical Manufacturing article help? Maybe a paper on Measurement System Capability. Really, I would start with Measurement Systems Analysis methods as described by the automotive industry.
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