Validating test methods


25-May-2020 13:44

It is common for a physical property to be strongly affected by the precise method of testing or measuring that property.

As such, fully documenting experiments and measurements while providing needed documentation and descriptions of specifications, contracts, and test methods is vital.

“The beauty of FDA [regulation] is that it is up to you to pick a position and justify it,” says Laura Bix, Ph D, assistant professor, Michigan State University School of Packaging.The results of testing can be qualitative (yes/no), quantitative (a measured value), or categorical and can be derived from personal observation or the output of a precision measuring instrument.



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