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The following message was posted to: PharmPK
We have been discussing batch acceptance criteria in GLP studies. The
FDA guideline allows at least 2 out of 6 QC to be outside the 15%
acceptance criterion for accuracy. But it also states in section IV.F
of the 2001 guideline that the mean should be within 15% of the
theoretical value and 15% precision. In a given batch one can have, for
example, 2 out of 6 values outside this range which may give a mean
values and precision outside the 15% zone. What is the practice in
dealing with situations like this one?
Thanks for the inputs.
Luis E. Sojo, PhD.
Associate Director Analytical Development
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