The USP has published a new general chapter that will among others have an
influence on the handling of OOS results. The new USP General Chapter <1010> Analytical Data –
Interpretation and Treatment contains information on how to conduct
the analysis and consistent interpretation of data obtained from chemical
and other analyses. The monograph can be found in this year's USP 28 (pp
2516-).
The monograph describes basic statistical approaches. Furthermore, the
handling of outliers (among others with Dixon-type Tests and Hampel's
Rule) and the comparison of analytical methods (as to precision and
accuracy) are discussed. Biological assays, in which the variability of
measurements is usually greater, are dealt with in USP Chapter <111> Design and Analysis of Biological
Assays. In contrast to this older chapter, the new USP Chapter
<1010> refers to measurement results obtained from chemical analyses of
medicinal products and describes statistical tools that can be helpful in
the interpretation of analytical data.
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