Question 2:
There is a new General Chapter <1010> in the USP. Will the statistical recommendations in <1010> be acceptable for the agency if they were part of an internal procedure? Answer:
It would be OK for a firm to incorporate the procedures of <1010> except in the cases where they are in conflict with the recommendations of our (FDA) guidances. For instance, FDA guidance recommends that outlier testing has a very limited role for chemical analysis, while USP <1010> gives quite an extensive discussion of the use of outlier tests.
The principle in our guidance remains the same: a result that is identified as a statistical outlier should not in itself lead to excluding it or invalidating the result. It can be used as supporting evidence, along with other evidence developed in the investigation, that the result is invalid. Question 3:
What's the agency's position regarding the methodologies of <1010>? Answer:
FDA guidance makes no recommendations about the choice of statistical outlier tests to be used. It only says that the use of outlier tests should be specified in an SOP and should be scientifically sound. 其实outlier testing适用范围有限,可以用,但是担心的很多企业真的能做好相关统计学的支持嘛?
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