New USP Requirements with an Influence on the Handling of OOS Results

GMP News No. 597

GMP News
1September 2005

New USP Requirements with an Influence
on the Handling of OOS Results

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.

The European Compliance Academy has designed a workshop dealing exclusively with this new USP monograph. During this course, which takes place in Dublin on 7 and 8 November 2005, the requirements laid down in this new USP chapter will be presented to you in detail, and several practice-oriented statistical exercises will be worked through in small working groups. Please click here for the detailed event programme.

Dr Günter Brendelberger
on behalf of ECA

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