Update of USP General Chapter <1010> "Analytical Data - Interpretation and Treatment" Suggested

GMP News
4 October 2007

Update of USP General Chapter <1010> "Analytical Data - Interpretation and Treatment" Suggested

In the USP's Pharmacopeial Forum of July/August 2007, the Statistics Expert Committee suggested several changes for General Chapter <1010> - "Analytical Data - Interpretation and Treatment". Among them are:

  • an explanation for the correct implementation of the Dixon test for identifying outliers

  • an additional statement in Appendix B on the topic of precision explaining how the variance of the mean value decreases and how - as a consequence - a test's precision can be improved by increasing the number of individual measurements ("replicates") within a test run

  • in the section "Measurement Principles and Variation", the term "relative standard deviation" is changed to "per cent relative standard deviation"

In the revision of the General Chapter, the term "reportable value" has been included, which was already established officially in FDA's final OOS Guideline in force since October 2006.

You will be given valuable insight into the requirements of this USP General Chapter at ECA's GMP Education Course "Analytical Data - Interpretation and Treatment" to be held in Barcelona on 5-6 November 2007. Here, you will get to know all important requirements on the statistical approach to the evaluation of analytical data of USP General Chapter <1010>. Further issues discussed in this course are:

  • Calibration models
  • Trend analyses within the framework of the Product Quality Review, and
  • Statistics of the detection limit and quantitation limit

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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