USP <1010> - Analytical Data, Interpretation and Treatment

What it says

General Chapter <1010> is an informational chapter that offers statistical tools for describing and interpreting analytical data. It covers topics such as summarizing results, confidence intervals, comparing data sets and the identification and treatment of outlying results. It supports sound data interpretation but does not set mandatory requirements for a specific laboratory.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Statistical outlier tests are aids to judgment, not permission to discard results. A result generally cannot be set aside on statistical grounds alone, without a documented, assignable cause found through investigation.
• The approach for handling data, including averaging, replicates and the use of statistical tests, should be defined in advance in procedures rather than chosen after the results are known.
• This chapter works alongside regulatory expectations on out-of-specification results, which require an investigation instead of repeated testing until a passing result appears.

What inspectors look for

• Whether results were excluded, averaged or retested based on documented investigations rather than on statistics applied after the fact.
• Whether statistical methods are defined in controlled procedures and applied consistently.
• Whether the full set of data, including results that were excluded, remains available and traceable.

Related regulations