Method Validation of Analytical Procedures

Pharmaceutical sampling


I would like to ask if there is a specific acceptance criteria for an accuracy test, in method validation of assay procedure of a general pharmaceutical finished product, which has been agreed by ISO, ICH and USP?

Based on what I’ve read the acceptance criteria for accuracy may depend on the product itself. However, some ASEAN nations adopt a general acceptance criteria of 98-102% for accuracy test.

I would highly appreciate your response.

Thank you very much.


Let’s start with the objective and purpose of Analytical Method Validation to demonstrate that the analytical procedure is suitable for its intended purpose.  The intended purpose will guide the decision for acceptance criteria.  If we need the method to have accuracy within +/- 2% then that is what the acceptance criteria will be.  This issue of +/- 2% for accuracy in ASEAN is misinterpreted.  The source for that is from an industry Q&A about percent recovery of dissolved active ingredients.

Q1 : The method of determination of an amount of dissolved active ingredients and the method of determination of active ingredients in preparations (assay) in order to determine precision of the method, how much percent for rate of recovery should be accepted?
A1 : Percent recovery depends on concentration of the analyte in the sample. For example, if concentration of the analyte is in the range of 10-100 %, the recovery should be within the range of 98-102%.

Hope that helps!

Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
Principal Statistician, BD

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