Considering the ICH Concept of ‘Total Analytical Error’ in Validation of Analytical Procedures of Pharmaceuticals

Raphael Bar, BR Consulting, Ness Ziona, Israel (rbar@netvision.net.il)

Common practice in the pharmaceutical industry is not to report final test results with an uncertainty value.  However, a new draft ICH Q14 guide and a new draft revision of ICH Q2(R2) guide suggest to consider the so-called Total Analytical Error (TAE) during the procedure validation study

TAE is taken to represent the overall error in a test result that is attributed to imprecision and inaccuracy. Therefore, TAE is the combination of both systematic error of the procedure and random measurement error. While measurement uncertainty is associated with a single reportable result, TAE is rather associated with the analytical methodology. Thus, considering an acceptable TAE  during the validation study of an analytical procedure will provide appropriate overall knowledge of the suitability of the analytical procedure and demonstrate the capability of the procedure to support the acceptance criterial of  the method performance characteristics.

This presentation will demonstrate how statistical intervals are used to consider TAE of an analytical procedure of two pharmaceuticals during combined Accuracy/Precision studies, as suggested by the new ICH guides.

Short Biography of Presenting Author

Raphael Bar has been a pharmaceutical consultant for the Pharma and bio-Pharma industries for the last thirteen years.  Dr. Bar headed the Analytical R&D Laboratories at Teva  Pharmaceuticals and the analytical QC Laboratory at Pharmos.