Traceability without uncertainty: Current situation in the pharmaceutical industry

Abstract

The current situation in the pharmaceutical industry is discussed, when the traceability of measurement (analytical) results to certified values of pharmacopoeial reference standards is required, without evaluating their uncertainties. It is shown that the evaluation of measurement uncertainty is necessary for understanding the level of confidence of the analytical results and their comparability, particularly during preparation and characterisation of the reference standards. © 2005 Springer-Verlag Berlin Heidelberg.