Fit-for-purpose risks in conformity assessment of a substance or material – A case study of synthetic air

A technique is described for evaluation of the fit-for-purpose risks in conformity assessment chemical composition a substance or material, based on multivariate Bayesian approach. The approach takes into account measurement uncertainty, correlation and mass balance constraint. Two datasets related to synthetic air (provided as electronic supplementary material this paper) were studied. first dataset was from an industrial factory producing routinely medicinal according European Pharmacopoeia. second National Metrology Institutes which participated key comparison CCQM-K120 “Carbon dioxide at background urban level”. fitness purpose preparation interpreted total false decisions tolerance limits contents its main components. Calculations these performed with code written R programming environment.