GMP Compliance of Essential Oils as Atypical Actives by Risk Assessment
Michael Hubbert1, Sigrid Drewes2, Robert Hahn3, Andrea Lutz-Röder4, Iris Müller5, Claudia Valder6, Ehrhard Anhalt7, Barbara Steinhoff7
MADAUS GmbH1, Troisdorf (Germany), Merz Consumer Care GmbH2, Frankfurt/Main (Germany), IMG – Institut für
For many essential oils imported from outside Europe full GMP requirements can hardly be fulfilled. Therefore they require a specific approach suitable for Atypical Actives. Such a risk-based approach is proposed using the established model of the Failure Mode and Effective Analysis (FMEA). It consists in the quantification of the risk by numbers and its expression by multiplication of the severity by the probability and by the detectability of the occurence of the failure/risk. A specific template is presented which can be used for a risk assessment of essential oils in order to guarantee their quality and safety.
pharmind 2011, Nr. 6, Seite 1020