TY - CONF A1 - Weber, M. A1 - Lodi, A. A1 - Charoud-Got, J. A1 - Rienitz, O. A1 - Röthke, A. A1 - Richter, Silke T1 - European Pharmacopoeia reference standards to underpin the legal requirements in Europe for the control of elemental impurities in medicinal products for human use N2 - Guideline ICH Q3D on elemental impurities (EI) was adopted by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and published in December 2014. The European Medicines Agency (EMA) Committee for Medicinal Products for Human use (CHMP) adopted guideline Q3D in December 2014 and defined the dates for coming into effect . ICH Q3D is the first globally harmonised guidance to control 24 elemental impurities in drug products administered by oral, parenteral and inhalation routes. The policy entails a paradigm shift, moving away from substance-based testing towards risk-based assessment and control strategy. In the context of implementing Q3D in Europe, several texts and monographs of the European Pharmacopoeia (Ph. Eur.) were revised, rendering the guideline legally binding in 38 European countries. Ph. Eur. general chapter 5.20. has been modified to reflect ICH Q3D guideline and the old fashioned heavy metals test, Ph. Eur. 2.4.8., has been deleted from individual Ph. Eur. monographs for substances for human use. Furthermore, general chapter Ph. Eur. 2.4.20. Determination of metal catalyst and metal reagent residues has been completely revised and renamed Determination of elemental impurities. Whatever the chosen analytical method, reference materials with a known content of the target element are required for the quantification of elemental impurities. This led EDQM to consider the establishment of suitable reference materials. However, due to lack of specific experience and technical equipment, external partners were sought. Three key European institutes (JRC, BAM and PTB) were identified and involved in the project. To mitigate the overall risk at first the project focussed on the elements classified by ICH Q3D as Class 1: lead, cadmium, mercury and arsenic. A key necessity was the traceability of the element content to the SI (International System of Units Measurement) to allow metrologically reliable and reproducible determination. This required new and specific approaches to be developed by the partners in charge (BAM and PTB). Since January 2018 lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS are available to the users of the Ph. Eur. . T2 - BERM-15 CY - Berlin, Germany DA - 23.09.2018 KW - Pharmacopea KW - Reference standards KW - Elemental impurities KW - Medicinal products PY - 2018 AN - OPUS4-46217 LA - eng AD - Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin, Germany ER -