The July 2017 publishing by the European Pharmacopoeia (Ph. Eur.) of revisions to its general chapter, method, and monograph sections is the latest development in the effort by the pharmacopeia to align its coverage of elemental impurities (EI) with the implementation of the International Conference on Harmonization (ICH) Q3D guideline.
The ICH Q3D implementation effort by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which overseas Ph. Eur., has also included clarifying the impact on the expectations for the Certificates of Suitability (CEPs) it issues. CEPs are used by pharmaceutical substance manufacturers as evidence that their substances are suitably controlled in accord with the relevant Ph. Eur. monographs, and the certificates are included in a marketing authorization application (MAA) by drug manufacturers in lieu of detailed substance CMC descriptions.
At an international stakeholder conference held by EDQM in Tallinn, Estonia in September 2016 in conjunction with the release of the ninth edition of Ph. Eur., Director Susanne Keitel highlighted the control of elemental impurities as among the top priorities on the pharmacopeia’s agenda going forward.
Other high priorities, she explained, will be: ● standards for biotherapeutic products ● new technologies and their potential impact on monographs, and ● excipients, other components and international harmonization.