During its 173rd session in June 2022, the European Pharmacopoeia Commission (EPC) approved the creation of a new Excipients Strategy Working Party (EXS) (see “Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022”). The EXS Working Party will focus on continuing to address the specificities of these important pharmaceutical ingredients in European Pharmacopoeia (Ph. Eur.) monographs and will also reflect on how best to further develop the Ph. Eur. excipient strategy.
The Ph. Eur. general monograph on Substances for pharmaceutical use (2034) covers both active substances and excipients. However, several parts of this general monograph, as well as the Technical Guide for the Elaboration of Monographs, apply only to active substances. In addition, certain aspects beyond quality – functionality and interactions, for example – are recognised as being specific to excipients. Therefore, in the spirit of continuous improvement, the EPC wishes to assess whether the current approach to these essential and widely used substances is optimal.
The members of the EXS Working Party – all experts with experience in both developing and carrying out pharmaceutical analytical procedures for the quality control of pharmaceutical excipients (see Terms of reference) – were put forward by Ph. Eur. member states’ national pharmacopoeial authorities and by non-Ph. Eur. member states, and appointed by the EPC during its 174th session in November 2022. Their first task will be to take stock of the current situation, reflect on potential areas for development and opportunities for the Ph. Eur. in the future with regard to standard setting for excipients. The aim is to make concrete recommendations to the Ph. Eur. Commission.
Involvement of stakeholders in this process is key to establishing a future-proof approach that takes into account the specificities of excipients compared to active substances. Focus areas include setting impurity specifications – including for mutagenic impurities – and matrix effects, for example.
Stakeholders will be regularly updated on the outcome of the discussions.