15/16 February 2022
In a press release dated 30 November 2015, the EDQM announced the revision of two general pharmacopoeial monographs: "Substances for pharmaceutical use" (2034) and "Pharmaceutical preparations" (2619). The decision was taken during the 153rd session of the European Pharmacopoeia Commission; the Commission follows its strategy for implementing the ICH Guideline Q3D "Guideline for Elemental Impurities" in the European Pharmacopoeia. A section "Elemental Impurities" has been added to both monographs which emphasizes that the provisions laid down in General Chapter 5.20 of the Pharmacopoeia (identical in wording with ICH Q3D) apply to the limits of metallic impurities and to their control. For pharmaceutical preparations and substances for pharmaceutical use outside the scope of Chapter 5.20 (e.g. unlicensed patient-specific preparations, herbal products, radiopharmaceuticals, etc.), the manufacturer is obliged to perform a risk assessment with regard to the limits of those impurities and - if necessary - to use validated analytical procedures for their determination. The principles to be applied for such a risk assessment arise from a press release from the EDQM dated 7 August 2015: it is expected that the provisions defined on the Guidelines ICH Q3D or ICH Q9 are followed. Lastly, according to this press release, the control strategy of elemental impurities as well as the substantial demonstration of suitability of the analytical methods used in the marketing authorisation dossier remains in the responsibility of the manufacturer.
The definition of "Substances for pharmaceutical use" in the monograph 2034 states: "Substances for pharmaceutical use are any organic or inorganic substances or excipients for the production of medicinal products for human or veterinary use. ... Substances for pharmaceutical use may be used as such or as starting materials for subsequent formulation to prepare medicinal products. Depending on the formulation, certain substances may be used either as active substances or as excipients."
The drafts of the two revised general monographs are accessible for free in the Journal "Pharmeuropa", Edition 28/2. You only need to register and log in with your password. The comment deadline for both monograph drafts ends on 30 June 2016.