ICH Q3D implemented in the European Pharmacopoeia: Revision of Two General Monographs with Regard to Elemental Impurities

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Two general monographs of the European Pharmacopoeia have been revised and published for comment in the newest “Pharmeuropa” edition. Read more about what you will have to consider in future with regard to the control of elemental impurities in pharmaceutical preparations, APIs and excipients.

see

http://www.gmp-compliance.org/enews_05296_ICH-Q3D-implemented-in-the-European-Pharmacopoeia-Revision-of-Two-General-Monographs-with-Regard-to-Elemental-Impurities_15499,15332,S-AYL_n.html

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…