Offer extended until 31 July 2026: get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
Elemental Impurities: Harmonized chapter finalized
Recommendation
Thursday, 3 September 2026 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
In late November 2024, it was reported on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) that the new harmonized chapter "Elemental Impurities (G-07)" of the "Pharmacopoeial Discussion Group (PDG)" had been signed in June 2024. The PDG consists of representatives from the European Pharmacopoeia (Ph. Eur.), the Indian Pharmacopoeia Commission (IPC), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP).
In particular, the harmonization focused on the implementation of the updated requirements of the ICH Q3D guideline and the harmonization of analytical procedures. Special focus was placed on the following three points:
- Sample preparation
- Examples of suitable methods and detection techniques
- Requirements for the validation of procedures
The new harmonized chapter "Elemental Impurities (G-07)" will be published in the regional pharmacopoeias according to the following timelines:
- Ph. Eur: July 2025
- USP: December 2025
- JP: April 2026
- IPC: July 2026
The announcement of the new harmonized chapter "Elemental Impurities (G-07)" can be found in the "Newsroom" section of the EDQM website.
Related GMP News
06.07.2026GMP for Active Substances - What are the fundamental Requirements of the ICH Q7 Guideline? - Part 1
10.06.2026What are the Requirements for Testing for Impurities in the Pharmaceutical Industry?
03.06.2026Recycled Solvents: To use or not to use?
13.05.2026How are Reference Standards used in the Pharmaceutical Industry?
06.05.2026FDA: New Draft Guidance on Impurities in Antibiotics