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
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