I would appreciate your regulatory insight regarding Water for Injections (WFI) in containers (sterile WFI as a finished drug product).
Since WFI has a minimal matrix and strict continuous monitoring (Conductivity and TOC) according to the Ph. Eur. monograph, we are evaluating whether a formal Elemental Impurities Risk Assessment (EIRA) under ICH Q3D / Ph. Eur. 5.20 is mandatory for the CTD dossier (Module 3.2.P.5.5).
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Does a finished containerized WFI require a dedicated EIRA report in the dossier, or can it be waived based on compliance with the WFI monograph?
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If required, have you successfully justified omitting elemental impurities tests using ICP-MS for WFI?
Thank you for your expertise!