Elemental Impurities Testing Implementation Presentation by: Wayland Rushing, Ph.D, EAG Laboratories’ Director of Scientific Affairs
The deadline for Phase II implementation of ICH Q3D, USP <232> and <233> is January 1, 2018. In this presentation we review the history of implementing elemental impurities testing, along with the new testing requirements including:
New USP Chapters
A risk assessment approach is presented, to determine the potential sources of elemental impurities in drug products and drug product components. The challenge of gathering information from manufacturers is discussed, as well as container/closure elemental impurities. Typical elemental impurities programs are described, along with case studies.
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