ICHQ3(D) for Elemental Impurities define the requirements for complying the drug products with the PDE requirements, carrying out the risk assessment for elemental impurities and control of elemental impurities.
This methodology explains USFDA Guidance for Elemental Impurities, United States Pharmacopoeia Chapter 232 & Chapter 233.
The presentation defines sources of elemental impurities including incoming materials, equipment, container closure system. It defines intentionally added as well as unintentionally introduced elemental impurities.
It gives examples for determining the elemental impurities in drug products including calculating PDE values using different approaches.
The presentation also covers the USP Chapter requirement for carrying out finished product testing by ICP-MS or ICP-AES.
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