White Paper: Requirements for Elemental Impurities Testing
This paper highlights the significance of testing for elemental impurities in the drug development process to ensure product safety. It discusses the importance of conducting risk assessments and adhering to applicable standards, particularly the USP <232> and USP <233> standards aligned with ICH guidelines. With regulatory agencies like the FDA and EMA harmonizing standards with ICH Q3D, compliance with USP <232> and <233> is essential for products entering the US market after January 1, 2018. The paper serves as a guide for proper risk assessment and testing to meet these requirements.
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