International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Elemental Impurities." Prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), this guidance is intended to develop a harmonized approach for the control of elemental impurities that helps industry avoid the uncertainty and duplication of work resulting from differing requirements across ICH regions. It includes the specific elements to be limited and the appropriate limits for impurities, and emphasizes control of supply chains and risk assessments. It is expected to provide appropriate safety-based limits for the control of elemental impurities, consistent expectations for test requirements and regulatory filings, and a global policy for limiting elemental impurities, both qualitatively and quantitatively, in drug products and ingredients.