FDA finalizes ICH guidance on elemental impurities

FDA issued final guidance on August 7 that explains when to conduct risk assessments for elemental impurities in drug products for applicants and holders of new drug applications or abbreviated new drug applications.

FDA issued final guidance on August 7 that explains when to conduct risk assessments for elemental impurities in drug products for applicants and holders of new drug applications or abbreviated new drug applications. Recommendations outlined throughout the guidance provide a risk-based approach, which is intended to ease the regulatory burden in conducting this type of risk assessment as it was developed via the International Council for Harmonization (ICH). The guidance states that documentation that demonstrates compliance must be maintained at manufacturing facilities. Additionally, firms are required to document any changes made to the conditions established in approved applications in upcoming annual reports, though FDA recommends including a risk assessment summary in these reports "even if no changes are made.