Issue Date: July 24, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q3C Maintenance Procedures
This Maintenance Procedure has been developed by the International Council for Harmonisation (ICH) for revising the existing ICH guidance for industry Q3C Impurities: Residual Solvents (ICH Q3C) to include new solvents and revising existing permitted daily exposures (PDEs) for solvents already listed in ICH Q3C as new toxicity data for solvents becomes available.
Download the Guidance Document
