Genotoxic Impurity Control

Genotoxic impurity control establishes procedures preventing mutagenic contaminant introduction or accumulation. Process chemistry design minimises impurity generation at source. Purification methods remove genotoxic species. Analytical surveillance detects emerging genotoxic impurities. Risk-based approaches prioritise highest-concern impurities.

Regulatory thresholds establish acceptable genotoxic impurity limits. Structural alerts predict genotoxicity hazards. Toxicology testing confirms impurity acceptability. Manufacturing controls prevent exceeding thresholds. Post-approval monitoring ensures ongoing compliance.