This function focuses on the detection, assessment, and mitigation of genotoxic impurities (GTIs) and nitrosamines in APIs, intermediates, and drug products. It ensures that pharmaceutical compounds meet global safety and regulatory standards and supports the preparation of robust regulatory submissions.
Key Deliverables
- Detection & Quantification: Sensitive analytical testing for genotoxic impurities and nitrosamines using LC-MS/MS, GC-MS, and other validated techniques.
- Risk Assessment: Evaluating the potential impact of genotoxic impurities and nitrosamines on patient safety.
- Regulatory Support: Generating reports and safety assessments for inclusion in IND, NDA, ANDA, and DMF submissions.
- Mitigation Strategies: Providing recommendations to minimize or eliminate formation of GTIs and nitrosamines during synthesis, storage, and formulation.
- Compliance with Guidelines: Ensuring adherence to ICH M7, EMA, FDA, and other global regulatory recommendations.
- Data Integrity & Documentation: Providing validated analytical reports, supporting risk assessments, and regulatory filings.