This function focuses on the detection, quantification, and control of elemental impurities (heavy metals and other elements) in APIs, intermediates, and drug products, in line with ICH-Q3D regulatory requirements. It ensures product safety, quality, and global regulatory compliance.
Key Deliverables
- Elemental Impurity Analysis: Measurement of trace metals (e.g., Cd, Pb, As, Hg) and other elemental impurities using ICP-MS.
- Risk Assessment: Evaluating sources of elemental impurities in raw materials, reagents, and manufacturing processes.
- Regulatory-Compliant Testing: Providing validated methods and reports aligned with ICH-Q3D for IND, NDA, ANDA, and DMF submissions.
- Mitigation & Control Strategies: Recommendations to minimize elemental impurities during synthesis and manufacturing.
- Ongoing Monitoring: Periodic testing for commercial batches to ensure continued compliance.
- Documentation & Reporting: Detailed analytical reports and certificates of analysis for regulatory and quality assurance purposes.