This function focuses on designing and establishing analytical methods that are accurate, precise, and reproducible across the drug development and manufacturing lifecycle. It ensures that analytical procedures meet ICH, USP, and other global regulatory standards, supporting both internal decision-making and regulatory submissions.
Key Deliverables
- Method Development: Designing new analytical methods for APIs, intermediates, and impurities using HPLC, UPLC, GC, MS, and other advanced techniques.
- Method Validation: Demonstrating method reliability through precision, accuracy, specificity, linearity, robustness, and sensitivity assessments in accordance with ICH Q2(R2).
- Method Verification: Confirming that validated methods perform as expected in different laboratories, scales, or matrices, ensuring transferability.
- Analytical Documentation: Comprehensive SOPs, validation reports, and protocols to support regulatory filings and GMP compliance.
- Support for Stability Studies & Process Monitoring: Ensuring methods are suitable for ongoing quality control and process analytics.