Reference Material Producers (RMPs) are responsible for producing and fully characterizing high-quality reference standards that support analytical testing, method validation, and regulatory submissions. This function ensures that reference materials are reliable, well-documented, and compliant with global regulatory expectations, providing a critical foundation for quality control, stability studies, and CMC documentation.
Key Deliverables
- Synthesis and isolation of reference materials for APIs, intermediates, and impurities
- Comprehensive characterization including purity, identity, structure, and physicochemical properties
- Analytical method validation support using the produced reference materials
- Batch documentation and traceability records to meet regulatory and GMP standards
- Stability and storage recommendations to ensure long-term integrity
- Supply of certified reference materials for global regulatory submissions and internal quality programs