CMCServices药物制剂及质量研究服务CMC介绍.PDF

CMC Services /药物制剂及质量研究 CMC Services/药物制剂及质量研究服务 Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control, our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and CFDA guidelines. ICH CFDA Project Advisory Planning 项目咨询规划 • Feasibility study • 项目注册法规可行性 • Project planning • 项目技术可行性 Synthesis 合成工艺研究 • Establish synthesis • 合成路线确定 • “Freeze” the synthesis • 合成工艺优化 • Establish large-scale • 合成工艺放大 Formulation Development 制剂工艺研究 • Preformulation testing • 处方前研究 • Formulation development • 处方筛选 • Process optimization • 工艺优化 • IVIV correlation • 体内外相关研究 • Scale up • 工艺放大 05 CMC Services /药物制剂及质量研究 CMC Services/药物制剂及质量研究服务 Analytical Development 质量分析研究 • Establish HPLC methods for API, impurities , • 原料药，杂质，异构体 isomers and drug product 及制剂分析方法建立 • Develop HPLC method for stability testing • 分析方法稳定性研究 • Conduct HPLC method validation • 分析方法验证 • Set API and drug product specifications • 质量标准确定 Stability Study 稳定性研究 • Perform stability study for API and drug • 按照ICH和CFDA指导原则进行