Development Phase
Technical development plan
Technical development plan
Process Development Report
Process development plan, process route screening, process optimization, impurity design, preparation, small-scale trial confirmation, process development report
Quality Studies
Quality research plan, development and standard establishment of starting material analysis methods, development and standard establishment of intermediate analysis methods, development and standard establishment of raw material analysis methods, process development batch product testing, quality research report
Technical Development Report
Technical Development Report
Node
work content
Technology Transfer
Technology Transfer Plan
Technology Transfer Plan
Production technology transfer
Transfer production plan, production documents, transfer production (impurity transfer, intermediate stability), transfer production report
Quality and technology transfer
Pre validation of starting material analysis methods, intermediate analysis methods, raw material analysis methods, impurity transfer, stability of key intermediates, and stability of finished products
Technology Transfer Report
Process Validation
Process validation production
Production documents, process validation plan, process validation production (intermediate stability, impurity transfer), process validation report
Quality Inspection
Validation of Starting Material Analysis Method, Intermediate Analysis Method, Raw Material Analysis Method, Impurity Transfer, Stability of Key Intermediates, Production Control and Finished Product Testing
Stability research (accelerated, long-term)
Stability study plan (accelerated, long-term), stability study, stability study report
Registration Declaration
Writing and reviewing the process module of application materials
Writing and reviewing the quality module of application materials
Overseas submission
Domestic submission
