1) FDA Compliance for Manufacturing of Ab intermediate, DS and DP (Combination products with drug/device):
Assessment of clonal derivation for the production cell line
Safety testing of MCB, WCB and UPB
Viral clearance validation
Process validation strategy
Stability data requirements
2) FDA Compliance for Raw materials, Manufacturing process, Testing method, Formulation, Container Closure and DP Format change
3)FDA Compliance for IPC, Release and Stability testing and method validation: Submission requirements for Methods SOPs, Method qualification and validation, and Reference standard qualification
