Product  development steps Redevelopment  activity requirement
Step-1: Pre-formulation Comparison of API specifications, Polymorphs, Monographs compliance, Physical and chemical characterisation.
Step-2: Formulation(Lab scale) 1. Perform the Step 1 activities
2. Re-evaluate the drug substance (DS) & DP risk assessments
3. Re assess the QTPP,CQA,CMA (critical material attributes),CPP (critical process parameters) & design space
4. Evaluate the DP stability
Step-3: Formulation (Pilot scale)
Table 1: API supplier change requirements at various development stage.