| 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) |