Document title Contents
Comparison report on both APIs Synthetic route (starting material, impurities profile, residual solvents), Physical properties (particle size, bulk density, polymorphism, solubility), Specifications, Analytical procedures and Method validation
DP development Comparison report for API physicochemical properties, DP impurity profile, Updated components and composition statement, analytical method validation reports. Risk assessments and QbD elements reconfirmation.
New manufacturing batches with proposed API Intended master batch records for the largest intended commercial batch size (US), Executed batch manufacturing record (for USFDA), Batch analysis CoA, in-vitro dissolution results, in-vitro dissolution comparison report with old API mfg. batches, 6months accelerated and long term stability data and stability commitment for long term/intermediate conditions.
CTD sections DS CMC part: Module-2 QOS and Module-3 DS part
Table 4: Documentation requirements for quality part.