Spring Intro 2023

28/03/2023

Manufacturing Process NCE

Manufacturing Process

Underlying Synthetic route

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3.2.S.2.2 : Manufacture - NCEs

• Flow diagram of synthetic process including molecular formulae, weights, yield ranges, chemical structures of starting materials, intermediates, reagents and drug substance reflecting stereochemistry, and identifies operating conditions and solvents. • Sequential procedural narrative of the manufacturing process including quantities of raw materials, solvents, catalysts and reagents reflecting the representative batch scale for commercial manufacture, identification of critical steps, process controls, equipment and operating conditions (e.g., temperature, pressure, pH, time). • Alternative processes should be described and justified – may not be acceptable in some jurisdictions

• Any re-processing steps should be identified and justified

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