Should the drug substance manufacturing process be provided in technical documentation of the drug substance?

刊登日期:2019-11-12  |  點閱次數 : 655 次 

Yes, the drug substance manufacturing process should be provided in 3.2.S.2.2. A sequential procedural narrative of the manufacturing process should be submitted. The narrative should include, for example, quantities of raw materials, solvents, catalysts and reagents reflecting the representative batch scale for commercial manufacture, identification of critical steps, process controls, quipment and operating conditions (e.g., temperature, pressure, pH, time).



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