The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...
What not to do with active pharmaceutical ingredient (API) batch records? Tear them out of a company logbook ahead of an FDA inspection, for one. Earlier this month, Indian drugmaker Indiana Chem-Port ...
From his time in the industry before the contemporary good manufacturing practice (cGMP), senior drug substance consultant at DSI, a ProductLife Group company, Dave Adams quickly grasped the necessity ...
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