That part of pharmaceutical development that deals with the nature of the drug substance and drug product, the manner in which both are made, and the manner by which the manufacturing process is shown to be in control. The Chemistry, Manufacturing, and Controls section of the IND is the section in which the sponsor describes the product: including, but not limited to, the cell bank(s) characterization, adventitious agent testing, manufacturing procedures for the drug substance, manufacturing procedures for the formulation and filling of the drug product, in-process controls, bulk and final container lot release controls and specifications, release test methods, product characterization, and any other relevant product information (e.g., excipients, raw materials, adjuvants, delivery devices).
Glossary
Chemistry, Manufacturing and Controls (CMC)
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