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...Why is there cmc to assure that the drug sold public will have quality attributes similar those of demonstrated be safe and effective meets appropriate standards consistent you are using described onthe label critical elements how where made raw materials tested monitored what control procedures in place product consistency adequately identified characterized for test methods used monitor long does maintain its after it shelf life expiry clinical studies helps connection between marketed consumers commercial one links connecting batches safety effectiveness pilot information engineering scale up from process validation implementation manufacturing processes specific sterile injectable sterility endotoxin concentration controlled release profile active ingredient over time oral tablet dissolution soluble powder drinking water moisture content as solubility...