Robert A. Nash
Abstract
This chapter reviews the requirements of the U.S. Food and Drug Administration (FDA) for process validation of manufacturing pharmaceutical active ingredients (APIs) and inactive ingredients used in human and veterinary drug products.
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This chapter reviews the requirements of the U.S. Food and Drug Administration (FDA) for process validation of manufacturing pharmaceutical active ingredients (APIs) and inactive ingredients used in human and veterinary drug products.
Key concepts: Process validation, Process engineering, Process (computing), Computer science, Business, Engineering, New product development, Marketing