临床药理学与生物药剂学

抽象的

Biopharmaceutical Manufacturing Process Validation and Quality Risk Management

Raghu Tadagavadi

Manufacturing processes for biopharmaceuticals must be designed to produce products that have harmonious quality attributes. This entails removing contaminations and pollutants that include endotoxins, contagions, cell membranes, nucleic acids, proteins, culture media factors, process chemicals, and ligands percolated from chromatography media, as well as product variations, summations, and inactive forms. Manufacturing processes should be validated by applying a scientifically rigorous and well- proved exercise demonstrating that the process, and every piece of outfit used in it, constantly performs as intended, and that the process, when operated within established limits, generates a product that routinely and reliably meets its required quality norms.