Manufacturing processes for biopharmaceuticals must be designed to produce products that have harmonious quality attributes. This entails removing impurities and adulterants that include endotoxins, contagions, cell membranes, nucleic acids, proteins, culture media factors, process chemicals, and ligands oozed from chromatography media, as well as product variations, aggregates, 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 morals. The principles of process evidence were firstly established in the 1987 US Food and Drug Administration( FDA) document “ Guideline on General Principles of Process evidence, ” which defined process evidence as “ establishing proved validation which provides a high degree of assurance that a specific process will constantly produce a product meeting its pre- determined specifications and quality attributes