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To manufacture biopharmaceutical products with highly assured and consistent quality, it should be controlled and produced under quality management system. So it is important that quality must be considered from the product design and development phases and to minimize
risks and to protect consumers from it, risk management is needed over the parameters that can affect on the product quality (1-4). Manufacturing facilities that may have impact on the product quality must be qualified for their design, installation, operation and performance according to the characteristics of each equipment and facility (5-6). Validation must be conducted on the critical process parameters of each manufacturing process of biopharmaceuticals to assure high quality and continued process verification is required (7).