（Background）: With the development of International economy and the speeding up of globalization, almost pharmaceutical enterprises, especially large pharmaceutical enterprise group, is facing unprecedented challenges from. Products to the European market, according to cGMP regulations, carry out production and through the certification; Products to the U.S. market should according to the United States food and Drug Administration (FDA standards) for production and authenticated. As the market is increasing strict requirements in production process and quality, companies have been looking for optimizing production processes, standardization of production process; more and more companies have realized the importance of information technology, which is the most appropriate way to improve the management level of enterprises. Old mode of production is unsustainable: 1. Manual records method. May due to the negligence of the staff, appear mistakes during the production process. 2. For biological engineering, injection, infusion, such as high risk, high value, and stricter with production process, we need to have a system to its production process real-time monitoring, when problems occur, such as high efficiency filter leak, the emergency alarm can control in the time. 3. Not form a unified data management platform, record and transmit data needs to be artificial, resource utilization and the efficiency is very low. How production management work in intelligent pharmaceutical factory? 1.Production process management Intelligent machine could supervise the production process, automatically correct or improve, provide information feedback to the operator. Alarm management mechanism to ensure that production personnel to understand than in the production process of deviation allowed range. 2.Production documents control file It includes the SOP, production instructions, formulation, program control system, process flow chart alarm message, batch production records and some other production documentation. 3.Labor management Machineries will replace more human resources; there only need 1 or 2 operators. 4.Product quality management 5.Equipment maintenance and management 6.Batch data acquisition 7.Product batch data tracking 8.Product batch data analysis
Pharmaceutical industry is a special of the regulated industry, enforcing GMP management norms, with standard production processes, standardize the production process.
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