关键词: font-size:medium, ">药品制剂生产过程监管；药品制剂质量安全；智慧监管

Abstract: The informatization supervision in pharmaceutical preparation manufacturing process collects data in the entire manufacring whole life cycle of pharmacentical preparation， including key quality data, key data in processing， final inspection data of pharmaceutic preparations of raw materials and auxiliary materials and intermediate products， etc， in order to monitor the quality safety，provide early warnings when certain data exceeds the standard limit， and track key changes and major deviations during the process. By analyzing the data models， it is able to find and warn the risks within the manufacturing process， and improve regulation efficiency of regulatory agencies， thus better guarantee the quality and safety of drug manufacturing. According to the national conditions in China， the development and widely use of informaization supervision still depends on the informatization level of the pharmaceutical preparation manufactaring enterprises and the improvement of relevant standards， laws and regulations. This study expounds the significance of informatization supervision of pharmaceutical preparation manufacturing process， analyzes the path of informatization supervision of pharmaceutical preparation manufacturing process， and summarizes the limitations of the informatization supervision of pharmaceutical preparation manufacturing process， in order to provide a reference for improving the informatization supervision of pharmaceutical preparation manufacturing process.

Key words: font-size:medium, ">Supervision of pharmaceutical preparation manufacturing process；Quality safety of pharmaceutical preparation；Intelligent supervision