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药厂生产环境的监测及风险评估
引用本文:徐华. 药厂生产环境的监测及风险评估[J]. 医药工程设计, 2014, 0(5): 58-63
作者姓名:徐华
作者单位:上海朗脉洁净技术股份有限公司;
摘    要:生产环境是保证药品质量的关键环节之一,主要阐述了如何设计药厂生产环境的监测系统,以及如何运用风险评估理论,量化和处理生产环境的关键要素,从而提高和保证药品的生产质量。

关 键 词:环境监测系统  风险评估  BMS  EMS

Monitoring of Production environment and Risk Assessment for Pharmaceutical Plant
Xu Hua. Monitoring of Production environment and Risk Assessment for Pharmaceutical Plant[J]. Pharmaceutical Engineering Design, 2014, 0(5): 58-63
Authors:Xu Hua
Affiliation:Xu Hua (Shanghai Macroprocess Lustration Technology Co., Ltd, Shanghai, 200100)
Abstract:The production environment is one of the key links to ensure the quality of medical products. In this paper, the design of the system for monitoring the production environment in pharmaceutical factory, us of the theory of risk assessment, and quantification and key elements of the processing production environment were expounded, which is hoped to be helpful in improving and ensuring the quality of products.
Keywords:environmental monitoring system  risk assessment  BMS  EMS
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