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    “十三五”我国新药研发过程中的EHS管理

    摘要

    提升EHS(环境、职业健康和安全)管理水平是我国医药工业转型升级和可持续发展的需要,如何做好新药研发过程中的EHS管理是很多企业面临的全新课题。新药研发阶段的EHS管理应考虑两方面内容:一是各项研发活动应符合环境保护、安全管理、职业健康管理的要求;二是按照EHS源于设计的理念,从产品开发源头减少废水、废气、废渣的产生,从工艺源头解决本质安全问题。在环境保护方面,企业应树立清洁生产的理念,推动绿色化学技术的应用。在安全管理方面,企业应重视工艺安全信息的收集和维护,开展工艺危害分析,并保证实验室安全运行。在职业健康方面,企业应识别存在的职业病危害因素,建立危害评估和监测制度,采取适宜的控制措施,降低从业人员的职业健康风险。

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    Abstract

    Improving the management level of EHS (Environment,Occupational Health and Safety) is a requirement for the transformation,upgrading and sustainable development of China’s pharmaceutical industry. How to perform well in the EHS management in the R&D of new drugs is a new topic faced by many companies. Two aspects should be considered in the EHS management in the R&D of new drugs:various research and development activities should meet the requirements of environmental protection,safety management,and occupational health management;with the concept of EHS by Design,to reduce the generation of waste water,waste gas and residue from the start of product development,and solve intrinsic safety problems from the source of the process. In terms of environmental protection,companies should establish the concept of clean production and promote the application of green chemical technologies. In terms of safety management,companies should pay attention to the collection and maintenance of process safety information,conduct process hazard analysis,and ensure the safe operation of laboratories. In terms of occupational health,companies should identify existing occupational disease hazards,establish a hazard assessing and monitoring system,and adopt appropriate control measures to reduce occupational health risks of employees.

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    作者简介
    王学恭:王学恭,中国医药企业管理协会副会长。
    李海霞:李海霞,中国医药企业管理协会EHS专委会高级工程师。
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