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随着《萨班斯法案》、《中央企业风险管理指引》、《企业内部控制基本规范》和18个指引的颁布,要求上市公司和大型企业执行标志着我国的内部控制将步入新的阶段。生物医药行业是与人的生命息息相关的高科技制药行业,要同时遵守GMP(药品生产企业管理规范)和GSP(药品经营企业管理规范)的内容要求。在经济下滑和的背景下,如何确保企业经营的效率和效果,本文针对生物制品的行业特殊性,对其企业的物流内部控制管理从其投入至产出的成本、效益、质量的角度阐述现代生物医药企业成本效益内部控制新体系的全面风险管理控制模式,以内部控制角度为视角,放大至企业的全局管理思维方式。
With the promulgation of the Sarbanes-Oxley Act, the Guidelines on Risk Management of Central Enterprises, the Basic Norms for Internal Control and the promulgation of 18 guidelines, the implementation of listed companies and large-scale enterprises requires that the internal control of our country will enter a new phase . The biomedical industry is a high-tech pharmaceutical industry closely related to people’s life. It is required to comply with the content requirements of GMP (Drug Production Enterprise Management Practices) and GSP (Drug Administration Enterprise Management Practices) at the same time. In the context of economic downturn and how to ensure the efficiency and effectiveness of business operations, this paper aims to explain the characteristics of the industry of biological products, and expounds the cost, benefit and quality of its internal logistics management from input to output. The overall risk management and control mode of the new system of cost-effectiveness and internal control of biomedical enterprises is enlarged from the perspective of internal control to the overall management thinking mode of the enterprise.