新版GSP的药品冷链物流质量风险管理研究
发布时间：2019-04-07 20:31
【摘要】：众所周知,药品是用于维护健康,延长生命的。近年来药品安全一直是受到广泛关注的社会热点问题之一,药品质量直接关系到广大百姓的身体健康和生命安全,关系到经济健康发展和社会和谐稳定。医药行业虽然是一个传统行业,但却是知识和技术密集型的产业,从科研、生产、流通、运输、储存到使用安全,都不能出任何差错。一个行业的良性发展,来自新技术的应用,来自于市场的理性需求,安全诉求,来自国家政策监管标准的提升。医药物流在我国经过多年的发展与探索,已形成初具系统的行业发展规律,表现出高度集中化、专业化趋势。就医药冷链物流来说,目前还属于初步发展水平,虽已有了理论概念及行业规范,但在具体标准的执行、新技术的应用、监控管理的体系上还需不断完善,有较大的发展空间。 随着我国医药市场的不断发展,对冷链物流的需求也日益增大,近年来接连发生的重大药害事件,集中暴露出医药冷链物流体系存在严重影响药品质量安全的隐患,新版GSP因此而实施。新修订的GSP不仅充分吸收了现代质量管理学的理论成果,还创新性地引入供应链管理理念,对药品经营企业提出建立质量体系并使之有效运行的基本要求,在结构上将质量体系组成要素与药品经营过程密切结合起来,实行药品流通质量全过程管理。同时,国家有关部门也不断要求各级政府加大监管力度,督促药品经营企业在承担国家税收、员工福利、诚信经营等一般社会责任外,还应积极承担保证药品质量,规范安全使用,促进行业健康发展等特殊社会责任。本文正是在此背景下,对新版GSP的药品冷链物流流程风险管理展开研究,以达到保证药品质量安全的目的。 本文首先阐述了实施GSP的意义、GSP在国内外的发展、药品冷链物流的特点及冷链断裂的后果,分析了我国现阶段药品冷链物流的现状及发展对策。接着以冷藏药品中的高风险品种生物制品为例,采用HACCP法和FMEA法进行风险评估和质量控制,构建冷链物流过程的风险管理模型。然后归纳了新版GS P冷藏药品经营所需的硬件条件、软件要求和人员资质,对我省药品批发企业新版GSP认证的冷链主要问题进行分析,并选取典型案例加以讨论,总结得出药品冷链质量风险管理的对策。最后对新版GSP全面推行后,未来我国药品冷链物流企业的发展方向进行了探讨。 本文还启动质量风险管理流程,应用质量风险管理工具,采用问卷调查的方法,对新版GSP规定的冷藏药品物流采购、收货、验收、储存、出库、运输等各核心环节的可能存在的风险进行系统分析,识别出风险点后确定风险等级,采取针对性预防控制措施,将潜在的风险降低至可接受的范围内。其研究的结果比较切合实际、科学、合理、可信,能够给药品经营企业实施新版GSP及我国未来冷链物流行业的健康有序发展提供借鉴和参考。
[Abstract]:It is well known that medicines are used to maintain health and prolong life. In recent years, drug safety has always been one of the hot issues in the society, and the quality of drugs is directly related to the health and life safety of the general public, to the healthy development of economy and to the harmony and stability of society. Although the pharmaceutical industry is a traditional industry, but it is a knowledge-and technology-intensive industry, from scientific research, production, circulation, transportation, storage to use safety, there can be no mistakes. The benign development of an industry comes from the application of new technology, the rational demand of the market, the demand for safety, and the promotion of the national policy supervision standard. After years of development and exploration in China, medical logistics has formed a systematic law of industry development, showing a trend of high concentration and specialization. As far as medical cold chain logistics is concerned, it is still a preliminary level of development. Although there have been theoretical concepts and trade norms, there is still room for development in the execution of specific standards, the application of new technologies, and the monitoring and management system. With the continuous development of the pharmaceutical market in China, the demand for cold chain logistics is increasing day by day. In recent years, serious drug damage events have occurred one after another, and the hidden dangers that seriously affect the quality and safety of drugs exist in the cold chain logistics system of medicine. The new version of GSP was implemented as a result. The newly revised GSP not only fully absorbs the theoretical achievements of modern quality management, but also creatively introduces the concept of supply chain management, and puts forward the basic requirements of establishing a quality system and making it run effectively in pharmaceutical enterprises. In the structure, the components of the quality system are closely combined with the drug management process, and the whole process management of the drug circulation quality is carried out. At the same time, relevant departments of the state continue to ask governments at all levels to step up supervision and supervision, and urge drug-selling enterprises to actively assume the assurance of drug quality in addition to general social responsibilities such as national taxation, employee welfare, integrity management, and so on. Regulate safe use, promote the healthy development of the industry and other special social responsibilities. Under this background, this paper studies the risk management of drug cold chain logistics process of the new version of GSP, in order to ensure the quality and safety of drugs. This paper first expounds the significance of implementing GSP, the development of GSP at home and abroad, the characteristics of drug cold chain logistics and the consequences of cold chain breaking, and analyzes the present situation and development countermeasures of drug cold chain logistics in China at present. Then, taking the high-risk biological products in refrigerated drugs as an example, the risk assessment and quality control are carried out by means of HAC and FMEA methods, and the risk management model of cold chain logistics process is constructed. Then it sums up the hardware conditions, software requirements and personnel qualification of the new GSP refrigerated drug management, analyzes the main problems of the cold chain of the new version of GSP certification in pharmaceutical wholesale enterprises of our province, and selects the typical cases to discuss. The countermeasures of drug cold chain quality risk management are summarized. Finally, after the implementation of the new version of GSP, the future development direction of drug cold chain logistics enterprises in China is discussed. This article also starts the quality risk management process, applies the quality risk management tool, adopts the questionnaire survey method, to the new edition GSP regulation refrigerated medicine logistics procurement, the receipt, the acceptance, the storage, the stock, the storage, the warehouse, In order to reduce the potential risk to an acceptable range, the possible risks of transportation and other core links are systematically analyzed, the risk levels are determined after the risk points are identified, and targeted preventive and control measures are taken to reduce the potential risks to an acceptable range. The results of the study are practical, scientific, reasonable and credible, which can provide reference for the implementation of the new version of GSP and the healthy and orderly development of cold chain logistics industry in China in the future.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
本文编号：2454400
[Abstract]:It is well known that medicines are used to maintain health and prolong life. In recent years, drug safety has always been one of the hot issues in the society, and the quality of drugs is directly related to the health and life safety of the general public, to the healthy development of economy and to the harmony and stability of society. Although the pharmaceutical industry is a traditional industry, but it is a knowledge-and technology-intensive industry, from scientific research, production, circulation, transportation, storage to use safety, there can be no mistakes. The benign development of an industry comes from the application of new technology, the rational demand of the market, the demand for safety, and the promotion of the national policy supervision standard. After years of development and exploration in China, medical logistics has formed a systematic law of industry development, showing a trend of high concentration and specialization. As far as medical cold chain logistics is concerned, it is still a preliminary level of development. Although there have been theoretical concepts and trade norms, there is still room for development in the execution of specific standards, the application of new technologies, and the monitoring and management system. With the continuous development of the pharmaceutical market in China, the demand for cold chain logistics is increasing day by day. In recent years, serious drug damage events have occurred one after another, and the hidden dangers that seriously affect the quality and safety of drugs exist in the cold chain logistics system of medicine. The new version of GSP was implemented as a result. The newly revised GSP not only fully absorbs the theoretical achievements of modern quality management, but also creatively introduces the concept of supply chain management, and puts forward the basic requirements of establishing a quality system and making it run effectively in pharmaceutical enterprises. In the structure, the components of the quality system are closely combined with the drug management process, and the whole process management of the drug circulation quality is carried out. At the same time, relevant departments of the state continue to ask governments at all levels to step up supervision and supervision, and urge drug-selling enterprises to actively assume the assurance of drug quality in addition to general social responsibilities such as national taxation, employee welfare, integrity management, and so on. Regulate safe use, promote the healthy development of the industry and other special social responsibilities. Under this background, this paper studies the risk management of drug cold chain logistics process of the new version of GSP, in order to ensure the quality and safety of drugs. This paper first expounds the significance of implementing GSP, the development of GSP at home and abroad, the characteristics of drug cold chain logistics and the consequences of cold chain breaking, and analyzes the present situation and development countermeasures of drug cold chain logistics in China at present. Then, taking the high-risk biological products in refrigerated drugs as an example, the risk assessment and quality control are carried out by means of HAC and FMEA methods, and the risk management model of cold chain logistics process is constructed. Then it sums up the hardware conditions, software requirements and personnel qualification of the new GSP refrigerated drug management, analyzes the main problems of the cold chain of the new version of GSP certification in pharmaceutical wholesale enterprises of our province, and selects the typical cases to discuss. The countermeasures of drug cold chain quality risk management are summarized. Finally, after the implementation of the new version of GSP, the future development direction of drug cold chain logistics enterprises in China is discussed. This article also starts the quality risk management process, applies the quality risk management tool, adopts the questionnaire survey method, to the new edition GSP regulation refrigerated medicine logistics procurement, the receipt, the acceptance, the storage, the stock, the storage, the warehouse, In order to reduce the potential risk to an acceptable range, the possible risks of transportation and other core links are systematically analyzed, the risk levels are determined after the risk points are identified, and targeted preventive and control measures are taken to reduce the potential risks to an acceptable range. The results of the study are practical, scientific, reasonable and credible, which can provide reference for the implementation of the new version of GSP and the healthy and orderly development of cold chain logistics industry in China in the future.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
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