新版GSP的藥品冷鏈物流質(zhì)量風險管理研究
發(fā)布時間：2019-04-07 20:31
【摘要】：眾所周知,藥品是用于維護健康,延長生命的。近年來藥品安全一直是受到廣泛關(guān)注的社會熱點問題之一,藥品質(zhì)量直接關(guān)系到廣大百姓的身體健康和生命安全,關(guān)系到經(jīng)濟健康發(fā)展和社會和諧穩(wěn)定。醫(yī)藥行業(yè)雖然是一個傳統(tǒng)行業(yè),但卻是知識和技術(shù)密集型的產(chǎn)業(yè),從科研、生產(chǎn)、流通、運輸、儲存到使用安全,都不能出任何差錯。一個行業(yè)的良性發(fā)展,來自新技術(shù)的應(yīng)用,來自于市場的理性需求,安全訴求,來自國家政策監(jiān)管標準的提升。醫(yī)藥物流在我國經(jīng)過多年的發(fā)展與探索,已形成初具系統(tǒng)的行業(yè)發(fā)展規(guī)律,表現(xiàn)出高度集中化、專業(yè)化趨勢。就醫(yī)藥冷鏈物流來說,目前還屬于初步發(fā)展水平,雖已有了理論概念及行業(yè)規(guī)范,但在具體標準的執(zhí)行、新技術(shù)的應(yīng)用、監(jiān)控管理的體系上還需不斷完善,有較大的發(fā)展空間。 隨著我國醫(yī)藥市場的不斷發(fā)展,對冷鏈物流的需求也日益增大,近年來接連發(fā)生的重大藥害事件,集中暴露出醫(yī)藥冷鏈物流體系存在嚴重影響藥品質(zhì)量安全的隱患,新版GSP因此而實施。新修訂的GSP不僅充分吸收了現(xiàn)代質(zhì)量管理學(xué)的理論成果,還創(chuàng)新性地引入供應(yīng)鏈管理理念,對藥品經(jīng)營企業(yè)提出建立質(zhì)量體系并使之有效運行的基本要求,在結(jié)構(gòu)上將質(zhì)量體系組成要素與藥品經(jīng)營過程密切結(jié)合起來,實行藥品流通質(zhì)量全過程管理。同時,國家有關(guān)部門也不斷要求各級政府加大監(jiān)管力度,督促藥品經(jīng)營企業(yè)在承擔國家稅收、員工福利、誠信經(jīng)營等一般社會責任外,還應(yīng)積極承擔保證藥品質(zhì)量,規(guī)范安全使用,促進行業(yè)健康發(fā)展等特殊社會責任。本文正是在此背景下,對新版GSP的藥品冷鏈物流流程風險管理展開研究,以達到保證藥品質(zhì)量安全的目的。 本文首先闡述了實施GSP的意義、GSP在國內(nèi)外的發(fā)展、藥品冷鏈物流的特點及冷鏈斷裂的后果,分析了我國現(xiàn)階段藥品冷鏈物流的現(xiàn)狀及發(fā)展對策。接著以冷藏藥品中的高風險品種生物制品為例,采用HACCP法和FMEA法進行風險評估和質(zhì)量控制,構(gòu)建冷鏈物流過程的風險管理模型。然后歸納了新版GS P冷藏藥品經(jīng)營所需的硬件條件、軟件要求和人員資質(zhì),對我省藥品批發(fā)企業(yè)新版GSP認證的冷鏈主要問題進行分析,并選取典型案例加以討論,總結(jié)得出藥品冷鏈質(zhì)量風險管理的對策。最后對新版GSP全面推行后,未來我國藥品冷鏈物流企業(yè)的發(fā)展方向進行了探討。 本文還啟動質(zhì)量風險管理流程,應(yīng)用質(zhì)量風險管理工具,采用問卷調(diào)查的方法,對新版GSP規(guī)定的冷藏藥品物流采購、收貨、驗收、儲存、出庫、運輸?shù)雀骱诵沫h(huán)節(jié)的可能存在的風險進行系統(tǒng)分析,識別出風險點后確定風險等級,采取針對性預(yù)防控制措施,將潛在的風險降低至可接受的范圍內(nèi)。其研究的結(jié)果比較切合實際、科學(xué)、合理、可信,能夠給藥品經(jīng)營企業(yè)實施新版GSP及我國未來冷鏈物流行業(yè)的健康有序發(fā)展提供借鑒和參考。
[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.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R95
本文編號：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.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R95
【參考文獻】
相關(guān)期刊論文 前9條
1 葛立清;張靜超;吳艷云;;關(guān)于我國藥品冷鏈物流服務(wù)模式的研究[J];中國商界(上半月);2010年05期
2 易靜薇;張春穎;王棟;李娜;王福清;;我國冷藏藥品冷鏈物流的現(xiàn)狀及問題研究[J];物流科技;2009年08期
3 張維;;冷鏈物流在醫(yī)藥方面的應(yīng)用[J];商場現(xiàn)代化;2011年15期
4 王亞莉;季愷綺;;藥品流通環(huán)節(jié)冷鏈物流管理的現(xiàn)狀分析及對策研究[J];中國醫(yī)藥指南;2012年08期
5 師繪敏;;我國醫(yī)藥冷鏈物流發(fā)展中存在的問題及對策研究[J];中國醫(yī)藥指南;2012年19期
6 趙賢;;中美藥品冷鏈物流體系的比較研究[J];中國藥業(yè);2012年16期
7 李作聚;;美國物流業(yè)發(fā)展現(xiàn)狀分析[J];中國流通經(jīng)濟;2012年11期
8 蘇磊;;北京JHJS公司醫(yī)藥冷鏈物流企業(yè)的案例分析[J];信息與電腦;2011年04期
9 尹雅姝;徐峰;黃金鳳;;關(guān)于藥品冷鏈系統(tǒng)驗證的探討[J];中國藥房;2014年09期
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