藥品生產(chǎn)監(jiān)管信息系統(tǒng)分析與設計
發(fā)布時間：2018-10-23 11:42
【摘要】：藥品是一種特殊的商品。對藥品實施政府監(jiān)管,既關(guān)系到廣大人民群眾的用藥安全,關(guān)系到公眾生命健康權(quán)益的維護和保障,更關(guān)系到政府的形象與權(quán)威。藥品監(jiān)督管理工作是我國人民健康事業(yè)的重要組成部分。藥品GMP是藥品生產(chǎn)管理與質(zhì)量監(jiān)控的基本要求,適用于藥品生產(chǎn)的全過程。實施GMP的目的是為了確保能夠持續(xù)、穩(wěn)定的生產(chǎn)出用于預定用途,并且符合注冊標準或規(guī)定質(zhì)量標準的藥品。既然有這樣的生產(chǎn)規(guī)范要求,為什么近些年來還會頻頻發(fā)生藥品安全質(zhì)量事故呢?究其原因,固然有某些制藥企業(yè)利欲熏心、以次充好、自身管理水平低、GMP意識淡薄等因素,但我們藥品監(jiān)管部門的工作不到位也使得一些藥品安全隱患沒有被及時發(fā)現(xiàn)和制止。在我國,藥品生產(chǎn)企業(yè)的數(shù)量眾多,且分布比較廣泛,藥品種類繁多,生產(chǎn)工藝比較復雜,這也給藥品監(jiān)管工作帶來很大的難度。此外,監(jiān)管人員人數(shù)不足、專業(yè)能力參差不齊等自身原因,也使得日常的藥品監(jiān)督檢查工作的效果難以保障。那么,要如何解決這種藥品生產(chǎn)監(jiān)管上的矛盾,及時發(fā)現(xiàn)問題,將藥品生產(chǎn)過程中存在的安全隱患扼殺在萌芽中呢? 本文首先對我國的藥品生產(chǎn)及藥品監(jiān)管工作中存在的問題進行了分析,并通過與生產(chǎn)企業(yè)和藥監(jiān)部門工作人員的溝通,了解了企業(yè)和監(jiān)管部門的主要業(yè)務情況,利用信息手段在完善我國的藥品生產(chǎn)監(jiān)管工作方面進行了一點嘗試：基于藥品生產(chǎn)的流程及GMP規(guī)范,結(jié)合質(zhì)量管理理論,設計一套藥品生產(chǎn)監(jiān)管信息系統(tǒng)。該系統(tǒng)由備案管理、統(tǒng)計分析、實時預警報告、質(zhì)量信息追溯、整改管理等模塊組成,采集藥品生產(chǎn)中與質(zhì)量密切相關(guān)的“人、機、料、法、環(huán)、測”(5mle)關(guān)鍵信息數(shù)據(jù),再針對這些數(shù)據(jù)設計了統(tǒng)計、預警、追溯等各種日常質(zhì)量管理功能。既可以滿足藥監(jiān)部門日常監(jiān)管工作的需要,同時也可以協(xié)助企業(yè)及時了解企業(yè)生產(chǎn)動態(tài),加強企業(yè)生產(chǎn)質(zhì)量管理,提高產(chǎn)品質(zhì)量。 本文的創(chuàng)新點主要有以下幾方面：一、實現(xiàn)了一種新的藥品生產(chǎn)監(jiān)管手段。比較原先的現(xiàn)場檢查、產(chǎn)品抽查等手段,利用信息系統(tǒng)既節(jié)省了人力,發(fā)現(xiàn)問題也更及時,提高了監(jiān)管工作的主動性,提升了工作效率；二、梳理了藥品生產(chǎn)及藥品生產(chǎn)監(jiān)管工作的主要流程,通過5mle分析法整理出可能影響藥品生產(chǎn)質(zhì)量的諸多因素,并將這些因素作為日后監(jiān)管工作的重點；三、采取“一戶一檔”的管理模式。通過關(guān)聯(lián)關(guān)系,將產(chǎn)品批次和物料批次進行關(guān)聯(lián),實現(xiàn)了從物料采購到產(chǎn)品出庫全過程的監(jiān)控,便于問題產(chǎn)品的追溯工作。
[Abstract]:Medicine is a special commodity. The implementation of government supervision on drugs is not only related to the safety of drug use by the broad masses of the people, but also to the protection and protection of the public's rights and interests in life and health, as well as to the image and authority of the government. Drug supervision and administration is an important part of Chinese people's health. Drug GMP is the basic requirement of drug production management and quality control, which is suitable for the whole process of drug production. The purpose of implementing GMP is to ensure the sustainable and stable production of drugs for intended use and compliance with registration standards or prescribed quality standards. Since there is such a production standard requirements, why in recent years there will be frequent accidents in drug safety and quality? The reason is that, although there are some pharmaceutical enterprises, poor management, low level of management, weak awareness of GMP and other factors, but the work of our drug regulatory department is not in place, some hidden dangers of drug safety have not been detected and stopped in time. In our country, the number of pharmaceutical production enterprises is numerous, and the distribution is relatively wide, and the kinds of drugs are various, and the production process is quite complex, which also brings great difficulties to the supervision of drugs. In addition, the insufficient number of supervisors and uneven professional ability make it difficult to guarantee the effect of daily drug supervision and inspection. So, how to solve the contradiction in the supervision of drug production, find out the problem in time, and nip the hidden danger of safety in the process of drug production in the bud? This paper first analyzes the problems existing in the drug production and supervision work in China, and through the communication with the production enterprise and the staff of the drug supervision department, we understand the main business situation of the enterprise and the supervision department. This paper attempts to improve the supervision of drug production by means of information: based on the process of drug production and GMP standard, combined with the theory of quality management, a set of drug production supervision information system is designed. The system is composed of record management, statistical analysis, real-time early warning report, quality information traceability, rectification management and so on. It collects the key information data of "people, machine, material, law, ring, measurement" (5mle), which are closely related to quality in drug production. For these data design statistics, early warning, traceability and other daily quality management functions. It can not only meet the needs of the daily supervision work of drug supervision department, but also help enterprises to understand the production trends in time, strengthen the production quality management and improve the product quality. The innovations of this paper are as follows: first, a new method of drug production supervision has been realized. Compared with the original methods such as on-site inspection and product spot check, the use of information systems not only saves manpower, but also finds problems more timely, improves the initiative of supervision work and improves work efficiency; second, Combing the main process of drug production and drug production supervision, sorting out many factors that may affect the quality of drug production by 5mle analysis, and taking these factors as the focus of future supervision work; third, Adopt the management mode of "one household one file". By associating product batches with material batches, the whole process from material purchasing to product exiting is monitored, which is convenient for the tracing work of problematic products.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2013
【分類號】：F426.72;F203
本文編號：2289130
[Abstract]:Medicine is a special commodity. The implementation of government supervision on drugs is not only related to the safety of drug use by the broad masses of the people, but also to the protection and protection of the public's rights and interests in life and health, as well as to the image and authority of the government. Drug supervision and administration is an important part of Chinese people's health. Drug GMP is the basic requirement of drug production management and quality control, which is suitable for the whole process of drug production. The purpose of implementing GMP is to ensure the sustainable and stable production of drugs for intended use and compliance with registration standards or prescribed quality standards. Since there is such a production standard requirements, why in recent years there will be frequent accidents in drug safety and quality? The reason is that, although there are some pharmaceutical enterprises, poor management, low level of management, weak awareness of GMP and other factors, but the work of our drug regulatory department is not in place, some hidden dangers of drug safety have not been detected and stopped in time. In our country, the number of pharmaceutical production enterprises is numerous, and the distribution is relatively wide, and the kinds of drugs are various, and the production process is quite complex, which also brings great difficulties to the supervision of drugs. In addition, the insufficient number of supervisors and uneven professional ability make it difficult to guarantee the effect of daily drug supervision and inspection. So, how to solve the contradiction in the supervision of drug production, find out the problem in time, and nip the hidden danger of safety in the process of drug production in the bud? This paper first analyzes the problems existing in the drug production and supervision work in China, and through the communication with the production enterprise and the staff of the drug supervision department, we understand the main business situation of the enterprise and the supervision department. This paper attempts to improve the supervision of drug production by means of information: based on the process of drug production and GMP standard, combined with the theory of quality management, a set of drug production supervision information system is designed. The system is composed of record management, statistical analysis, real-time early warning report, quality information traceability, rectification management and so on. It collects the key information data of "people, machine, material, law, ring, measurement" (5mle), which are closely related to quality in drug production. For these data design statistics, early warning, traceability and other daily quality management functions. It can not only meet the needs of the daily supervision work of drug supervision department, but also help enterprises to understand the production trends in time, strengthen the production quality management and improve the product quality. The innovations of this paper are as follows: first, a new method of drug production supervision has been realized. Compared with the original methods such as on-site inspection and product spot check, the use of information systems not only saves manpower, but also finds problems more timely, improves the initiative of supervision work and improves work efficiency; second, Combing the main process of drug production and drug production supervision, sorting out many factors that may affect the quality of drug production by 5mle analysis, and taking these factors as the focus of future supervision work; third, Adopt the management mode of "one household one file". By associating product batches with material batches, the whole process from material purchasing to product exiting is monitored, which is convenient for the tracing work of problematic products.
【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2013
【分類號】：F426.72;F203
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