药品生产监管信息系统分析与设计
发布时间：2018-10-23 11:42
【摘要】：药品是一种特殊的商品。对药品实施政府监管,既关系到广大人民群众的用药安全,关系到公众生命健康权益的维护和保障,更关系到政府的形象与权威。药品监督管理工作是我国人民健康事业的重要组成部分。药品GMP是药品生产管理与质量监控的基本要求,适用于药品生产的全过程。实施GMP的目的是为了确保能够持续、稳定的生产出用于预定用途,并且符合注册标准或规定质量标准的药品。既然有这样的生产规范要求,为什么近些年来还会频频发生药品安全质量事故呢?究其原因,固然有某些制药企业利欲熏心、以次充好、自身管理水平低、GMP意识淡薄等因素,但我们药品监管部门的工作不到位也使得一些药品安全隐患没有被及时发现和制止。在我国,药品生产企业的数量众多,且分布比较广泛,药品种类繁多,生产工艺比较复杂,这也给药品监管工作带来很大的难度。此外,监管人员人数不足、专业能力参差不齐等自身原因,也使得日常的药品监督检查工作的效果难以保障。那么,要如何解决这种药品生产监管上的矛盾,及时发现问题,将药品生产过程中存在的安全隐患扼杀在萌芽中呢? 本文首先对我国的药品生产及药品监管工作中存在的问题进行了分析,并通过与生产企业和药监部门工作人员的沟通,了解了企业和监管部门的主要业务情况,利用信息手段在完善我国的药品生产监管工作方面进行了一点尝试：基于药品生产的流程及GMP规范,结合质量管理理论,设计一套药品生产监管信息系统。该系统由备案管理、统计分析、实时预警报告、质量信息追溯、整改管理等模块组成,采集药品生产中与质量密切相关的“人、机、料、法、环、测”(5mle)关键信息数据,再针对这些数据设计了统计、预警、追溯等各种日常质量管理功能。既可以满足药监部门日常监管工作的需要,同时也可以协助企业及时了解企业生产动态,加强企业生产质量管理,提高产品质量。 本文的创新点主要有以下几方面：一、实现了一种新的药品生产监管手段。比较原先的现场检查、产品抽查等手段,利用信息系统既节省了人力,发现问题也更及时,提高了监管工作的主动性,提升了工作效率；二、梳理了药品生产及药品生产监管工作的主要流程,通过5mle分析法整理出可能影响药品生产质量的诸多因素,并将这些因素作为日后监管工作的重点；三、采取“一户一档”的管理模式。通过关联关系,将产品批次和物料批次进行关联,实现了从物料采购到产品出库全过程的监控,便于问题产品的追溯工作。
[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.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F426.72;F203
本文编号：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.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F426.72;F203
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