某原料药生产企业质量体系的构建研究
发布时间：2019-01-01 15:25
【摘要】：随着GMP在原料药生产企业中不断推广与实施,构建一个规范的质量体系显得尤为重要。尤其是新版GMP(2010版)实施以后,药品生产企业所面临的生产压力日渐增大,实施GMP管理的愿望也变得更加迫切。本文以江苏南通某药品生产企业为实例样本,依据各规范要点,分析该企业在构建GMP质量体系中所存在的问题和质量风险,提出针对性的整改措施,有利于其它公司进行对比和借鉴。本文对建立质量体系所需要的关键要点进行了阐述,参考新版GMP及国外的一些前沿理念,重点研究分析了机构人员、厂房、空调系统、水系统、设备设施、物料、质量保证、文件系统等各个环节。对人员机构方面,阐述了生产企业组织机构的构建、部门设置、人员配置、培训等方面的细节管理。尤其强调了培训,这是GMP关注的重点,绝大部分生产管理问题都与培训有关系,因此需要做好培训的记录管理。对空调系统方面,讲述了空调的滤材管理,送风流程等。水系统讲述了饮用水、纯化水、注射用水三类水质的制备工艺,日常管理细节等。设备设施方面重点涵盖了生产企业的设备维护与管理。物料方面分析了原料进厂到产品出厂的整个流转过程要求。质量保证方面涵盖了QA与QC管理,在文件系统方面进行了详细的文件框架结构描述。通过对该生产企业质量体系的构建研究,搭建了一个质量体系的基本框架,尤其是软件系统方面,更是以实例的方式进行了说明,将整个文件目录以附件的形式进行了描述。便于新建原料药(非无菌)企业参考,对已经建立质量体系的企业也有借鉴参考意义。药品生产企业在推行GMP管理时,可根据此质量体系框架进行实施,已经建立起GMP管理体系的企业,也可进行对比参考,最终完善整个GMP质量管理体系。文中对GMP的概念与发展进行了阐述,形成一个明确的直观印象,对构建GMP质量体系的每个环节要点进行分析,对该公司的实际情况依据分析的要点找出不符合项,然后针对性的提出整改措施,并根据措施进行整改。这些不符合项,都是官方或客户进行质量审计时关注的重点。通过这些问题的整改,便于企业提高整体GMP管理水平。
[Abstract]:With the popularization and implementation of GMP in raw drug manufacturing enterprises, it is very important to construct a standard quality system. Especially after the implementation of the new version of GMP (2010 edition), the production pressure faced by pharmaceutical manufacturing enterprises is increasing day by day, and the desire to implement GMP management becomes more urgent. Taking a pharmaceutical manufacturing enterprise in Nantong, Jiangsu Province as an example, according to the key points of each specification, this paper analyzes the problems and quality risks existing in the construction of GMP quality system in the enterprise, and puts forward targeted rectification measures. Is advantageous to other companies to carry on the contrast and the reference. This paper expounds the key points needed to establish the quality system, referring to the new version of GMP and some advanced concepts of foreign countries, focusing on the research and analysis of the personnel, plant, air conditioning system, water system, equipment and facilities, materials, quality assurance, etc. File system and other links. In terms of personnel organization, the detailed management of organization, department setting, staffing, training and so on are discussed. In particular, training is emphasized, which is the focus of GMP. Most of the production management problems are related to training, so it is necessary to do a good job of training record management. For the air-conditioning system, the filter material management, air-supply flow and so on are described. The water system describes the preparation process of drinking water, purified water and injection water, daily management details and so on. Equipment and facilities focus on covering the equipment maintenance and management of production enterprises. Material analysis of the raw materials from the factory to the whole process of product flow requirements. The quality assurance aspect covers QA and QC management, and gives a detailed description of the file framework structure in the file system. Through the research on the construction of the quality system of the manufacturing enterprise, a basic frame of the quality system is built, especially the software system, which is explained by an example, and the whole file catalogue is described in the form of attachment. It is convenient for the new material medicine (non-aseptic) enterprises to refer to, and also to the enterprises that have established the quality system. When implementing GMP management, pharmaceutical manufacturing enterprises can carry out it according to this quality system framework. Enterprises that have established GMP management system can also make a comparative reference to perfect the whole GMP quality management system. This paper expounds the concept and development of GMP, forms a clear and intuitionistic impression, analyzes the key points of constructing GMP quality system, and finds out the nonconforming items according to the analysis of the actual situation of the company. Then the pertinence proposes the rectification measure, and carries on the rectification according to the measure. These nonconformities are the focus of official or customer quality audits. Through the rectification of these problems, it is convenient for enterprises to improve the overall GMP management level.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R95
本文编号：2397745
[Abstract]:With the popularization and implementation of GMP in raw drug manufacturing enterprises, it is very important to construct a standard quality system. Especially after the implementation of the new version of GMP (2010 edition), the production pressure faced by pharmaceutical manufacturing enterprises is increasing day by day, and the desire to implement GMP management becomes more urgent. Taking a pharmaceutical manufacturing enterprise in Nantong, Jiangsu Province as an example, according to the key points of each specification, this paper analyzes the problems and quality risks existing in the construction of GMP quality system in the enterprise, and puts forward targeted rectification measures. Is advantageous to other companies to carry on the contrast and the reference. This paper expounds the key points needed to establish the quality system, referring to the new version of GMP and some advanced concepts of foreign countries, focusing on the research and analysis of the personnel, plant, air conditioning system, water system, equipment and facilities, materials, quality assurance, etc. File system and other links. In terms of personnel organization, the detailed management of organization, department setting, staffing, training and so on are discussed. In particular, training is emphasized, which is the focus of GMP. Most of the production management problems are related to training, so it is necessary to do a good job of training record management. For the air-conditioning system, the filter material management, air-supply flow and so on are described. The water system describes the preparation process of drinking water, purified water and injection water, daily management details and so on. Equipment and facilities focus on covering the equipment maintenance and management of production enterprises. Material analysis of the raw materials from the factory to the whole process of product flow requirements. The quality assurance aspect covers QA and QC management, and gives a detailed description of the file framework structure in the file system. Through the research on the construction of the quality system of the manufacturing enterprise, a basic frame of the quality system is built, especially the software system, which is explained by an example, and the whole file catalogue is described in the form of attachment. It is convenient for the new material medicine (non-aseptic) enterprises to refer to, and also to the enterprises that have established the quality system. When implementing GMP management, pharmaceutical manufacturing enterprises can carry out it according to this quality system framework. Enterprises that have established GMP management system can also make a comparative reference to perfect the whole GMP quality management system. This paper expounds the concept and development of GMP, forms a clear and intuitionistic impression, analyzes the key points of constructing GMP quality system, and finds out the nonconforming items according to the analysis of the actual situation of the company. Then the pertinence proposes the rectification measure, and carries on the rectification according to the measure. These nonconformities are the focus of official or customer quality audits. Through the rectification of these problems, it is convenient for enterprises to improve the overall GMP management level.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R95
【参考文献】
相关期刊论文 前2条
1 吴双燕;;中小企业人力资源管理对策研究[J];中外企业家;2011年09期
2 彭红英;浅议GMP认证质量管理[J];中药材;1999年10期
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