基于新版GMP要求的制药企业设备管理研究

发布时间：2018-04-09 09:39

本文选题：新版GMP　切入点：制药企业　出处：《河北科技大学》2014年硕士论文

【摘要】：设备是药品生产的重要资源之一,新版GMP对直接参与药品生产的相关制药设备与设施作了指导性的规定,但对设备的要求大部分都是指导性条款,如何使设备真正做到为GMP保驾护航,为企业经营提供有力保障,这是制药企业生产部门、设备管理部门以及公司领导层必须思考和需要解决的问题。制药企业设备管理是一个系统工程,应将设备一生管理、预防性维护管理纳入到公司日常管理,从设备选型、设计、采购、到货、安装、调试、验证、运行、实施以及后序维护、润滑、故障处理及后序设备改进,都应围绕GMP要求这一主线进行设备有效管理。首先对国内外设备管理理论研究发展现状、理论思想进行了汇总分析,提出了基于新版GMP要求、以人为本的,借助于信息化设备管理,实现设备前期、中期、后期设备一生管理思想。其次全面分析了设备一生管理的理念及新版GMP中设备管理要求,重点分析了设备设计、设备预防性维护保养、设备验证、设备故障分析系统,提出了制药技术要求下的设备管理系统性思路。对影响设备正常运行的关键节点,采用系统性的分析、探讨,采用PDCA管理理念提高设备管理水平,为制药企业产品质量提供有效保证。最后以石药集团中诺药业铝塑包装机为例,阐述了设备前期、中期、后期管理中各个环节的工作流程、工作方法,实例阐述了制药企业基于新版GMP要求的设备管理思想。
[Abstract]:Equipment is one of the important resources in drug production. The new version of GMP provides guiding regulations for related pharmaceutical equipment and facilities directly involved in drug production, but most of the requirements for equipment are guidance clauses.How to make the equipment really protect GMP and provide sufficient guarantee for the enterprise management is the problem that must be considered and solved by the production department, equipment management department and the company leadership of pharmaceutical enterprise.Equipment management in pharmaceutical enterprises is a system engineering, which should include equipment life management, preventive maintenance management into the company's daily management, from equipment selection, design, procurement, delivery, installation, commissioning, verification, operation,Implementation and post-sequence maintenance, lubrication, troubleshooting and post-sequence equipment improvement should be carried out around the main line of GMP requirements for effective equipment management.First of all, the research and development of equipment management theory at home and abroad are summarized and analyzed. Based on the new version of GMP, this paper puts forward a new version of GMP, which is people-oriented, with the aid of information equipment management, to realize the early and middle period of equipment management.The later period equipment life management thought.Secondly, the concept of equipment lifetime management and the requirements of equipment management in the new GMP are analyzed, and the design of equipment, preventive maintenance of equipment, equipment verification and equipment fault analysis system are analyzed.The systematic thinking of equipment management under the requirement of pharmaceutical technology is put forward.The key nodes affecting the normal operation of the equipment are analyzed and discussed systematically, and the management level of the equipment is improved by using the PDCA management concept, which provides an effective guarantee for the product quality of pharmaceutical enterprises.Finally, taking the aluminum and plastic packaging machine of Zhongnuo Pharmaceutical Industry of Shiyao Group as an example, the working flow and working methods of each link in the management of the equipment in the early, middle and later periods are expounded. The equipment management ideas of pharmaceutical enterprises based on the new version of GMP requirements are expounded by an example.
【学位授予单位】：河北科技大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：F273.4;F426.72

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