浅探5S在药品GMP缺陷整改中的应用

发布时间：2018-06-28 09:23

本文选题：药品生产质量管理规范 + 5S　；参考：《华东理工大学》2017年硕士论文

【摘要】：《药品生产质量管理规范》强制施行至今已有十四年,其管理理论已日趋完善,但就各企业实际执行情况来看,并不尽如人意。企业生产现场在药品GMP检查中查见的问题分布于人、机、料、法、环各要素。部分诸如物料标签不全、生产记录无法追溯、现场操作规程缺漏等缺陷,不仅有着较高的发生率,更有着较高的重复性,反映出企业生产现场GMP管理的薄弱性,给药品质量带来风险。GMP的执行现状固然有其施行时间短、行业发展迅猛等外因,更有企业现场管理方法缺失、专业人才缺乏、成本压力大等内因。因此,如何建立一套有效的缺陷整改方法,以理顺生产现场管理流程、降低GMP缺陷的发生率,成为摆在众多企业面前的重要课题。本文从日常监管中所发现的GMP现场缺陷整改入手,以人、机、料、法、环五大要素为研究对象,通过研究、分析2013-2014年度监管检查中查见的现场缺陷,明确了当前药品生产企业GMP现场管理的现状,查明了其存在的主要缺陷,探寻到缺陷产生的主要原因。其后,通过在GMP缺陷整改的PDCA循环中引入5S管理"忠于现场"的核心理念及步骤,形成了一套较为成熟的缺陷改进模式,为企业的缺陷整改建立了规范的流程。同时通过缺陷整改的实践活动,既培养了企业"现场管理"的思维方式、提升了其管理能力,又规范了其生产行为,基本实现了药品生产企业现场缺陷的有效纠正及长期预防,降低了 GMP缺陷的发生率。
[Abstract]:It has been 14 years since the compulsory implementation of "quality Management Standard of Pharmaceutical production", and its management theory has been perfected day by day, but in terms of the actual implementation of the enterprises, it is not satisfactory. The problems found in GMP inspection are distributed in human, machine, material, law and environment. Some defects, such as incomplete labelling of materials, untraceable production records, absence of on-site operating procedures, etc., not only have a higher incidence rate, but also have a higher repeatability, reflecting the weakness of GMP management in the production site of an enterprise. There are many external factors, such as short time, rapid development of industry, lack of on-site management methods, lack of professional personnel, high cost pressure and so on. Therefore, how to establish a set of effective defect rectification methods to rationalize the production site management process and reduce the incidence of GMP defects has become an important issue in front of many enterprises. This paper starts with the improvement of GMP site defects found in daily supervision, taking the five elements of human, machine, material, law and environment as the research object, through the research, analyzes the spot defects found in the supervision inspection in 2013-2014. This paper clarifies the current situation of GMP field management in pharmaceutical manufacturing enterprises, finds out its main defects, and explores the main reasons for the defects. Then, by introducing the core idea and steps of 5S management "loyalty to the site" in the PDCA cycle of GMP defect rectification, a more mature defect improvement mode is formed, and a standardized process is established for the defect rectification and reform of enterprises. The incidence of GMP defects was reduced.
【学位授予单位】：华东理工大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F275

【参考文献】