本文選題：藥品生產(chǎn)質(zhì)量管理規(guī)范 + 5S��； 參考：《華東理工大學》2017年碩士論文

【摘要】：《藥品生產(chǎn)質(zhì)量管理規(guī)范》強制施行至今已有十四年,其管理理論已日趨完善,但就各企業(yè)實際執(zhí)行情況來看,并不盡如人意。企業(yè)生產(chǎn)現(xiàn)場在藥品GMP檢查中查見的問題分布于人、機、料、法、環(huán)各要素。部分諸如物料標簽不全、生產(chǎn)記錄無法追溯、現(xiàn)場操作規(guī)程缺漏等缺陷,不僅有著較高的發(fā)生率,更有著較高的重復性,反映出企業(yè)生產(chǎn)現(xiàn)場GMP管理的薄弱性,給藥品質(zhì)量帶來風險。GMP的執(zhí)行現(xiàn)狀固然有其施行時間短、行業(yè)發(fā)展迅猛等外因,更有企業(yè)現(xiàn)場管理方法缺失、專業(yè)人才缺乏、成本壓力大等內(nèi)因。因此,如何建立一套有效的缺陷整改方法,以理順生產(chǎn)現(xiàn)場管理流程、降低GMP缺陷的發(fā)生率,成為擺在眾多企業(yè)面前的重要課題。本文從日常監(jiān)管中所發(fā)現(xiàn)的GMP現(xiàn)場缺陷整改入手,以人、機、料、法、環(huán)五大要素為研究對象,通過研究、分析2013-2014年度監(jiān)管檢查中查見的現(xiàn)場缺陷,明確了當前藥品生產(chǎn)企業(yè)GMP現(xiàn)場管理的現(xiàn)狀,查明了其存在的主要缺陷,探尋到缺陷產(chǎn)生的主要原因。其后,通過在GMP缺陷整改的PDCA循環(huán)中引入5S管理"忠于現(xiàn)場"的核心理念及步驟,形成了一套較為成熟的缺陷改進模式,為企業(yè)的缺陷整改建立了規(guī)范的流程。同時通過缺陷整改的實踐活動,既培養(yǎng)了企業(yè)"現(xiàn)場管理"的思維方式、提升了其管理能力,又規(guī)范了其生產(chǎn)行為,基本實現(xiàn)了藥品生產(chǎn)企業(yè)現(xiàn)場缺陷的有效糾正及長期預防,降低了 GMP缺陷的發(fā)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.
【學位授予單位】：華東理工大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：F275

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