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(xué)》2017年碩士論文

【摘要】：《藥品生產(chǎn)質(zhì)量管理規(guī)范》強(qiáng)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(shí)際執(zhí)行情況來(lái)看,并不盡如人意。企業(yè)生產(chǎn)現(xiàn)場(chǎng)在藥品GMP檢查中查見的問(wèn)題分布于人、機(jī)、料、法、環(huán)各要素。部分諸如物料標(biāo)簽不全、生產(chǎn)記錄無(wú)法追溯、現(xiàn)場(chǎng)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(fù)性,反映出企業(yè)生產(chǎn)現(xiàn)場(chǎng)GMP管理的薄弱性,給藥品質(zhì)量帶來(lái)風(fēng)險(xiǎn)。GMP的執(zhí)行現(xiàn)狀固然有其施行時(shí)間短、行業(yè)發(fā)展迅猛等外因,更有企業(yè)現(xiàn)場(chǎng)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(chǎng)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(chǎng)缺陷整改入手,以人、機(jī)、料、法、環(huán)五大要素為研究對(duì)象,通過(guò)研究、分析2013-2014年度監(jiān)管檢查中查見的現(xiàn)場(chǎng)缺陷,明確了當(dāng)前藥品生產(chǎn)企業(yè)GMP現(xiàn)場(chǎng)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(guò)在GMP缺陷整改的PDCA循環(huán)中引入5S管理"忠于現(xiàn)場(chǎng)"的核心理念及步驟,形成了一套較為成熟的缺陷改進(jìn)模式,為企業(yè)的缺陷整改建立了規(guī)范的流程。同時(shí)通過(guò)缺陷整改的實(shí)踐活動(dòng),既培養(yǎng)了企業(yè)"現(xiàn)場(chǎng)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(shí)現(xiàn)了藥品生產(chǎn)企業(yè)現(xiàn)場(chǎng)缺陷的有效糾正及長(zhǎng)期預(yù)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(xué)位授予單位】：華東理工大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：F275

【參考文獻(xiàn)】

相關(guān)期刊論文 前9條

1 彭姣嬌;向雷;曹鴿;彭文利;;IE在SMT車間現(xiàn)場(chǎng)管理中的應(yīng)用研究[J];科技視界;2015年23期

2 丁榮華;;制藥企業(yè)的“5S”管理[J];上海醫(yī)藥;2014年09期

3 張義卓;丁海燕;羅昆;;新版藥品GMP實(shí)施過(guò)程中發(fā)現(xiàn)的問(wèn)題及監(jiān)管對(duì)策[J];大家健康(學(xué)術(shù)版);2014年04期

4 李勝勇;;中小制造型企業(yè)“5S”生產(chǎn)現(xiàn)場(chǎng)管理問(wèn)題與實(shí)施對(duì)策[J];商業(yè)經(jīng)濟(jì);2013年20期

5 余麗麗;常峰;;新版GMP對(duì)藥品成本影響及對(duì)策分析[J];現(xiàn)代商貿(mào)工業(yè);2013年18期

6 李保東;池潔;;精益5S現(xiàn)場(chǎng)管理方法的理論研究[J];價(jià)值工程;2013年11期

7 梁展豪;俞國(guó)方;;中小制造企業(yè)生產(chǎn)現(xiàn)場(chǎng)能效提升——“5S”與“PDCA”整合應(yīng)用[J];經(jīng)營(yíng)與管理;2013年01期

8 楊宏強(qiáng);;5S管理的概念、特點(diǎn)和實(shí)施[J];科技與管理;2011年03期

9 梁毅;;新版GMP的主要變化與對(duì)制藥企業(yè)的影響[J];機(jī)電信息;2011年11期

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