【摘要】：隨著GMP在原料藥生產(chǎn)企業(yè)中不斷推廣與實(shí)施,構(gòu)建一個(gè)規(guī)范的質(zhì)量體系顯得尤為重要。尤其是新版GMP(2010版)實(shí)施以后,藥品生產(chǎn)企業(yè)所面臨的生產(chǎn)壓力日漸增大,實(shí)施GMP管理的愿望也變得更加迫切。本文以江蘇南通某藥品生產(chǎn)企業(yè)為實(shí)例樣本,依據(jù)各規(guī)范要點(diǎn),分析該企業(yè)在構(gòu)建GMP質(zhì)量體系中所存在的問題和質(zhì)量風(fēng)險(xiǎn),提出針對(duì)性的整改措施,有利于其它公司進(jìn)行對(duì)比和借鑒。本文對(duì)建立質(zhì)量體系所需要的關(guān)鍵要點(diǎn)進(jìn)行了闡述,參考新版GMP及國(guó)外的一些前沿理念,重點(diǎn)研究分析了機(jī)構(gòu)人員、廠房、空調(diào)系統(tǒng)、水系統(tǒng)、設(shè)備設(shè)施、物料、質(zhì)量保證、文件系統(tǒng)等各個(gè)環(huán)節(jié)。對(duì)人員機(jī)構(gòu)方面,闡述了生產(chǎn)企業(yè)組織機(jī)構(gòu)的構(gòu)建、部門設(shè)置、人員配置、培訓(xùn)等方面的細(xì)節(jié)管理。尤其強(qiáng)調(diào)了培訓(xùn),這是GMP關(guān)注的重點(diǎn),絕大部分生產(chǎn)管理問題都與培訓(xùn)有關(guān)系,因此需要做好培訓(xùn)的記錄管理。對(duì)空調(diào)系統(tǒng)方面,講述了空調(diào)的濾材管理,送風(fēng)流程等。水系統(tǒng)講述了飲用水、純化水、注射用水三類水質(zhì)的制備工藝,日常管理細(xì)節(jié)等。設(shè)備設(shè)施方面重點(diǎn)涵蓋了生產(chǎn)企業(yè)的設(shè)備維護(hù)與管理。物料方面分析了原料進(jìn)廠到產(chǎn)品出廠的整個(gè)流轉(zhuǎn)過(guò)程要求。質(zhì)量保證方面涵蓋了QA與QC管理,在文件系統(tǒng)方面進(jìn)行了詳細(xì)的文件框架結(jié)構(gòu)描述。通過(guò)對(duì)該生產(chǎn)企業(yè)質(zhì)量體系的構(gòu)建研究,搭建了一個(gè)質(zhì)量體系的基本框架,尤其是軟件系統(tǒng)方面,更是以實(shí)例的方式進(jìn)行了說(shuō)明,將整個(gè)文件目錄以附件的形式進(jìn)行了描述。便于新建原料藥(非無(wú)菌)企業(yè)參考,對(duì)已經(jīng)建立質(zhì)量體系的企業(yè)也有借鑒參考意義。藥品生產(chǎn)企業(yè)在推行GMP管理時(shí),可根據(jù)此質(zhì)量體系框架進(jìn)行實(shí)施,已經(jīng)建立起GMP管理體系的企業(yè),也可進(jìn)行對(duì)比參考,最終完善整個(gè)GMP質(zhì)量管理體系。文中對(duì)GMP的概念與發(fā)展進(jìn)行了闡述,形成一個(gè)明確的直觀印象,對(duì)構(gòu)建GMP質(zhì)量體系的每個(gè)環(huán)節(jié)要點(diǎn)進(jìn)行分析,對(duì)該公司的實(shí)際情況依據(jù)分析的要點(diǎn)找出不符合項(xiàng),然后針對(duì)性的提出整改措施,并根據(jù)措施進(jìn)行整改。這些不符合項(xiàng),都是官方或客戶進(jìn)行質(zhì)量審計(jì)時(shí)關(guān)注的重點(diǎn)。通過(guò)這些問題的整改,便于企業(yè)提高整體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.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R95

【參考文獻(xiàn)】

相關(guān)期刊論文 前2條

1 吳雙燕;;中小企業(yè)人力資源管理對(duì)策研究[J];中外企業(yè)家;2011年09期

2 彭紅英;淺議GMP認(rèn)證質(zhì)量管理[J];中藥材;1999年10期

，

本文編號(hào)：2397745