本文選題：GMP + 質(zhì)量管理程序問題分析和改善��； 參考：《河北經(jīng)貿(mào)大學(xué)》2017年碩士論文

【摘要】：本文以SJZ藥業(yè)公司為研究對象,該公司從2010年至今多次通過歐盟認證和美國FDA認證,整個質(zhì)量管理體系符合歐盟和美國CGMP的要求,但是我們在質(zhì)量管理的幾個關(guān)鍵程序的日常運行過程中仍然發(fā)現(xiàn)不少的問題,比如變更管理,偏差管理,人員培訓(xùn)管理,還有供應(yīng)商管理等方面的問題。本文主要采用風(fēng)險管理的工具對每一個問題進行詳細具體地分析,從而找出影響該管理程序的根源問題。變更管理不夠完善,管理效果不太理想,變更控制缺乏有效的指導(dǎo);由于人員,設(shè)備,物料等原因?qū)е碌钠?由于人員的培訓(xùn)管理不到位導(dǎo)致各種問題;還有供應(yīng)商的管理過程中出現(xiàn)的問題。通過對這些管理程序進行風(fēng)險分析,找到根本影響因素,并且針對根本影響因素制定有效的糾正預(yù)防措施,并付諸實施,總結(jié)實施效果和經(jīng)驗,得出本論文的研究結(jié)論。第一、通過改善變更管理程序,對于所有變更,在現(xiàn)有歐美藥品法規(guī)和指南的指導(dǎo)下,制定有效可行的行動方案;各部門協(xié)調(diào)配合執(zhí)行,各部門共同參與討論和決策。第二、通過改善偏差管理程序,有效降低了偏差發(fā)生頻率,減少物料損失和延長工期的事件發(fā)生率。第三、通過建立嚴格的人員培訓(xùn)制度并嚴格執(zhí)行,同時建立嚴格的考核制度,提高大家的責(zé)任感,降低了因人員誤差導(dǎo)致偏查的發(fā)生率。第四、通過改善供應(yīng)商管理程序,加強了對供應(yīng)商的管理,有效降低原輔料質(zhì)量問題的發(fā)生率,充分保證原輔料的質(zhì)量。通過對這幾項管理程序改善,提高了質(zhì)量管理水平和管理能力,從而更加有效的管理變更、減少偏差的發(fā)生、提高人員培訓(xùn)的效果、提高對供應(yīng)商的管理水平,充分保障原輔料的質(zhì)量,從根源上杜絕質(zhì)量安全隱患;使該公司的質(zhì)量管理水平上升一個全新的高度,充分保證產(chǎn)品的質(zhì)量,維護好公司良好的品牌價值形象。
[Abstract]:This paper takes SJZ Pharmaceutical Company as the research object, the company has passed the European Union certification and the United States FDA certification many times since 2010, the entire quality management system conforms to the European Union and the United States CGMP request, the entire quality management system conforms to the European Union and the American CGMP request, However, we still find many problems in the daily operation of several key procedures of quality management, such as change management, deviation management, personnel training management, and supplier management. In this paper, we use risk management tools to analyze each problem in detail, and find out the root problem that affects the management program. The change management is not perfect, the management effect is not very ideal, the change control lacks the effective guidance; because of the personnel, the equipment, the material causes the deviation, because the personnel training management is not in place causes each kind of question; There are also problems in the management of suppliers. Through the risk analysis of these management procedures, find out the fundamental factors, and make effective corrective and preventive measures against the fundamental factors, and put them into practice, summarize the implementation effect and experience, and draw the conclusion of this paper. First, through the improvement of change management procedures, for all changes, under the guidance of existing European and American drug regulations and guidelines, to formulate effective and feasible action plan; all departments coordinate the implementation, and all departments participate in discussions and decisions. Secondly, by improving the deviation management program, the frequency of deviation is reduced effectively, the loss of materials and the occurrence rate of extended period are reduced. Thirdly, through the establishment of strict personnel training system and strict implementation, at the same time, the establishment of strict assessment system, improve the sense of responsibility of everyone, and reduce the incidence of personnel errors caused by biased investigation. Fourth, by improving the supplier management procedures, the management of suppliers has been strengthened, and the occurrence rate of quality problems of raw and auxiliary materials has been effectively reduced, and the quality of raw and auxiliary materials has been fully guaranteed. Through the improvement of these management procedures, the quality management level and management ability are improved, thus more effective management changes, reduce the occurrence of deviation, improve the effect of personnel training, improve the management level of suppliers, The quality of raw and auxiliary materials is fully guaranteed, the hidden dangers of quality and safety are eliminated from the root, the quality management level of the company is raised to a new height, the quality of products is fully guaranteed, and the good brand value image of the company is maintained.
【學(xué)位授予單位】：河北經(jīng)貿(mào)大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：F426.72;F273.2
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本文編號：1885141