本文選題：制藥公司 + 生產(chǎn)質(zhì)量�。� 參考：《電子科技大學(xué)》2017年碩士論文

【摘要】：藥品安全與人類的生命健康息息相關(guān),藥品的作用是治病救人,如果藥品質(zhì)量不合格,就可能會(huì)反過來威脅使用者的身體健康,甚至是生命安全。所以,國(guó)家非常重視藥品生產(chǎn)的質(zhì)量管理問題。2010年,我國(guó)藥品食品管理局頒布了新一版的藥品生產(chǎn)質(zhì)量規(guī)范(以下簡(jiǎn)稱GMP),新版GMP對(duì)1998年的舊版GMP進(jìn)行了一些調(diào)整。為了保證藥品生產(chǎn)質(zhì)量標(biāo)準(zhǔn)與國(guó)際接軌,在此輪調(diào)整中,參考了一些美國(guó)和歐盟等國(guó)對(duì)藥品生產(chǎn)質(zhì)量的規(guī)范。因此,新版GMP對(duì)藥品生產(chǎn)質(zhì)量提出了更高的要求。藥品食品管理要國(guó)內(nèi)的制藥企業(yè)必須嚴(yán)格按照新版GMP的要求開展藥品生產(chǎn)管理工作,如果發(fā)現(xiàn)醫(yī)藥產(chǎn)品不符合新版GMP的要求,藥品生產(chǎn)企業(yè)將會(huì)受到處罰,影響惡劣的甚至?xí)灰笸I(yè)整頓,甚至于吊銷醫(yī)藥生產(chǎn)資格證。新版GMP推行以后,國(guó)內(nèi)醫(yī)藥生產(chǎn)企業(yè)叫苦不迭,認(rèn)為新版GMP要求過于嚴(yán)格,但是醫(yī)療無小事,對(duì)醫(yī)藥質(zhì)量高標(biāo)準(zhǔn)、嚴(yán)要求也是為了把好生產(chǎn)關(guān),從源頭上杜絕問題藥品流入市場(chǎng),這也是對(duì)廣大人民群眾負(fù)責(zé)。所以要求高并沒有錯(cuò),醫(yī)藥企業(yè)應(yīng)該強(qiáng)化自身,提高藥品生產(chǎn)管理水平,不斷朝著新版GMP的標(biāo)準(zhǔn)靠近,生產(chǎn)出質(zhì)量過硬的好藥。正是在這樣的背景下,制藥公司開始加強(qiáng)對(duì)藥品生產(chǎn)質(zhì)量的重視。M制藥公司由于被食品藥品管理局的一次抽查查出藥品質(zhì)量不符合GMP標(biāo)準(zhǔn)并接受了處罰之后,痛定思痛,對(duì)現(xiàn)有的藥品質(zhì)量管理現(xiàn)狀進(jìn)行了重新審視,發(fā)現(xiàn)在藥品生產(chǎn)質(zhì)量管理方面存在諸多問題,所以便提出建立藥品質(zhì)量監(jiān)管體系,以新版GMP作為藥品生產(chǎn)質(zhì)量的管理標(biāo)準(zhǔn),全面致力于藥品質(zhì)量的提升。本文研究的正是M制藥公司藥品質(zhì)量監(jiān)督建設(shè)項(xiàng)目,將項(xiàng)目管理思想引入到M制藥公司的生產(chǎn)質(zhì)量監(jiān)管體系建設(shè)之中,利用項(xiàng)目管理的目標(biāo)思想,提升質(zhì)量監(jiān)管體系建設(shè)的執(zhí)行力。本文著重分析項(xiàng)目實(shí)施之后存在的問題,對(duì)問題及時(shí)加以改進(jìn)才能保證后續(xù)工作在項(xiàng)目計(jì)劃內(nèi)展開,才能保證最終達(dá)到項(xiàng)目對(duì)質(zhì)量、成本和進(jìn)度的要求。項(xiàng)目雖然具有周期性,但是藥品質(zhì)量提升卻任重而道遠(yuǎn),在這里可以將M公司的項(xiàng)目視為一個(gè)不斷優(yōu)化藥品質(zhì)量的循環(huán),促進(jìn)M制藥公司藥品質(zhì)量管理體系上升到一個(gè)新的臺(tái)階。
[Abstract]:Drug safety is closely related to human life and health. The role of drugs is to cure diseases and save people. If the quality of drugs is not qualified, it may threaten the health of users, even the safety of life. Therefore, the state attaches great importance to the quality management of drug production. In 2010, China's Drug and Food Administration issued a new edition of the quality Standards for Drug production (hereinafter referred to as GMP), and the new version of GMP made some adjustments to the old version of GMP in 1998. In order to ensure that the quality standard of drug production is in line with the international standard, some countries, such as the United States and European Union, have been consulted in this round of adjustment on the quality of drug production. Therefore, the new GMP has put forward higher requirements to the quality of drug production. Drug and food management requires domestic pharmaceutical enterprises to carry out drug production management work strictly in accordance with the requirements of the new GMP. If they find that pharmaceutical products do not meet the requirements of the new GMP, drug manufacturing enterprises will be punished. Those with bad effects may even be required to close down and even revoke their pharmaceutical production qualifications. After the implementation of the new version of GMP, domestic pharmaceutical manufacturers have been complaining about it. They think that the new version of GMP is too strict, but the medical treatment is not trivial, and the high standard and strict requirements for the quality of medicine are also aimed at making production work well. From the source to stop the flow of problematic drugs into the market, this is responsible for the broad masses of the people. Therefore, there is no wrong with high demand, pharmaceutical enterprises should strengthen themselves, improve the level of drug production management, constantly close to the new GMP standards, and produce good medicine of excellent quality. It was against this background that pharmaceutical companies began to pay more attention to the quality of drug production. M Pharmaceutical Company learned from pain after a spot check by the Food and Drug Administration found that the quality of drugs did not meet GMP standards and was punished. This paper reviews the current situation of drug quality management, finds that there are many problems in drug production quality management, and puts forward the establishment of drug quality supervision system with the new edition of GMP as the management standard of drug production quality. We are fully committed to the improvement of drug quality. This paper studies the pharmaceutical quality supervision and construction project of M Pharmaceutical Company. The project management idea is introduced into the construction of production quality supervision system of M Pharmaceutical Company, and the goal of project management is used. Improve the implementation of quality supervision system construction. This paper focuses on the analysis of the problems existing after the implementation of the project, the timely improvement of the problems in order to ensure that the follow-up work is carried out in the project plan, and finally to meet the requirements of quality, cost and schedule of the project. Although the project has periodicity, but drug quality improvement is a long way to go, here we can regard M Company's project as a cycle of continuous optimization of drug quality. To promote M pharmaceutical company drug quality management system to a new level.
【學(xué)位授予單位】：電子科技大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：F426.72;F273.2

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