【摘要】：近年來,隨著人們對(duì)于醫(yī)療衛(wèi)生事業(yè)的重視以及國家對(duì)于藥品生產(chǎn)監(jiān)管力度的逐漸加強(qiáng),越來越多的藥品生產(chǎn)質(zhì)量問題被重視起來。藥品生產(chǎn)的過程以及最終產(chǎn)品管理中有很多控制因素,熱原在藥品生產(chǎn)過程中是必須加以控制的,也是藥品質(zhì)量檢驗(yàn)的重要項(xiàng)目之一。在項(xiàng)目管理領(lǐng)域中,項(xiàng)目質(zhì)量管理是為了確保項(xiàng)目達(dá)到客戶所規(guī)定的質(zhì)量要求所實(shí)施的一系列的管理過程。本文以一種被廣泛地應(yīng)用于醫(yī)藥與化妝品等行業(yè)的藥品T產(chǎn)品為例,研究和分析其質(zhì)量管理中對(duì)于熱原控制的影響因素,以提高和改善熱原的控制管理水平,從而提高產(chǎn)品質(zhì)量,增強(qiáng)產(chǎn)品的市場(chǎng)競(jìng)爭(zhēng)力。本文首先闡述藥品中熱原問題的背景,然后通過魚骨圖和風(fēng)險(xiǎn)分析法等工具得出了藥品中可能產(chǎn)生的途徑和原因。在整體項(xiàng)目中通過運(yùn)用領(lǐng)導(dǎo)、組織、用人、計(jì)劃和控制幾個(gè)因素,實(shí)現(xiàn)了對(duì)于產(chǎn)品的質(zhì)量規(guī)劃、質(zhì)量控制和質(zhì)量保證。從某市X公司生產(chǎn)T產(chǎn)品的藥品生產(chǎn)的全過程出發(fā),針對(duì)生產(chǎn)過程特性、工藝特性等原因進(jìn)行分析,深入探討優(yōu)化改善熱原控制的方案,并且結(jié)合產(chǎn)品微生物菌種發(fā)酵和吸附過濾工藝的特點(diǎn),以發(fā)酵菌種、發(fā)酵pH、吸附過濾工藝為關(guān)鍵控制指標(biāo),尋求過程控制與產(chǎn)品質(zhì)量合格之間的關(guān)系。最終通過工藝參數(shù)優(yōu)化和工藝改進(jìn)的研究,提出藥品生產(chǎn)中熱原控制和質(zhì)量改善的解決方案。在解決問題的過程中,通過成立項(xiàng)目組,運(yùn)用相關(guān)的項(xiàng)目管理理論并結(jié)合產(chǎn)品的實(shí)際結(jié)果進(jìn)行總結(jié)、討論、原因分析和改進(jìn)方案制定。通過此項(xiàng)目的研究,能夠提升藥品生產(chǎn)中的熱原質(zhì)量控制,同時(shí)提高公司產(chǎn)品的市場(chǎng)競(jìng)爭(zhēng)力。
[Abstract]:In recent years, with the attention of people to medical and health care and the strengthening of national supervision on drug production, more and more problems of drug production quality have been paid attention to. There are many controlling factors in the process of drug production and final product management. Pyrogen must be controlled in the process of drug production, and it is also one of the important items of drug quality inspection. In the field of project management, project quality management is a series of management processes to ensure that the project meets the quality requirements set by the customer. Taking a pharmaceutical T product widely used in pharmaceutical and cosmetic industries as an example, this paper studies and analyzes the factors affecting pyrogen control in its quality management, in order to improve and improve the level of pyrogen control and management. In order to improve product quality, enhance the market competitiveness of products. In this paper, the background of pyrogen problem in drugs is introduced, and then the possible ways and causes of drug production are obtained by means of fish bone map and risk analysis. In the overall project through the use of leadership, organization, personnel, planning and control of several factors to achieve the quality of the product planning, quality control and quality assurance. Starting from the whole process of the production of T products in a certain city X Company, the characteristics of the production process and the process characteristics are analyzed, and the scheme of optimizing and improving the pyrogen control is discussed in depth. According to the characteristics of microbial fermentation and adsorption filtration process, the key control index is fermentation strain and fermentation pH, adsorption filtration process, and the relationship between process control and product quality qualification is sought. Finally, through the research of process parameter optimization and process improvement, the solution of pyrogen control and quality improvement in pharmaceutical production is put forward. In the process of solving the problem, the project team is set up, and the relevant project management theory is used to sum up, discuss, analyze and improve the project. Through the research of this project, the quality control of pyrogen in pharmaceutical production can be improved, and the market competitiveness of the company's products can be improved.
【學(xué)位授予單位】：天津大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：F426.72

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