【摘要】：隨著我國醫(yī)藥行業(yè)的迅速發(fā)展,醫(yī)藥產(chǎn)品也越來越豐富,但隨之而來的還有許多非常嚴(yán)重的藥害事件,藥品質(zhì)量問題一度被推向風(fēng)口浪尖。在藥品質(zhì)量備受廣大人民群眾矚目的大背景下,我國藥品監(jiān)督管理部門對藥品質(zhì)量的監(jiān)管也越來越重視。恰逢我國《藥品生產(chǎn)質(zhì)量管理規(guī)范》(2010年修訂)(以下簡稱現(xiàn)行版GMP,GMP:Good Manufacturing Practice for Drugs)的推行實施階段,相關(guān)藥品生產(chǎn)企業(yè)的GMP認(rèn)證工作也緊鑼密鼓地開展中,我國藥品生產(chǎn)行業(yè)正面臨一場“大變革”。抓住現(xiàn)行版GMP認(rèn)證的準(zhǔn)備階段,回過頭從生產(chǎn)的核心單位出發(fā),以車間為突破口,重新審查藥品生產(chǎn)企業(yè)自身的生產(chǎn)質(zhì)量管理狀況,并結(jié)合現(xiàn)行版GMP的相關(guān)標(biāo)準(zhǔn)進(jìn)行整改,不但有益于企業(yè)自身的效益,也是整個藥品生產(chǎn)領(lǐng)域?qū)λ幤飞a(chǎn)質(zhì)量加大重視程度的體現(xiàn),對提升整體藥品質(zhì)量意義重大。本文以HY公司制藥一車間的生產(chǎn)質(zhì)量管理現(xiàn)狀為研究對象,目的在于提升車間的生產(chǎn)質(zhì)量管理水平,為其現(xiàn)行版GMP認(rèn)證的準(zhǔn)備工作提供理論參考。在以藥品生產(chǎn)質(zhì)量管理概述為理論基礎(chǔ)的前提下,運(yùn)用文獻(xiàn)研究法、實地調(diào)查法、實證分析法,對HY公司制藥一車間的生產(chǎn)質(zhì)量管理狀況進(jìn)行剖析,發(fā)現(xiàn)其中存在的問題,并結(jié)合現(xiàn)行版GMP的相關(guān)要求,圍繞車間工藝布局、潔凈級別、軟件系統(tǒng)、工作人員、質(zhì)量回顧五方面,提出相應(yīng)的改進(jìn)方案,最終得出結(jié)論。
[Abstract]:With the rapid development of pharmaceutical industry in China, pharmaceutical products are becoming more and more abundant, but there are still many very serious drug hazards, and the problem of drug quality was once pushed to the cusp of the storm. Under the background that drug quality has attracted the attention of the broad masses of the people, the drug supervision and administration departments in China pay more and more attention to the supervision of drug quality. This coincides with the implementation of the Standard for the quality Management of Drug production in China (revised in 2010) (hereinafter referred to as the implementation stage of the current version of GMP,GMP:Good Manufacturing Practice for Drugs), and the GMP certification work of relevant drug production enterprises is also being carried out intensively. China's drug production industry is facing a "great change". Grasp the preparation stage of the current version of GMP certification, turn back from the core units of production, take the workshop as a breakthrough, re-examine the production quality management of drug production enterprises, and carry out rectification and reform in combination with the relevant standards of the current version of GMP. It is not only beneficial to the benefit of the enterprise itself, but also the embodiment of the whole drug production field to pay more attention to the quality of drug production, which is of great significance to improve the overall drug quality. In this paper, the present situation of production quality management in HY Pharmaceutical Workshop is taken as the research object, in order to improve the production quality management level of the workshop and provide theoretical reference for the preparation of its current version of GMP certification. On the premise of summarizing the quality management of drug production, this paper analyzes the production quality management of HY Pharmaceutical Workshop by using the methods of literature research, field investigation and empirical analysis, and finds out the existing problems. Combined with the related requirements of the current version of GMP, the corresponding improvement scheme is put forward around five aspects: workshop process layout, cleanliness level, software system, staff and quality review, and finally the conclusion is drawn.
【學(xué)位授予單位】：遼寧中醫(yī)藥大學(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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