HY公司制药一车间生产质量管理研究

发布时间：2019-05-17 01:32

【摘要】：随着我国医药行业的迅速发展,医药产品也越来越丰富,但随之而来的还有许多非常严重的药害事件,药品质量问题一度被推向风口浪尖。在药品质量备受广大人民群众瞩目的大背景下,我国药品监督管理部门对药品质量的监管也越来越重视。恰逢我国《药品生产质量管理规范》(2010年修订)(以下简称现行版GMP,GMP:Good Manufacturing Practice for Drugs)的推行实施阶段,相关药品生产企业的GMP认证工作也紧锣密鼓地开展中,我国药品生产行业正面临一场“大变革”。抓住现行版GMP认证的准备阶段,回过头从生产的核心单位出发,以车间为突破口,重新审查药品生产企业自身的生产质量管理状况,并结合现行版GMP的相关标准进行整改,不但有益于企业自身的效益,也是整个药品生产领域对药品生产质量加大重视程度的体现,对提升整体药品质量意义重大。本文以HY公司制药一车间的生产质量管理现状为研究对象,目的在于提升车间的生产质量管理水平,为其现行版GMP认证的准备工作提供理论参考。在以药品生产质量管理概述为理论基础的前提下,运用文献研究法、实地调查法、实证分析法,对HY公司制药一车间的生产质量管理状况进行剖析,发现其中存在的问题,并结合现行版GMP的相关要求,围绕车间工艺布局、洁净级别、软件系统、工作人员、质量回顾五方面,提出相应的改进方案,最终得出结论。
[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.
【学位授予单位】：辽宁中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F426.72;F273.2

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