医药企业产品质量管理及提升实践

发布时间：2018-04-30 13:36

本文选题：全面质量管理 + PDCA循环　；参考：《天津大学》2014年硕士论文

【摘要】：天津医药集团津康制药是一家以医药中间体、原料药及制剂为主要产品的医药企业,其中,头孢类抗生素原料药及其制剂为津康制药的拳头产品,头孢地尼原料药及头孢地尼胶囊均为国内首研产品,国内销量排名第一。目前在全球范围内,随着人类对抗生素需求的持续增加,抗生素的市场占有率也在不断攀升。现阶段,中国已成为全球抗生素产量最大的国家,尤其在部分抗生素原料药的生产方面,中国拥有绝对优势。然而,由于中国的抗生素产业几乎是靠仿制为主,并且同质化严重、产能过剩,缺乏核心竞争力,因此,加强抗生素生产企业产品的全面质量管理,推动抗生素产业从“中国仿造”向“中国制造”升级,已成为当前中国抗生素行业的一项迫切要求。本文以天津医药集团津康制药有限公司的头孢地尼原料药、头孢地尼胶囊及头孢泊肟酯颗粒等抗生素产品为研究对象,运用全面质量管理理论,基于质量管理的PDCA循环,使用质量管理工具,对上述产品的质量管理和提升进行了研究。本文首先根据全面质量管理理论,通过PDCA循环,以头孢地尼原料药为研究对象,找出管理过程中的问题所在,应用合适的质量管理工具,深入研究解决方法并达到产品质量提升的目的,然后进行结果的巩固,同时将管理经验进行推广,应用到头孢地尼胶囊和头孢泊肟酯颗粒等产品的质量管理中去,最终实现企业整体质量管理水平的提升。本文的研究结论,通过推广可以进一步应用到其他头孢类抗生素产品或者非头孢类产品的质量管理上,从而带动企业生产、质量等各方面管理效率的提高,进一步提高企业在行业内的核心竞争力。
[Abstract]:Tianjin Pharmaceutical Group Jinkang pharmaceutical is a pharmaceutical enterprise with pharmaceutical intermediates, raw materials and preparations as the main products. Among them, cephalosporins and their preparations are the fist products of Jinkang pharmaceutical. Cefidii raw materials and Cefdinir Capsules are all the first domestic products in China. The domestic sales rank the first. As the demand for antibiotics continues to increase, the market share of antibiotics is also rising. At this stage, China has become the largest country in the production of antibiotics in the world, especially in the production of some antibiotic raw materials, China has an absolute advantage. However, the antibiotic industry in China is mainly based on imitation. Therefore, it has become an urgent requirement for the current Chinese antibiotic industry to strengthen the overall quality management of the products of the antibiotic production enterprises and promote the promotion of the antibiotic industry from "Chinese imitation" to "China made". This article is based on Tianjin Pharmaceutical Group Jinkang Pharmaceutical Co., Ltd. Cefidione, Cefdinir Capsules and Cefpodoxime Proxetil Granule are the research subjects. The quality management and promotion of the above products are studied using quality management theory, quality management based PDCA cycle and quality management tools. First, this article is based on the total quality management theory and through PDCA Ring, taking cefidione as the research object, finding out the problems in the management process, applying the appropriate quality management tools, studying the solution and improving the quality of the product, then consolidating the results, and popularizing the management experience, which should be used in Cefdinir Capsules and Cefpodoxime Proxetil Granule. The conclusion of this paper can be further applied to the quality management of other cephalosporins or non cephalosporins, thus improving the efficiency of enterprise production, quality and other aspects of management, and further improving the business of enterprises. The core competitiveness of the industry.

【学位授予单位】：天津大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：F426.72;F273.2

【参考文献】