随着2015年8月18日，由国务院印发的《关于改革药品医疗器械审评审批 制度的意见》里，将“提高仿制药质量，加快仿制药质量一致性评价”作为改革 药品审评审批制度的五大目标之一，仿制药一致性评价正式走进了大众视野。质 量管理是保障药品生产质量的重要活动，在仿制药一致性评价工作中扮演重要角 色。将质量管理理念贯穿于整个评价过程中，才能确保仿制药的生产全过程符合 质量规范并具有疗效一致性。 本文采用了企业调查访谈以及文献分析的方法。通过对全面质量管理、风险 管理、质量源于设计等理论方法的学习，结合PDCA循环方法的使用，对国内外 仿制药一致性评价的质量管理要求进行解读，剖析天安药业仿制药一致性评价项 目开展情况以及质量管理现状，将存在的问题以及产生原因进行总结，为天安药 业质量管理水平提升提供策略选择。 通过研究分析认为，仿制药一致性评价是行业洗牌，开展仿制药一致性评价 是对国内制药行业的一次巨大冲击，是制药企业的优胜劣汰过程。天安药业坚定 的开展仿制药一致性评价就是为了在行业重塑的过程中抢占先机，立足于糖尿病 药物市场，这是天安药业的机遇，也是巨大挑战。其次，天安药业质量管理存在 一致性评价项目药学研究资料不完善、产品试制成本高、质量偏差呈上升趋势以 及风险识别评估不及时四方面主要问题。 为了提升天安药业质量管理水平，本文结合全面质量管理、质量源于设计等 质量相关理论，进行了质量管理水平提升的策略分析与选择。建议将PDCA循环 与质量管理工作相结合，做到常态化的质量管理、信息化的数据管理，通过质量 源于设计与仿制药一致性评价项目结合，使产品研发的质量设计、技术转移及过 程执行有质量体系的保障。最后，通过人力资源、企业战略、硬件设施三方面作 为保障，完成质量管理组织架构优化，建立质量绩效管理办法，形成企业的质量 文化，建设企业发展所需的硬件设施。 本文以天安药业的质量管理现状为研究对象，通过分析问题，提出企业质量 管理改进的策略，以此提升质量管理水平，确保仿制药一致性评价的顺利开展。 天安药业作为中小制药企业，本文研究对其发展具有重要的意义。同时，对同行 业同类规模的企业具有借鉴意义。 关键词：仿制药一致性评价 天安药业 质量管理 2 Abstract As of August 18,2015, the Opinions of the State Council on the Reform of the Review and Approval System of the Drug Medical Device will improve the quality of the generic drugs and speed up the evaluation of the quality of the generic drugs as one of the five objectives of the reform and approval system of the drug review, and the consistency evaluation of the generic drugs has entered the public field of view. Quality management is an important activity to guarantee the quality of drug production, and plays an important role in the evaluation of generic drug consistency. The quality management idea is run through the whole evaluation process, so that the whole process of the generic medicine is ensured to be in accordance with the quality standard and has the curative effect consistency. This paper adopts the methods of enterprise investigation, interview and literature analysis. Through the study of the theories and methods of total quality management, risk management, quality originated from design and so on, combined with the method of PDCA cycle, This paper interprets the quality management requirements of generic drug consistency evaluation at home and abroad, analyzes the development of generic drug consistency evaluation project in Tianan Pharmaceutical Industry and the current situation of quality management, and summarizes the existing problems and the causes. For Tianan Pharmaceutical Industry to improve the level of quality management to provide a strategic choice. Through the research and analysis, the consistency evaluation of the generic drug is an industry reshuffle, and the evaluation of the consistency of the generic drug is a great impact on the domestic pharmaceutical industry, which is the process of the fittest of the pharmaceutical enterprise. The consistent evaluation of the generic drug in Tianan Pharmaceutical Industry is to seize the first machine in the process of remolding the industry, and based on the diabetes drug market, this is the opportunity of Tianan Pharmaceutical Industry, and it is also a great challenge. Secondly, the quality management of Tianan Pharmaceutical Industry is not perfect, the product trial production cost is high, the deviation of the quality system is on the rise, and the risk identification evaluation is not in time. In order to improve the quality management level of Tianan Pharmaceutical Industry, this paper considers that combined with total quality management, quality originated from design and other quality theories, the strategic analysis and selection of 3 the improvement of quality management level have been carried out. It is suggested that the PDCA cycle should be combined with the quality management work, so as to make the quality design of the product R&D through the combination of the quality originating from the design and the conformity evaluation project of the generic drugs, so as to achieve the normal quality management and the information-based data management. Technology transfer and process execution are guaranteed by quality system. Finally, through the guarantee of human resources, enterprise strategy and hardware facilities, the organizational structure of quality management is optimized and the quality performance is established. Management measures to form the quality culture of the enterprise and build the hardware facilities necessary for the development of the enterprise. This paper takes the present situation of quality management in Tianan Pharmaceutical Industry as the research object, through analyzing the existing problems, puts forward the strategy of improving the quality management, in order to improve the quality management level and ensure the smooth development of the evaluation of the consistency of generic drugs. Tianan Pharmaceutical Industry as a small and medium-sized pharmaceutical enterprises, this paper has important significance for its development. At the same time, it can be used for reference to enterprises of the same size in the same industry.。。。。。。以下内容略