HY药业质量风险管理体系构建研究

发布时间：2019-07-06 16:52

【摘要】：在医药行业,医药产品的制造过程管理必须全过程遵循《药品生产质量管理规范》(GMP)的要求,由于社会不断发展变化,医药产品越来越丰富,出现了许多非常严重的药害事件,各国药品监督管理机构和医药界都越来越重视药品生产质量过程中的风险管理,怎么样才能将医药产品生产过程的风险降到可接受水平是-个新的课题,有相当重要的意义,这是对GMP十分必要的补充和完善,是确保医药产品安全,有效的必要举措。医药产品从研发,生产,流通到临床应用,产品的组份,含量,有关物质,必然存在安全的风险。医药产品存在多种风险,质量风险是其中主要的一个。关键是必须认识到,医药产品质量包含于整个的生命周期中,必须确保产品始终保持与临床研究时的工艺质量一致。本文首先阐述了选题的研究背景及意义、国内外关于质量风险管理研究现状、本文的主要内容及研究方法,为下文打下基础；接着分析了质量风险管理相关理论原理,主要包括风险管理、药品的质量风险管理以及药品质量风险管理的基本原则；进而对HY药业公司质量管理现状进行了分析,提出了在企业推动质量风险管理工作的必要性；研究了企业各阶段面临的风险,并在研究分析基础上,结合HY公司特点,设计建立了一套符合该公司实际需求,具有较强操作性的质量风险管理体系。基于此体系,进一步列举了运用已经建立的风险管理体系开展风险管理活动的实例,证明了相应的风险管理体系的适用性,可行性。该体系的建立,为其他企业提供了有益的借鉴。
[Abstract]:In the pharmaceutical industry, the manufacturing process management of pharmaceutical products must follow the requirements of (GMP) in the whole process. Due to the continuous development and changes of society, pharmaceutical products are becoming more and more abundant, and many very serious drug hazards have occurred. Drug supervision and administration institutions and medical circles in various countries pay more and more attention to risk management in the process of drug production quality. How to reduce the risk of pharmaceutical product production process to acceptable level is a new subject, which is of great significance, which is a very necessary supplement and improvement to GMP, and is a necessary measure to ensure the safety and effectiveness of pharmaceutical products. Medical products from research and development, production, circulation to clinical application, product composition, content, related substances, there must be safety risks. There are many risks in pharmaceutical products, and quality risk is one of the main risks. The key is to recognize that the quality of pharmaceutical products is included throughout the life cycle and that the product must always be kept in line with the quality of the process at the time of clinical research. This paper first expounds the research background and significance of the selected topic, the research status of quality risk management at home and abroad, the main contents and research methods of this paper, which lays the foundation for the following, and then analyzes the relevant theoretical principles of quality risk management, including risk management, drug quality risk management and the basic principles of drug quality risk management. Furthermore, this paper analyzes the present situation of quality management in HY pharmaceutical company, puts forward the necessity of promoting quality risk management in enterprises, studies the risks faced by enterprises in each stage, and on the basis of research and analysis, combined with the characteristics of HY company, designs and establishes a set of quality risk management system which meets the actual needs of the company and has strong operation. Based on this system, this paper further enumerates the examples of using the established risk management system to carry out risk management activities, and proves the applicability and feasibility of the corresponding risk management system. The establishment of the system provides a useful reference for other enterprises.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F273.2;F426.72

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