【作者】 王霞；

【导师】 朱建伟； 陈恒青；

【作者基本信息】 上海交通大学 ， 制药工程（专业学位）， 2019， 硕士

【摘要】 随着中国加入人用药品注册技术要求国际协调会议(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,ICH),以及为提升制药行业整体水平,保障药品安全性和有效性,促进医药产业升级和结构调整,增强企业国际竞争力,国务院药品监督管理部门相继推出一些政策和指导,这就有对制药企业的质量提出很高的要求。同时,美国食品药品监督管理局(Food&Drug Administration,FDA)鼓励实施现代的、基于风险的药物质量评估体系,实现21世纪制药行业的愿景,也提出了质量量度计划,这一计划对于提高企业的质量水平有很大的指导意义。本文介绍了FDA质量量度计划指南草案,国际药物工程协会(International Society for Pharmaceutical Engineering,ISPE)以及美国注射剂协会(Parenteral Drug Association,PDA)等组织在质量量度工具以及质量文化方面研究所取得的进展和成果。阐述了如何选择质量量度以及衡量质量文化,并为我国制药企业实施质量量度,持续改进质量体系提供了思路。本文第一章介绍研究背景。第二章概述质量量度计划的发展与现状,详细追溯了质量量度计划的开展历程,概括了各组织在这一计划中的作用。第三章介绍美国FDA质量量度指南草案,介绍了FDA实施质量量度的目的,并对其发布的两版指南草案进行异同点分析。第四章介绍了ISPE质量量度试点项目,对其两期试点项目的成果进行汇总,说明了各个质量量度的意义,为后续企业进行选择合适的质量量度提供指导。第五章介绍了质量文化,包括PDA质量文化调研项目,以及如何衡量质量文化。第六章通过分析质量量度与数据可靠性以及关键绩效指标(Key Performance Indicator,KPI)之间的关系,详细阐述了质量量度的应用,并以一家公司如何选择、收集、分析质量量度以及数据,通过实施质量量度如何进行质量持续改进为实例进行介绍,为国内其他制药企业实施质量量度提供参考。最后通过全文进行总结并展望,以期中国制药行业应紧跟发展,通过实施质量量度,提高自己质量水平、提高产品质量、增强企业竞争力。更多还原

【Abstract】 With China joining International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use（ICH）,Regulatory agency in China published a number of new policies and guidelines to rise the overall quality standard of the pharmaceutical industry,to ensure the safety and effectiveness of drug products,and to enhance competitive ability on global market.Meanwhile,US Food&Drug Administration（FDA）proposes a quality metics plan to encourage the implementation of a modern,risk-based pharmaceutical quality assessment system and fulfill the 21^st century vision for manufacturing and quality.This plan has great guiding significance for improving the quality level of pharmaceutical industry.This article introduces the Draft Guidance for Industry about Quality Metrics published by FDA and reviews the progress and results of research on quality metrics and quality culture by International Society for Pharmaceutical Engineering（ISPE）and Parenteral Drug Association（PDA）.We would like to explain how to select quality metrics and how to measure quality culture,which will provide ideas for Chinese pharmaceutical industries to implement quality metrics and continuous improvement of quality system.Chapter 1 introduced background of the study.Chapter 2 the history of quality metrics was traced in detail and summarized the status of the quality metics plan,as well as introduced the roles of orignaztions and industries in this plan.Chapter 3 introduced the contents of draft guidance of quality metics.FDA’s purposes to implement quality metrics were simply introduced,and the differences and similarities between the two versions of the draft guidance were analyzed.Chapter 4 introduced the ISPE’s two pilot programs and the results of the programs are summarized to illustrate the significance of each quality metics and provide guidance for subsequent pharmaceutical industries to select appropriate quality metics.Chapter5 introduced quality culture and PDA’s quality culture survey program.The way to measure the quality culture is provided.Through analysis of the relationship of quality metrics,data integrity and Key Performance Indicator（KPI）,Chapter 6 described the implementation of quality metrics.Then,an example of an industry of how to select,collect and analyze the quality metrics and metrics data is introduced.Provide reference for other pharmaceutical industries to implement quality metrics.Finally,the whole paper was summarized and prospects of the China’s pharmaceutical industries,China’s pharmaceutical industries should keep up with the development and improve its own quality level,product quality and enhance the competitiveness of enterprises through the implementation of quality metircs.更多还原