【作者】 张玉成；

【导师】 汪春红；

【作者基本信息】 武汉大学 ， 卫生毒理学， 2017， 硕士

【摘要】 中国是人口大国和农业大国,食品生产和消耗量都居世界首位,食品安全成为我国当前较为突出的一个社会问题。近年来国内的食品安全事件频发,给我国人民的健康带来了严重损害,也极大地阻碍了我国社会经济发展,食品安全性越来越成为中国人民关注的焦点。食品安全性毒理学评价是在食品上市前保障其安全性的一种重要手段,而毒理学评价工作的质量也需要相应的管理体系来保证。良好实验室规范(Good Laboratory Practice,GLP)是为保障非临床健康与环境安全性研究质量而制订的一套质量管理体系,是世界上大多数国家均认可的实验室质量管理体系,尤其适用于非临床安全性研究。目前,我国食品毒理学评价标准已趋于完善,但尚未建立相应的GLP体系,不利于食品毒理学数据的同行认可、国际互认和被国际上采用。因此,尽早建立中国食品毒理GLP体系具有重要意义。本研究对各国建立并实施的GLP体系进行对比分析,探究国内外GLP的实施情况。通过收集中国知网、PubMed数据库、万方数据库和维普数据库等文献数据,对近40年的GLP发展情况进行文献计量学分析,明确GLP体系发展动态。采用专家.咨询法和访谈的方式对我国食品毒理学研究的实施情况进行评价,并收集对于构建我国食品GLP体系的多种观点。同时,从9个方面对FDA版GLP、OECD版GLP原则和CFDA版GLP的异同进行比较,明确提出食品GLP体系的概念、范围、认证部门和认证方式及主要框架和关注重点。本文主要研究结论如下:1.从计量学上看,GLP研究在近40年中呈不断增长的趋势;英、美、日等发达国家处于GLP研究领先地位,国内GLP发展也存在区域发展不平衡现象;研究内容和范围不够全面,主要以药物、化学品和农药为主,GLP应用、质量保证和认证监督受到关注较多。2.各国GLP实施的进展也存在较大差距,美国、部分欧洲国家、日本的实施时间早、进展快、涵盖范围广;我国GLP实施工作在不断完善,GLP体系仍在不断丰富,但仍存在不少问题,如GLP的覆盖范围窄、多数机构还由政府主办、通过国外GLP认证的机构不多等。3.国内外食品毒理学评价标准趋于成熟,评价工作开展顺利,但国内食品毒理学评价机构参差不齐、多数规模较小,监管部门多,尚未出台相应GLP规范。4.构建中国食品毒理GLP体系十分必要,应当以OECD、FDA、CFDA版GLP为基础,结合食品毒理学评价工作特点来建立;中国食品GLP应分层发展、逐渐完善。更多还原

【Abstract】 China is a big country with a large population and developed agriculture,the food production and consumption in China are ranked first in the world.Now food safety has become a more prominent social problem in China.In recent years,frequent food safety incidents not only have brought serious damage to the health of people in our country,but also have greatly hindered social and economic development.Food safety has become increasingly the focus of attention of the Chinese people.Pre-market toxicological safety evaluation for food is an important means of ensuring food safety,and toxicology evaluation work also need a corresponding management system to ensure quality.Good Laboratory Practice(GLP)is a set of quality management systems developed to ensure the quality of non-clinical health and environmental safety studies,especially for non-clinical safety studies,and it is the laboratory quality management system recognized by most countries in the world.At present,China’s food toxicology evaluation standards have tended to reach perfection,but the corresponding GLP system has not been established,this is not conducive to food toxicology data peer recognition,international mutual recognition or international access.Therefore,it is of great significance to establish the GLP system of food toxicology in China as soon as possible.In this study,the GLP systems established and implemented in some countries were compared and analyzed to explore the implementation of GLP at home and abroad.The articles on GLP from CNKI,Wanfang,VIP and PubMed database were collected and bibliometrics analysis of GLP development in the last 40 years was conducted to clarify the development trend of GLP system.Expert consultation and interviews were used to assess the implementation of food toxicology studies in China and a variety of views on the construction of China’s food GLP system were collected.At the same time,the similarities and differences of FDA GLP,OECD GLP principles and CFDA GLP were compared from nine aspects.The concept,scope,certification departments,certification methods,the main framework and focus of the food GLP system were clearly stated.The main conclusions of this paper are as follows:1.From a metrological point of view,GLP research in the past 40 years shows a growing trend.Britain,the United States,Japan and other developed countries have been in the leading position of GLP research,and the development of GLP in China also exists regional development imbalances.The research contents and scope of GLP are not comprehensive,mainly in drugs,chemicals and pesticides,and GLP applications,quality assurance and certification supervision are more concerned about.2.There are some big gaps of GLP implementation progress between different countries,among them,the United States,some European countries,Japan begin to implement early with a rapid progress and a wide range.GLP implementation of our country is constantly improving,and GLP system is becoming more and more complete,but there are still many problems,such as GLP coverage is narrow,most agencies are also sponsored by the government,institutions passed foreign GLP certification are less and so on.3.Domestic and international food toxicology evaluation standards become more and more mature and evaluation works carry out smoothly,but the domestic food toxicology evaluation institutions are uneven,and most institutions are held on small scales.There are more regulatory authorities in China,but it has not yet introduced the corresponding GLP specification.It is necessary to construct GLP system of food toxicology in China and it should be based on OECD,FDA and CFDA GLP,combined with the characteristics of food toxicology evaluation to do.GLP system of food toxicology should develop in different levels and gradually improves in China.更多还原