本文關(guān)鍵詞：GLP組織機構(gòu)和管理體系的建立與運行　出處：《中國藥理學(xué)與毒理學(xué)雜志》2013年03期 　論文類型：期刊論文

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【摘要】：我國藥物非臨床研究質(zhì)量管理規(guī)范(GLP)制定的目的是提高藥物非臨床研究的質(zhì)量,確保實驗資料的真實性、完整性和可靠性。與其它國家(美國、歐洲等)同樣,我國的規(guī)范包括了組織機構(gòu)和人員、實驗設(shè)施、儀器設(shè)備和實驗材料、標準操作規(guī)程、研究工作的實施、資料檔案等內(nèi)容。其中,組織機構(gòu)和管理體系的建立是其他各項內(nèi)容運行或?qū)嵤┑幕A(chǔ)和載體,是一個GLP機構(gòu)保證GLP規(guī)范復(fù)合性的最重要的軟件核心和實力象征。本文以國家藥物安全評價監(jiān)測中心組織機構(gòu)模式的建立和發(fā)展為例,交流GLP管理體系運行中的心得體會,希望業(yè)界同行取長補短,完善各自機構(gòu)的管理,最大限度保證非臨床研究的規(guī)范符合性。本中心目前的組織機構(gòu)包括機構(gòu)負責(zé)人全權(quán)負責(zé)下的質(zhì)量保證室、實驗動物技術(shù)室、一般毒理室、生殖遺傳毒理室、安全藥理室、臨床檢驗與病理室、藥物代謝動力學(xué)室、綜合辦公室8個部門科室。共同擔(dān)當著GLP體制下研究項目管理和質(zhì)量體系管理的各項功能及分工。SOP/文書檔案/、設(shè)備/試劑管理由綜合辦公室管理,供試品管理由藥物代謝動力學(xué)室負責(zé)、動物管理和動物在體操作由實驗動物技術(shù)室負責(zé)、標本檔案由臨床檢驗與病理室負責(zé),一般毒理室、生殖遺傳毒理室、安全藥理室主要由專題負責(zé)人(SD)構(gòu)成,負責(zé)研究項目的設(shè)計、執(zhí)行和報告。質(zhì)量保證部門負責(zé)對質(zhì)量體系和研究項目進行檢查和核查,并向各相關(guān)負責(zé)人以及機構(gòu)負責(zé)人報告檢查情況、督促整改。為了解決管理上的共性問題,設(shè)置了四個專門委員會來協(xié)調(diào)跨部門工作。包括GLP委員會、倫理(IACUC)委員會、環(huán)境健康安全(EHS)委員會和學(xué)術(shù)委員會,分別負責(zé)GLP法規(guī)事務(wù)、動物使用和福利、安全健康、學(xué)術(shù)和科研活動。上述組織機構(gòu)看似更接近一種行政體系,但是在一個符合GLP規(guī)范的專題研究進行過程中,上述組織機構(gòu)的行政屬性將依從于其功能屬性,在運行過程中,上述大的組織框架又包含著各自小的運行結(jié)構(gòu)。將以實例介紹在上述組織機構(gòu)下,研究專題進行時研究方案制定、研究實施、總結(jié)報告的各個階段GLP符合性的保證。上述組織機構(gòu)的發(fā)展變化、優(yōu)缺點,并與國內(nèi)外同行機構(gòu)的組織機構(gòu)對比;任何形式的GLP組織結(jié)構(gòu),基本要素均為GLP規(guī)范要求的人員(機構(gòu)負責(zé)人、質(zhì)量保證部門負責(zé)人和相應(yīng)的工作人員)、資源(設(shè)施、儀器設(shè)備和實驗材料)和管理文件(標準操作規(guī)程)。在滿足上述要素的基礎(chǔ)上,可以建立適合本機構(gòu)的合理的組織管理框架,以便使上述要素合理配置、充分溝通和配合,達到使非臨床研究資料真實、完整、可靠的目的。
[Abstract]:Specification for quality management of clinical research in China (GLP) the purpose is to improve the quality of non clinical drug research, experimental data to ensure the authenticity, integrity and reliability. And other countries (America, Europe) as experimental facilities in our specification includes organization and personnel, equipment, and the experimental materials, standard operating procedures, the implementation of the research work, archives and so on. Among them, the establishment of the organization and management system is the foundation and carrier of the operation or implementation of other content, is a GLP mechanism to ensure the GLP specification of the compound of the most important software and core strength symbol. The establishment and development of the National Center for safety evaluation of drugs organization mode as an example, operation experience of GLP management system in the exchange of experience, I hope the colleagues learn from each other, improve their management mechanism, ensure the maximum non pro Study on the bed specification. The quality of the center at the organization including institutions responsible solely responsible for the experimental animal room, technical room, general toxicology, reproductive and genetic toxicology, safety pharmacology, clinical examination and pathology, pharmacokinetics room, 8 Department of General Office jointly with GLP department. Under the system of project management and quality management system and functions of the division of.SOP/ documents / equipment / reagent management from the integrated office management, sample management by pharmacokinetics lab is responsible for the management and responsible for animal, animal by animal technical room in gymnastics, specimens of archives by clinical inspection and pathology department responsible for the general toxicology room, reproductive and genetic toxicology, safety pharmacology is mainly composed of a special person in charge (SD), responsible for the design of research projects, implementation and report the quality assurance department responsible for quality. System and research projects for examination and verification, and to the relevant responsible person and organization responsible for the inspection, supervision and rectification report. In order to solve the common problems in management, four special committees set up to coordinate the inter departmental working committee. Including GLP (IACUC), ethics committee, environmental health and safety committee (EHS) and the academic committee, responsible for GLP regulatory affairs, and the use of animal welfare, health and safety, academic and research activities. The organization seems closer to a kind of administrative system, but in a research topic conforming to the GLP process, the administrative attribute of the organization will depend on its functional properties in the running process in the large organizational framework and contains their small operation structure. This paper introduces with examples in the organization, research topics of research scheme, implementation research, summary Each stage of the report of GLP compliance assurance. The organization development and change, the advantages and disadvantages, and compare the organization of domestic and foreign counterparts of the organization; organizational structure of GLP in any form, the basic elements are the requirements of GLP personnel (responsible person, the quality assurance department responsible person and relevant staff). Resources (facilities, equipment and materials) and file management (SOP). Based on satisfying the above elements, can establish the mechanism of the rational management framework, in order to make reasonable allocation of the elements of the full communication and coordination, to make non clinical research data is true, complete and reliable purpose.

【作者單位】： 中國食品藥品檢定研究院食品藥品安全評價研究所;
【分類號】：R95
【正文快照】： GLP組織機構(gòu)和管理體系的建立與運行@霍艷$中國食品藥品檢定研究院食品藥品安全評價研究所!北京100176 @謝寅$中國食品藥品檢定研究院食品藥品安全評價研究所!北京100176 @汪巨峰$中國食品藥品檢定研究院食品藥品安全評價研究所!北京100176我國藥物非臨床研究質(zhì)量管理規(guī)范(G，

本文編號：1428935