本文關(guān)鍵詞：GLP組織機(jī)構(gòu)和管理體系的建立與運(yùn)行　出處：《中國(guó)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(guó)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(shí)驗(yàn)資料的真實(shí)性、完整性和可靠性。與其它國(guó)家(美國(guó)、歐洲等)同樣,我國(guó)的規(guī)范包括了組織機(jī)構(gòu)和人員、實(shí)驗(yàn)設(shè)施、儀器設(shè)備和實(shí)驗(yàn)材料、標(biāo)準(zhǔn)操作規(guī)程、研究工作的實(shí)施、資料檔案等內(nèi)容。其中,組織機(jī)構(gòu)和管理體系的建立是其他各項(xiàng)內(nèi)容運(yùn)行或?qū)嵤┑幕A(chǔ)和載體,是一個(gè)GLP機(jī)構(gòu)保證GLP規(guī)范復(fù)合性的最重要的軟件核心和實(shí)力象征。本文以國(guó)家藥物安全評(píng)價(jià)監(jiān)測(cè)中心組織機(jī)構(gòu)模式的建立和發(fā)展為例,交流GLP管理體系運(yùn)行中的心得體會(huì),希望業(yè)界同行取長(zhǎng)補(bǔ)短,完善各自機(jī)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(jī)構(gòu)包括機(jī)構(gòu)負(fù)責(zé)人全權(quán)負(fù)責(zé)下的質(zhì)量保證室、實(shí)驗(yàn)動(dòng)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(yàn)與病理室、藥物代謝動(dòng)力學(xué)室、綜合辦公室8個(gè)部門科室。共同擔(dān)當(dāng)著GLP體制下研究項(xiàng)目管理和質(zhì)量體系管理的各項(xiàng)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(dòng)力學(xué)室負(fù)責(zé)、動(dòng)物管理和動(dòng)物在體操作由實(shí)驗(yàn)動(dòng)物技術(shù)室負(fù)責(zé)、標(biāo)本檔案由臨床檢驗(yàn)與病理室負(fù)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(fù)責(zé)人(SD)構(gòu)成,負(fù)責(zé)研究項(xiàng)目的設(shè)計(jì)、執(zhí)行和報(bào)告。質(zhì)量保證部門負(fù)責(zé)對(duì)質(zhì)量體系和研究項(xiàng)目進(jìn)行檢查和核查,并向各相關(guān)負(fù)責(zé)人以及機(jī)構(gòu)負(fù)責(zé)人報(bào)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(gè)專門委員會(huì)來協(xié)調(diào)跨部門工作。包括GLP委員會(huì)、倫理(IACUC)委員會(huì)、環(huán)境健康安全(EHS)委員會(huì)和學(xué)術(shù)委員會(huì),分別負(fù)責(zé)GLP法規(guī)事務(wù)、動(dòng)物使用和福利、安全健康、學(xué)術(shù)和科研活動(dòng)。上述組織機(jī)構(gòu)看似更接近一種行政體系,但是在一個(gè)符合GLP規(guī)范的專題研究進(jìn)行過程中,上述組織機(jī)構(gòu)的行政屬性將依從于其功能屬性,在運(yùn)行過程中,上述大的組織框架又包含著各自小的運(yùn)行結(jié)構(gòu)。將以實(shí)例介紹在上述組織機(jī)構(gòu)下,研究專題進(jìn)行時(shí)研究方案制定、研究實(shí)施、總結(jié)報(bào)告的各個(gè)階段GLP符合性的保證。上述組織機(jī)構(gòu)的發(fā)展變化、優(yōu)缺點(diǎn),并與國(guó)內(nèi)外同行機(jī)構(gòu)的組織機(jī)構(gòu)對(duì)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(jī)構(gòu)負(fù)責(zé)人、質(zhì)量保證部門負(fù)責(zé)人和相應(yīng)的工作人員)、資源(設(shè)施、儀器設(shè)備和實(shí)驗(yàn)材料)和管理文件(標(biāo)準(zhǔn)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(jī)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(dá)到使非臨床研究資料真實(shí)、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(guó)食品藥品檢定研究院食品藥品安全評(píng)價(jià)研究所;
【分類號(hào)】：R95
【正文快照】： GLP組織機(jī)構(gòu)和管理體系的建立與運(yùn)行@霍艷$中國(guó)食品藥品檢定研究院食品藥品安全評(píng)價(jià)研究所!北京100176 @謝寅$中國(guó)食品藥品檢定研究院食品藥品安全評(píng)價(jià)研究所!北京100176 @汪巨峰$中國(guó)食品藥品檢定研究院食品藥品安全評(píng)價(jià)研究所!北京100176我國(guó)藥物非臨床研究質(zhì)量管理規(guī)范(G，

本文編號(hào)：1428935