的規(guī)程和原則

1、GLP的規(guī)程和原則前 言應(yīng)客戶的需求，我們將陸續(xù)提供一些經(jīng)國(guó)際權(quán)威機(jī)構(gòu)認(rèn)可的論文和文章，涉及實(shí)驗(yàn)室管理者和技術(shù)人員通常所關(guān)心的問(wèn)題。文章的第一篇中，我們重點(diǎn)介紹歐洲GLP法規(guī)，共含有十一節(jié)。在第二篇里，我們著重講述實(shí)驗(yàn)室的設(shè)計(jì)、建設(shè)和改造。中國(guó)實(shí)驗(yàn)室管理網(wǎng)將每月刊發(fā)兩節(jié)內(nèi)容，以供大家參考并保存、收集。GLP的規(guī)程和原則實(shí)驗(yàn)室設(shè)計(jì)、建設(shè)和改造 1 執(zhí)行概述實(shí)驗(yàn)室的裝備非常復(fù)雜，技術(shù)含量高，密集的結(jié)構(gòu)建設(shè)和維護(hù)費(fèi)用都比較高，所以對(duì)這些設(shè)施的設(shè)計(jì)、建設(shè)和改造就是所有相關(guān)事務(wù)中的最大挑戰(zhàn)。在改造或新建設(shè)之前或期間，需要做成百上千個(gè)決策；這些決策將決定在建設(shè)、改造完成后，如何成功有效地發(fā)揮設(shè)施的功能，如

2、何在其一投入使用的時(shí)候就能順利運(yùn)轉(zhuǎn)和維護(hù)。許多決策必須由用戶和管理者做出，他們的基礎(chǔ)及更多專業(yè)實(shí)驗(yàn)室設(shè)計(jì)、建造和改造的知識(shí)在項(xiàng)目開始時(shí)可能還略顯匱乏，但必須快速提高在該方面的認(rèn)知度。 一些書籍中論述了實(shí)驗(yàn)室設(shè)計(jì)問(wèn)題，包括以前由國(guó)家研究委員會(huì)(NRC，1930, 1951，1962)所做的三篇論文和由國(guó)家衛(wèi)生學(xué)院（協(xié)會(huì)）以及美國(guó)建筑師協(xié)會(huì)制訂的方針(NIH, 1998; AIA, 1999)。但是這些書介紹的專業(yè)設(shè)計(jì)團(tuán)體，其成員都已非常熟悉設(shè)計(jì)和建設(shè)事宜及流程，所缺乏的是服務(wù)于科研工作者和管理者等這些用戶群的基礎(chǔ)和針對(duì)實(shí)驗(yàn)室的信息。該用戶群將與建筑師、實(shí)驗(yàn)室設(shè)計(jì)者和設(shè)計(jì)裝設(shè)的工程師以及建筑施工人

3、員簽訂合約。此報(bào)告為科學(xué)工作者和管理人員服務(wù)，所以著重于如何成功建設(shè)實(shí)驗(yàn)室設(shè)施而不是具體的實(shí)驗(yàn)室建筑規(guī)格標(biāo)準(zhǔn)。本文中，一套成功實(shí)驗(yàn)室設(shè)施是指對(duì)實(shí)驗(yàn)室工作人員來(lái)說(shuō)非常安全、高效、具有靈活性的實(shí)驗(yàn)室，并與周圍環(huán)境相協(xié)調(diào)，它應(yīng)該得到來(lái)自臨近機(jī)構(gòu)和政府部門的支持，以合理成本建造。2實(shí)驗(yàn)室的設(shè)計(jì)、建設(shè)和改造此報(bào)告包含許多總體設(shè)計(jì)、改造和建設(shè)項(xiàng)目的基本內(nèi)容，以及與實(shí)驗(yàn)室有關(guān)的特定問(wèn)題。后部分內(nèi)容中，重點(diǎn)考慮的是化學(xué)和生化實(shí)驗(yàn)室的有關(guān)問(wèn)題，而不涉及特殊建筑，如動(dòng)物設(shè)施，也不涉及多用途的建筑如教學(xué)和研究設(shè)施。(Narum, 1995,具體講述了教學(xué)實(shí)驗(yàn)室的問(wèn)題)總體來(lái)講，委員會(huì)闡明的總則可以幾乎應(yīng)用于所有實(shí)驗(yàn)

4、室的建設(shè)或改造。通過(guò)調(diào)研，委員會(huì)發(fā)現(xiàn)盡管單個(gè)項(xiàng)目不同，但是成功的實(shí)驗(yàn)室建設(shè)和改造具有一定的共性，包括正確的參與人和人員的連續(xù)性，一套清晰、說(shuō)明詳細(xì)而周全的流程，和與該事務(wù)相關(guān)的廣博知識(shí)。"人員問(wèn)題"、"流程問(wèn)題"和"技術(shù)問(wèn)題"是第一章到第三章的共同主題。許多曾經(jīng)在第一章和第二章里討論的因素，可能是一些眾所共知的常識(shí)，卻經(jīng)常在某些項(xiàng)目中被人們忽視。至于其它主題對(duì)實(shí)驗(yàn)室設(shè)施來(lái)講就更加具有特殊性了。以下是委員會(huì)確定的標(biāo)志成功實(shí)驗(yàn)室建設(shè)或改造項(xiàng)目的四個(gè)關(guān)鍵因素： 1. 項(xiàng)目經(jīng)理是指對(duì)項(xiàng)目的成功做出巨大貢獻(xiàn)的人，他給予客戶組高度信任，并自始至終

5、參與了整個(gè)項(xiàng)目。2. 設(shè)計(jì)專家，多為建筑師，在實(shí)驗(yàn)室的成功設(shè)計(jì)和建設(shè)方面具有豐富的經(jīng)驗(yàn)和閱歷。3. 從開展項(xiàng)目的前設(shè)計(jì)到后建設(shè)階段，一個(gè)說(shuō)明詳細(xì)、闡述清晰的流程。4. 在整個(gè)過(guò)程中，參與者要與權(quán)威機(jī)構(gòu)保持良好的溝通。上述因素還只是獲得成功實(shí)驗(yàn)室的設(shè)計(jì)和建造的基本條件。PrefaceThe following articles have been provided for your interest.They mainly consist of papers or articles from internationally recognised authorities concerning su

6、bjects of general interest to laboratory managers and technicians. In the first series, we look at Good Laboratory Practice from an E.U. perspective.There are eleven sections. The second series, we focus on laboratory design, construction and refurbishment.Inpro will post two sections every month, s

7、o save and collect them for your reference.LABORATORY DESIGN,CONSTRUCTION AND RENOVATIONLABORATORY DESIGN, CONSTRUCTION, AND RENOVATIONflexible laboratories, is safe for laboratory workers, is compatible with the surrounding environment, has the support of the neighboring community and governmental

8、agencies, and can be constructed in a cost-effective manner. Thisreport covers many basic aspects of design, renovation, and construction projectsin general as well as specific laboratory-oriented issues. In its discussion of thelatter, the committee considered primarily chemistry and biochemistry l

9、aboratories; it did not deal specifically with specialized buildings such as animal facilities, nor did it address multiple-use buildings such as teaching and researchfacilities. (Narum, 1995, deals with teaching laboratories.)Overall, the general principles elucidated by the committee make its reco

10、mmendations applicable to the construction or renovation of almost any laboratorybuilding. Through its investigations the committee found that although individual projects differ, there are certain commonalities in successful laboratory construction and renovation projects. These include the right p

11、articipants and acontinuity of personnel; a thorough, well-defined, and thoughtful process; and abroad knowledge of the relevant issues. These common themes are discussed inChapters 1 through 3: "Human Issues," "Process Issues," and "Technical Issues.Many of these elements,

12、especially those discussed in Chapters 1 and 2,may appear to be common sense, but they were found to have been overlookedin some of the projects described to the committee. Other themes are morespecific to laboratory facilities.Transcending specific issues and recommendations are four critical facto

13、rsidentified by the committee as characterizing successful laboratory constructionor renovation projects:1. A "champion" who is strongly committed to the success of the project,who has the confidence of the entire client group, and who stays with the projectfrom beginning to end;2.A design professional, often an architect, who has experience and demonstrated success in laboratory design and construction;3. A well-defined and well-articulated process for carrying out the projectfrom pre-design- through post-