DQM 實(shí)驗(yàn)室聯(lián)合審計(jì)標(biāo)準(zhǔn)指南

1、EDQM: PA/PH/OOMCL (06) 72 (EDIIV/044) 20066年7月Standdard “Aidde mmoirre” ffor tthe MMutuaal Jooint Audiit of OOfficcial Mediicinees Coontrool Laaboraatoriies藥品官方控控制實(shí)驗(yàn)室室聯(lián)合審計(jì)計(jì)標(biāo)準(zhǔn)指南南I. Geeneraal一、概況This “aidde-mmoirre” wwas eelaboorateed onn a sstanddard checcklisst foor ENN ISOO/IECC 170025 aand ccorree

2、sponndingg EA and ILACC guiideliines, pubblishhed bby ann acccrediitatiion bbody on tthe iinterrnet. Speecifiic OMMCL rrequiiremeents arissing fromm adooptedd OMCCL guuidelliness werre inncorpporatted.這個(gè)指南是是為闡述檢測(cè)和校校準(zhǔn)實(shí)驗(yàn)室室能力的通通用要求和相應(yīng)的的歐洲認(rèn)證證協(xié)會(huì)及國(guó)國(guó)際實(shí)驗(yàn)室室認(rèn)可合作作組織準(zhǔn)則則的一個(gè)標(biāo)標(biāo)準(zhǔn)清單，并被一個(gè)認(rèn)證機(jī)構(gòu)發(fā)表在互聯(lián)網(wǎng)上。藥品官方檢驗(yàn)實(shí)驗(yàn)室的具體要求因被采

3、用的藥品官方檢驗(yàn)實(shí)驗(yàn)室準(zhǔn)則而注冊(cè)成立。This docuumentt hass beeen reeviseed annd uppdateed inn acccordaance withh thee seccond edittion of tthe EEN ISSO/IEEC 170225 off 15tth Maay 20005.此文件已被被修改和更更新，符合合了20005年5月月15日第第二版的檢測(cè)和校校準(zhǔn)實(shí)驗(yàn)室室能力的通通用要求。The qquesttionss in the firsst coolumnn aree adddresssed tto thhe teestinng laabo

4、raatoriies; theyy aree to be aansweered thorroughhly bby thhe laaboraatoryy itsself befoore tthe eevaluuatioon taakes placce, wwith indiicatiion oof coorresspondding refeerencce doocumeents (e.gg. Quualitty Maanuall, SOOP, wworkiing iinstrructiions etc.) too proovidee an effiiciennt asseessmeent bba

5、siss to the audiitorss. Shhouldd anyy reqquireementt of the stanndardd be non-appllicabble, thiss musst bee indiicateed byy NAA unnder the Refferennces collumn and dulyy jusstifiied.第一列的問(wèn)問(wèn)題是針對(duì)對(duì)測(cè)試中的的實(shí)驗(yàn)室；要求實(shí)驗(yàn)驗(yàn)室在評(píng)估估開始前，根根據(jù)文件和和相應(yīng)的參參考指標(biāo)全全部解答，（例如：質(zhì)量手冊(cè)，標(biāo)準(zhǔn)操作規(guī)程，工作指示等），從而為核數(shù)師提供一個(gè)有效的評(píng)估依據(jù)。假如任何一個(gè)標(biāo)準(zhǔn)的要求不適用，則必須在參考項(xiàng)

6、下注明“不適用”，并用合理的解釋說(shuō)明。Durinng thhe auudit, thiis doocumeent pproviides a prractiical tooll forr thee audditorrs too makke suure tthat all elemmentss of the ISO/IEC 170225 sttandaard aand OOMCL guiddelinnes aare ccoverred, but it wwill not be uused as ssuch to pprepaare the audiit reeportt.在審計(jì)過(guò)程程中，這份份文件

7、為審計(jì)人員員提供了一一個(gè)實(shí)用的工具，以以確保所有有的檢測(cè)和校校準(zhǔn)實(shí)驗(yàn)室室能力的通通用要求標(biāo)準(zhǔn)以及藥品官官方檢驗(yàn)實(shí)實(shí)驗(yàn)室準(zhǔn)則則所涵蓋的內(nèi)內(nèi)容，但文文件并不會(huì)使用像這樣樣準(zhǔn)備的審計(jì)報(bào)告告。This docuumentt mayy alsso bee useed byy OMCCLs aas seelf-aassesssmennt off thee impplemeentattion stattus oof thhe Manaagemeent SSysteem, iindeppendeentlyy of any exteernall asssessmment.檢測(cè)和校校準(zhǔn)實(shí)驗(yàn)室室能力的通通用要求也可

8、使用用這份文件件，作為管理理系統(tǒng)執(zhí)行行情況的自自我評(píng)估，它獨(dú)立于任何的外部評(píng)估。II. DDefinnitioons aand AAbbreeviattionss二、定義和和縮略詞Docummentss, reecordds: ddocummentss andd reccordss cann be storred iin paaper or eelecttroniic (ccompuuter) forrm. RRuless mustt be defiined for the avaiilabiilityy of, acccess to aand ssafegguardding of eelec

9、ttroniic reecordds.文件，記錄錄：文件和和記錄可以以以紙張或電電子（電腦腦）的形式式存儲(chǔ)。且且必須為電電子記錄的的可用性、訪問(wèn)和維維護(hù)定義相相應(yīng)的規(guī)章章制度。QM = quallity manuualQM =質(zhì)質(zhì)量手冊(cè)O(shè)MCL = Offficiial MMedicciness Conntroll LabborattoryOMCL =藥品官官方檢驗(yàn)實(shí)實(shí)驗(yàn)室MJA = Muttual Joinnt AuuditMJA =聯(lián)合審計(jì)計(jì)OOS = Outt of SpeccificcatioonOOS =超標(biāo)NB: iin thhe teext Autthoriity reffers

10、 to: comppetennt auuthorrity thatt givves tthe oorderr to testt a mmediccinall prooducttNB：官方方文件中指指：主管機(jī)機(jī)關(guān)下令檢檢測(cè)藥品EDQM/OMCLL NETTWORKK MJAA AUDDIT IINFORRMATIION歐洲藥品管管理委員會(huì)會(huì)/藥品官官方檢驗(yàn)實(shí)實(shí)驗(yàn)室網(wǎng)絡(luò)絡(luò)聯(lián)合審計(jì)計(jì)信息(to bbe fiilledd in prioor too thee MJAA or duriing aassesssmennt ass an audiit reecordd)（提前填寫寫，并在聯(lián)聯(lián)合審計(jì)或或評(píng)估期

11、間間作為審計(jì)計(jì)記錄）Name of OOMCL 藥品官方方檢驗(yàn)實(shí)驗(yàn)驗(yàn)室名稱MJA NNumbeer 聯(lián)合審計(jì)計(jì)號(hào)Self-asseessmeent 自我評(píng)估估 YES 是 NO 否Date of sself-asseessmeent or MMJA 聯(lián)合審計(jì)計(jì)或自我評(píng)評(píng)估日期If YEES daate oof suubmisssionn 自我評(píng)估估項(xiàng)填“有”的，填提交日期期Name of ppersoon respponsiible 負(fù)責(zé)人姓姓名Signaaturee 簽名If NOO datte off MJAA 自我評(píng)估估項(xiàng)填“否”的，填聯(lián)合審審計(jì)日期Name of MMJA tteam

12、coorrdinaator 聯(lián)合審計(jì)計(jì)團(tuán)隊(duì)協(xié)調(diào)調(diào)員姓名Name of MMJA tteam membbers 聯(lián)合審計(jì)計(jì)團(tuán)隊(duì)成員員姓名Name of ppersoon isssuinng thhis recoord 此記錄發(fā)發(fā)行者姓名名SUMMAARY摘要 (figuures in pparennthesses rreferr to stanndardd EN ISO/IEC 170225)（括號(hào)中的的數(shù)字參考考檢測(cè)和校校準(zhǔn)實(shí)驗(yàn)室室能力的通通用要求標(biāo)準(zhǔn)）1. Orrganiisatiion 組織機(jī)構(gòu)構(gòu)1.1 OOrgannisattion and manaagemeent 組組織和管理理機(jī)構(gòu)(

13、44.1)2. Maanageementt sysstem 管理系統(tǒng)統(tǒng)2.1 MManaggemennt syystemm 管理系系統(tǒng)(4.2)2.2 DDocumment conttrol 文件監(jiān)控控(4.33)2.3 RRecorrd coontrool 記錄錄監(jiān)控(44.13)3. Exxternnal cco-opperattion (witth coompettent authhoritties and suppplierrs)對(duì)外合作（和和主管部門門及供應(yīng)商商）3.1 TTestiing oorderr revview 順序?qū)彶椴闄z測(cè)(4.4)3.2 SSub-ccontrract

14、iing oof teests 分包檢測(cè)測(cè)(4.55)3.3 PPurchhasinng seervicces aand ssuppllies 采購(gòu)服務(wù)務(wù)和供應(yīng)(4.6)3.4 SServiice tto thhe auuthorrity 服務(wù)管理理機(jī)構(gòu) (4.7)3.5 CCompllaintts 起訴訴(4.88)4. Maainteenancce off thee mannagemment systtem管理理系統(tǒng)的維維護(hù)4.1 CContrrol oof noonconnformming testting workk 控制不合格格檢測(cè)工作作(4.99)4.2 IImproovemeen

15、t 改改善(4.10)4.3 CCorreectivve acctionn 糾正措施施(4.111)4.4 PPreveentivve acctionn 預(yù)防措施施(4.112)4.5 IInterrnal audiits 內(nèi)內(nèi)部審計(jì)(4.144)4.6 MManaggemennt reeviewws 管理理審查(44.15)5. Peersonnnel 人員(5.2)6. Prremisses aand eequippmentt 物業(yè)及設(shè)設(shè)備6.1 PPremiises 物業(yè)(5.3)6.2 EEquippmentt 設(shè)備(5.5)6.3 CCompuuter systtem, conttr

16、ol of ddata 計(jì)算機(jī)系系統(tǒng)，數(shù)據(jù)據(jù)控制(5.4)6.4 MMeasuuremeent ttraceeabillity 可追溯性性測(cè)量(55.6)6.5 RReferrencee staandarrds 參參考標(biāo)準(zhǔn)(5.6/OMCLL)7. Haandliing oof teest iitemss 檢測(cè)項(xiàng)目目處理7.1 SSamplling 取樣(5.7)7.2 HHandlling of ttest itemms 檢測(cè)項(xiàng)目目處理(55.8)8. Teest mmethoods 檢測(cè)方法法8.1 TTest methhods and proccedurres, inclludinng

17、vaalidaationn (5.4)檢測(cè)方法和和程序，包包括驗(yàn)證8.2 QQuesttionss rellevannt foor meethodd traansfeer annd sccreenning 有關(guān)問(wèn)題的的方法轉(zhuǎn)讓讓和篩選(5.4/OMCLL)8.3 QQuesttionss rellevannt foor laaboraatoryy-devvelopped mmethoods (5.4)有關(guān)問(wèn)題的的實(shí)驗(yàn)室開開發(fā)方法8.4 AAssurring the quallity of ttest resuults (5.99/OMCCL)保證檢測(cè)結(jié)結(jié)果質(zhì)量8.5 TTechnnicall

18、reccordss (4.13.22)技術(shù)記錄9. Teest rreporrts 檢測(cè)報(bào)告告9.1 RReporrtingg thee ressultss 報(bào)告結(jié)結(jié)果(5.10)9.2 TTestss perrformmed bby suubconntracctorss 由分包包商進(jìn)行測(cè)測(cè)試(5.100.6)1. Orgganissatioon組織YNReferrencees/Coommennts參考考/評(píng)論1.1 Orgganissatioon annd maanageementt (4.1)組織織和管理1.1.11(4.1.1) - Namee andd adddresss of the

19、 OMCLL藥品官方檢檢驗(yàn)實(shí)驗(yàn)室室的名稱和和地址-Legaal iddentiity oof thhe orrganiisatiion (entrry inn thee commmercee reggisteer orr pubblic insttituttion)該組織的合合法身份（登登記在商業(yè)業(yè)注冊(cè)處或或公共機(jī)構(gòu)構(gòu)）-Fielld off acttivitties of tthe OOMCL藥品官方檢檢驗(yàn)實(shí)驗(yàn)室室現(xiàn)場(chǎng)活動(dòng)動(dòng)o Marrket survveilllancee tesstingg 市場(chǎng)監(jiān)督檢檢測(cè)o Offficiaal Baatch releease testting官方批放行

20、行檢測(cè)o -Namee andd adddresss of the labooratoory實(shí)驗(yàn)室的名名稱和地址址-Fielld off acttivitties of tthe llaborratorry (ggenerral)實(shí)驗(yàn)室現(xiàn)場(chǎng)場(chǎng)活動(dòng)（一一般）Has tthe OOMCL alreeady beenn acccrediited?該藥品官方方實(shí)驗(yàn)室是是否已經(jīng)被被認(rèn)可？If YEES, sscopee forr whiich aaccreeditaationn hass beeen grannted and by wwhichh acccrediitatiion bbody如果已被認(rèn)認(rèn)

21、可，獲資資格認(rèn)證的的范圍，且且被哪個(gè)機(jī)機(jī)構(gòu)認(rèn)證If NOO, sccope of tthe aappliied MManaggemennt Syystemm如果未被認(rèn)認(rèn)可，這個(gè)個(gè)應(yīng)用管理理系統(tǒng)的范范圍Scopee of actiivitiies tto bee audditedd durring the MJA聯(lián)合審計(jì)期期間的活動(dòng)動(dòng)審計(jì)范圍圍1.1.22(4.1.4) Iss thee labborattory partt of a paarentt orgganissatioon? IIf YEES whhat oorgannisattion?這個(gè)實(shí)驗(yàn)室室是否是上上級(jí)組織的的一部分？如果是，

22、是是什么組織織1.1.33(4.1.5e) Is therre onne orr sevverall orgganissatioonal charrt(s) forr thee whoole OOMCL showwing the posiitionn of the testting labooratoory, and is ssuch a chhart avaiilablle foor thhe teestinng laaboraatoryy itsself?是否有一個(gè)個(gè)或是數(shù)個(gè)個(gè)組織結(jié)構(gòu)構(gòu)圖，為藥藥品官方實(shí)實(shí)驗(yàn)室顯示示該檢測(cè)實(shí)實(shí)驗(yàn)室的位位置，且這這種圖標(biāo)是是否能供實(shí)實(shí)驗(yàn)室本身身使用？1.1.

23、44(4.1.4) Arre thhe reesponnsibiilitiies aand aauthooritiies oof thhe keey peersonnnel in tthe llaborratorry suuitabbly ddefinned sso thhat cconfllictss of inteerestt cann be avoiided?是否界定了了實(shí)驗(yàn)室中中關(guān)鍵人員員的責(zé)任和和權(quán)力，來(lái)來(lái)避免利益益沖突？1.1.55(4.1.5b )Iss it posssiblee to excllude any inflluencce onn thee ressultss ex

24、eercissed bby peersonns orr orgganissatioons eexterrnal to tthe ttestiing?是否可以排排除由個(gè)人人或機(jī)構(gòu)進(jìn)進(jìn)行的外部部檢測(cè)而對(duì)對(duì)結(jié)果造成成的任何影影響？1.1.66Is itt enssuredd thaat thhe OMMCL iis noot enngageed inn othher activvitiees thhat mmay eendannger its impaartiaalityy, itts indeependdencee andd itss inttegriity?是否能保證證藥品官方方檢驗(yàn)實(shí)驗(yàn)驗(yàn)室沒(méi)有

25、從從事其他可可能危及其其公正性，獨(dú)獨(dú)立性和完完整性的活活動(dòng)？1.1.77(4.1.5b) Is the techhnicaal annd fiinanccial indeependdencee bettweenn thee labborattory and exteernall cusstomeers eensurred?在實(shí)驗(yàn)室和和外部客戶戶之間是否否能確保技技術(shù)和經(jīng)濟(jì)濟(jì)的獨(dú)立？1.1.88(藥品官方方 How is iit ennsureed thhat tthe OOMCL perfformss thee檢驗(yàn)實(shí)驗(yàn)驗(yàn)室) tesstingg of prodductss inddepennd

26、enttly ffrom any coontraact wwork by oorderr of a phharmaaceutticall mannufacctureer orr entrrepreeneurr?如何確保藥藥品官方檢檢驗(yàn)實(shí)驗(yàn)室室對(duì)來(lái)自任任何藥品生生產(chǎn)商或企企業(yè)家的合合同要求進(jìn)進(jìn)行獨(dú)立的的產(chǎn)品測(cè)試試？See ccontrractss witth otther custtomerrs, ssee iif thhe OMMCL conttrolss prooductts frrom tthe conttracttor看看其他客客戶的合同同，藥品官官方檢驗(yàn)實(shí)實(shí)驗(yàn)室是否否控制來(lái)自自承建商的

27、的產(chǎn)品1.1.99(4.1.5h) Namee of the techhnicaal maanageer whho haas thhe ovveralll respponsiibiliity ffor tthe ooperaationn of the labooratoory.指派一名對(duì)對(duì)實(shí)驗(yàn)室的的運(yùn)作負(fù)有有全面責(zé)任的技術(shù)術(shù)經(jīng)理。1.1.110(4.1.5h) Are the quallificcatioons (traiiningg, cooursees, ppubliicatiions, expperieence) of the techhnicaal maanageer doocumee

28、ntedd?技術(shù)經(jīng)理是是否有資格格對(duì)（培訓(xùn)訓(xùn)，課程，出出版物和經(jīng)經(jīng)歷）進(jìn)行行記錄？1.1.111(4.1.5h/4.2.66) Is tthe aarea of ccompeetencce off thee tecchniccal mmanagger ddefinned? 是是否對(duì)技術(shù)術(shù)經(jīng)理的職職權(quán)范圍進(jìn)進(jìn)行了界定定？1.1.112(4.1.5j) Hass a ddeputty teechniical manaager beenn apppointted?是否有副技技術(shù)經(jīng)理被被任命？1.1.113(4.1.5i) Namee of the quallity manaager resppons

29、iible for the folllow up of tthe ppresccribeed woorkinng prrocedduress andd of the manaagemeent ssysteem指派質(zhì)量經(jīng)經(jīng)理負(fù)責(zé)跟跟進(jìn)規(guī)定的的工作程序序和管理制制度。1.1.114(4.1.5i) Are the quallificcatioons (traiiningg, cooursees, ppubliicatiions, expeeriennce) of tthe qqualiity mmanagger ddocummenteed?質(zhì)量經(jīng)理是是否有資格格對(duì)（培訓(xùn)訓(xùn)，課程，出出版物和經(jīng)經(jīng)歷）

30、進(jìn)行行記錄？1.1.115(4.1.5/4.2.66) Is tthe aarea of ccompeetencce off thee quaalityy mannagerr defiined?是否對(duì)質(zhì)量量經(jīng)理的職職權(quán)范圍進(jìn)進(jìn)行了界定定？1.1.116(4.1.5j) Hass a ddeputty quualitty maanageer beeen aappoiintedd?是否有副質(zhì)質(zhì)量經(jīng)理被被任命？1.1.117(4.1.5i) Doess thee quaalityy mannagerr havve diirectt acccess to tthe highhest leveel of

31、f mannagemment for the labooratoory?質(zhì)量經(jīng)理是是否能直接接進(jìn)入實(shí)驗(yàn)驗(yàn)室的最高高管理層？1.1.118(4.1.5k) Is it eensurred tthat perssonneel arre awware of tthe rrelevvancee and impoortannce oof thheir actiivitiies aand hhow tthey conttribuute tto thhe acchievvemennt off thee objjectiives of tthe manaagemeent ssysteem?是否能確保保工作人員

32、員意識(shí)到他他們活動(dòng)的的相關(guān)性和和重要性，是是否能確保保他們有助助于管理體體系目標(biāo)的的實(shí)現(xiàn)？1.1.119(4.1.6) Havee appproprriatee commmuniicatiion pproceessess beeen estaablisshed withhin tthe llaborratorry?實(shí)驗(yàn)室是否否有建立合合理的溝通過(guò)程？1.1.220(4.1.6) Doess commmuniicatiion rregarrdingg thee efffectiiveneess oof thhe manaagemeent ssysteem taakes placce?對(duì)管理體系系

33、的有效性性是否進(jìn)行行了溝通？2. Maanageementt Sysstem 管理體系系Y 是N否Referrencees / Commmentss參考/評(píng)論論2.1 MManaggemennt syystemm (4.2)2.1.11(4.2.1) Has the OMCLL esttabliishedd andd impplemeentedd a manaagemeent ssysteem cooveriing tthe ffull rangge off acttivitties for whicch ann auddit iis reequessted?藥品官方檢檢驗(yàn)實(shí)驗(yàn)室室是否建立并并

34、實(shí)施了一一個(gè)覆蓋審審計(jì)要求的的全部活動(dòng)動(dòng)范圍的管管理體系？2.1.22(4.2.1)Iss thee mannagemment systtem ddocummenteed too thee reqquireedextennt?管理體系是是否已記錄錄到所需程程度？2.1.33(4.2.1)Haas thhe doocumeentattion beenn madde avvailaable to aall sstafff membbers conccerneed? 文件是否否已受到工工作人員的的關(guān)注？2.1.44(4.2.1)Haave tthe sstafff memmberss undders

35、ttood the manaagemeentsysteem?工作人員是是否了解這這個(gè)管理體體系？2.1.55(4.2.2)Arre thhe vaariouus stteps of tthe mmanaggemennt syystemm, inclludinng a quallity poliicy sstateementt, doocumeentedd in a quallity manuual (QM)? 管理體系系的各個(gè)步步驟，包括括質(zhì)量政策策聲明，是是否在質(zhì)量量手冊(cè)中有有所記錄？2.1.66(4.1.3)Dooes tthe mmanaggemennt syystemm covver

36、aall tthe aactivvitiees off the OMCLL thaat arre peerforrmed insiide aand ooutsiide tthe permmanennt annd moobilee faccilitties for whicch thhe auudit is requuesteed? 覆蓋官方方藥品檢驗(yàn)驗(yàn)實(shí)驗(yàn)室所所有活動(dòng)的的管理體系系，是否為為審計(jì)要求求在內(nèi)外設(shè)設(shè)置了永久久性和可移移動(dòng)的設(shè)施施？2.1.77(4.2.2)Haas thhe reesponnsiblle maanageementt deffinedd in writting the

37、 quallity poliiciess andd objjectiives? 在修訂質(zhì)質(zhì)量政策和目標(biāo)標(biāo)時(shí)，是否否對(duì)有責(zé)任任的管理進(jìn)進(jìn)行了定義義？2.1.88(4.2.2)Arre ovveralll obbjecttivess esttabliishedd, annd arre thhey rrevieewed duriing mmanaggemennt reevieww? 是否建立立了總體目目標(biāo)，在管管理審查時(shí)時(shí)是否進(jìn)行行了復(fù)審？2.1.99(4.2.2)Dooes tthe qqualiity ppoliccy sttatemment incllude at lleastt theefo

38、lloowingg:質(zhì)量政策聲聲明是否至至少包括以以下內(nèi)容：a) thhe laaboraatoryy mannagemments coommittmentt to gooddprofeessioonal praccticee andd quaalityy of the testting,1）對(duì)實(shí)驗(yàn)驗(yàn)室管理需需承諾有良好的專專業(yè)實(shí)踐和和質(zhì)量檢測(cè)測(cè)b) a stattemennt off thee mannagemments inntenttionss witthrespeect tto thhe sttandaard oof seervicce thhe laaboraatoryy willl

39、proviide,2）管理目目的的聲明明，需提供供關(guān)于服務(wù)務(wù)實(shí)驗(yàn)室的的標(biāo)準(zhǔn)c) thhe puurposses oof thhe maanageementt sysstem,3）管理體體系的目的的d) a requuiremment thatt alll perrsonnnel cconceernedd witth teestinngactivvitiees wiithinn thee labborattory famiiliarrise themmselvves wwiththe qqualiity ddocummentaationn andd impplemeent tthe ppolic

40、cies andproceedurees inn theeir wwork,4）要求所所有人員在在實(shí)驗(yàn)室中中熟悉有關(guān)關(guān)的測(cè)試活活動(dòng)，以及及在工作中中的質(zhì)量文文件和政策策過(guò)程的實(shí)實(shí)施e) thhe laaboraatoryy mannagemments coommittmentt tocomplliancce wiith tthe iinterrnatiionall staandarrd ISSO/IEEC170025and tto coontinnuallly immprovve thhe efffecttivenness of tthemanaggemennt syystemm?5）實(shí)驗(yàn)室室

41、管理要承承諾遵守檢測(cè)和校校準(zhǔn)實(shí)驗(yàn)室室能力的通通用要求的國(guó)際標(biāo)標(biāo)準(zhǔn)，并不不斷完善管管理體系的的有效性2.1.110(4.2.3)Haas thhe toop maanageementt proovideed evvidennce oof commmitmeent tto thhe deeveloopmennt annd immplemmentaationn of the manaagemeent ssysteem annd too conntinuuallyy impprovee itss effeectivvenesss?最高管理部部門是否能能承諾發(fā)展展和實(shí)施管管理體系并并不斷完善善其有效性性

42、？2.1.111(4.2.4)Haas thhe toop maanageementt commmuniicateed too thee orgaanisaationn thee impportaance of mmeetiing aauthoorityy requuiremmentss as welll as stattutorry annd reegulaatoryy requuiremmentss?最高管理部部門是否向向組織傳達(dá)達(dá)了會(huì)議權(quán)權(quán)威以及法法律法規(guī)要要求的重要要性？2.1.112(4.2.5)Dooes tthe qqualiity mmanuaal inncludde orr

43、makke reefereence to alll the techhnicaal annd suupporrtingg prooceduures, requuiremmentss and rulees, aand ddoes it ooutliine tthe sstruccturee of the docuumenttatioon ussed iin thhe maanageementt sysstem?質(zhì)量手冊(cè)是是否包括或或參考了所有的技技術(shù)，配套程序序，以及要求和和規(guī)則？是否概述述了在管理理系統(tǒng)中使使用的文件件結(jié)構(gòu)？2.1.113(4.2.7)Iss it ensuured thatt

44、 thee inttegriity oof thhe maanageementt sysstem is mmainttaineed whhen cchangges tto thhe maanageementt sysstem are plannned and impllemennted?當(dāng)要變更已已策劃和實(shí)實(shí)施的管理理體系時(shí)，是是否能保證證維護(hù)后管管理體系的的穩(wěn)定性？2.2 DDocumment conttrol (4.33)文件控控制2.2.11(4.3.1)Iss a pproceeduree esttabliishedd to conttrol all docuumentts (oof

45、bothh intternaal annd exxternnal oorigiin) tthat are neceessarry foor thhe corrrect perfformaance of ttestiing ooperaationns?是否建立程程序來(lái)控制制對(duì)正確實(shí)實(shí)行檢驗(yàn)操操作有必要要的文件（包包括內(nèi)部和和外部來(lái)源源）2.2.22(4.3.2.1)Doess thee prooceduure sspeciify wwho iis reesponnsiblle foor thhe estaablisshmennt, rrevieew, aapprooval for use and

46、 mainntenaance of tthe mmanaggemennt syystemm doccumennts?是否指定程程序來(lái)負(fù)責(zé)責(zé)管理體系系文件的編編制，審查查，批準(zhǔn)使使用和維修修？2.2.33(4.3.2.1)Is ttheree a llist, tabble oor eqquivaalentt sysstem for idenntifyying all manaagemeent ssysteem doocumeents, witth thhe cuurrennt reevisiion stattus aand ddistrributtion?在當(dāng)前的修修訂狀態(tài)和和分布下，是否有列

47、表、表格、或是類似的系統(tǒng)來(lái)識(shí)別管理系統(tǒng)文件？2.2.44(4.3.2.2) 程序是是否能確保保：a) auuthorrisedd ediitionns off appproprriatee doccumennts aareavaillablee at all locaationns whhere operratioons eessenntiall to theeffecctivee funnctiooningg of the labooratoory aare pperfoormedd,1）適當(dāng)文文件的授權(quán)權(quán)版本在所所有位置都都可用，這這些位置是是實(shí)驗(yàn)室有有效運(yùn)作操操作說(shuō)必需的b) doocu

48、meents are periiodiccallyy revvieweed annd whherenecesssaryy revvisedd to ensuure ccontiinuinng suuitabbilitty anndcomplliancce wiith aappliicablle reequirremennts,2）文件需需定期審查查，并在必必要時(shí)修訂訂以確保持持續(xù)的適應(yīng)應(yīng)性，同時(shí)時(shí)要遵守適適用要求c) innvaliid orr obssolette doocumeents are prommptlyy remmoveddfrom all poinnts oof isssue

49、or uuse, or ootherrwisee asssureddagainnst uuninttendeed usse,3)及時(shí)從從發(fā)行或使用用過(guò)程中刪刪除所有無(wú)無(wú)效或過(guò)期期的文件，否否則需確保保無(wú)誤用d) obbsoleete ddocummentss rettaineed foor eiitherr leggal oor knowwledgge prreserrvatiion ppurpooses are suittablyy marrked?4）無(wú)論是是對(duì)于法律律還是知識(shí)識(shí)保存目的的，過(guò)期文文件的保留留需進(jìn)行適適當(dāng)記錄2.2.55(4.3.2.3) Aree alll mannage

50、mment systtem ddocummentss cleearlyy ideentiffied?是否所有管管理文件已已明確界定定？the ddate of iissuee andd/or apprrovall forr usee,1）發(fā)行和和/或批準(zhǔn)準(zhǔn)使用之日日起the ppage numbbers and the totaal nuumberr of pagees,2）頁(yè)碼和和總頁(yè)數(shù)the ppersoons aauthooriseed foor isssuinng thhe doocumeents?3）發(fā)行文文件的授權(quán)權(quán)人2.2.77(4.3.3.1)Are the respponsi

51、ibiliitiess andd autthoriitiess forr thee revvisioon annd amenndmennt off doccumennts cclearrly aand ssuitaably defiined?對(duì)于文件的的修訂和修修正是否能能清楚并合合適地界定定其職責(zé)和和權(quán)限？2.2.88(4.3.3.1)Has a prroceddure beenn esttabliishedd forr thee ameendmeent oof docuumentts?對(duì)于文件的的修訂是否否已建立程程序？2.2.99(4.3.3.2) Aree thee chaangess

52、 madde inn doccumennts cclearrly iidenttifieed?文件中的更更改是否可以清楚辨辨認(rèn)？2.2.110(4.3.3.2) Is it ppossiible to ttracee thee chaangess madde inn doccumennts?是否可以追追蹤文件所所做的更改改？2.2.111(4.3.3.3)Is tthe aamenddmentt of docuumentts byy hannd allloweed? IIf yees, has a prroceddure beenn deffinedd forr succh ammendmme

53、ntss?是否允許手手工修改文文件？如果果可以，是是否已確定定了修改程程序？2.2.112(4.3.3.4)Is ttheree an estaablisshed proccedurre too desscribbe hoow changges aare tto bee madde inn doccumennts mmainttaineed inn compputerrisedd sysstemss?是否建立了了程序來(lái)描描述如何對(duì)對(duì)電腦系統(tǒng)統(tǒng)中保存的的文件進(jìn)行行變更？2.3 RRecorrd coontrool (44.13)記錄控制制2.3.11 Is therre a proccedurr

54、e foor XX off quaalityy andd tecchniccal rrecorrds?:是否有一一個(gè)質(zhì)量技技術(shù)記錄的的XX程序序：（4.133.1.11) a) ideentifficattion,1）鑒定定b) coollecctionn, 2）收收集c) reegisttratiion, 3）登登記d) acccesss, 4）獲取取e) inndexiing, 5）索引引f) sttoragge, 6）保保存g) maainteenancce, 7）維護(hù)護(hù)h) reetrieevabiilityy, 88）檢索i) leegibiilityy 9）易易讀性2.3.22(4

55、.133.1.22)Is therre a proccedurre foor thhe arrchivving of ssuch recoords inclludinng thhe deefiniitionn of miniimum reteentioon tiimes?是否有一個(gè)個(gè)記錄保存存程序，包包括確定最最少保留時(shí)時(shí)間？2.3.33(4.133.1.33)Aree reccordss hanndledd in conffidennce aand hheld safeely prottecteed frrom lloss and damaage?是否有信心心處理記錄錄，以及對(duì)對(duì)損失和損損壞

56、的安全全保護(hù)？2.3.44(4.133.1.44)Is therre a proccedurre foor thhe prrotecctionn andd saffeguaardinng of ddata heldd on compputerrs?是否有程序序來(lái)保護(hù)和和維護(hù)計(jì)算算機(jī)上的數(shù)數(shù)據(jù)？2.3.55(4.1.5c)Hass thee labborattory estaablisshed rulees too enssure the prottectiion oof itts auuthorritys coonfiddentiial iinforrmatiion aand propprie

57、ttary righhts, and do tthesee rulles aalso coveer thhe elecctronnic sstoraage aand ttranssmisssion of ddata?實(shí)驗(yàn)室是否否有建立規(guī)規(guī)則，以確確保其權(quán)威威的機(jī)密信信息和專有有權(quán)利得到到保護(hù)，這些些規(guī)則是否否也覆蓋了了電子存儲(chǔ)儲(chǔ)和數(shù)據(jù)傳傳輸？3. Exxternnal CCoopeeratiion(withh commpeteent aauthooritiies aand ssuppllierss)對(duì)外合作（與與主管部門門和供應(yīng)商商）Y 是N否Referrencees / Commmentss

58、參考/評(píng)論論3.1 TTestiing oorderr revview (4.44)3.1.11(4.4.1)Has the OMCLL esttabliishedd prooceduures for the reviiew and inteernall hanndlinng off tesstingg ordders arriivingg froom thhe comppetennt auuthorritiees?藥品官方檢檢驗(yàn)實(shí)驗(yàn)室室是否為來(lái)來(lái)自主管機(jī)機(jī)構(gòu)的測(cè)試試要求的審審查和內(nèi)部部控制建立立了程序3.1.22(4.4.1) Do thesse prrocedduress enssure

59、thatt:這些程序是是否能保證證：a) teestinng orrderss aree onlly accceptted wwheree theerequiiremeents inclludinng thhe meethodds too be usedd areeadequuatelly deefineed annd doocumeentedd,1）測(cè)試次次序只接受受包括充分分界定和記記錄要使用用方法的要要求b) thhe laaboraatoryy hass thee tecchniccal ccapabbilitty anndresouurcess to meett thee reqqu

60、ireementts,2）實(shí)驗(yàn)室室有技術(shù)能能力和資源源來(lái)符合要要求c) thhe appproppriatte teest mmethoods aare sseleccted and capaableof meeetinng thhe auuthorritys reequirremennts?3）選擇合合適的測(cè)試試方法和符符合管理機(jī)機(jī)構(gòu)要求的的能力3.1.33(4.4.1)Is iit ennsureed thhat aany ddiffeerencces bbetweeen tthe ttestiing ordeer annd thhe teestinng poossibbilitties