direct ec european parliament council februari harmonis law regul administr provis relat applic principl good laboratori practic verif applic test chemic substanc codifi version text eea relev european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion european econom social committe act accord procedur laid articl treati council direct eec decemb harmonis law regul administr provis relat applic principl good laboratori practic verif applic test chemic substanc significantli amend interest clariti ration direct codifi council direct eec june approxim law regul administr provis relat classif packag label danger substanc requir test carri chemic substanc order enabl potenti risk man environ determin activ substanc pesticid undergo test accord direct eec direct ec european parliament council novemb commun code relat veterinari medicin product direct ec european parliament council novemb commun code relat medicin product human lai clinic test pharmaceut product carri accord principl good laboratori practic glp forc commun chemic substanc complianc requir commun legisl method test laid annex direct eec compli principl glp carri test laid direct eec ensur result compar high qualiti resourc devot test wast repeat test ow differ laboratori practic member state council organis econom cooper develop oecd decis mutual accept data evalu chemic product issu recommend juli mutual recognit complianc glp principl glp modifi oecd council decis final anim protect requir number experi conduct anim restrict mutual recognit result test obtain standard recognis method essenti condit reduc number experi area set procedur allow rapid adapt principl glp direct prejudic oblig member state time limit transposit direct set annex ii part adopt direct articl member state measur ensur laboratori carri test chemic product accord direct eec compli principl good laboratori practic glp laid annex direct paragraph appli commun provis provid applic principl glp respect test chemic product evalu safeti man environ articl submit result laboratori refer articl certifi test carri conform principl glp refer articl articl member state adopt measur verif complianc principl glp measur includ inspect studi check accord recommend oecd area member state notifi commiss name author author respons verifi complianc principl glp refer paragraph commiss inform member state thereof articl adapt principl glp mention articl adopt accord procedur refer articl direct eec articl commun provis requir applic principl glp entri forc direct test chemic product member state ground relat principl glp prohibit restrict imped place market chemic product principl appli laboratori concern conform mention articl member state establish basi detail evid applic principl glp verif applic test chemic substanc show chemic substanc examin accord requir direct present danger man environ member state provision prohibit make subject special condit market substanc territori immedi inform commiss member state thereof give ground decis commiss week consult member state concern give opinion suitabl measur delai commiss technic adapt direct adapt adopt commiss council accord procedur refer articl case member state adopt safeguard measur maintain entri forc adapt articl direct eec repeal prejudic oblig member state time limit transposit direct set annex ii part refer made repeal direct constru made direct read accord correl tabl annex iii articl direct enter forc dai public offici journal european union articl direct address member state strasbourg februari european parliament presid cox council presid mcdowel oj opinion european parliament juli publish offici journal decis council januari oj direct amend commiss direct ec oj oj direct amend regul ec oj oj oj direct amend commiss direct ec oj annex oecd principl good laboratori practic glp content gt tabl gt section introduct prefac govern industri concern qualiti clinic health environment safeti studi hazard assess base consequ oecd member state establish criteria perform studi avoid scheme implement imped intern trade chemic oecd member state pursu intern harmonis test method good laboratori practic intern group expert establish special programm control chemic develop quot oecd principl good laboratori practic quot glp utilis common manageri scientif practic experi nation intern sourc principl glp adopt oecd council annex council decis mutual accept data assess chemic final group expert form revis updat principl current document result consensu reach group cancel replac origin principl adopt purpos principl good laboratori practic promot develop qualiti test data compar qualiti test data form basi mutual accept data countri individu countri confid reli test data develop countri duplic test avoid save time resourc applic principl avoid creation technic barrier trade improv protect human health environ scope principl good laboratori practic appli clinic safeti test test item contain pharmaceut product pesticid product cosmet product veterinari drug food addit feed addit industri chemic test item frequent synthet chemic natur biolog origin circumst live organ purpos test test item obtain data properti safeti respect human health environ clinic health environment safeti studi cover principl good laboratori practic includ work conduct laboratori greenhous field specif exempt nation legisl principl good laboratori practic appli clinic health environment safeti studi requir regul purpos regist licens pharmaceut pesticid food feed addit cosmet product veterinari drug product similar product regul industri chemic definit term good laboratori practic good laboratori practic glp qualiti system concern organis process condit clinic health environment safeti studi plan perform monitor record archiv report term organis test facil test facil mean person premis oper unit conduct clinic health environment safeti studi multisit studi conduct site test facil compris site studi director locat individu test site individu collect consid test facil test site mean locat phase studi conduct test facil manag mean person author formal respons organis function test facil principl good laboratori practic test site manag appoint mean person respons ensur phase studi respons conduct principl good laboratori practic sponsor mean entiti commiss support submit clinic health environment safeti studi studi director mean individu respons conduct clinic health environment safeti studi princip investig mean individu multisit studi act behalf studi director defin respons deleg phase studi studi director respons conduct studi deleg princip investig includ approv studi plan amend approv final report ensur applic principl good laboratori practic qualiti assur programm mean defin system includ personnel independ studi conduct design assur test facil manag complianc principl good laboratori practic standard oper procedur sop mean document procedur describ perform test activ detail studi plan test guidelin master schedul mean compil inform assist assess workload track studi test facil term clinic health environment safeti studi clinic health environment safeti studi henceforth refer simpli quot studi quot mean experi set experi test item examin laboratori condit environ obtain data properti safeti intend submiss regulatori author short term studi mean studi short durat wide routin techniqu studi plan mean document defin object experiment design conduct studi includ amend studi plan amend mean intend chang studi plan studi initi date studi plan deviat mean unintend departur studi plan studi initi date test system mean biolog chemic physic system combin thereof studi raw data mean origin test facil record document verifi copi thereof result origin observ activ studi raw data includ photograph microfilm microfich copi comput readabl media dictat observ record data autom instrument data storag medium recognis capabl provid secur storag inform time period state section specimen mean materi deriv test system examin analysi retent experiment start date mean date studi specif data collect experiment complet date mean date data collect studi studi initi date mean date studi director sign studi plan studi complet date mean date studi director sign final report term test item test item mean articl subject studi refer item control item mean articl provid basi comparison test item batch mean specif quantiti lot test item refer item produc defin cycl manufactur expect uniform charact design vehicl mean agent serv carrier mix dispers solubilis test item refer item facilit administr applic test system section ii good laboratori practic principl test facil organis personnel test facil manag respons test facil manag ensur principl good laboratori practic compli test facil minimum ensur statement exist identifi individu test facil fulfil respons manag defin principl good laboratori practic ensur suffici number qualifi personnel facil equip materi time proper conduct studi ensur mainten record qualif train experi job descript profession technic individu ensur personnel understand function perform provid train function ensur technic valid standard oper procedur establish approv origin revis standard oper procedur ensur qualiti assur programm design personnel assur qualiti assur respons perform accord principl good laboratori practic ensur studi individu qualif train experi design manag studi director studi initi replac studi director establish procedur document ensur event multisit studi need princip investig design appropri train qualifi experienc supervis deleg phase studi replac princip investig establish procedur document ensur document approv studi plan studi director ensur studi director made approv studi plan qualiti assur personnel ensur mainten histor file standard oper procedur ensur individu identifi respons manag archiv ensur mainten master schedul ensur test facil suppli meet requir studi ensur multisit studi clear line commun exist studi director princip investig qualiti assur programm studi personnel ensur test refer item appropri characteris establish procedur ensur computeris system suitabl intend purpos valid oper maintain accord principl good laboratori practic phase studi conduct test site test site manag appoint respons defin except studi director respons studi director singl point studi control respons conduct studi final report respons includ limit function studi director approv studi plan amend studi plan date signatur ensur qualiti assur personnel copi studi plan amend time manner commun effect qualiti assur personnel requir conduct studi ensur studi plan amend standard oper procedur studi personnel ensur studi plan final report multisit studi identifi defin role princip investig test facil test site involv conduct studi ensur procedur studi plan assess document impact deviat studi plan qualiti integr studi correct action acknowledg deviat standard oper procedur conduct studi ensur raw data gener fulli document record ensur computeris system studi valid sign date final report accept respons valid data extent studi compli principl good laboratori practic ensur complet includ termin studi studi plan final report raw data support materi archiv princip investig respons princip investig ensur deleg phase studi conduct accord applic principl good laboratori practic studi personnel respons personnel involv conduct studi knowledg part principl good laboratori practic applic involv studi studi personnel access studi plan standard oper procedur applic involv studi respons compli instruct document deviat instruct document commun directli studi director princip investig studi personnel respons record raw data promptli accur complianc principl good laboratori practic respons qualiti data studi personnel exercis health precaut minimis risk ensur integr studi commun person relev health medic condit order exclud oper affect studi qualiti assur programm gener test facil document qualiti assur programm assur studi perform complianc principl good laboratori practic qualiti assur programm carri individu individu design directli respons manag familiar test procedur individu involv conduct studi assur respons qualiti assur personnel respons qualiti assur personnel includ limit function maintain copi approv studi plan standard oper procedur test facil access date copi master schedul verifi studi plan inform requir complianc principl good laboratori practic verif document conduct inspect determin studi conduct accord principl good laboratori practic inspect determin studi plan standard oper procedur made studi personnel inspect type qualiti assur programm standard oper procedur studi base inspect facil base inspect process base inspect record inspect retain inspect final report confirm method procedur observ accur complet report result accur complet reflect raw data studi promptli report inspect result write manag studi director princip investig respect manag applic prepar sign statement includ final report specifi type inspect date includ phase studi inspect date inspect result report manag studi director princip investig applic statement serv confirm final report reflect raw data facil gener test facil suitabl size construct locat meet requir studi minimis disturb interfer valid studi design test facil provid adequ degre separ activ assur proper conduct studi test system facil test facil suffici number room area assur isol test system isol individu project involv substanc organ suspect biohazard suitabl room area diagnosi treatment control diseas order ensur unaccept degre deterior test system storag room area need suppli equip storag room area separ room area hous test system provid adequ protect infest contamin deterior facil handl test refer item prevent contamin mix up separ room area receipt storag test refer item mix test item vehicl storag room area test item separ room area test system adequ preserv ident concentr puriti stabil ensur safe storag hazard substanc archiv facil archiv facil provid secur storag retriev studi plan raw data final report sampl test item specimen archiv design archiv condit protect content untim deterior wast dispos handl dispos wast carri jeopardis integr studi includ provis collect storag dispos facil decontamin transport procedur apparatu materi reagent apparatu includ valid computeris system gener storag retriev data control environment factor relev studi suitabl locat design adequ capac apparatu studi period inspect clean maintain calibr standard oper procedur record activ maintain calibr traceabl nation intern standard measur apparatu materi studi interfer advers test system chemic reagent solut label ident concentr expiri date specif storag instruct inform sourc prepar date stabil expiri date extend basi document evalu analysi test system physic chemic apparatu gener physic chemic data suitabl locat design adequ capac integr physic chemic test system ensur biolog proper condit establish maintain storag hous handl care biolog test system order ensur qualiti data newli receiv anim plant test system isol health statu evalu unusu mortal morbid occur lot studi human destroi experiment start date studi test system free diseas condit interfer purpos conduct studi test system diseas injur studi isol treat maintain integr studi diagnosi treatment diseas studi record record sourc date arriv arriv condit test system maintain biolog test system acclimatis test environ adequ period administr applic test refer item inform need properli identifi test system hous contain individu test system remov hous contain conduct studi bear identif hous contain test system clean sanitis interv materi contact test system free contamin level interfer studi bed anim chang requir sound husbandri practic pest control agent document test system field studi locat avoid interfer studi sprai drift past usag pesticid test refer item receipt handl sampl storag record includ test item refer item characteris date receipt expiri date quantiti receiv studi maintain handl sampl storag procedur identifi order homogen stabil assur degre contamin mix preclud storag contain carri identif inform expiri date specif storag instruct characteris test refer item appropri identifi code chemic abstract servic registri number ca number biolog paramet studi ident includ batch number puriti composit concentr characterist appropri defin batch test refer item case test item suppli sponsor mechan develop cooper sponsor test facil verifi ident test item subject studi stabil test refer item storag test condit studi test item administ appli vehicl homogen concentr stabil test item vehicl determin test item field studi tank mix determin separ laboratori experi sampl analyt purpos batch test item retain studi short term studi standard oper procedur test facil written standard oper procedur approv test facil manag intend ensur qualiti integr data gener test facil revis standard oper procedur approv test facil manag separ test facil unit area immedi current standard oper procedur relev activ perform publish text book analyt method articl manual supplement standard oper procedur deviat standard oper procedur relat studi document acknowledg studi director princip investig applic standard oper procedur limit categori test facil activ detail head consid illustr exampl test refer item receipt identif label handl sampl storag apparatu materi reagent apparatu mainten clean calibr computeris system valid oper mainten secur chang control back materi reagent solut prepar label record keep report storag retriev code studi data collect prepar report index system handl data includ computeris system test system room prepar environment room condit test system procedur receipt transfer proper placement characteris identif care test system test system prepar observ examin conclus studi handl test system individu found moribund dead studi collect identif handl specimen includ necropsi histopatholog site placement test system test plot qualiti assur procedur oper qualiti assur personnel plan schedul perform document report inspect perform studi studi plan studi written plan exist prior initi studi studi plan approv date signatur studi director verifi glp complianc qualiti assur personnel section ii studi plan approv test facil manag sponsor requir nation regul legisl countri studi perform amend studi plan justifi approv date signatur studi director maintain studi plan deviat studi plan explain acknowledg date time fashion studi director princip investig maintain studi raw data short term studi gener studi plan accompani studi specif supplement content studi plan studi plan limit inform identif studi test item refer item descript titl statement reveal natur purpos studi identif test item code iupac ca number biolog paramet refer item inform sponsor test facil address sponsor address test facil test site involv address studi director address princip investig phase studi deleg studi director respons princip investig date date approv studi plan signatur studi director date approv studi plan signatur test facil manag sponsor requir nation regul legisl countri studi perform propos experiment start complet date test method refer oecd test guidelin test guidelin method issu applic justif select test system characteris test system speci strain substrain sourc suppli number bodi weight rang sex ag pertin inform method administr reason choic dose level concentr frequenc durat administr applic detail inform experiment design includ descript chronolog procedur studi method materi condit type frequenc analysi measur observ examin perform statist method record list record retain conduct studi uniqu identif studi item studi carri identif specimen studi identifi confirm origin identif enabl traceabl specimen studi studi conduct accord studi plan data gener conduct studi record directli promptli accur legibl individu enter data entri sign initial date chang raw data made obscur previou entri reason chang date sign initial individu make chang data gener direct comput input identifi time data input individu respons direct data entri computeris system design provid retent full audit trail show data obscur origin data associ data person made time date electron signatur reason report studi result gener final report prepar studi case short term studi standardis final report accompani studi specif extens prepar report princip investig scientist involv studi sign date final report sign date studi director accept respons valid data extent complianc principl good laboratori practic correct addit final report form amend amend reason correct addit sign date studi director reformat final report compli submiss requir nation registr regulatori author constitut correct addit amend final report content final report final report includ limit inform identif studi test item refer item descript titl identif test item code iupac ca number biolog paramet identif refer item characteris test item includ puriti stabil homogen inform sponsor test facil address sponsor address test facil test site involv address studi director address princip investig phase studi deleg applic address scientist contribut report final report date experiment start complet date statement qualiti assur programm statement list type inspect made date includ phase inspect date inspect result report manag studi director princip investig applic statement serv confirm final report reflect raw data descript materi test method descript method materi refer oecd test guidelin test guidelin method result summari result inform data requir studi plan present result includ calcul determin statist signific evalu discuss result conclus storag locat studi plan sampl test refer item specimen raw data final report store storag retent record materi retain archiv period author studi plan raw data sampl test refer item specimen final report studi record inspect perform qualiti assur programm master schedul record qualif train experi job descript personnel record report mainten calibr apparatu valid document computeris system histor file standard oper procedur environment monitor record absenc requir retent period final disposit studi materi document sampl test refer item specimen dispos expiri requir retent period reason justifi document sampl test refer item specimen retain long qualiti prepar permit evalu materi retain archiv index facilit orderli storag retriev personnel authoris manag access archiv movement materi archiv properli record test facil archiv contract facil busi legal successor archiv transfer archiv sponsor studi annex ii part repeal direct amend articl gt tabl gt part deadlin transposit nation law articl gt tabl gt annex iii correl tabl gt tabl gt