direct ec european parliament council februari inspect verif good laboratori practic glp 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 june inspect verif good laboratori practic glp significantli amend time interest clariti ration direct codifi applic standardis organis process condit laboratori studi plan perform record report clinic test chemic protect man anim environ hereinaft refer quot good laboratori practic quot glp contribut reassur member state qualiti test data gener annex decis mutual accept data assess chemic council organis econom cooper develop oecd adopt principl good laboratori practic accept commun european parliament council direct ec februari harmonis law regul administr provis relat applic principl good laboratori practic verif applic test chemic substanc conduct test chemic desir specialist manpow test laboratori resourc wast ow duplic test differ laboratori practic member state appli anim protect requir number experi anim restrict accord council direct eec novemb approxim law regul administr provis member state protect anim experiment scientif purpos mutual recognit result test obtain standard recognis method essenti condit reduc number experi area order ensur test data gener laboratori member state recognis member state provid harmonis system studi audit inspect laboratori ensur work glp condit member state design author respons carri monitor complianc glp committe member appoint member state assist commiss technic applic direct cooper effort encourag free movement good mutual recognit member state procedur monitor complianc glp committe set council direct eec june approxim law regul administr provis relat classif packag label danger substanc purpos committe assist commiss applic direct contribut exchang inform experi field measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss direct prejudic oblig member state time limit transposit direct set annex ii part adopt direct articl direct appli inspect verif organis process condit laboratori studi plan perform record report clinic test carri accord rule regul chemic cosmet industri chemic medicin product food addit anim feed addit pesticid order assess effect product man anim environ purpos direct quot good laboratori practic quot glp laboratori practic conduct accord principl set direct ec direct concern interpret evalu test result articl procedur laid articl member state verifi complianc glp test laboratori territori claim glp conduct test chemic provis paragraph compli result inspect verif satisfactori member state question provid endors claim laboratori test carri compli glp formula quot assess conform glp direct ec date quot articl member state design author respons inspect laboratori territori audit studi carri laboratori assess complianc glp author refer paragraph inspect laboratori audit studi accord provis laid annex articl year member state draw report relat implement glp territori report list laboratori inspect date inspect carri summari conclus inspect report forward commiss year march commiss commun committe refer articl committe request inform addit element mention paragraph articl member state ensur commerci sensit confidenti inform gain access result glp complianc monitor activ made commiss nation regulatori design author laboratori studi sponsor directli concern inspect studi audit name laboratori subject inspect design author glp complianc statu date laboratori inspect studi audit conduct consid confidenti articl prejudic articl result laboratori inspect studi audit glp complianc carri member state bind member state member state consid laboratori territori claim glp complianc fact compli glp extent integr authent studi perform compromis forthwith inform commiss commiss inform member state articl member state suffici reason laboratori member state claim glp complianc carri test accord glp request inform member state request studi audit possibl conjunct inspect member state concern reach agreement member state question immedi inform member state commiss give reason decis commiss examin reason put forward member state committe refer articl measur accord procedur refer articl connect expert opinion design author member state commiss consid amend direct order resolv matter refer paragraph initi procedur refer articl view adopt amend articl commiss assist committe set articl direct eec hereinaft quot committe quot refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month committe adopt rule procedur articl committe examin question refer chairman initi request repres member state implement direct cooper author design member state technic administr matter aris implement glp exchang inform train inspector amend adapt formula refer articl annex account technic progress adopt accord procedur refer articl 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 regul ec european parliament council oj page offici journal oj oj direct amend council regul ec oj oj annex provis inspect verif glp contain part contain annex guid complianc monitor procedur good laboratori practic ii guidanc conduct test facil inspect studi audit oecd council decis recommend complianc principl good laboratori practic final octob revis oecd council decis amend annex council decis recommend complianc principl good laboratori practic march final part revis guid complianc monitor procedur glp facilit mutual accept test data gener submiss regulatori author oecd member countri harmonis procedur adopt monitor glp complianc compar qualiti rigour essenti aim part annex provid detail practic guidanc member state structur mechan procedur adopt establish nation glp complianc monitor programm programm internation accept recognis member state adopt glp principl establish complianc monitor procedur nation legal administr practic prioriti give scope initi subsequ coverag categori chemic type test member state establish glp monitor author due legal framework chemic control glp complianc programm establish guidanc set paragraph concern author complianc programm definit term definit term oecd principl good laboratori practic adopt articl direct ec european parliament council applic part annex addit definit appli glp principl principl good laboratori practic consist oecd principl good laboratori practic adopt articl direct ec glp complianc monitor period inspect test facil audit studi purpos verifi adher glp principl nation glp complianc programm scheme establish member state monitor glp complianc test facil territori mean inspect studi audit nation glp monitor author bodi establish member state respons monitor glp complianc test facil territori discharg function relat glp nation determin understood bodi establish member state test facil inspect site examin test facil procedur practic assess degre complianc glp principl inspect manag structur oper procedur test facil examin kei technic personnel interview qualiti integr data gener facil assess report studi audit comparison raw data record interim final report order determin raw data accur report determin test carri accord studi plan standard oper procedur obtain addit inform provid report establish practic emploi develop data impair valid inspector person perform test facil inspect studi audit behalf nation glp monitor author glp complianc statu level adher test facil glp principl assess nation glp monitor author regulatori author nation bodi legal respons aspect control chemic compon good laboratori practic complianc monitor procedur administr nation glp complianc programm respons properli constitut legal identifi bodi adequ staf work defin administr framework member state ensur nation glp monitor author directli respons adequ quot team quot inspector technic scientif expertis ultim respons team publish document relat adopt glp principl territori publish document provid detail nation glp complianc programm includ inform legal administr framework programm oper refer publish act norm document regul code practic inspect manual guidanc note period inspect criteria inspect schedul maintain record test facil inspect glp complianc statu studi audit nation intern purpos confidenti nation glp monitor author access commerci valuabl inform occas remov commerci sensit document test facil refer detail report member state make provis mainten confidenti inspector person gain access confidenti inform result glp complianc monitor activ ensur commerci sensit confidenti inform excis report test facil inspect studi audit made regulatori author test facil inspect concern studi audit studi sponsor personnel train nation glp monitor author ensur adequ number inspector number inspector requir depend number test facil involv nation glp complianc programm frequenc glp complianc statu test facil assess number complex studi undertaken test facil number special inspect audit request regulatori author ensur inspector adequ qualifi train inspector qualif practic experi rang scientif disciplin relev test chemic nation glp monitor author ensur arrang made train glp inspector regard individu qualif experi encourag consult includ joint train activ staff nation glp monitor author oecd member countri order promot intern harmonis interpret applic glp principl monitor complianc principl ensur inspector personnel includ expert contract financi interest test facil inspect studi audit firm sponsor studi provid inspector suitabl mean identif ident card inspector perman staff nation glp monitor author perman staff bodi separ nation glp monitor author emploi contract nation glp monitor author perform test facil inspect studi audit case nation glp monitor author ultim respons determin glp complianc statu test facil qualiti accept studi audit take action base result test facil inspect studi audit nation glp complianc programm glp complianc monitor intend ascertain test facil implement glp principl conduct studi capabl assur result data adequ qualiti member state publish detail nation glp complianc programm inform inter alia defin scope extent programm nation glp complianc programm cover limit rang chemic industri chemic pesticid pharmaceut includ chemic scope monitor complianc defin respect categori chemic type test subject physic chemic toxicolog ecotoxicolog provid indic mechan test facil enter programm applic glp principl health environment safeti data gener regulatori purpos mandatori mechan test facil complianc glp principl monitor nation glp monitor author provid inform categori test facil inspect studi audit nation glp complianc programm includ provis test facil inspect inspect includ gener test facil inspect studi audit complet studi provis special test facil inspect studi audit request regulatori author prompt queri aris submiss data regulatori author defin power inspector entri test facil access data held test facil includ specimen sop standard oper procedur document inspector enter test facil facil manag circumst aris test facil entri access data essenti protect public health environ power nation glp monitor author case defin describ test facil inspect studi audit procedur verif glp complianc document procedur examin organis process condit studi plan perform monitor record guidanc procedur part annex describ action follow test facil inspect studi audit follow test facil inspect studi audit test facil inspect studi audit complet inspector prepar written report find member state action deviat glp principl found test facil inspect studi audit action document nation glp monitor author test facil inspect studi audit reveal minor deviat glp principl facil requir correct minor deviat inspector time return facil verifi correct introduc minor deviat found nation glp monitor author issu statement test facil inspect found oper complianc glp principl date inspect categori test inspect test facil time includ statement provid inform nation glp monitor author oecd member countri provid regulatori author request studi audit detail report find deviat found action nation glp monitor author depend circumst case legal administr provis glp complianc monitor establish countri action includ limit issuanc statement give detail inadequaci fault found affect valid studi conduct test facil issuanc recommend regulatori author studi reject suspens test facil inspect studi audit test facil administr remov test facil nation glp complianc programm exist list regist test facil subject glp test facil inspect requir statement detail deviat attach specif studi report action court warrant circumst legal administr procedur permit appeal procedur problem differ opinion inspector test facil manag resolv test facil inspect studi audit agreement reach procedur exist test facil make represent relat outcom test facil inspect studi audit glp complianc monitor relat action glp monitor author propos thereon part revis guidanc conduct test facil inspect studi audit introduct purpos part annex provid guidanc conduct test facil inspect studi audit mutual accept oecd member countri princip concern test facil inspect activ occupi time glp inspector test facil inspect includ studi audit review part inspect studi audit conduct time time request regulatori author gener guidanc conduct studi audit found end annex test facil inspect conduct determin degre conform test facil studi glp principl determin integr data assur result data adequ qualiti assess decis make nation regulatori author result report describ degre adher test facil glp principl test facil inspect conduct regular routin basi establish maintain record glp complianc statu test facil clarif point part annex obtain refer oecd consensu document glp role respons studi director definit term definit term oecd principl glp adopt articl direct ec part annex applic part annex test facil inspect inspect complianc glp principl place test facil gener health environment safeti data regulatori purpos inspector requir audit data relat physic chemic toxicolog ecotoxicolog properti substanc prepar case inspector assist expert disciplin wide divers facil term physic layout manag structur varieti type studi encount inspector mean inspector judgment assess degre extent complianc glp principl inspector strive consist approach evalu case test facil studi adequ level complianc glp principl achiev section guidanc provid aspect test facil includ personnel procedur examin inspector section statement purpos illustr list specif item consid test facil inspect list meant comprehens inspector concern scientif design studi interpret find studi respect risk human health environ aspect respons regulatori author data submit regulatori purpos test facil inspect studi audit inevit disturb normal work facil inspector carri work carefulli plan practic respect wish manag test facil time visit section facil inspector conduct test facil inspect studi audit access confidenti commerci valuabl inform essenti ensur inform authoris personnel respons respect establish nation glp complianc monitor programm inspect procedur pre inspect purpos familiaris inspector facil inspect respect manag structur physic layout build rang studi prior conduct test facil inspect studi audit inspector familiaris facil visit exist inform facil review includ previou inspect report layout facil organis chart studi report protocol curricula vita cv personnel document provid inform type size layout facil rang studi encount inspect manag structur facil inspector note defici previou test facil inspect previou test facil inspect conduct pre inspect visit made obtain relev inform test facil inform date time inspector arriv object visit length time expect premis test facil ensur personnel document case document record examin identifi test facil advanc visit immedi test facil inspect start confer purpos inform manag staff facil reason test facil inspect studi audit place identifi facil area studi i select audit document personnel involv administr practic detail test facil inspect studi audit discuss manag facil start visit start confer inspector outlin purpos scope visit describ document requir test facil inspect list complet studi studi plan standard oper procedur studi report access arrang copi relev document agre time clarifi request inform manag structur organis personnel facil request inform conduct studi subject glp principl area test facil glp studi conduct make initi determin part facil cover test facil inspect describ document specimen need complet studi i select studi audit close confer held complet inspect proceed test facil inspect advis inspector establish contact facil qualiti assur qa unit gener rule inspect facil inspector find help accompani member qa unit inspector request room set examin document activ organis personnel purpos determin test facil suffici qualifi personnel staff resourc support servic varieti number studi undertaken organis structur manag establish polici train staff health surveil studi undertaken facil manag ask produc document floor plan facil manag scientif organis chart cv personnel involv type studi select studi audit list complet studi inform type studi initi complet date test system method applic test substanc studi director staff health surveil polici staff job descript staff train programm record index facil standard oper procedur sop specif sop relat studi procedur inspect audit list studi director sponsor studi i audit inspector check list complet studi ascertain level work undertaken test facil ident qualif studi director head qualiti assur unit personnel exist sop relev area test qualiti assur programm purpos determin mechan assur manag studi conduct accord glp principl adequ head qa unit ask demonstr system method qa inspect monitor studi system record observ made qa monitor inspector check qualif head qa qa staff qa unit function independ staff involv studi qa unit schedul conduct inspect monitor identifi critic phase studi resourc qa inspect monitor activ studi short durat monitor studi impractic arrang exist monitor sampl basi extent depth qa monitor practic phase studi extent depth qa monitor routin test facil oper qa procedur check final report ensur agreement raw data manag receiv report qa problem affect qualiti integr studi action qa deviat found qa role studi part studi contract laboratori part plai qa review revis updat sop facil purpos determin test facil indoor outdoor suitabl size design locat meet demand studi undertaken inspector check design enabl adequ degre separ test substanc anim diet patholog specimen studi confus environment control monitor procedur exist function adequ critic area anim biolog test system room test substanc storag area laboratori area gener housekeep adequ facil pest control procedur care hous contain biolog test system purpos determin test facil engag studi anim biolog test system support facil condit care hous contain adequ prevent stress problem affect test system qualiti data test facil carri studi requir divers anim plant speci microbi cellular cellular system type test system determin aspect relat care hous contain inspector monitor judgment inspector check test system facil adequ test system test arrang quarantin anim plant introduc facil arrang work satisfactorili arrang isol anim element test system suspect diseas carrier diseas adequ monitor record keep health behaviour aspect test system equip maintain environment condit requir test system adequ maintain effect anim cage rack tank contain accessori equip suffici clean analys check environment condit support system carri requir facil exist remov dispos anim wast refus test system oper minimis vermin infest odour diseas hazard environment contamin storag area provid anim feed equival materi test system area storag materi test substanc pest control chemic disinfect separ area anim hous biolog test system store feed bed protect deterior advers environment condit infest contamin apparatu materi reagent specimen purpos determin test facil suitabl locat oper apparatu suffici quantiti adequ capac meet requir test conduct facil materi reagent specimen properli label store inspector check apparatu clean good work order record oper mainten verif calibr valid measur equip apparatu includ computeris system materi chemic reagent properli label store temperatur expiri date label reagent sourc ident concentr pertin inform specimen identifi test system studi natur date collect apparatu materi alter appreci extent test system test system purpos determin adequ procedur exist handl control varieti test system requir studi undertaken facil chemic physic system cellular microb system plant anim physic chemic system inspector check requir studi plan stabil test refer substanc determin refer substanc test plan autom system data gener graph record trace comput print out document raw data archiv biolog test system take account relev aspect refer relat care hous contain biolog test system inspector check test system studi plan test system adequ uniqu identifi studi record exist receipt test system document fulli number test system receiv replac discard hous contain test system properli identifi inform adequ separ studi conduct anim speci biolog test system substanc adequ separ anim speci biolog test system space time biolog test system environ studi plan sop aspect temperatur light dark cycl record receipt handl hous contain care health evalu test system written record examin quarantin morbid mortal behaviour diagnosi treatment anim plant test system similar aspect biolog test system provis dispos test system end test test refer substanc purpos determin test facil procedur design ensur ident potenc quantiti composit test refer substanc accord specif ii properli receiv store test refer substanc inspector check written record receipt includ identif person respons handl sampl usag storag test refer substanc test refer substanc contain properli label storag condit preserv concentr puriti stabil test refer substanc written record determin ident puriti composit stabil prevent contamin test refer substanc applic procedur determin homogen stabil mixtur test refer substanc applic contain hold mixtur dilut test refer substanc label record homogen stabil content applic test longer week durat sampl batch test refer substanc analyt purpos retain time procedur mix substanc design prevent error identif cross contamin standard oper procedur purpos determin test facil written sop relat import aspect oper import manag techniqu control facil oper written sop relat directli routin element test conduct test facil inspector check test facil area immedi relev authoris copi sop procedur exist revis updat sop amend sop authoris date histor file sop maintain sop necessarili limit activ receipt determin ident puriti composit stabil label handl sampl usag storag test refer substanc ii mainten clean calibr valid measur apparatu computeris system environment control equip iii prepar reagent dose formul iv record keep report storag retriev record report prepar environment control area test system vi receipt transfer locat characteris identif care test system vii handl test system termin studi viii dispos test system ix pest control clean agent qualiti assur programm oper perform studi purpos verifi written studi plan exist plan conduct studi accord glp principl inspector check studi plan sign studi director amend studi plan sign date studi director date agreement studi plan sponsor record applic measur observ examin accord studi plan relev sop result measur observ examin record directli promptli accur legibl sign initial date raw data includ data store comput obscur previou entri includ reason chang identifi person respons chang date made comput gener store data identifi procedur protect unauthoris amend loss adequ computeris system studi reliabl accur valid unforeseen event record raw data investig evalu result present report studi interim final consist complet correctli reflect raw data report studi result purpos determin final report prepar accord glp principl examin final report inspector check sign date studi director accept respons valid studi confirm studi conduct accord glp principl sign date princip scientist report cooper disciplin includ qualiti assur statement includ report sign date amend made respons personnel list archiv locat sampl specimen raw data storag retent record purpos determin facil gener adequ record report adequ provis made safe storag retent record materi inspector check person identifi respons archiv archiv facil storag studi plan raw data includ discontinu glp studi final report sampl specimen record educ train personnel procedur retriev archiv materi procedur access archiv limit authoris personnel record personnel access raw data slide inventori maintain materi remov return archiv record materi retain requir period time protect loss damag fire advers environment condit studi audit test facil inspect gener includ inter alia studi audit review complet studi specif studi audit request regulatori author conduct independ test facil inspect wide variat type studi audit gener guidanc inspector take part studi audit exercis judgment natur extent examin object reconstruct studi compar final report studi plan relev sop raw data archiv materi case inspector assist expert order conduct effect studi audit examin tissu section microscop conduct studi audit inspector obtain name job descript summari train experi select personnel engag studi i studi director princip scientist check suffici staff train relev area studi i undertaken identifi individu item apparatu special equip studi examin calibr mainten servic record equip review record relat stabil test substanc analys test substanc formul analys feed attempt determin interview process work assign select individu particip studi ascertain individu time accomplish task studi plan report obtain copi document control procedur form integr part studi includ studi plan ii sop time studi iii logbook laboratori notebook file worksheet print out comput store data check calcul iv final report studi anim rodent mammal inspector follow percentag individu anim arriv test facil autopsi pai attent record relat anim bodi weight food water intak dose formul administr clinic observ autopsi find clinic chemistri patholog complet inspect studi audit test facil inspect studi audit complet inspector prepar discuss find repres test facil close confer prepar written report inspect report test facil inspect larg facil reveal number minor deviat glp principl suffici affect valid studi eman test facil case reason inspector report facil oper complianc glp principl criteria establish nation glp monitor author detail inadequaci fault detect provid test facil assur sought senior manag action remedi inspector revisit facil period time verifi action deviat glp principl identifi test facil inspect studi audit opinion inspector affect valid studi studi perform facil inspector report back nation glp monitor author action author regulatori author depend natur extent complianc legal administr provis glp complianc programm studi audit conduct request regulatori author full report find prepar relev nation glp monitor author 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