commiss direct ec octob lai principl guidelin good manufactur practic respect medicin product human investig medicin product human text eea relev commiss european commun regard treati establish european commun regard direct ec european parliament council novemb commun code relat medicin product human amend commiss direct ec articl thereof medicin product human manufactur import commun includ medicin product intend export manufactur accord principl guidelin good manufactur practic principl guidelin set commiss direct eec june lai principl guidelin good manufactur practic medicin product human articl direct ec european parliament council april approxim law regul administr provis member state relat implement good clinic practic conduct clinic trial medicin product human requir detail guidanc drawn accord guidelin good manufactur practic element account evalu investig medicin product human object releas batch commun extend adapt provis direct eec cover good manufactur practic investig medicin product provis direct eec adjust sake clariti direct replac order ensur conform principl guidelin good manufactur practic lai detail provis inspect compet author oblig manufactur manufactur oper effect qualiti manag system manufactur oper requir implement pharmaceut qualiti assur system principl guidelin good manufactur practic set relat qualiti manag personnel premis equip document product qualiti control contract complaint product recal inspect order protect human be involv clinic trial ensur investig medicin product trace specif provis label product measur provid direct accord opinion stand committe medicin product human set articl direct ec adopt direct articl scope direct lai principl guidelin good manufactur practic respect medicin product human manufactur requir authoris refer articl direct ec respect investig medicin product human manufactur requir authoris refer articl direct ec articl definit purpos direct definit appli quot medicin product quot mean product defin articl direct ec quot investig medicin product quot mean product defin articl direct ec quot manufactur quot mean person engag activ authoris refer articl direct ec authoris refer articl direct ec requir quot qualifi person quot mean person refer articl direct ec articl direct ec quot pharmaceut qualiti assur quot mean total sum organis arrang made object ensur medicin product investig medicin product qualiti requir intend quot good manufactur practic quot mean part qualiti assur ensur product consist produc control accord qualiti standard intend quot blind quot mean deliber disguis ident investig medicin product accord instruct sponsor quot unblind quot mean disclosur ident blind product articl inspect mean repeat inspect refer articl direct ec mean inspect refer articl direct ec member state ensur manufactur respect principl guidelin good manufactur practic laid direct member state account compil publish commiss commun procedur inspect exchang inform interpret principl guidelin good manufactur practic manufactur compet author account detail guidelin refer paragraph articl direct ec publish commiss quot guid good manufactur practic medicin product investig medicin product quot articl conform good manufactur practic manufactur ensur manufactur oper carri accord good manufactur practic manufactur authoris provis appli medicin product intend export medicin product investig medicin product import countri import ensur product manufactur accord standard equival good manufactur practic standard laid commun addit import medicin product ensur product manufactur manufactur duli authoris import investig medicin product ensur product manufactur manufactur notifi compet author accept purpos articl complianc market authoris manufactur ensur manufactur oper medicin product subject market authoris carri accord inform provid applic market authoris accept compet author case investig medicin product manufactur ensur manufactur oper carri accord inform provid sponsor pursuant articl direct ec accept compet author manufactur regularli review manufactur method light scientif technic progress develop investig medicin product variat market authoris dossier amend request refer articl direct ec applic modif submit compet author articl qualiti assur system manufactur establish implement effect pharmaceut qualiti assur system involv activ particip manag personnel depart articl personnel manufactur site manufactur suffici number compet appropri qualifi personnel dispos achiev pharmaceut qualiti assur object duti manageri supervisori staff includ qualifi person respons implement oper good manufactur practic defin job descript hierarch relationship defin organis chart organis chart job descript approv accord manufactur intern procedur staff refer paragraph suffici author discharg respons correctli personnel receiv initi ongo train effect verifi cover theori applic concept qualiti assur good manufactur practic requir manufactur investig medicin product hygien programm adapt activ carri establish observ programm includ procedur relat health hygien practic cloth personnel articl premis equip premis manufactur equip locat design construct adapt maintain suit intend oper premis manufactur equip laid design oper minimis risk error permit effect clean mainten order avoid contamin cross contamin gener advers effect qualiti product premis equip manufactur oper critic qualiti product subject qualif valid articl document manufactur establish maintain document system base specif manufactur formula process packag instruct procedur record cover manufactur oper perform document clear free error date pre establish procedur gener manufactur oper condit specif document manufactur batch set document enabl histori manufactur batch introduc develop investig medicin product trace medicin product batch document retain year expiri date batch relat year certif refer articl direct ec whichev longer period investig medicin product batch document retain year complet formal discontinu clinic trial batch sponsor market authoris holder respons ensur record retain requir market authoris accord annex direct ec requir subsequ market authoris electron photograph data process system written document manufactur valid system show data appropri store anticip period storag data store system made readili legibl form provid compet author request electron store data protect method duplic back transfer storag system loss damag data audit trail maintain articl product product oper carri accord pre establish instruct procedur accord good manufactur practic adequ suffici resourc made process control process deviat product defect document investig technic organis measur avoid cross contamin mix up case investig medicin product attent paid handl product blind oper medicin product manufactur import modif manufactur process medicin product valid critic phase manufactur process regularli valid investig medicin product manufactur process valid entireti take account stage product develop critic process step sterilis valid step design develop manufactur process fulli document articl qualiti control manufactur establish maintain qualiti control system author person requisit qualif independ product person dispos access qualiti control laboratori appropri staf equip carri examin test start materi packag materi test intermedi finish product medicin product includ import countri contract laboratori authoris accord articl direct point articl direct ec investig medicin product sponsor ensur contract laboratori compli content request refer articl direct ec accept compet author product import countri analyt control mandatori final control finish product releas sale distribut clinic trial qualiti control system account addit analyt result essenti inform product condit result process control examin manufactur document conform product specif includ final finish pack sampl batch finish medicin product retain year expiri date investig medicin product suffici sampl batch bulk formul product kei packag compon finish product batch retain year complet formal discontinu clinic trial batch whichev period longer longer period requir law member state manufactur sampl start materi solvent gase water manufactur process retain year releas product period shorten period stabil materi relev specif shorter sampl maintain dispos compet author condit defin agreement compet author sampl retain start materi product manufactur individu small quantiti storag rais special problem articl work contract manufactur oper oper link thereto carri contract subject written contract contract defin respons parti defin observ good manufactur practic contract acceptor manner qualifi person respons certifi batch discharg respons contract acceptor subcontract work entrust contract written authoris contract giver contract acceptor compli principl guidelin good manufactur practic submit inspect carri compet author pursuant articl direct ec articl direct ec articl complaint product recal emerg unblind case medicin product manufactur implement system record review complaint effect system recal promptli time medicin product distribut network complaint defect record investig manufactur manufactur inform compet author defect result recal abnorm restrict suppli countri destin recal made accord requir refer articl direct ec case investig medicin product manufactur cooper sponsor implement system record review complaint effect system recal promptli time investig medicin product enter distribut network manufactur record investig complaint defect inform compet author defect result recal abnorm restrict suppli case investig medicin product trial site identifi countri destin case investig medicin product market authoris issu manufactur investig medicin product cooper sponsor inform market authoris holder defect relat authoris medicin product sponsor implement procedur rapid unblind blind product prompt recal refer paragraph sponsor ensur procedur disclos ident blind product articl inspect manufactur conduct repeat inspect part qualiti assur system order monitor implement respect good manufactur practic propos correct measur record maintain inspect correct action subsequ articl label case investig medicin product label ensur protect subject traceabl enabl identif product trial facilit proper investig medicin product articl repeal direct eec direct eec repeal refer repeal direct constru refer direct articl transposit member state bring forc law regul administr provis compli direct april latest forthwith commun commiss text provis correl tabl provis provis direct member state adopt provis refer direct accompani refer occas offici public member state determin refer made member state commun commiss text main provis nation law adopt field cover direct articl entri forc direct enter forc dai public offici journal european union articl addresse direct address member state brussel octob commiss erkki liikanen member commiss oj oj oj oj