commiss direct juli lai principl guidelin good manufactur practic veterinari medicin product eec commiss european commun regard treati establish european econom commun regard council direct eec septemb approxim law member state relat veterinari medicin product amend direct eec articl regard council direct eec decemb extend scope direct eec approxim law member state relat veterinari medicin product lai addit provis immunolog veterinari medicin product veterinari medicin product manufactur import commun includ medicin product intend export manufactur accord principl guidelin good manufactur practic accord nation legisl member state requir complianc principl good manufactur practic manufactur product intend clinic trial detail guidelin mention articl direct eec publish commiss consult pharmaceut inspect servic member state form quot guid good manufactur practic medicin product quot manufactur oper effect qualiti manag manufactur oper requir implement pharmaceut qualiti assur system offici repres compet author report manufactur compli good manufactur practic report commun reason request compet author member state principl guidelin good manufactur practic primarili concern personnel premis equip document product qualiti control contract complaint product recal inspect principl guidelin envisag direct conform opinion committe adapt technic progress direct remov technic barrier trade veterinari medicin product sector creat articl direct eec septemb approxim law member state relat analyt pharmaco toxicolog clinic standard protocol respect test veterinari medicin product amend direct eec adopt direct chapter gener provis articl direct lai principl guidelin good manufactur practic veterinari medicin product manufactur requir author refer articl direct eec articl purpos direct definit medicin product set articl council direct eec definit veterinari medicin product set articl direct eec appli addit quot manufactur quot holder author refer articl direct eec quot qualifi person quot person refer articl direct eec oj oj oj oj oj oj quot pharmaceut qualiti assur quot sum total organ arrang made object ensur veterinari medicin product qualiti requir intend quot good manufactur practic quot part qualiti assur ensur product consist produc control qualiti standard intend articl mean repeat inspect refer articl direct eec member state ensur manufactur respect principl guidelin good manufactur practic laid direct interpret principl guidelin good manufactur practic manufactur agent compet author refer detail guidelin refer articl direct eec detail guidelin publish commiss quot guid good manufactur practic medicin product quot annex offic offici public european commun rule govern medicin product european commun volum iv articl manufactur ensur manufactur oper carri accord good manufactur practic manufactur author veterinari medicin product import countri import ensur veterinari medicin product manufactur manufactur duli author conform good manufactur practic standard equival laid commun articl manufactur ensur manufactur oper subject author market carri accord inform applic market author accept compet author manufactur regularli review manufactur method light scientif technic progress modif market author dossier applic modif submit compet author chapter ii principl guidelin good manufactur practic articl qualiti manag manufactur establish implement effect pharmaceut qualiti assur system involv activ particip manag personnel servic involv articl personnel manufactur site manufactur compet appropri qualifi personnel dispos suffici number achiev pharmaceut qualiti assur object duti manageri supervisori staff includ qualifi person respons implement oper good manufactur practic defin job descript hierarch relationship defin organiz chart organiz chart job descript approv accord manufactur intern procedur staff refer paragraph suffici author carri respons correctli personnel receiv initi continu train includ theori applic concept qualiti assur good manufactur practic hygien programm adapt activ carri establish observ programm includ procedur relat health hygien cloth personnel articl premis equip premis manufactur equip locat design construct adapt maintain suit intend oper lai design oper aim minim risk error permit effect clean mainten order avoid contamin cross contamin gener advers effect qualiti product premis equip intend manufactur oper critic qualiti product subject qualif articl document manufactur system document 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 make trace histori manufactur batch batch document retain year expiri date batch relat year certif refer articl direct eec whichev longer electron photograph data process system written document manufactur valid system prove data appropri store anticip period storag data store system made readili legibl form electron store data protect loss damag data duplic back transfer storag system articl product product oper carri pre establish instruct procedur accord good manufactur practic adequ suffici resourc made process control technic organiz measur avoid cross contamin mix up manufactur import modif manufactur process valid critic phase manufactur process regularli revalid articl qualiti control manufactur establish maintain qualiti control depart depart author person requir qualif independ depart qualiti control depart dispos qualiti control laboratori appropri staf equip carri examin test start materi packag materi intermedi finish product test resort laboratori author accord articl direct author refer articl direct eec grant final control finish product releas sale distribut addit analyt result qualiti control depart account essenti inform product condit result process control examin manufactur document conform product specif includ final finish pack sampl batch finish product retain year expiri date member state manufactur longer period requir sampl start materi solvent gase water retain year releas product period shorten stabil mention relev specif shorter sampl maintain dispos compet author veterinari medicin product manufactur individu small quantiti storag rais special problem sampl retain condit defin agreement compet author articl work contract manufactur oper oper link manufactur carri contract subject written contract contract giver contract acceptor contract defin respons parti observ good manufactur practic contract acceptor manner qualifi person respons releas batch undertak full respons contract acceptor contract work entrust contract giver written author contract giver contract acceptor respect principl guidelin good manufactur practic submit inspect carri compet author provid articl direct eec articl complaint product recal manufactur implement system record review complaint effect system recal promptli time veterinari medicin product distribut network complaint qualiti defect record investig manufactur compet author inform manufactur qualiti defect result recal abnorm restrict suppli countri destin recal made accord requir refer articl direct eec articl inspect manufactur conduct repeat inspect part qualiti assur system order monitor implement respect good manufactur practic propos correct measur record inspect correct action maintain chapter iii final provis articl member state bring forc law regul administr provis compli direct juli forthwith inform commiss thereof member state adopt provis refer direct accompani refer time offici public procedur refer adopt member state articl direct address member state brussel juli commiss martin bangemann vice presid