Transcription of 1 2) ガイドラインアネックス 13 和訳
1 12) PIC/S GMP 13.. MANUFACTUREOFINVESTIGATIONAL . MEDICINALPRODUCTS. lnv estig ation alm e dicina lp rod uctss ho uldbe GMP j l . producedina cc or d ancew i tht h ep ri ncip lesandt h e . det ailedguid eline so fGoodM anufac turingPract ice . fo rM edic inalProducts .O therguid eline ss ho uldbe . takenintoaccountwherer el evantanda s . appr opriatetothes tag eo fdevelopmentofthe . pro roc eduresneedt obef le xib letop r ovide fo rc hangesask nowledgeofthep r ocessincrea ses, anda p propri atet othestageofd evelop mentoft h e pro duct. I. nclin ica ltria lst h eremaybeaddedr i skto L . p arti cipa tingsubjectscomparedt opati entst r eated . w ithmarketedp rod ppl icati ono fGMPt o GMP . t hem anufact u r eo finve stig atio nalm e dicinal . pr oductsisintendedtoe n suret h attri als ub jects . a ren otplacedatris k,andt ha tt heresul tso fcli nic al.
2 T ri alsareunaffectedbyi n adequatesafe ty,q u alit yo r GMP . e ffica cya r isi ngf romunsat isfact orym anuf a c t u re Jt . E. qual ly,itisintendedtoensurethatthereis . co nsistencybetweenb atch eso fthesame . i nvest iga tiona lm edi cinalproductu s edint hesame . o rd i ffer entclin ica lt r ia ls ,a ndthatc han gesd urin g t hed evelopmentofani nv esti gati onalmedicina l pr oductarea dequ atelydocumentedandj usti fied . Thep roduc t i o nofi n vesti gationalmedicina lp rodu ctsj . inv olvesaddedc omple xityi nc ompari s onto . marketedp roductsbyv irtueoft helackoffixed . ro utine s,v arietyofclin ica lt nald e signs,consequent . packag i n gd esigns,theneed ,often ,f o r . rando misationa n dbli ndingandi ncreasedriskof . productcrossc ont aminationandm ixup.. Furthe r m o r e,t heremaybei ncompleteknowledgeof.
3 Thepoten cyan dtoxi cityoft hep rodu c tandal ack . ffu llpro c e ssvalid atio n,o r ,m arketedp roductsmay beu sedwhi chh avebeenr e-packagedorm odi fiedin somewav Thesec halle ng esrequ irep ersonnelwithat horough GMP . unders tandingo f ,andt rainingin ,t heapplic ationof . GMPt oinvestig ation alm edicina lp rodu cts Co- . oper ationisr equire dw ithtria ls ponsorswho . undertaketheu ltima ter espo1 ibi li tyforal la spects . fthec l ini caltria li n cludingtheq ua lityof inv esti gationa lm e dicina lp roducts. Theincr eas edcompl exi tyinman ufact uring . ope rat ionsre qui resahig hlye ffe cti veq u ali tys yst em.. Theannexalsoinc ludesguid anceono r der ing, . sh ipp ing ,andr etu rnin gc l in ic alsupp lies ,w h icha r eat GCP . thein terf acewit h,andcomplementaryto ,g u idel ins . e onGoodC l ini calPrac tice.
4 N. otes . j N. on- inve st1. gat 1on alm ed1. c1n alp rod uct . 7 . 1I1. Productsothert h a nthet e stp rodu ct,p la ceboo r . comparatormaybes u ppliedtos ubj ects . pa 1cipa tinginat a r o d u ctsmaybeu s d . e ass u p p orto resca p em edicationforpreve ntati ve, . dia gnosticort h erapeuticreasonsand/ orneededt o . ensurethata dequ a temedicalc ar eisp rovi dedf r . o thesubjec ls ob eu sedina ccord an e . c wit ht hep r otocoltoi nduceap hys iolog icalrespons.. e Thesep roduct sd on otfa llw i thinthed e fini tio no f . in vestig ation alm ed i c inalp rod u c tsa ndmaybe . sup pliedbyt hes p o n sor,o rthei n vesti gato . sponsorshoulde n s urethattheya reinaccordance . wit ht hen o tifica tion/req uestf o ra ut horisa tionto .. conductt h et r ia la ndt ha tt heya r eo fappro priate . qu alityforthep urposesoft hetri altakin gi n to.
5 Accountthes ourceoft hemateria ls,whethero rnot . theyaret hesubjectofam arketingauthor isati on . andw hethertheyh avebeenr epackaged,Thea dvie . c andi nvo lvementofa nA ut h o risedP erson1s . recommendedmt hist a sk.. M. anu fac tur inga uth ori sat iona ndr eco nst itu tio n . Bot ht hetot ala ndpar tia lm an ufactur eo f . i nves tiga tion alm e dicin alp r oduct s,asw e llast he . v ariou sp roces seso fdiv idi ngup,packag ingor . p resen tatio n,iss ub jecttotheauth oris atio h is B . a utho risat ion,however ,s h allnotberequir edfor . r econ stit ution .F orthepurposeofthi sp r ovis ion, r econs titut ionsha llbeu ndersto odasas imple p rocessof. di sso lvi ngordis per sin gtheinv est iga tio nal .. med ici nalprod uctfo radmi nis tra tio nofthep r odu ct . toatr ia ls u bJe ctor , . d pr o i l d u u t i c n t go (s rm )wi i t x ingth.
6 Ein hsome t v h e e st rs i g u a b t s i o t n a n a c lm e(. e s di c )u i s n e a l dasa . ve hicl ef ort hep u rpo sesofadmi nister ingit , Re const 1tut1. on1snotm1xmgsever alingr edi ent s, . i nclu dingtheac tivesubs tance ,t o geth ertop r odue . c t hei n vest iga tio nalmed icina lp r oduc t.. Aninv est iga tio nalm edi cin alprodu ctmustexi st l . be for eap roce sscanbedef ine da sr eco nst itut io.. n Thepro cessofrec onsti tuti onhastobeunder tak en . asso ona spr act icabl eb ef orea dmin ist rat ion .. T. hisproc e s shastobedefin edi nt h ecli nic altr il IMP. a . a ppl ica tionIIMP doss ierandcl in ic altr ia lprot oco, . l o rrela teddocu men t ,av ail abl eatthesi te .. GLOSSARY . 7 . 2I1. Bli ndin g . Ap roced u reinwhichoneo rmorep arti estot he . t ria la r ek eptu nawar eo fthet re atment.
7 Ass ignment(s ).S in gleblindi ngusual lyr e ferstothe . sub ject(. s)b eingunaware ,a ndd o uble- blind ing . usu allyreferstothes u bjec t(s). ,i nv est igat or(s ), . mon itor,and,insomec a ses,dataa n alys t(s)being . unawareo fthetreatmentassig nment(. s).Inrelat ion . toani n vestiga tion almedicin alp ro duct,bli nding . meanst hedelibe ratedisgu isin go ftheiden tityofthe . produc tina ccordancewitht h ei ns truct ionsofthe spon nbl indingmeanst hediscl osureofthe ide nti tyo fblinde dp r oducts. Cl inic altri al . Anyi n vest igatio ninhumans ub jectsintend edt o j . disco verorv e rifytheclin ic al,phar macolog ical . and/orotherphar rr c o d ynamice f fect so fan . inv esti gati onalproduct (s)and/ortoi d enti fyan y . adversereac tionstoa ninve stig atio nalprodu ct(s, j ) . and/ortos t udya d sorpti on,dist rib utio n,metabolis m.
8 Andexcreti ono foneo rmorei n vest 1gat 1ona l medi cinalproduc t(s)withtheo b jectofascert ning it s/th eirsafetyand/oreffic acy . Comparatorp roduct . Ani n vestig ation alo rmarketedp roduct(. c tive . co ntro l),o rplace bo,u seda sar ef erenceInac hrn cal . t ria l . lnv estiga tiona lm edic inalp r o d uct . Ap harmac euticalf ormofana ctiv es ubstanceor . placebobeingtestedoru seda sar ef e re nceina . cl ini caltri al ,i n cludin gap r oductw i tham ar keting I j . aut horisati onwhenu sedora ssembled( fo rmula ted . orpackaged)inawayd iffe rentfromt heauthor ised . for m,o rwhenu s e dforanu nauth orisedi n dic atio n, . orwhenu sedtogainf u rtherinform ationa b outt h e auth orisedf o rm. Inv estigat or . Ap ersonrespons iblef o rt heconducto fthecli nic al . t ria la tatria ls i te .Ifat ri alisconductedbyateam.
9 Ofindi vidua lsa tatri alsite ,t heinves tigato rist e . h resp onsibleleaderoft h eteama ndmaybec all ed j . theprinc ipalinves ti gato r . Manuf a ct urer/impo rterofInves tiga tiona lMedicinl . a Products . Anyh o lderoft h ea ut hori satio nt o manu facture/import Order . In struc tiontop r ocess,packageand rs hipa . ce rtainnumbero funi tsofi n vest igat iona lm ed icinal . pr oduct (s). ProductSpec ifica tionFi le . Ar e ferencefi leconta ini ng,orr e fer ringto les . co ntai ning,al lt h ei nf ormat ionnecessarytodraftthe . de tail edw ri tteninstr uct ionsonp ro cessi ng, i . pa ckaging ,q ua lit yc on tro lt es tin g,b a tchr e leaseand J. l , . sh ippingofani nv esti gat iona lm ed icina lp ro duct.. 7 . 3/1. Rando misat i o n . Theprocessofass ignin gtr ia lsubj ect stot rea tment J. I . orcon tro lg roup su s inganelem entofchanceto.
10 Det erminetheassign mentsi norde rtoreducebia s. Ra ndomis atio nCode . Alis ti nginw hichth etrea tmenta ssi gne dt oeach . s ubjec tfromther ando mis ati onproc essisid ent ifi ed. i . Shi pping . Theoperat ionofpack agingf ors hip mentandsend ing . ford eredm e dic ina lp ro duct sfo rcl ini ca ltri al s.. Sponsor . Ani n div idu al,company,ins titu tio noro rg anisat ion . whichtakesre spons ibil ityforthein it iat ion, l . managementand/ o rf i nanc ingofac l ini caltr . I. QUALITYMANAGEMENT . 1..TheQ ual itySystem ,d es igne d,setu pandv e rif ied1. L . bythemanufa c t urerorimpo rter ,s h ouldb e GMP . des cribe dinwritte np ro cedure sa v aila bletothe . spo nsor ,t a kingint oaccounttheGMPp r inci ple . sand l g uide linesapp lic abletoinve sti gati onalme dici nal pr oducts . 2..Thep roductsp ecif ica tionsandmanuf acturi ng 2.
