ĐỀ THI ĐÁP ÁN CÔNG NGHIỆP DƯỢC 2015 ĐẠI HỌC Y DƯỢC TPHCM

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Phan .Ouan Iy ehath/gng thudc:

Cciu 1. Thea GMP ASEANtieu chuan 'Ie sinh gam cac cap:

(~ Tat ca dieu dung 'li(1P;''.. IE!:II~I.\~I.V.t...... C. I " III IV D. Trang ..Trang ..Xam ..Den

Celu 2. Chinh sach chat IlfQ'ng,chon du sai: ;IJ.<.

A. dltQ'c ngllai lanh dqo cao nhat cua cong ty chinh thtic tuven bo va chap nhan

B. La dl,l'dinh va djnh hlfong tong the cua mot cong ty doi vCrivan de chat IlfQ'ng dlfQ'exac dinh bang van bang

.,~. La cam ketve chat hrong

;D)dlfQ'Cnglla.i uy (;juyencua cfmg tv chinh thtic tuyen bo va chap nh~n

esca Chat IlfC,Yngthudc on dioh.gilta cac lola db giai dean: ..

A. Kiem nghiem ____.....,!li)san xuat . C. Thiet k~ ': \> s: ,D. Ll:fu kho

Cau 4. GMP fa: Cl L, cL",t '~"F-': iL·...·~\.

'@Toan be;. nhfrng kien nghi c~n tllilc hien de cho phep dam bao ~hat Iltc;1ngcua 'motthuoc xac dinh trong dieu

kieh tot nhat .-'

B. La chat hlQ',ngcua thuoe.

C. La mot phan eua QC

D. BaQ~Qm QA

Cau 5. Kiem tra chat ILlQ'ng:~'\.~

A. Tham gia vaa CClc hoqt de;.ng kiem soatqua trinh (IPC),Slr dl,mg cac ki thu~t phan tfch de ket lu~n dqt hay khong

d?t. --,_ .....'.....

B. La mot phsn eua GMP, lieri quan den thlr ng,hiem lay mau, xay dl,l'ngUeu ehuan, thief I~p ccieho Sd lien quan

den viee xuat 10.nh~m dam baa r~ng cae thLi ngniem can thiet da dlfqc thl,le hien. , L ..

. ~I

~ Neu diilt thi dLlqe phep xuat 10 ~,.,:" ..

';Wea A,:8 di'eu dung .

Cau 6. So tieu phan toi. <fatrong mot m3 khong khi ·ze;l

~. cap 11'1 <= 3.500.000tit~ll phan tit 0,.5..5 urn va <=4.-0crdtieu phan > 5 urn

~._I¥Cap I <= 3.500 tieu .e_hantlr D,S .. 5 um va khong co tieu phan naD > 5 um,........

C. Cap IV <= 3~go:Ob6tieu phan tlr 0,5 - 5 urn va <";2,(}.OOatieuphan > 5 urn

D. Cap IB <= ;1S,

0:00Cft

..... ,:;;:"'

ieu00-

phan tit 0,5-

..5. um va <=2.0Go-t

eo

ieu phan > 5 um

Cau 7.150 ap dung tren loan eau tren cac ITnhVI,I'C: . ;--

.~Tat ca cac eC1 so Kinh t'e ..xa hQ(._ . B. San xuat thl,l'c pham

C. Ca quan him'h chinh ...., D. San xuat thuoc

Cau 8. Dam baa chat Ilfqng itchQn cau sai?

A. La toan bo ke ho~eh baa .gam ea GMP, DI1Q'ctien hanh thea trinh tl/ de dam baa dLlQ'Cph~m phu hQ'pvCticong

. dvng cu~ hO.

~fa."Tham gia vao Ccie haitlt dong kiem soat qua trinh (IP.C),Slr dvng cac ki thu~t phan tfch de ket lu~n 09t hay khang

ergt. C.'L -

C. Bao gem toan b{) cae van de rieng h~hay t6hg hQ'panh hlfang den chat 1!.tQ'i:1sang pham

D. Dam bao chat IVQ'ngla t6ng tM cae ke n0geh dlfQ'Cthl/c hl~n' nh~m ml,lc tieu dam bao cae san pham diilt chat

lU'c;mgyeu cau de Slt d,.mg.

Cau 9; Vi~e djnh hlfong va kiem,soat chat IlIQ'ng bao gem: _, L01') ",~C:vJ, :~h _,;..;,O'::{~.L ~'..~\ -'~ ~''''.:ii{

A. Dam bflO chat IltQ'ngv;acai tien cha't ILlc;1ng rQin't Cci dieu dung""""- 1

"'" • ,'-k' _.111 ,. '" C. hO(,lehdinh chat 1U'Q'ng D. Kiem soat chat hlQ'ng

E. L~p chinh sikh va ml,lCtieu chat 1U'Q'ng

----~Ca~fD~~onaola5~ke~t~h~~p~.~g·~lfr~a~IS~O~v~a~G~M~.~P-----------------------------------------------

_(~ ISO15378 ~ _~. IS? 157..48 '. '_ .C. ISO1~O'.f t1.,~"

D. I~O90?! Ci-r--I\~.,''_\~I~I'(, cll-~I c

Cau 11 •.~MP quy.dlnh nguyen h~u s.anxuat ban da_ugom f{i.MiI ~.I .va 1.\ ~ i~bl'

":"'r. r .f".)"?' ~ - - ,.. , ....."'41"\ '"., . ~

.................... '(t~_.·... ".. ;-;i~......... .1_ , .. " .l,v~_".~

- ~ 1/ ....- Cau.12. Neu nha may chi d(,lt GMP thi: ; • . , :~

;~;'Nha tlO'i khac kier:ndinh chat 11IqngthlJoc"""", . <., ~ '"",:-.l':- .'. i,

.....- I' J"""", .~u.\'r:o-...sl\,.o~,·\ B. Khong can kiem dinh, khi alta ra thi_trlfang Vien kiem nghiem se kiem dinh - :Y' ",,<r .1- ,i

C. Khong can l<iemdjnh, khi dlfa ra thj trlfO'l'lg sa y te se kiem dinh /:-'""- \"'':; , ~

D. f)11.Q'epbep kiem tra chat hlQ'ngthuoc 0. nO'iSX .. r '~..;'_' ;"c:1.. 1'~\,_]L_'.

Ciiu 13.ISO9,001 phien ban 2000co baa nhieu d,ie.uk.hoan.:_. . . '.

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