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1 1. ONDANSETRON 8 MG/4 ML SOL. FOR INJ. [INJ] d5u1m 36,830 AMP 2. ONDANSETRON 8 MG FILM COATED TAB. FOIL DAB] d?uim 202,950 TAB 3. FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ. [INJ] d%im 41,400 AMP 4. DOPAMINE 250 MG SOL. FOR INJ. [INJ] IN 14,200 AMP 5. MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ. [INJ] d h i ~ 46,600 AMP 6. SODIUM BICARBONATE 7.5 % SOL. FOR INJ. [INJ] d?~1161d 11,900 AMP fiiswp5~auasinioa6oqin~aug &iald6 I 1. r r ~ l ~ ~ ~ ~ ~ L ~ ~ ~ 8 ~ ~? ~ $ ~ b ~ ~ d i ~ d i ~ ~ ~ ~ s d " 9 ~ ~? ~ 5 2. ~~~u~~~ns~~dilu~~!siu~o~~~~iuuo~wi~sivnis~~aal6~~~~~ 3. W~5u$6?uioniiw$danaiu{un"u &aiodj~as~riuou$umia~nu ~iuu~ifauiauoq~~aua51mi l6i6i~~l~aaaiw~naiu[un"u~4u~i~u d 4 w 4. l~~5u~~wadsabuvsd'~aun"un"u~aaua~ini~iu~u~~.ui~nua~inil~~~ri nma~~wwumiamf uni?wuia"uasuaiun3uw< N Tuds~nifl~aua~ini w?a~~~$u(nsa~inis~u~~uni~gm.uai~ni~~~~~gu~ 2,' z.2' ~~usssulunis~aunsiniwoms~u 5. y~mw?oir~ynna~oa~.iii~$u~~~~i~a~'bbio~~u~iua~~u~~~~am~9~"~!~1 ~'iaunmq 'J"s~siu~u~iudiulri~n~a~~su6auluaisa~iK~ 6. ynnnw?~d~~nnadoa~~i~~u~k~~in"u~~au~iu.ua~?~~~~6m"i~duni~~m~a?dnwso%?! (e- Government Procurement: e-gp) 6osaswabbudusauu~~~n~sadnfi'ua~nsus~"~!nai~~b~u1"(16 r?ubbya~ol&jolhqninq ~iwum~u~o~aoum $qdqwiqld~~ib~~aada6aumubo4 &bbi<u$ 18 i?uainu unrilru 2558 risutu~9rno~luluiunais1'11nisyna"u 4 ndauqmis chuma'anssu i?u 1 aimids.r~uiuiaa.ruai ~aulo~nieua?u/$~~onaisaausimilusini~maz uin lid wdaqsnis iliurniianlsu iu 1 oini~bsawuiuiaa~vaiun?uwi noraa~wwupliamf uwi?wuia"ua;l.uaium~uw<?nuiaamwidw4 saw-dis<ui 18 e v d i?u?i~u 2557 odaun 9 unriru 2558 qsiuaa~um16i~~u ~'iaaouniun?.~ bnsflww'wuiu~au , ~?obwsais w?a sdusit@medicine.psu.ac.th wiobw~~~w'wuiulau ~4 60 intiaudsaaiuqiu uwi~wui~~a~.uaiun~uw< ~nwuaquw1:wuigu &.I 11 1ua"Pd~aaisi.uni~

2 ... ~~~L~WMUHIHW< u~i'?~ui~ua~uaiun~uw~ ~nu~a~qd"ldiu~sl~~n53u'b6fuuou~lul~~7n~01~~ m w GI~J mma~~'~~ufii'~n< u~~~wuiayuasuaiuw~pdmj 213/2555 as~ui 6 as~inu 2555) &ioidii~unji u~1inuibaaaaium5uni Pnaiud.raaaR'oxnovsini"~~o Taqoarirun' mix~iun1~6~~ i 2 1. ONDANSETRON 8 MG/4 ML SOL. FOR INJ. [INJ] d?~761d 36,830 AMP 2. ONDANSETRON 8 MG FILM COATED TAB. FOIL FA01 d?u~m 202,950 TAB 3. FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ. [INJI e]?uim 41,400 AMP 4. DOPAMINE 250 MG SOL. FOR INJ. [INJ] d5u7m 14,200 AMP 5. MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ. [INJ] ~%IIN 46,600 AMP 6. SODIUM BICARBONATE 7.5 % SOL. FOR INJ. [INJ] d%lm 11,900 AMP

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7 A. ao~l~ans~nzelazrm I. ~mqdszas6nisl.iiqiu Igjie?nis?n"n~~iiIlrau 2. drzlnw ~8uiaq~a'uKmiui 6 siunir 1. ONDANSETRON 8 MG/4 ML SOL. FOR INJ. 2. ONDANSETRON 8 MG FILM COATED TAB. FOIL 3. FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ. 4. DOPAMINE 250 MG SOL. FOR INJ. 5. MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ. 6. SODIUM BICARBONATE 7.5 % SOL. FOR INJ. u1 3) di~uilu~i6~nis~uwz~~uuii~uui (LLUU ~u.2 Mia wu.3 M%I ~u.4 u.2 u<3ba@inri) Y ~~6iuvljika% ria ns[iiiinis~d~uu~das~~n"b~~?9~o~~iwabazaniud~~m I~uuuii~~u~d~u~u~~~el~uu~~da~~iuni waaduu~1'7?uui~8uan"u~?uo~~101~~n~nniudwl~1 (MUU u.4) ui~~ounupd6-~u 4) h~ui~~s~o?~s~~uim~~iunir~~mui~1iu~a"nbn~~~"5nirim%unir~~mi (Good Manufacturinq a w. 4 Practicer) 1uvuamj/~8u~$o~bui$~auo (aguaiqmmiurounirmrailaoubmu~~anir?uso~n~~u~~~u~ ~ ~ i ~ l ~ ~ ~ ~ $ ~ ~ i ~ ~ l ~ ~ b ~ ~ ~ n " ~ ~t~uilii~gou) d 7 b ~ i ~ Inuio~d3znil~6au s a " ~ d ~? ~ ~ ~ ~ n i 9 ~ ~ R 4 4.1) Certificate of GMP Raw Material / Active Pharmaceutical Inyedient (API) w%6?unis?usos GMP m l ~ ~ I mgmp-pic/s 5 ~ 1 ~ 0in PIC/S participatins authorities M% WHO-GMP aosdsabwh{w2m alaa 4.2) Certificate of GMP Finished Product i?uso~miuuims2iu GMP-PIC/S w?o WHO-GMP - n~dui~~~dudraa~fl~~1u6o~~~?unis?uso~ GMP miuuimsyu GMP-PIC/S oiniiiinqiu nasnssuniraiwisuaztn v~ol6?unis?u~o~ GMP miuuimr~iu GMP-PIC/S oin PIC/S participatin2 authorities

8 - nsiuipa"i~u"7il~nii~dsa~~p160~l6?unis?uso GMP (~~IUUIC~~~~IU GMP-PIC/S mn PIC/S participatinq authorities dl 5) dlrrndiuauuv)a!uuii?uu7 (uuu mu.1 Go u.1) ~~;jtiiu~lliiuaa~& wtaus7uar8unqm~nnwwz~awi: voau1di~~il~d~~na.u"on"i~9umuims~iu"~o~?~n1ss~~siadui (Finished Product Specification and Analytical Procedures) d~unr~iiuuliinurnr~~u1~~7u~s:n7fin~a~sa~a7sism~u ~11qsa~iisiu7 W.H ns~~nis~d~uu~daq~~f%u l~b~uud1~u161u~~~~v~d~uu~~da~s1un~slunzbduui1?uui (bauu wu.9) '~1% dibui~iuo~~v~el~uu~~da~cjiunis~una~~uu~i?u~i (LL~U u.5) uiwiau5u62u 6) ~ILUI~I~IUI [Pharmacopoeial i?l~unir<unr~iiuuui $aa"mq?uhu~iii6q imt.wanriol4u181dg:d a5uaiqn wiamiuc~n"iwumuims,siu"~o~ui~~a:~"sn~s?~~s~ag %udszni~nszws?sai57smq'u a";osszyi~si Ul W.A ) dibuiw~d~o?usosni5"abnsi~d (Certificate of Analysis) w~a81m7si~b~uu~!uu~u811ms~i~d~i?uui [Pharmacopoeial ~flunis<unaiiiuuui ~~u~~a:baumiud~zn~~nsz~sa~ai~is~~"~~ ~$84 IUI I I~I$I Y w.m ~~Tmq~u~auidi&-g ~azwgmkmdn'uidi~ta1d Inu6aadaanau62iau 7.1) dibuiw$~~o?~~o~nis?b~sia99'a"mq?u~auiafi~~ (Certificate of Analysis of Raw Material / Active Pharmaceutical Inyredient) ~mu6aadsanou6au 7.1.1) iibuiw$~~o%~sa~ "11~g~Ema"mq?u$~uiAi6su_ (Supplier) 7.1.2) dibu19/1c~io?uso~ "UD~QW~~W:~KW~~'U~~IL$B~~I (Manufacturer) 7.2) dibui~~~~a?u~n~ni~~~n~~a~w~m~~~uidi~~il~d (Certificate of Analysis of Finished Product) Inunasdsanou63iau 7.2.1) h~umc~jo?usoa slo~~~'ulmwflmriot4uidi~iil~el (Manufacturer) ~ ~junisw~mdds~~adi~ bba:~u"a"mq?u~auidi~~~u~~uan"ud1~uiw$~~a?usa~nis?bns1zda"mq~u~auidi6~ (P91nkifiva"nqiu uan~~uniswgm%q?u~auid1~~%udi~ui~ca~o?usa~ni~~~nsi~99'~em~~~u~di~~0 fiaa~uu wc~3o?usoo;lain~wsp1w~mfim4uidi~f iladijuu"u) ) di~ui~cd3~?usoa ~odausivnis6u ~~aani~u~u~ni~~aan~u ($du~&~f &[Rz~uI~L'~P~~ 5-1~7) ih%unis<u"er%o~ Good Laboratory Practices (Certificate of GLP) M%I ISO/IEC (ws"ouuuud1auiw$q3a?usa4 GLP w:o e w uunsaubc1'7rauo5ini [;15] ISO/IEC va~~ai~u~yu~) diwanis~ainsiz~?iiiiu 8) dibuibonaisuan~nis~n~~inaiun~~~ (Stability data) ~mu6asdsanoukau 8.1) Lon? term stability (n96 i<uwra~uuuiuiusiauinnii 2 g) 8.2) Accelerated stability ~raa 8.3) In - use stability 9) ~ILUIMG~~~~Y~~~~~WGWK~UG~I~IL~F~~~ (Certificate of Pharmaceutical Product / Certificate of Free Sale) [ nsi~~~uiw'i~'u"iui~ud~~~~~~~~] 10) di~ui~anais~am~~o~anisi~tunis~ss~iu Green Book vaq nsu?wu7~11aminisbawmd [61iil 11) di~ui~onais~~anseo~nis'b6?unisuss~lu nun1sweniiruviu~a1~~i9~i~~~~1ui~i~!uu~~dnis 615n?n"nsr1in"eruifiu~~uu mi dicn~iunmanssunisoi~~s~~azui [KIZI 12) h~uiw~n,siunaium;a"~~o~w~mkm~u~ (Bioequivalence) mi~mmdn' ~di~niiu~~~ns~un~~ai' ~~i 81 iiwum ns~~3uuiiaai~cg [~IGI 13) ~ibuiuam~nis?uso~~~uu~~niwb~~~iuw~mw~m~~du~d~~fil~d miuui~s~iu 810n.9001 M%I 810n.9002 lu"nnisb~aaaouiiu ilindi$n~iuuims~iuw~mk6~~qm~~~nssu ~~aaln~5u?usa~uim~~iu IS0 9/1% wliau~iudnsamsaagmaiwn~su~~ni~~usa~s~uu~iu nsi$uuiwrmiu~samfiiwu [o'iiii 14) hodi~uiio~aiu~s~luvuimuss~~ilail"iwgiuod~aod"au 5 ~Gauuss~flmd ~~~~u$a~~n~~an~~iuax~ 16ni~x~~umiu~~1~umIu~au"0~maufiw"~ld.~"i~~u Inuu~i?nuibn.r~aiu~~u~~ vonqadw~~i?iu ~aorii~lirjinstil'lm~ nw8a4o ~~iu~~dioarjpii~uimiu~"ik~~~ilin~m~~~~wu~iam ~9ur2m7 iluiuqn~cyqi 5 3

9 niadwauui 1) [viun?s~szuuil~mi~ui~n"?unis?uso Good Distribution Practices (Certificate of GDP) bmuaawizuid 6o~~misImusauuiasbsic"1aiua6u (Cotd chain system) aaaz6os;mdsuitw"d dlu~navn5-d~ b-sswuiuia asvaiun5uwi wiubiuaudn"iwun niuh 30 5u ~erointuw%6?u~i$dk 2) ~viuea~osus%!$ugo bua~und>n~n~ui aaazbiuauui (wgauxwn"n3u) 199"azm?nionismsa~Yu sau& ~zy%ouiarazbiuauuu~uiodu'm~i1u ni-iiudsm'uqorniwui~~~~op1 1) u1~~cilunlsiyols~1~~61iwm1u~a"n~iui~iwum ~mziiii~~z~~n~una~~~uo~n~i~n~iunm oi~is~~azu-~ 2) oi~vo~uic(da~~u~~~0i~in~uwgw1i~iiu 12 afic~u unzl$siul~iu'ouni1 12 ~tiau un~iuuidiioi~ain Tuwlmi?u (riouni~w?odiriu 18 ~Rou) oa4io~iioiylkiul~~u'ounii 6 atiou 3) ui~n~a~l~~isuou~zm"o~~~di~uiwd~doyu~a~nis7~n~izvi~gw~m4ui~ia5o~d juda~~~uvoq(w~n~a:: diaui~~~~o?uso;lnis7ac"1~1z~a"w~~u'11os(wzma"w~~u~u'w~wuijudi~u0u 4) 'luns~~uwii~uibad'~~~u~?u~<w"in~s~u~ao~ii~uic(~suou~~o~~m~a~~~n~

10 1. ONDANSETRON 8 MG/4 ML SOL. FOR INJ. 2. ONDANSETRON 8 MG FILM COATED TAB. FOIL 3. FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ. 4. DOPAMINE 250 MG SOL. FOR INJ. 5. MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ. 6. SODIUM BICARBONATE 7.5 % SOL. FOR INJ. nuu * iiun/aams * h~na~~arn * %estn * sgfiidswg6 * wu~~~nutwsfiwgdiwq11'imda : pll~lulny~w4fil9 : e - Mail: &qa&a?u~anaqs * L ~ Y ~? S ~ I K ~ ~ S Z ' ~ ~ ~ ~ M * ~lgl~$7 (UIU / UIP / UIUfil? / $Id.] 1d~~14~~) d * Tfl : * u7ufiqa : *?'sd$tu~nnfiis : * ~anfi7sd~ilrnrgn~w (~~~~i~msds:~~fi~dfz"~~i~ I w&iia?usa\l I ~G~iIa~au4iiu7~) as&, fi?u 1 Download anf fils Ala9fiu78 f~tfi15 r; vv : (fu / Download L~nfiIffiQ~~7~11 il5:nam~iml ~osnsanslun~l~~maanz~s.daysu ~anawh+i& (qruws?w8 ugr$ : M?Q mpornt~p@rnedlc~ne psu ac th H B ~ ~ ~ L: V- l%diwtu~flupll~n~iun7ttu I ~ I Download aanfi~sfiaus~ni/ds:namsimi I Download - u~1~~~~rjufi~aa~un3~wb~~~~~w3~~~~1sb~1s~m~aasfiafi~asni hni~d~ridtin~~nfi~fiu~ nnisw% l~uiyl~tu~anfi1~fiaus~m11dsznams1n1~~~ues~"a~~~g~~~'11n

11 I. 4o~nsdnis ~ousinibaraa~bwpi qiuu~ms~nwiwuiuia ~~wu.riuu~nisqvniw /vsdaumu~6iaosbns4n7% diubnzvns%u n~u~,~,wwu(alian< u~7?~~15ua~"~iun3uwi d vw u 2. asfiusudsuuiawlmsu~mass... 3,526, uiw 3. iucl~ivun~ininai~ (51ni~i~lai ~RIRU ) ONDANSETRON 8 MG/4 ML SOL. FOR INJ. d s bd9dbdl.i , uw sini6o~pdau 2) ONDANSETRON 8 MG FILM COATED TAB. FOIL... d s bdubdu... 1,737, U~W 3) FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ. d 4 ~,dub~u e 1 i [5 ~ AMP] vnidovpdau uiw 110 TAB] , uiw %~~idov"du 5.35 uiw 4) DOPAMINE 250 MG SOL. FOR INJ. d s ~du~w , uiw s7ni6o~pdau uiw 5) MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ. d 4 bdubdu , uiw sinidovpdau UIW [50 AMP] 6) SODIUM BICARBONATE 7.5 % SOL. FOR INJ. E: 4 bdubd~ , uiw simidov9dau ulw 4. ~~visiuiaod%ininaid (=~-IWI~I~E~)

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