piiaw3muon~lox6oaimoraug 6a9id-d: 1. ~uiuo:~a~8u~8m~~o~~~wudiw9diu~~~~a~o?usasoin~~8m
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- Sophia Burns
- 6 years ago
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1 CLONAZEPAM 0.5 MG COMPRESSED TAB. FOlL CLONAZEPAM 2 MG COMPRESSED TAB. FOlL FLUOXETINE 20 MG COMPRESSED TAB. FOlL MlANSERlN 30 MG FlLM COATED TAB. FOlL NORTRIPTYLINE 10 MG FlLM COATED TAB. FOlL NORTRIPVLINE 25 MG FlLM COATED TAB. FOlL OLANZAPINE 10 MG FlLM COATED TAB. FOlL QUETlAPlNE FUMARATE 200 MG FlLM COATED TAB. FOlL VENLAFAXINE HCL 75 MG CONTROL RELEASED CAP. FOlL piiaw3muon~lox6oaimoraug 6a9id-d: 1. ~uiuo:~a~8u~8m~~o~~~wudiw9diu~~~~a~o?usasoin~~8m a 2. W~9u[d~nr-y~diluu"qi~~~~o[~aaiu~oawiasi~nis~~~al6~~Cs~~uu~a~~~~ 3. W~8u$m"Yu~on~w~w?onaiu~un"u Froiod j~as~~uau$uaia~wu ~iu~~i?;uiauoa(~nunm li;ii~i$ai~aan8n$rni~~~un"u~?jurji~u d d v 4. l$du[~wadszlua~ia~~n"un"~q~auos~~isiu~uw~ui~auas~n~l.j;~~ri norar~wwua1an5 uwi~wuia'uaaaaiun5uw5 6~ Tuelssnia~auam ~?oli~9u[nsaiin1s~u~8uni~.u"mua1~ni~~ai~u"usin1a~i~ ~9usssuIunis~nuos1niion4a~ 5. ~ R ~ ~? ~ C, ~ ~ R ~ ~ ~ ~ ~ ~ ~ L ~ " I L ~ U ~ ~ " ~ ~ I ~ mis~~ams ; ~ ~ ~ ~ ~ ~ ~ ~ I ~ ~ I ~~ls~uyusi7uiiul$~n6oans~bauiuai~aal'i~~ 6. ~~naw~o~~~n~ad~~~.u"i~~u~~~~in"uwdauaiuuoa~~~a~6rsl"ib~unis~m~?%inwsoi=jnai (e- Government Procurement: e-gp) m~oaaswa~~udusau~~adnwso~na'uoan~us~"suy~naia~~4~1~6 s?udly ak&lhaninia TAB TAB TAB TAB TAB TAB TAB TAB CAP 8 ~au~ordoaniu/m~anais~o'usini~u~ini~maa -...,. uin 164 vdauqsnn dlurnlns3u 1 oinis~s~wuiuia~auaiuw3uw< RN~LL~MUP~-I~W< uwilwuicua~uaipdn?uwi?wui~~wwimlw$ ~:s/ld~a%~i 17 4 w d t?uainu2557 n-saun 9 unnnu 2558 ~r~uax~unli;~~4ularsi ~'fonsuoiuwi4 lwsm'w6wuiu~au , w?olnsnis w?a sdusit@medicine.psu.ac.th w%~~ws~ww'wuiu~au iwdaudsaaiusiu u~i?wuia'uasua~un?uwi 6inwuaau~l?wu?~u $u 11 Iuiu~aaisiunis
2 ... nmauwwufiiam< u~i?wuia"uaduaiu~~~uw~ ( ~ ~ U ~ ~ M ~ ~ Y I ~ I ~ ~ ~ ~ " L I ~ ~ WIU ~ ~ ~ ~ ~ U ~ ~ U ~ I U I i184 FImabwwufiiam< ~ M i? W ~ l ~ ~ ~ i d 213/2555 ~ a i ~ W aa~ui ~ ~ 6 ~ i?~iwu < 2555) &do~di~un-ji 4' u~i?nuiriuamaiumiuvlt ii~ailrdsznadilzao~~51migo iaq~~sifi~d miuslunimd 1. CLONAZEPAM 0.5 MG COMPRESSED TAB. FOIL [TAB] el?uim 413,000 TAB 2. CLONAZEPAM 2 MG COMPRESSED TAB. FOIL [TAB] ~?UIN 217,000 TAB 3. FLUOXETINE 20 MG COMPRESSED TAB. FOIL [TAB] ~~MIN 585,500 TAB 4. MlANSERlN 30 MG FILM COATED TAB. FOIL RAE] ~?UIN 46,000 TAB 5. NORTRlPTYLlNE 10 MG FILM COATED TAB. FOIL [TAB] d?b11m 371,000 TAB 6. NORTRIPTYLINE 25 MG FILM COATED TAB. FOIL [TAB] d5uln 219,000 TAB 7. OLANZAPINE 10 MG FILM COATED TAB. FOIL DAB] d?~i6u 5,790 TAB 8. QUETlAPiNE FUMARATE 200 MG FILM COATED TAB. FOIL DAB] d%ln 19,140 TAB 9. VENLAFAXlNE HCL 75 MG CONTROL RELEASED CAP. FOIL [CAP] el;uim 37,184 CAP x 3" da~a~dimslaumo~~6u7~0~~~~ as~iwi W~mu~i~iuuirisu ii~6uuawii~iiu eqiuaniw~oz~~~iu~4ijiuciu i~a-ii ~m~nnw~~rawi~msdmiudn'i~umt~ubanaisao9~simia91"~~d bnu&$abauzii uazian"i9-1um~~ciiold6 I. L ~ ~ ~ I ~ L ~ ~ o ~ u P ; ~ I u L ~ ~ ~ I ~ ~ D u ~ I ~ I 1.1 siuaab~um~~a"ns~mz~awiz 1.2 bb'udubi3~~57~17 x 1.3 bbuaus~~su_su_iozbdoilz"~~iu Y 1.4 uererwg3aiidszn"pdu (1) 9-1a"nds~n"PduG~~i 1.5 UM~~JIBI (1) [~auo~ini~iiwod~zfusiiiaun"u (2) nis.u"~vai~ni~~~is.u"usimioeii~~3u~ss%1 1.6 ueru91"qibonais (1) s~"su_"ijonaisdau$~ (2) s~"~~~onaisdaui siuaa~~umm1u~s~n1fimmans~un1sdo~~u~~azdsi~d~i81nis~~~m~~~~"11i~ 2. qmaa3va~~~aui1~1m x 2.1 [~aunsim19~~4u~ii~i0w'~iu~a~$a0u~ini~o d vpy 2.2 [~auonmk~~i~~u[~~n~~u~a~~u91"ruv~si~~oe?w~~iu~o~w~~s~~ ~?di~;~u~~n'~~ua9]0dnisa"~~w"~~~mmaw~a~m~a~u~~u~~ddiumi81~zb~~e 2.3 Q~auosimi6oiojli~~uQ3~ad~z~u~dia81n"un"~~~~uo~iwi~iu~u N Tudrznifinsus1rn~4al~ b6u[ns~w"ini~~~a~uni~.u"muaidn1s~~~~u"us1nio~idb~u~ss81 m181$ [suonniio~~i~~u~n"~u~on~wd'~?~naiu~un"u k!aeiad j~a~l~uou~ufiialwuba"ua~cii?~~ia ~o~~~aunnni~iiiiiik~i.jiaaz~~~~~azmaiu~81~u~~ui~.d"u
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7 A. aoerbambba:d%z~nw I. Tmqdsaa;rn'ni>lu"qiu I$u5nis?nwi(dau 2. dsa~nw ~3uTa~~a~dflmdui 9 mun CLONAZEPAM 0.5 MG COMPRESSED TAB. FOIL RAE1 2. CLONAZEPAM 2 MG COMPRESSED TAB. FOIL DAB1 3. FLUOXETINE 20 MG COMPRESSED TAB. FOIL DAB1 4. MlANSERlN 30 MG FILM COATED TAB. FOIL DAB] 5. NORTRIPTYLINE 10 MG FILM COATED TAB. FOIL [TAB] 6. NORTRIPlYLINE 25 MG FILM COATED TAB. FOIL DAB1 7. OLANZAPINE 10 MG FILM COATED TAB. FOIL [TAB1 8. QUETlAPlNE FUMARATE 200 MG FILM COATED TAB. FOIL DAB1 9. VENLAFAXINE HCL 75 MG CONTROL RELEASED CAP. FOIL [CAP] B. ~aiu6asn15 I. qmaudiald 1) aainui6o~u"naou nsuiau kiau~3au~~azwqniiu dsanau6-w ~om'aui51'16~ uuimaiubasd ~auwz~fiuw di5yuu-1 junisw$m Tuw$m btaz?u~uoiu ~fluodiqcou e w e 2) u~~~riorn'l~~~ui~auluni~n~-aniw~il$m~~mniwmai]m~~au~uoi~uo~u~ 2. qmauc5wiqaw~qn u"on"iwunm,mau~~i~b~m~~~n~b~u~d~iuu"o~i~~dn ~~aa~im~~iuua~nis~~n~ia6~2~~m~uia" au iinuiln i ~ n u i miudranmnszanqaiiiis~4"11 ~ d ~ lina sayailsiui nt-i 2556 ~hri 1) Piisidiiuiln~~uu0~a~?~0~u3ni ag~yidnfd 34 (m.t ) M ~ O 2) 6151u~iiudiiui6m~~u a6u m.w biud 1-5 baaaa~ub6u~iiu w%~ 3).'invh~ui~n~~uuo~awniw~~sd a~uyinl$nfad 7 PI. 2010) 1mralju~6u~au via 4).'isi~u~~loi~~uvuiadiiuilm~~u ~C~Y~BIWIFI~~~ 4 t.~azasj"u~iu~?u M ~ O 5) 61siui"uo~dsa~~~11nu a ~ u2 i 14ui 1 b~azas~"u~6ub~u nr4cbiiiln'iwun ~m~uimqiuus-lni~i~~siz6~~m~6~.n'ui51'i~~~~d luhnuihq6u ian'iaun?omud ny~nm~n~oioa~~ui~mi~u"o~iwumm"a~~ uequilu;duuuilu35u ~ i U ~ i ~ l d ~ ~ ~ ~ ~ b ~ ~ n%n 34 (m.t ) 3. douh;uq nisds~ana~~~snz~aaeiisui $r-a~r'o-duao.r~auosiwi ~oqi.1~onais~1az~aoi7q~qio1dd 1) niwriiuflw~~lriorn'uiii~~~~d uam~n~n*iolauar$uo~ui~~aaus~g~~n'~dnbi]u (mwvuin l~idaunii 4 -J : x 6 82) 2) aliwi~snaian'i5uu1 niwilnu rrnr/w?oniwi&nq9~ au"u~du i%6h5u ii~nn.11~~1~an~sunisaiais~baa u1 3) dibuihh~qnis~unab~uu.'i?9~ui (uuu nu.2 M% M~CI nu.4 w'is 8.2 bb;a~tin=ig) &6iuwlji~az wty4 nsniiinis~d~uuuda~~~n"l,'11~?ua~~imb~azaniu~~2m lii~uii~~ih~~~~~el~uu~~ela~~~u na~iiuuii?uui~$uan'u~?~a~~i~~~a~~niudw$~ (uuu u.4) uiwiauiiu6au 4) ~~bu~w~~~o?uroauims~i~nirw$mu~m~~~a"nan~~"a~n~s~~un~~~~m~ (Good Manufacturing 4-4 Practices) a~wu3nd~$ua~0a5~~uid~auo (a6u~i~mmiusnun~swsa~1aoulmu~~0ni=i?e,~a~n~auw~aua s1~iui~az~u~~~ui~ub~ua~~di~ui~9a"~do?uso~nis~~ms1aps' ~~wotiiqhu) ' I V ~ U ~ O ~ ~ S ~ ~ I D U ~ ~ U 4.1) Certificate of GMP Raw Material / Active Pharmaceutical Inyedient (API) &%uni~?u5i]09 GMP WluB1lm~~l~ GMP-PIC/S oin PIC/S participatiq authorities w?a WHO-GMP uo4d%abwpi~w~m bbaa 4.2) Certificate of GMP Finished Product i?u>o.~mi%ruim~iu GMP-PIC/S w?il WHO-GMP
8 - ns~uidwl&dsz~w~1wu6~a161uni~?u5ad GMP miuuimraiu GMP-PIC/S cnndign4-u nmznssunlsoimisuaau7 M?~~~?ttfll%?tt~~~ GMP m1u81ici1%zi9d GMP-PIC/S 81n PIC/S participatiny authorities - nsgu196"1~"u"7ondiael~ziww6o416?unis?u~o GMP ~IU~~IW~$IIJ GMP-PIC/S 81n PIC/S participatin? authorities Y 5) di~uiii~o~uwzduuhiuu1 (UUU wu.1 ~ 'io u.1) ~~diiu~liii~nzil8a wbu3iuaz~iun?m~n~~~z~awiz u~~uidi~fo~duazu'ori~um~im~~iu~o~s~n~~?~m~izw'u~ (Finished Product Specification and Analytical Procedures) d ~uwni~uu~< ~mums~$u~dmiudszniwnszw~aaai5ism~ ds4szvhriui N.R nd~nisrd~uuudadrbfl'u lsjib~uud~~~~i~uo~~%u~el$uu~~elaa~i~n~~lum~~~~uii~uu~ (a~uu wu.9) w?o di~u~iiuo~rmu~elduu~~ela~s~un~slu~~~d~~ii~~~ (rruu 8.5) u1w~ou6~6'1~ 6) diruiiiriui [Pharmacopoeial ~fiunn<uwz~iiauui ~atmqiuhuid16~ nlt.azw8m~m4uid1~5~ael au"ersiiqn ~~orniuu"on"1~umuims~iuuo~ui~raz?"5ni~?~~~izg apadszni~nszwsaaa1515mqu &oa~~~n'i51 ui W.B ) ~lbu7m~d8os"usodn75?bm~lz~ (Certificate of Analysis) wioumisi~b~uub~uu6u%1im5~~uii~~ui [Pharmacopoeia] fiu~,uni5~uwzb~uuui a~uuazdu~1udsm1~n~zy1~adai~i5mq"u dila zzyiisiui W.B aimq~uhuidi6tg ruazwam5mriuididezj Lun'oadxnouhu 7.1) diaum6~zotu"ersosi~s~nsizdtnqgun"auidi&tg (Certificate of Analysis of Raw Material / Active Pharmaceutical Inyredient) ~nu6osdsznou6'iu 7.1.1) diruiw~aid"sao?uso9 uos~w8m%qiern"auid16~ (Supplier) 7.1.2) di~~imsd"s8~?~32io;, '~09~W~~W~~flm~uld1bf0zd (Manufacturer) 7.2) diruiw6a~o?u~~~nis~bmsizd~lmkm.n'uia"i~~o~d (Certificate of Analysis of Finished Product) lmumasdssnou6au 7.2.1) di~uimga8siursa ~~9~Ww8~l~8~~~n'~ldlbf qd (Manufacturer) lujunirwlmdd~horiia ~ra~lu"a"mq~um"auidiktg~ur~uafiudi~ui~sd"sio?u~oaniss~m~izw'a"mqgu~au~d~~~ (win\aiz.wa"n~iu ~rama~uni~~8m?ynq~un"?u1di~~luiirui~6~io?u~o~n1~?ansizw'w8m~m9iu1di~i~~d myi).~bbuu ~~a~o?~so~oin~w8wwgmkm4uidi~fo~d~u~u) ) hb~i~6aid"saa?usaa va~dau=ii'11ni=i~u v?oa61i~u$u~ninbonvu (da~ddu~~w{w~mul~bauo 51~37) ~~?uni5?usoa Good Laboratory Practices (Certificate of GLP) V?~I ISO/IEC (w~~u~~uu~i~uiw~aio~uso~ GLP w ~o ISOIIEC PIO\IR~IUUU$U~) &~WR~I=A~R~IUM%I~~U 5.d"uiiaiuru"irauosini [6iZ] 8) di~ui~onai~uam~n1~4n9~1maiun~m"a (Stability data) ~mu6oselssnou6au 8.1) Long term stability (n5; i~uwzr~uuuiuiua"auinni1 2 a) 8.2) Accelerated stability bra: 8.3) In - use stability 9) diru7w~a~o?u5odw~mfim~uidir?~~d (Certificate of Pharmaceutical Product / Certificate of Free Sale) [n~~~~uui9a'i~u"iui~ud~1~w~~wu] 10) ~i~uibon~15uan9"uy~ani~~~?unis~~~~~u Green Book uo4 n5u?wuiala~<ni5~l~~6 [tilzl 11) dirui~onai~~amt~o~ani~in"juni~u~~~lu numsw8mriol4uiaid~~~~~inai%1aiia~uu~uni~ u'19j'm?n"ns~in"uui6u~ruu 6~39 d16n~iun6\azn~~uni~oiwi~~~azu1 12) h~ui~rin~iu~nuauuauoaw~m~m.n'ui Y Ul ~19916~S~L~U~J~?DRI~Q [hi781 [fiizl (Bioequivalence) miu~norrii dirinnunmzns3~n1~o1~915~1az 13) dibui~54~19ni5?uu~so~s~uu~mni~~~aaiu~~m~~~fimbn'uia"irf~~d miuuim~~iu uon.9001 ~ 'ia uon.9002 ~ufionisbraauouiiu oindi~nai~uims~iu~~mn"m.n'~mai'~~ns~u ~~oan~~u?u~aduirna~~u IS0.w?o ~~'1ua1udn~~wsa~~mni~n=i~u~9;in1~~u~~a=izu~~iu n~fpl~~uuiwwmludszawclinu [615l 14) ~ ~ ~ ~ ~ U ~ P ~ ~ A ~ ~ U5 M U$?uu~~~~N~" S ~ I %(b$~n"'i~~~~~~~flall~a%baufl ~ U ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 16nsuii?uniudii~umlu~au"o~~au~w"aZdu"i~6u buuwikui&naua~unfum< unanuiin~~i~u m"aobi9ixi4inst-clmq n75iata ~uiuor6o;n.lkd~uimi~~i~d~ooinm~z~rwwuniam ~tlunnl ouiiuqm~@@l
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