4-2545 GMP

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numuaintenlfiins 3 marina 2545; 44 (4) : 270-278 MavianinsndamananinnIsmsnaanAvaslsssuNan NanAuieindnuacuenifed aes musvius demhaz uasawnw feqassuqa Sninquurmuacenadacndvons naainemandmsunnd ouuirust wunys 11000 umiiatio iawiithywaadtouviendiagniin‘it ualseinaanigaucam Gosioduuaon (light fith) navinewrsed maumd Tesnasewradsoanléaienfomuayunsionrslun avian nfasadlaos uNannaaieunia nin 5 uvis, uswiltadaegy 3 uvis san 8 uve macauiumsuriaiumesdumow Sunowusniunsdalsenwses hthilnsatnenerarinrsunnd duseneunvudlaiounwios uaearvvianwdh Susouitaantunrsdrsz909 Vnmthiosdnviennsuacer Ussinaanigaadio (USFDA) @useneumauAleieunndes uacviamniinsy Anunmaninsumndarviamunsuiletounwias seuvaadalunsmaue na, 2543 fs 2544 3m 2D moWannnranfinunznaavadanlasew SondnineutanraKAniia (Good Manufacturing Practices ; GMP) 39 «duties muatungwanesasanigoininaAo Code of Federal Regulation 21 Part 110 Current Good Manufacturing Practices in Manufacturing, Packing or Holding Human Food (21 CFR 110) wanvsdrsvslassnmosna Fnvrenangunnd Tunwanviounwiosiiontinks Tavaneliavundinndnicutieny wutiounnies Tudosynains More auasdsduawaTavedn iefasila nandeuacnsaquAuNNaa usinsAsIsTIsTUAaA sanfanteinimatintd USDA wetounwinnameluiormosmeraruavisduauar Maza iafesiio ‘Tusnusiilsoruueniifidhieg! Linvtoumdositentiv pulls wavinasdadusnaasmaighovimmiaan ‘Dalseinauarinpun masse mag@nuaclssruada dug uaufiransoiannGMPreslswnliadwihlsssininm unt vumous wa. 2540 filszimalnuansy — Housema” adhwlsfensowndaaaniutlety ana Satuernalivfintigmausisdluaaelan athoauss Smfutsemagahitidolaoaty Tusnniziasugiivanoas Gesionansemuienyi Houusemauardinnnaiuadsonuseau Tnuriala Sosridudostaanmsmanandusiowarn MAvasimadis 7 Mlaniiuariwad wy madvean@uda uhunesmsnanatinniioite thGuanshevsemantuyaiugia uaciinbt wasugiethatiesnm ewadveantiududniit ernadiaqudrduduiaennviodauiuyianagie Tnuaasvasuseine Taveissantiszann 400,000 Sruvwmeiall AaifuSavas 13 vasdurassaan Accepted for publication, 22 April 2003 270 qnownivauduaragseiiuutiine mandy uazdeiaaanraasaaaoulsssundnawrsh dooyludseinadidsaan dathanaanad aga msqunsasguilnnluisemenosauios anigourinderfluanandniasiuaun armadsoanvesazinalne Taetuil wa. 2540 anailananrandineamdnineutainrsndndidaaslsooi vseomgua fa adudu Uusemauluuw Clinton's Food Safety Initiatives” valvinure suiufiavaurasanig4 leur Food and Drug Administration (U.S.FDA) fmuasiiasn7se539 aoulsesundnornsiidearluvseimadideoan Tanfauhanasmanivsaonsanoaiuarn uaagiiutua ws nvaiinfunaavusviawisvas U.S.FDA sedrafaqeunmannagwuasndadcuriuiundin Tunvssaiiunrsewngysne usitiofiersan Federal Food Drug and Cosmetic Act 311977 402 fiseyh omaudouiuewnstiadane Winanuminaafibionanvan wade wfivanasy Youtuim meléaounrsdlAli gnqndinsus Sonrehlugaraluiloudaanusn (filth) WatiGudumswdaqaaw” uaaslivin Anmafuesosiualanys US.FDA Lail@isianne mann andatoviduse usifesailufionrias9 aautiniawiavih (Good Manufacturing Prac- tices: GMP) vasliye1m war lénenufienasy Sansnandnransaaenilssnituasinaiidsoan vintayanrsiniududrsas U.SFDA Bein \Gunt1 Import Detention Report woiileqtiu Gunth Import Refusal Report wuhiaung, sail U.S.FDA dintuaudnusswamndadiout miniinife nian wuaniuiaannmunte annntnaneuiiamuel lu Defect Action Level” uUszinalnslaumtuanrlansinivasya wiorwhombusuiferios Wun dine AMENITINIOIUNALHT NowIaNNWAT aninouansgqundindurignsnnsay wae navinureraninrsunnd dashlseqailéiinns vaxsuuardualidninyanenssunse 7s uazeriunuiilu regulatory agency dquéin 3 win ausiud doses waza feqasstuns yniousrusiinda sumuamiily technical agen- ciesrimthrihiannuacbidnlinbunalavlys em aastseo dala vinmslésuseumane dondonsvinmnenaasnrsuwnl Tainasayns daaan slew dla lasses wlnidthud-ningeun in uazariniaandvann) FiHiagussavdties wan GMP veslieuadandadurainin uatusnilisdasegd euitymnniiniy @udiamas USFDA aaimqrindsvuilaon Jaquariins 1. Tassqufiann GMP Trew ufinaainermaninrsumndian Gop iiulsssiii U.S.FDA denwieliiy Aiingwanensnawruase uusiiu 2 nga Aa Tul) we, 2543 way wat. 2544. dail 91 2943 duu 5 Taesq iulswundia und uilstrad ulster §) 2544 dur 3 Tsse1m tiulsonunaa ueviitedadegl Tsornnis 8 wis doglutowinunnlgu sansa vaca 2. ngvanuses U.S.FDA maviawy GMP Tseeulaunsyinen maninraumnduacmadisisnlay US. FDA azfetarmuammngyaw fa Code of Federal Regulation 21 Part 110 Current Good Manufacturing Practices in Manufacturing, Packing or Holding Human Food wiatiunda7 4121 CFR 110° daudungunevasiguianans anigaurinailivoduaulsoounananais uszina Muuniy@afimimualalssounaa arnaiiosndin sag iuinn owmnsdmduanat 271 ‘The Good Manufacturing Practices Improvement Tanongpan Satjapala and Somchai_Kitsuwannakul manan GMP ngvanumond ude 5 au ‘mai 7 Aa unify sroresuasdednaw amuavenn wfosfouszainsed nswinuay nvsaaunanazuauManaia torhmunaosie unwiewardmit 3. tenavszzuU GMP saslsos1 nadifilssnuilensrsvesweuu GMP na AnennenraninvsunndssAnwionsrsvasla fifties Wiobinrniann GMP shifhiluady Auseandnw uses Gslsssufouvionaia uniulsssuniandadutieanin 1 Tse fanansvaszzuy GMP tonarsiidinsaiisell unurtonseuaunis WAA (process flow diagram) miaAIUuquded ‘We (pest control program) Jana AT INABA (cleaning procedure) Trvsia wast “ay anna a 4. msenifius iiumaiawi GMP (Witulssswlasnis Wa wesnainnmanin aun wasesdns anmauarenventsemanigoindauiu A dunoudtedl Furouusn pnusdasaslsas ru nner maninsunnians GMP Tsssnuilosiu (pre-audit) Taunisaannsawnianaauaslit shuveritunsuillevsinpuitowtoumanion fouiidonthit USDA saszdeulsoom fi vwaxiuadotl - Sannvdrsaslseew Gousenaullian aihifinainnmaninrund dua 2 aw x, aa. 2, 4. 7 xd Funouthiudunausuduiiariacdqitios 272 indasaidonynarnalierarsouitaa nla atneiivazaninw lnuredosdhszaunisel anujiias GMP ifiaiafnwwhanmints fungrane 21 CFR 110 waserasvand aavtav0 (pre-audit) maternyuedendn waren ‘vihuusthdtuvsnouiotinmwiiiannnaese Taser urikdontinfigesTseoruluns pre-audit ‘Wiotineiavaugnitios - TeumumsMuiue anusdsaanay Jnennaninaunni tayanraintudurrs U.S.FDA fhnuauuamanraian GMP Tru nu 21 CFR 110 lauwthiludasingiy : ms Dagiiu th¥a daswone (Pest) VnwAAIN uils Avlumanfialasat las: malin ani Hosiudetwme maequradadwome nai Jnmarnadiililumamriauuas nrairinnuy, viuitu - shaaalsoo1u (pre-audit) anuzdva9 nawnmantnrsumnd aan GMP Tass Tauirasiseaumsnaa néanriasvaeu Womhausdrsautsioitoviulys wilt Auustiney Tastntifilsse manson JnowboasduonahluujiAlaadwgniioa uscd lonaninaniénanannaldiovouty uanviniuiamhansdaasesiiv wo miu aananuudstonmosiulgdog anata salu - M3Aa7297AAIN (follow up audit ado 1) Hominusd sazenaviuysuaiavey voilnw ertmuesestetunnutle uarnransivfamdeaylurar 1-3 iow wdsoinmadaa Tavduayivan madsen ‘nestosiinasudoutlsnnviotaniissle Mawanninandaramaninumsnrwdahinadlsos 1K efemuanarausdraedstihasiany mauiflataunwiashlssswlaéudloiuuteu i) Funouh2 mahrvlsswsontnhh U.S.FDA (audit) - Movin USDA dasdasouis tinunns pre-audit s1nNaWIMNM AMIN UWE dla dell 1.2543 Wayttfi US FDA Ao Mr. Dirk Lincoln sdovaelssetundondundl uils 5 T0010 i 2544 mini U.S.FDA fla Mr. William G.Nelson Wat Mr. Bradley J. Maunder soaialiw1u afnusnilisdaiepl 3 Tas = asa9famn (follow up audit aZaf 2) Wont USFDA vensuimestustatly mauilafounwiassinmlswU uacaalt Wanthildelnadlugesaaana winui solwlsse mine unssulyeiounwias daria US.FDA Tauuusal ichegulganfousiom fownainasudusenauivrwsunisui le Tuusiastio nnitisatsssunamdund utvtnatya utter 5 Tiss Tauamedisa nin Jnenmaninvauwnd wuioitantupagls doi (Fuavluindy uanisiormunmm 21 CFR 110° Tauduammdrduarnaiungna) 1. Subpart A yawns BAN 110.10] 1.1 wins uiidsiistow 7s flasusions Wigndios Tnusairiutio Tiqefouassios WiarsneSesvaedy [87977 110.10 (b)] 12 Anausuiupaoubisenugztu minus demhas vaca fagresuqa Goonalfpiitligngndinway iu iuriouuts ae aes . fanasfiuthindulamaustidmournuis iui [31A97 110.10 (c)] 2 Subpart B aiArsuavaedue ersvaan Trosmuuazuivam Bran 110.20) 24 vannilssomiasiranaazeia oman tinavstieutee [anes 110.20 (a)) 22 thilamaviudsayinfadséasin fovoanunuriofiadsludnucuclallasuvan Uaaunduasluvuitiou (077 110.20 (b)} 23 Waaussuweime : Masia avoranurnld guns [31077 110.20 (b)] 24 Uszgmiteanvimnda das dhiau wanaiin osfwun use Prins 110.20 (o)] . 25 danumuiathiiisess. Taw lamereutzpenhinunasnfintnt nnn 110.20 (b)] 26 Uiuuqetuduimmaafuan newmetthunquihinds [snas1 110.20 (b)] 27 Tnfufuingfuuactownia ; dos thenwavoranernld quae vaviin uisitog oranlseg fu iavu fruws Bran 110.35 (a)] 28 Tinaaalwatiagehasou pnan 110.35 (a)] 29 wenifiuarsadalstunrn anwavora vaciiini_ummbtuvivot Wangan uaxinaaainhaubifawy [nes 110.35 (c)} 2.10 Dosiy rhiaun uasastulnds diudftautngiy uatuvavaenaa anon 110.35 (c)} 273 ‘The Good Manufacturing Practices Improvement - As wwATNAeMINA ADAMS waxniseqUAH [317997 110.37] 2.41 HawdawmosthyeInwaliign quinya: wavvhanwazornodwwadhiane fanani 110.37 (d)] 2.12 quaroldrefiadoosuuqedsd [xna91 110.37 (e)] - flayinardrsita lanareltiay maruuuiena - fliiaudndodgnavanwas Hoist isoursatwnanaa fit wuaastonraimauly wminsmdneiia 2.43 Ufuiawuilanfatisoanuan Vinavovbiudnioy 7 Waiosfunisiiandu nity tesarnnriouaawuisnnsy aunt finn 11037 (f] 2.14 Wiuulyslaoufiuvayqe imndos VailMufuftajadunasdawie Bren 11037 @) 3. Subpart C inZasiia - Sasilouaxainsal (nas 110.40] 34 fostuuquaiasins gunselfi iiuaily 32 Dosiullaiiahtusinuaieoitioy wiladadnetin nuaastude 4, Subpart E manaauazmuqunrsnaa Bins) 110.80] 41 omufiuinuriaiiiuinggudontiy tumeriflafiaaniatiosiudatwmn: [1997 110.80 (a)] 274 Tanongpan Satjapala and Somehai_Kitsuwannakul 42 dastiaqunrqudsudiin footy Mouvandaastoonduashiuiieu pnd 1080 b)) - nAUANAAVANA [IMT 110.93] 43 Mantufiesyiw pallet tu thus ualtivnarwazomuacariaaula anidanelave undinueniifiodaiepllan anvdrranvinnmanimaunnd wuiat Mosul iawielurioie “Subpart B a1A7s uardedmiweniazoin” oil - Un vanwaoravsiasoulsesw Tnftufuingiy Wounia Waanseuweama [w1A77 110.20 (a). (b)] - douuausouannradasiasosnts [AT 110.20 (b)) = Hunhyiuluuiinunaatisese thie [M97 110.20 (b)] - UFuuqequinanidrsiio Taunus, ina qunsobinbiiautis wacihwmouliineiia [W1A71 110.37 (e)] - Apsviluardiuugslsufutaqilal wt tlofostlutiuiloya tunasda twine [W1w97 110.37 (A) avian vine (follow up audit) aif 1 wh Tsesuunauvie Helssorunfandndnuti vinta uenilfivedviegy anwrsnuilsbeunwies difiounun uniulssomndetdunii uieiite ‘bisransnilostuttaun unas Tulndavivira AMaiiwtaqdy uavtuvAvanunda midrnelsounaedund uilsinvin uiltvuniier 5 Tsssw Tanto u.s.F0A aan ae ican wutounwinstidooutulgedell nraianainasnfamamdnnaitisnrsnanidaoslsasunia ausiud domha: waver Argavmqa 1. Subpart B ararsuarasdanwan aver - Troomuacutia 141 geniosinssewinsspuriausegt nuws Auciatlositumy usias nas 110.20 (b)] 1.2 *hanwazaraaArsnaa Tae amelndoviviagiudosvinuuavin uty anmétuann [aA77 110.35 (a) 1.3 Tssotuiiasilasiurhrdoun uae GisMFauavarw) Tulndoiutagiy uaclu VaLacuNA [WAT 110.35 (c)] 2. Subpart C inasiia TrsoTudiasanumuatastnianuwu Gotyya (ViMBauswWU Manwruzuandy) [ana 110.40) radaaaslsssunfioueniifiedsagd 3 Tass Tasidontina us.FDA liwuieunwias Atasuilniuugs manvaiianw atti 2 avievaAanw woh Trevnndunii ails ynuvvsaanso adugsiounwias uasses we untanmangy mucheliiime USFDA mulusseziai dsm USDA Agno maasialiseundnarnsulszinalne fidvoanarmslusmnwdsuseinaanagau3m seston USDA unvesenisuuNs HianraUdsqUereandnnumsBnrsndaiA (GMP) Somaftiwihi USDA asain asrelsocmunanownstudsemelnelaiy Ty msulgli mionianigawinrasdasudaiw mhununsmsvaslny Aa naunaAehsuseinA naenaqwidied uazvaanndusensinlssoM usiarursrion Sainestiuiiyatusuiudosaos anaduvan (consent) lailididy (command) dose maijdvoono maiivelianwdoadiothu ada uasfusantitnasalsonlandoiu uselumifie: euluniadsaanndafiot mans ‘Tssomnes U.S.FDA 9zSstarhmunnas 21 CFR 110 dafungmanemedrumaiiafiaaandosay wimaguemaeniwusemates Codex Aa General Principles of Food Hygiene dwiiu Tssoruffjiin 21 CFR 110. fisetihums Up Marusnaaguarnadsiuiiuertusas ussimaaainfin Codex 165 uszimadne diy 21 CFR 110 diiiadoinari Laistiiontimualt GMP goslaasudiasrthuanans dad iU.S.FDA, ‘Wiunsae1s001 (walk through) Taulailéine, aarsiansrsiiiuaiy GMP vinwvtsesw lait ‘aeuflu Sanitary Standard Operating Procedure, Cleaning Procedure, Pest Control “iat atiwls fimunravinizuy GMP Tuplasionars Sats anwilnpuasiimuenuaridualunralfiaessi Uselumhinssiigupadmuudadaledw uacaransmlfpialwasnagniias aqadas29 GMP vaanawine Arann und wutlswouynuvia donliuysary avormAnasoulasudwnyininasw: dh Fusing seuy GMP asoungufisaniiazen soananaulioow lilétriimameo anda ilosrinivmseulawutliavoneiduitoy arduuavundaiquaulavasdatwmcuacunas uansiniiiomuiyndesnmilsiazonano nian Waseuwermeatioananasouluvaraunia 275 ‘The Good Manufacturing Practices Improvement iimnnld quis fieoy domrsudlalawrimun dhewerraaliiinavhanwacormodvariiaa Tssequrrsuviswutlywdasindasans quosnifuaia nsveweyluvanunin ites Minmamahyinuniiviuma Geaieiindy avaniuioussdndatadt msuilatyd seitstiaatiuoanvinedostnstiinaetdurion udafomafiuatin usemahivdndunde soul Wianaafuannsimerunguitnds yuu undvazanuazwiquiulafanastoyauntd Guduundomauiou Fodoodonusuniiu dnllviion Taso uudouazndndiuvieanirdiiqnn wnnlusosmuaasiagauannasunssvwlulnds Vivingfiy uavuGounaa Fouanvinesiilu Hqmviovanuazarauda awtaghudendra Soduawnilivosdaiwms wWiliifiatm dodwmehilasonilanamelndututrasosyn Troon wuun uses dsifiiflaotuuila Aa - Jaseuunrsvhanuazerimawieso9 lawiagiy Taurrmuedagiufiavau anni uaslivhanmdzai SenavAnwaaiaay uils arslimosqardubvesdwultymnmails mznwoMEMATINAZOIA = Tymuntulnaviagiy dostoosta Amouaniomia Tnuianzdorislinseitos yondam uaeldmniw 2 fudoviaputuiiiadn unfidsarursonqasonuinartulndts = wavamnls souuszg Sosgadasin thin vfotostumy unas Tnvtvonieg analiusiueneia nadisosnoil damiiius FDA wivh dovwiafnewia 2 wuauns fiuena fie liimy (mouse) sinutrals 276 Tanongpan_Satjapala and Somchai_ Kitsuwannakul Tndsviuautnuartaqiudontusses aw pallet furunevialinhnanaazona uazasvaauld ihunsioodulailiuioy andunasdn tims 7 pre-audit Tiss1u wutfounwiast Moniuproutionn lanamzlowmdund uilswutaunwdasvinyn Subpart was 21 CFR 110 tudosmesyaains sorariuasisdruw anndzoin indasiia nrswiauazmaequAY nawaa usinradrsielsveusaddontit USFDA wutounwiositoonratuupiveuns Subpart Tnulssondunil uils wufiaunwias tamzludasnasmorariuasdsdauawany azonn infosiio lanes mueniitadwiagy binudounwiasiidaoutlaliialge Glauieuiies GMP tummasewine Trosiu 2 nija fa Tras nactundi ails uacTooon uewilfisdadegd Tsomilundamas fi GMP 4 ndilsvorulunguusn uassinuanaad anwasiafinga sansodostunrnluitey vinmauan uaviasiudatwin: Wadd ussanBaw iafestnsqinsaiuazded wie anwazaanaglusnwla uasiiniaeruq quanuauciivivewe maid USFOA idumenass aoulssswundnawns fialiindselusina qnsamnasunvadsaanawnaa ndvafavali rszinag@daduluqanmaniaaadAusos ndadinnfanndu iflesoindamini USDA Wi Giudnumuazerrarrudomndnnes Bhuthitiijquaiufaneusediny uazlsasulé uflousuuzs GMP muarauouurnasijase sou uacdeswsTuNAnraliuuqila USFDA martennimaaineamdninausnrwndativaslsoo muna musvius demhay uscawmw fesse Uuruaraddalunraimurlisousaa sGodcurvnirauasuenditeduseg! ffinern erasaufiatuadhstnéBauacsauilos sewn mesgfonsensversrsaiga wazmaonmiae Trovunaia uenviniugnamnsiaulsgundn- Aanferntn hugnamnssuiiitundyiagduey moeluusema ifunrsiiayaraauer (value added) wazdwnafiivinymsnsvesuseima wu Ante dunrnhrneléiniseinaitdy fanssadnvasidud yhtalsyeu Wiudpominaa Wosvinhlselomiieslaay sinnvadsaanndednumiasnaiuguossy Fuh Aofid wi nranainanrivasuseinmadwal iszanBmw odwlafinw anwwiowaslaew wiaormaduilstudagiae ya binaasiaeu Tse iinnwénuuandanradsaanaiaes useina dos Sumsiannuassuugslsoow aynasnie Sdacusuyaameidoddmid vindsemagiananssey Weiliiebivsema- Tnunseviiuipitunidsaanany wart aufiusonavaiitaussinalneniu supermarket ‘voslan «w madiiaa GMP vasliveumaimaaunil udadruau s Taam uaclassmveniliiedavtogy 3 Taso Tnunrsnsaafinmnilosdunosnay Tnermaniniaunnd vavevrianwdnaye wiivuasidontini U.S.FDA eamaninaiv Code of Federal Regulation 21 Part 110 Current Good Manufacturing Practices in Manufactur- ing, Packing or Holding Human Food 407% sautiumadendafenraviann GMP witiise01m wo 8 wis davuniontunraimaquiady anasnainitundadatiownsvevusenelneil aedsoonlusimiwdeusemannsgouvimuae ansothguuvudendlaniawienisasze Jom audastunssn arin maninraunnd ws Tunisia GMP aasliasiunaanaadiet oindrauasuenitiedudeguesllladauduns vanislsennundinornrdu 7 Wiiuadvea vile prinisnalesoaguSlnauaenysdsoon tanaraa wis 1. gaara A. Single Agency, mysannisnos gnarmna owe 36 - 7, 17 aortas 2546; 4(19) Center for Food Safety and Applied Nutrition, Food and Drug Administration. Food Safety Initia tive, In; List of Terms : F. September 2001 Available from: URL: http:\\www.cfsan.fda gow/-dms/a2z-fhimiitsi. AuAuiiia 27 nw. 46. ‘Anonymous. Federal Food, Drug and Cosmetic Act, as Amended, and Related Laws : US Govern- ment Printing Office, Washington, D.C. 1985 16-7. Office of Regulatory Affairs, Food and Drug Administration, Refusal Actions by FDA as Re- corded in OASIS for THAILAND, April 2002, Avail- able from : URL : http//www.fda gov/ora/oasis/4/ ora_oasis_c_thhim. @uAwile 17 uanew 2843, Center for Food Safety and Applied Nutrition, Food and Drug Administration. Food Defect Ac- tion Levels : np. May 1995 : | National Archives and Records Administration, Code of Federal Regulations, Food and Drug, 21 Part 100 to 169 : US. Government Printing office, Washington, D.C. 1995 ; 198 - 207. 277 ‘The Good Manufacturing Practices Improvement Tanongpan Saljapala and Somchai_Kitsuwannakul The Good Manufacturing Practices Improvement in the Rice Products and Instant Noodle Factories Tanongpan Satjapala and Somchai uwannakul Bureau of Quality and Safety of Food, Department of Medical Sciences, Tiwanond Road, Nonthaburi 11000, Thailand, ABSTRACT To solve the problem on rice products detention in USA. due to light fith contamination, the technical assistance to improve the processing of 5 rice product factories and 3 instant noodle factories (totally 8 factories) were carried out during the year 2543 to 2544 B E. (two years) by Division of Food-for-Export. Department of Medical Sciences. The improvement comprised of two steps. Firstly, the factories were inspected (pre-audit) by Department of Medical Sciences officers, corrective action performed by the factories ‘and follow up audit. Secondly, the factories were inspected (audit) by Food and Drug Administration officers from USA. (USFDA), corrective action performed by the factories and then Department of Medical Sciences officers performed the follow up audit. The development was focused on the area of The Good Manufacturing Practices (GMP) based on Code of Federal Regulation 21 Part 110 - Current Good Manufacturing Practices in Manufacturing, Packing or Holding Human Food. In conclusion, the factory inspection by Department of Medical Sciences indicated that the GMP aspects shall be improved particularly for the rice product factories where personnel, buildings and facilities, equipment as well as processing and quality control did not comply with subparts of 21CFR 110. However, when U.S FDA officers performed their inspections at the rice product factories, only buildings and facilities and equipment failed to comply with the regulation Whereas there was no such violation in instant noodle factories. Therefore, this GMP improvement by the government sectors, both Thai authorities and importing country authorities, and the factories were regarded as an effective measure for GMP development of the factories. Key words : GMP improvement, U.S.FDA inspection, rico product factories 278

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