Thaum tsim chav huv GMP rau zaub mov, qhov ntws rau tib neeg thiab cov khoom siv yuav tsum tau sib cais, yog li txawm tias muaj kev ua qias tuaj rau ntawm lub cev, nws yuav tsis kis mus rau cov khoom, thiab tib yam muaj tseeb rau cov khoom.
Cov ntsiab cai uas yuav tsum nco ntsoov
1. Cov neeg ua haujlwm thiab cov khoom siv nkag mus rau hauv thaj chaw huv yuav tsum tsis txhob sib koom tib lub qhov rooj nkag. Cov neeg ua haujlwm thiab cov channel nkag mus rau hauv cov khoom siv yuav tsum muab cais. Yog tias cov khoom siv raw thiab cov khoom siv pabcuam thiab cov khoom ntim khoom uas kov ncaj qha rau cov zaub mov tau ntim khoom ruaj khov, yuav tsis ua rau muaj kev sib kis, thiab cov txheej txheem ntws yog qhov tsim nyog, hauv paus ntsiab lus, ib qho nkag tuaj yeem siv tau. Rau cov khoom siv thiab cov khib nyiab uas yuav ua rau ib puag ncig muaj kuab paug, xws li cov pa roj carbon activated thiab cov khoom seem siv lossis tsim tawm thaum lub sijhawm tsim khoom, yuav tsum teeb tsa cov qhov rooj nkag thiab tawm tshwj xeeb kom tsis txhob muaj kev sib kis ntawm cov khoom siv raw, cov khoom siv pabcuam lossis cov khoom ntim sab hauv. Nws yog qhov zoo tshaj plaws los teeb tsa cov qhov rooj nkag thiab tawm sib cais rau cov khoom siv nkag mus rau hauv thaj chaw huv thiab cov khoom tiav xa tawm ntawm thaj chaw huv.
2. Cov neeg ua haujlwm thiab cov khoom siv uas nkag mus rau thaj chaw huv yuav tsum teeb tsa lawv chav ntxuav lossis ua cov kev ntsuas ntxuav kom huv. Piv txwv li, cov neeg ua haujlwm tuaj yeem nkag mus rau thaj chaw tsim khoom huv los ntawm lub qhov cua tom qab da dej, hnav khaub ncaws ua haujlwm huv (xws li lub kaus mom ua haujlwm, khau ua haujlwm, hnab looj tes, lub ntsej muag, thiab lwm yam), da dej cua, ntxuav tes, thiab tua kab mob tes. Cov khoom siv tuaj yeem nkag mus rau thaj chaw huv los ntawm lub qhov cua lossis lub thawv hla tom qab tshem cov ntim sab nraud, da dej cua, ntxuav qhov chaw, thiab tua kab mob.
3. Yuav kom tsis txhob muaj kuab paug rau cov khoom noj los ntawm lwm yam sab nraud, thaum tsim cov khoom siv ua haujlwm, tsuas yog cov khoom siv tsim khoom, cov chaw thiab cov chav khaws khoom siv yuav tsum tau teeb tsa hauv thaj chaw tsim khoom huv si. Cov chaw pabcuam pej xeem xws li compressors, cylinders, twj tso kua mis, cov khoom siv tshem plua plav, cov khoom siv dehumidification, cov kiv cua tso pa tawm rau cov pa roj compressed yuav tsum tau teeb tsa hauv thaj chaw tsim khoom dav dav ntev li qhov yuav tsum tau ua ntawm cov txheej txheem. Yuav kom tiv thaiv kev sib kis ntawm cov khoom noj, cov khoom noj ntawm cov lus qhia sib txawv thiab ntau yam tsis tuaj yeem tsim tawm hauv tib chav huv tib lub sijhawm. Vim li no, nws cov khoom siv tsim khoom yuav tsum tau teeb tsa hauv chav huv sib cais.
4. Thaum tsim ib txoj kev hla hauv thaj chaw huv si, xyuas kom meej tias txoj kev hla ncaj qha mus txog txhua qhov chaw tsim khoom, nruab nrab lossis chaw khaws cov khoom ntim. Cov chav ua haujlwm lossis chav khaws khoom ntawm lwm qhov chaw tsis tuaj yeem siv ua txoj kev hla rau cov khoom siv thiab cov neeg ua haujlwm nkag mus rau hauv qhov chaw no, thiab cov khoom siv zoo li qhov cub tsis tuaj yeem siv ua txoj kev hla rau cov neeg ua haujlwm. Qhov no tuaj yeem tiv thaiv kev sib kis ntawm ntau hom khoom noj uas tshwm sim los ntawm kev thauj khoom thiab kev ntws ntawm tus neeg ua haujlwm.
5. Yog tias cov txheej txheem ua haujlwm, cov txheej txheem ua haujlwm, thiab cov khoom siv tsis cuam tshuam rau cov txheej txheem, yog tias cov txheej txheem cua txias ntawm cov chav ua haujlwm huv si sib ze zoo ib yam, qhov rooj tuaj yeem qhib rau ntawm phab ntsa faib, cov thawv hla tuaj yeem qhib, lossis cov siv conveyor tuaj yeem teeb tsa los hloov cov ntaub ntawv. Sim siv tsawg dua lossis tsis muaj kev sib koom hla sab nraum chav ua haujlwm huv si.
6. Yog tias qhov chaw zom, sieving, tableting, filling, API ziab thiab lwm qhov chaw uas tsim cov hmoov av ntau tsis tuaj yeem kaw tag nrho, ntxiv rau cov khoom siv ntes thiab tshem tawm cov hmoov av tsim nyog, yuav tsum tsim chav ua haujlwm pem hauv ntej. Txhawm rau kom tsis txhob muaj kuab paug rau cov chav nyob ib sab lossis txoj kev taug kev sib koom. Tsis tas li ntawd, rau cov chaw uas muaj cua sov thiab dej noo ntau, xws li kev npaj khoom khov kho thiab kev npaj tshuaj txhaj, ntxiv rau kev tsim cov khoom siv tshem tawm dej noo, chav pem hauv ntej kuj tseem tuaj yeem tsim los kom tsis txhob cuam tshuam rau kev ua haujlwm ntawm chav huv si nyob ib sab vim muaj dej noo ntau thiab cua sov ntau thiab cov yam ntxwv ntawm huab cua ib puag ncig.
7. Nws yog qhov zoo tshaj plaws los cais cov elevators rau kev thauj cov ntaub ntawv thiab cov elevators hauv ntau chav Hoobkas. Nws tuaj yeem pab txhawb kev teeb tsa ntawm cov neeg ua haujlwm thiab cov khoom siv. Vim tias cov elevators thiab shafts yog qhov chaw loj ntawm kev ua qias tuaj, thiab huab cua hauv cov elevators thiab shafts nyuaj rau ntxuav. Yog li ntawd, nws tsis haum rau kev teeb tsa cov elevators hauv thaj chaw huv. Yog tias vim muaj kev xav tau tshwj xeeb ntawm cov txheej txheem lossis kev txwv ntawm cov qauv tsev Hoobkas, cov khoom siv txheej txheem yuav tsum tau npaj peb-seem, thiab cov ntaub ntawv yuav tsum tau thauj los ntawm sab saud mus rau hauv qab lossis hauv qab mus rau sab saud hauv thaj chaw huv los ntawm elevator, lub airlock yuav tsum tau teeb tsa ntawm lub elevator thiab thaj chaw tsim khoom huv. Lossis tsim lwm yam kev ntsuas kom ntseeg tau tias huab cua huv hauv thaj chaw tsim khoom.
8. Tom qab cov neeg nkag mus rau hauv lub chaw ua haujlwm los ntawm chav hloov pauv thawj zaug thiab chav hloov pauv thib ob, thiab cov khoom nkag mus rau hauv lub chaw ua haujlwm los ntawm txoj kev ntws khoom thiab txoj kev ntws neeg ua haujlwm hauv GMP chav huv si tsis sib cais. Txhua yam khoom siv yog ua los ntawm tib neeg. Kev ua haujlwm tsis nruj heev tom qab nkag los.
9. Txoj kev hla mus los ntawm cov neeg ua haujlwm kuj yuav tsum tau tsim los xav txog thaj chaw tag nrho thiab kev siv cov khoom. Qee lub chav hloov khaub ncaws ntawm cov neeg ua haujlwm hauv tuam txhab, chav buffer, thiab lwm yam tsuas yog tsim rau ob peb square meters xwb, thiab qhov chaw tiag tiag rau kev hloov khaub ncaws me me.
10. Nws yog ib qho tsim nyog kom tsis txhob muaj kev sib tshuam ntawm cov neeg ua haujlwm, cov khoom siv, cov khoom siv, thiab cov khib nyiab. Nws tsis yooj yim sua kom muaj kev xav zoo meej hauv cov txheej txheem tsim qauv tiag tiag. Yuav muaj ntau hom kev cob qhia tsim khoom sib dhos, thiab ntau hom kev ua haujlwm ntawm cov khoom siv.
11. Tib yam li ntawd rau kev xa khoom. Yuav muaj ntau yam kev pheej hmoo. Cov txheej txheem hloov pauv tsis tau ua raws li tus qauv, kev nkag mus rau cov ntaub ntawv tsis tau ua raws li tus qauv, thiab qee qhov yuav muaj txoj kev khiav tawm tsis zoo. Yog tias muaj kev puas tsuaj xws li av qeeg thiab hluav taws kub, thaum koj nyob hauv thaj chaw ntim khoom lossis qhov chaw nyob ze uas koj xav tau hloov khaub ncaws ntau zaus, nws yog qhov txaus ntshai heev vim tias qhov chaw tsim los ntawm GMP chav huv yog nqaim thiab tsis muaj qhov rais tshwj xeeb lossis qhov tawg.
Lub sijhawm tshaj tawm: Cuaj hlis-26-2023
