Kev tswj xyuas zoo ntawm HPMC (hydroxypropyl methylcellulose) cov chaw tsim tshuaj yog ib qho tseem ceeb los xyuas kom meej qhov sib xws, purity thiab kev nyab xeeb ntawm cov khoom thaum lub sij hawm tsim khoom.
1. Raw khoom tswj
1.1 Cov khoom siv raw khoom kuaj xyuas
Pharmaceutical factories yuav tsum xaiv cov khoom siv raw cov ntaub ntawv pov thawj thiab tshuaj xyuas thiab tshuaj xyuas lawv tsis tu ncua kom ntseeg tau tias kev ruaj ntseg ntawm cov khoom siv raw zoo.
1.2 Txais kev tshuaj xyuas cov khoom siv raw
Txhua batch ntawm raw cov ntaub ntawv yuav tsum tau soj ntsuam nruj me ntsis ua ntej nkag mus rau hauv cov txheej txheem ntau lawm, xws li cov tsos, tshuaj ntsuam xyuas muaj pes tsawg leeg, kev txiav txim siab cov ntsiab lus noo noo, thiab lwm yam, kom ntseeg tau tias lawv ua tau raws li cov qauv zoo.
1.3 Kev soj ntsuam kev cia khoom
Qhov chaw khaws cia ntawm cov ntaub ntawv raw yog nruj me ntsis tswj, xws li kub thiab av noo, tiv thaiv kev hloov pauv zoo thaum khaws cia.
2. Kev tswj cov txheej txheem ntau lawm
2.1 Txheej txheem validation
Cov txheej txheem tsim khoom yuav tsum raug lees paub kom paub meej tias nws tuaj yeem tsim cov khoom lag luam uas ua tau raws li cov qauv kev xav tau zoo. Kev lees paub suav nrog kev teeb tsa cov txheej txheem tsis raug, txheeb xyuas thiab saib xyuas cov ntsiab lus tseem ceeb (CCP) hauv cov txheej txheem tsim khoom.
2.2 Kev soj ntsuam online
Thaum lub sij hawm tsim khoom, cov cuab yeej saib xyuas hauv online siab heev yog siv los saib xyuas qhov tseem ceeb ntawm lub sijhawm, xws li kub, siab, nplawm nrawm, thiab lwm yam, kom ntseeg tau tias cov txheej txheem ntau lawm ua haujlwm nyob rau hauv qhov teeb tsa.
2.3 Kev tshuaj xyuas cov khoom nruab nrab
Cov khoom nruab nrab raug kuaj xyuas thiab tshuaj xyuas tsis tu ncua kom ntseeg tau tias lawv cov khoom zoo nyob ib puag ncig ntawm txhua theem ntawm kev tsim khoom. Cov kev tshuaj xyuas no suav nrog cov khoom siv lub cev thiab tshuaj lom neeg xws li pom, solubility, viscosity, pH tus nqi, thiab lwm yam.
3. Ua tiav cov khoom zoo tswj
3.1 Kev tshuaj xyuas cov khoom tiav
Cov khoom kawg yog raug rau kev soj ntsuam zoo, suav nrog cov tsos, lub cev thiab tshuaj lom neeg, purity, impurity cov ntsiab lus, thiab lwm yam, kom ntseeg tau tias cov khoom ua tau raws li cov tshuaj pharmacopoeia lossis cov qauv sab hauv.
3.2 Kev kuaj kev ruaj ntseg
Cov khoom tiav yog kuaj rau kev ruaj ntseg los ntsuas qhov kev hloov pauv ntawm cov khoom zoo thaum khaws cia. Cov khoom kuaj muaj xws li cov tsos, cov ntsiab lus uniformity, impurity tiam, thiab lwm yam.
3.3 Tso Tawm Kev Tshawb Fawb
Tom qab kev tshuaj xyuas cov khoom tiav tiav lawm, nws tseem yuav tsum tau tso tawm kev tshuaj ntsuam xyuas kom ntseeg tau tias cov khoom ua tau raws li txhua qhov kev xav tau zoo ua ntej muag lossis siv.
4. Cov khoom siv thiab kev tswj ib puag ncig
4.1 Cov cuab yeej ntxuav tu validation
Cov khoom siv ntau lawm yuav tsum tau ntxuav thiab tshuaj tua kab mob tsis tu ncua, thiab cov nyhuv ntxuav yuav tsum raug kuaj xyuas kom tsis txhob muaj kab mob sib kis. Validation muaj xws li residue detection, tu parameter teem thiab tu txheej txheem cov ntaub ntawv.
4.2 Kev saib xyuas ib puag ncig
Ib puag ncig tej yam kev mob hauv cheeb tsam tsim tau raug saib xyuas nruj me ntsis, suav nrog huab cua huv, microbial load, kub thiab av noo, kom ntseeg tau tias qhov chaw tsim khoom ua tau raws li GMP (Good Manufacturing Practice).
4.3 Cov cuab yeej tu thiab ntsuas ntsuas
Cov cuab yeej siv ntau lawm yuav tsum tau tswj xyuas thiab ntsuas tsis tu ncua kom ntseeg tau tias nws qhov kev ua haujlwm ib txwm muaj thiab ntsuas qhov tseeb, thiab kom tsis txhob muaj cov cuab yeej tsis ua haujlwm cuam tshuam rau cov khoom zoo.
5. Kev cob qhia neeg ua haujlwm thiab kev tswj hwm
5.1 Kev cob qhia neeg ua haujlwm
Kev tsim khoom thiab kev tswj xyuas cov neeg ua haujlwm zoo yuav tsum tau txais kev cob qhia tsis tu ncua kom paub txog cov txheej txheem ua haujlwm tshiab, kev tswj xyuas zoo thiab GMP cov cai los txhim kho lawv cov kev txawj ntse thiab kev paub zoo.
5.2 Txoj Haujlwm Lub Luag Haujlwm
Lub luag haujlwm lub luag haujlwm tau ua tiav, thiab txhua qhov txuas muaj ib tus neeg mob siab rau ua tus saib xyuas, qhia meej lawv lub luag haujlwm hauv kev tswj xyuas kom zoo thiab ua kom ntseeg tau tias cov kev tswj xyuas zoo tuaj yeem siv tau zoo hauv txhua qhov txuas.
5.3 Kev ntsuas kev ua tau zoo
Txheeb xyuas kev ua haujlwm ntawm cov neeg ua haujlwm tswj xyuas kom zoo los txhawb lawv kom txhim kho kev ua haujlwm zoo thiab ua haujlwm tau zoo, thiab tshawb xyuas tam sim thiab kho cov teeb meem hauv kev ua haujlwm.
6. Kev tswj cov ntaub ntawv
6.1 Cov ntaub ntawv thiab cov ntawv ceeb toom
Tag nrho cov ntaub ntawv thiab cov txiaj ntsig hauv cov txheej txheem tswj kev ua tau zoo yuav tsum tau sau tseg thiab daim ntawv qhia ua tiav yuav tsum raug tsim los tshuaj xyuas thiab taug qab. Cov ntaub ntawv no suav nrog kev lees txais cov khoom siv raw, cov txheej txheem kev tsim khoom, kev tshuaj xyuas cov khoom tiav, thiab lwm yam.
6.2 Cov ntaub ntawv tshuaj xyuas
Tsis tu ncua tshuaj xyuas thiab hloov kho cov ntaub ntawv ntsig txog kev tswj xyuas zoo kom ntseeg tau tias qhov tseeb thiab raws sijhawm ntawm lawv cov ntsiab lus thiab zam cov teeb meem zoo los ntawm cov ntaub ntawv tas sij hawm lossis tsis raug.
7. Kev tshuaj xyuas sab hauv thiab kev tshuaj xyuas sab nraud
7.1 Internal audit
Pharmaceutical factories yuav tsum tau ua kev soj ntsuam sab hauv tsis tu ncua los xyuas qhov kev siv ntawm kev tswj kom zoo nyob rau hauv txhua qhov txuas, txheeb xyuas thiab kho cov kev pheej hmoo zoo, thiab txuas ntxiv txhim kho kev tswj xyuas kom zoo.
7.2 Kev tshuaj xyuas sab nraud
Txais kev tshuaj xyuas tsis tu ncua los ntawm tsoomfwv cov cai tswjfwm thiab cov koomhaum pov thawj thib peb kom ntseeg tau tias kev tswj hwm kev ua tau zoo ua raws li cov kev cai lij choj, cov cai thiab cov qauv kev lag luam.
8. Kev tswj tsis txaus siab thiab rov qab los
8.1 Kev Tsis Txaus Siab
Pharmaceutical factories yuav tsum tsim kom muaj ib qho kev tsis txaus siab tshwj xeeb tuav cov txheej txheem los sau thiab txheeb xyuas cov neeg siv khoom tawm tswv yim raws sijhawm, daws teeb meem zoo, thiab ntsuas kev txhim kho zoo sib xws.
8.2 Rov qab cov khoom
Tsim thiab siv cov txheej txheem rov qab los ntawm cov khoom, thiab thaum muaj teeb meem loj lossis muaj kev phom sij txog kev nyab xeeb hauv cov khoom, lawv tuaj yeem rov qab tau cov khoom muaj teeb meem sai sai thiab siv cov kev daws teeb meem zoo sib xws.
9. Kev txhim kho tsis tu ncua
9.1 Tswj kev pheej hmoo zoo
Siv cov cuab yeej tswj kev pheej hmoo zoo (xws li FMEA, HACCP) rau kev soj ntsuam thiab kev tswj hwm, txheeb xyuas thiab tswj cov kev pheej hmoo zoo.
9.2 Cov phiaj xwm txhim kho kom zoo
Tsim ib lub tswv yim txhim kho kom zoo los txuas ntxiv txhim kho cov txheej txheem ntau lawm thiab txhim kho cov khoom zoo raws li cov ntaub ntawv tswj tau zoo thiab cov txiaj ntsig kev soj ntsuam.
9.3 Technology hloov tshiab
Qhia cov thev naus laus zis tshiab thiab cov cuab yeej siv, tsis tu ncua hloov kho thiab txhim kho kev tsim khoom thiab kev tswj kom zoo, thiab txhim kho kev tshawb pom qhov tseeb thiab kev ua haujlwm ntau lawm.
Cov kev tswj xyuas zoo no ua kom ntseeg tau tias HPMC cov chaw muag tshuaj tuaj yeem tsim cov khoom lag luam zoo, cov txheej txheem ua raws li cov txheej txheem tsim khoom, yog li ua kom muaj kev nyab xeeb thiab ua tau zoo ntawm cov tshuaj.
Post lub sij hawm: Jul-03-2024