3 Pharmaceutical Quality System (PQS)
3.1 Kev tsim cov khoom tsis muaj menyuam yog ib qho kev ua haujlwm nyuaj uas yuav tsum muaj kev tswj xyuas tshwj xeeb thiabkev ntsuas los xyuas kom meej qhov zoo ntawm cov khoom tsim. Raws li qhov chaw tsim khoom PQSyuav tsum encompass thiab hais txog cov kev cai tshwj xeeb ntawm sterile khoom tsim thiab xyuas kom meejtias txhua yam kev ua ub no tau tswj tau zoo kom muaj kev pheej hmoo ntawm microbial, particulate thiabendotoxin / pyrogen paug yog txo qis hauv cov khoom tsis muaj menyuam. Ntxiv rau PQSCov lus qhia ntxaws ntxaws hauv Tshooj 1 ntawm GMP cov lus qhia (Pib I - Cov Lus Qhia Tseem Ceeb rau Kev Kho MobCov khoom lag luam), PQS rau cov khoom lag luam tsis muaj menyuam yuav tsum xyuas kom meej tias:i. Kev tswj hwm kev pheej hmoo zoo yog kev koom ua ke rau txhua qhov chaw ntawm cov khoom lag luam lub neej voj voog nroglub hom phiaj kom txo tau cov kab mob microbial kom tsawg thiab ua kom cov khoom tsis zootsim.ii. Cov chaw tsim khoom muaj kev paub txaus thiab kev txawj ntse ntawm cov khoommanufactured thiab cov cuab yeej, engineering thiab manufacturing txoj kev ua hauj lwm uasmuaj kev cuam tshuam rau cov khoom zoo.iii. Lub hauv paus ua rau kev soj ntsuam ntawm cov txheej txheem, txheej txheem lossis cov cuab yeej tsis ua haujlwm yog ua raws li txoj hauv kevtias qhov kev pheej hmoo rau cov khoom raug txheeb xyuas thiab nkag siab kom tsim nyog kho thiabKev tiv thaiv kev tiv thaiv (CAPA) raug siv.ib iv. Kev tswj hwm kev pheej hmoo yog siv rau hauv kev txhim kho thiab kev saib xyuas ntawm CCS, txhawm rau txheeb xyuas,ntsuam xyuas, txo / tshem tawm (qhov twg muaj feem xyuam) thiab tswj kev pheej hmoo kis kab mob. Txaus ntshaikev tswj hwm yuav tsum tau sau tseg thiab yuav tsum suav nrog cov laj thawj rau kev txiav txim siabKev cuam tshuam txog kev txo qis thiab kev lees txais cov kev pheej hmoo seem.v. Cov thawj coj loj yuav tsum saib xyuas lub xeev tswj tau zoo thoob plaws hauv lub chaw thiabkhoom lifecycle. Cov txiaj ntsig kev tswj hwm kev pheej hmoo yuav tsum tau tshuaj xyuas tsis tu ncua raws li ib feem ntawm-mus rau kev tswj kom zoo, thaum hloov pauv, thaum muaj teeb meem tshwm sim tseem ceeb,thiab thaum lub sij hawm kev tshuaj xyuas cov khoom zoo.vi. Cov txheej txheem cuam tshuam nrog kev ua tiav, khaws cia thiab thauj cov khoom tsis muaj menyuam yuav tsum tsis txhob uacuam tshuam cov khoom tsis muaj menyuam. Yam uas yuav tsum tau xav txog muaj xws li: thawvkev ncaj ncees, kev pheej hmoo ntawm kev kis kab mob thiab zam kev degradation los ntawm kev xyuas kom meej tias cov khoom yogkhaws cia thiab khaws cia raws li cov kev cai khaws cia.vii. Cov neeg muaj lub luag haujlwm rau daim ntawv pov thawj / tso tawm cov khoom tsis muaj menyuam muaj peev xwm nkag tau raukev tsim khoom thiab cov ntaub ntawv zoo thiab muaj kev paub txaus thiab kev paub hauv lubkev tsim cov khoom tsis muaj menyuam thiab cov yam ntxwv tseem ceeb ntawm kev ua haujlwm zoo. Qhov no yog nyob rau hauv thiaj li yuavtso cai rau cov neeg no los txiav txim seb cov khoom tsis muaj menyuam puas tau raug tsim ua raws linrog rau cov ntawv teev npe tshwj xeeb thiab cov txheej txheem pom zoo thiab yog qhov xav tau zoo.
3.2 Tag nrho cov kev tsis sib haum xeeb, xws li kev xeem tsis ua tiav, kev soj ntsuam ib puag ncig los yogkev sib txawv ntawm cov txheej txheem tsim yuav tsum tau tshawb xyuas kom txaus ua ntej muab ntawv pov thawj / tso tawmntawm batch. Kev tshawb nrhiav yuav tsum txiav txim siab qhov muaj feem cuam tshuam rau cov txheej txheem thiab cov khoomzoo thiab seb puas muaj lwm yam txheej txheem lossis cov khoom siv uas muaj feem cuam tshuam. Yog vim li cas suav nroglos yog tsis suav nrog ib qho khoom lossis batch los ntawm qhov kev tshawb xyuas yuav tsum tau ua kom pom tseeb tseeb thiabkaw tseg.