GMP (Good Manufacturing Practice) yog cov txheej txheem tswj xyuas thiab saib xyuas cov tshuaj tsim khoom thoob ntiaj teb.Nws tseem yog qhov tsim nyog tso cai rau cov kws tsim tshuaj lag luam kom nkag mus rau hauv kev lag luam thoob ntiaj teb.
GMP muaj xws li: chaw, neeg, chaw, tu cev, validation, ntaub ntawv, ntau lawm, zoo, muag, reuse thiab soj ntsuam thiab lwm yam. Nws muaj cov kev cai nruj ntawm kev siv technology, tswj system thiab validation tswj los tiv thaiv: tsis meej pem ntawm cov khoom xyaw, hla kev kis kab mob thiab kis los ntawm lwm yam tshuaj, kev hloov pauv thiab kev sib txawv ntawm kev sib xyaw ntawm cov khoom sib txawv, kev sib tsoo ntawm cov kauj ruam ntawm kev soj ntsuam, kev ua haujlwm tsis raug thiab lwm yam txheej txheem tsis tsim nyog.
Lub tswv yim ntawm GMP tau coj los rau hauv lub 80s ntawm Tuam Tshoj thiab tau tshaj tawm raws li cov kev cai dav dav thiab yuav tsum tau ua nyob rau lub Xya hli ntuj 1st, 1999. Nyob rau hauv teb chaws USA, cGMP (luv luv rau Current Good Manufacture Practices) tau tso tawm hauv CFR part 210 thiab part 211 hauv 90s.
Zuag qhia tag nrho, lub hom phiaj, txoj cai, kev kawm thiab kev xav tau ntawm Suav GMP yuav luag zoo ib yam li Asmeskas cGMP tab sis muaj tseeb ntau qhov sib txawv raws li hauv qab no.
Txheej txheem kev pom zoo
Daim ntawv pov thawj ntawm Suav GMP tsuas yog daim ntawv pov thawj rau kev tso cai siv tshuaj, tsis suav nrog cov khoom sau npe.Tom qab cov chaw tsim khoom tau pom zoo rau cov khoom tshiab nrog tus lej sau npe, nws muaj peev xwm ua tiav daim ntawv thov GMP ntawv pov thawj.Ntxiv mus, cov ntaub ntawv ntawm peb batch ntawm ntau lawm thiab cov ntaub ntawv ntawm stability ntsuam xyuas nyob rau hauv tsawg kawg yog rau lub hlis yuav tsum tau xa mus rau lub npe khoom los yog GMP ntawv pov thawj.
Daim ntawv pov thawj ntawm American cGMP muaj ob ntu: Kev Tsim Khoom thiab Kev Tswj Xyuas Tshuaj.Qhov ntawd txhais tau hais tias kev sau npe tsim khoom thiab kev tso cai tsim khoom tab tom ua tib lub sijhawm.Muaj ob hom khoom sau npe hauv Tebchaws Meskas: Daim Ntawv Thov Tshuaj Tshiab (NDA) thiab Daim Ntawv Thov Tshuaj Tshiab (ANDA).NDA xav kom cov ntaub ntawv ntawm peb pawg ntawm kev tsim khoom thiab cov ntaub ntawv ntawm kev ntsuas kev ruaj ntseg hauv rau lub hlis.ANDA xav kom cov ntaub ntawv ntawm ib pawg ntawm kev tsim khoom thiab cov ntaub ntawv ntawm kev ntsuas kev ruaj ntseg hauv peb lub hlis.Cov ntaub ntawv ntawm kev soj ntsuam tas li thiab siv tau yuav raug khaws cia los ntawm cov chaw tsim khoom thiab tshaj tawm hauv daim ntawv tshaj tawm txhua xyoo rau FDA.
Xa koj cov lus rau peb:
Post lub sij hawm: Oct-27-2017