Iwe unoziva chii CMmm?

Chii chinonzi cgm?

Iyo Pasi rose Drap GMP yakazvarwa muUnited States muna 1963 Munda, kutamba basa rinowanda rakakosha mukushandisa kwakachengeteka uye nekubudirira kwezvinodhaka pasi rese. China yakatanga yakurudzira iyo Staturory Drapt GMP muna 1988, uye inonyanya kuongororwa zvitatu kubva muna 1992, 1998, uye 2010, iyo ichiri kuda kumwe kuvandudzwa. Pakati pemakore anopfuura makumi maviri ekusimudzira zvinodhaka gmp basa muChina, kubva pakusuma pfungwa yeGMP kusimudzira gmp certification, kubudirira kwePhosed kwakawanikwa. Nekudaro, nekuda kwekutanga kwekutanga kweGMP kuChina, kwave kune akawanda phenomena yekunyora kushandisa GMP, uye zvinorehwa neGMP haina kunyatsobatanidzwa mukugadzirwa chaiko uye manejimendi emhando yepamusoro.

 

Kuvandudzwa kweCGMP

Izvo zviripo zveGMP zvinodiwa muChina zvichiri mu "yekutanga nhanho" uye zvinongova zvangoita zvinodiwa. Kuti vaite zveChinese kuti vapinde mumusika wepasi rose nezvigadzirwa zvavo, ivo vanofanirwa kuunganidza manejimendi avo ekugadzira nemitemo yepasi rose kuitira kuti uwane kuzivikanwa kwemusika. Kunyangwe hurumende yeChinese isati yamboshanda makambani emishonga yemishonga yekuita cgmm, izvi hazvireve kuti hapana kukurumidza kweChina kuita cgp. Pane zvinopesana, kugadzirisa iyo yese yekugadzira maitiro zvichienderana neCGMm zviyero zvakakosha preerequisite yekufambisa yakananga kune yega yega. Neraki, parizvino muChina, makambani emishonga ane ruzivo rwekutarisa

Nhoroondo yeCGMP Development: Inhoroondo yose CGMP, ingave iri muUnited States kuongorora kweUnited States . Iyi spection yakatanga kubva kumusangano wepasi rose pane kuwirirana kwezvinhu zvekushandisa (ich nekuda kweGeneva) munaGunyana 1997. Muna Kurume 1998, CGMP Mune autumn ya1999, iyo European Union neUnited States yakasvika chibvumirano cheCGUAL yekuzivisa yechibvumirano cheakasviba. Mushure mekunge chibvumirano chakapinda mumhedzisiro, mapato ese ari maviri akabvuma kuziva mumwe nemumwe CGMP Certification inoguma nemari yekutengeserana yezvinhu zvisina kugadzirwa. Kune makambani API, CGMM yemirairo ndeyechokwadi chaicho mukati meicho yeiyo q7a.

 

Mutsauko pakati peCGMP uye GMP

CGMP ndeyeGMP chiyero chakaitwa nenyika dzakadai seUnited States, Europe, neJapan, inozivikanwawo se "International GMP Limm". CGMm zviyero hazvina kuenzana neGMP zviyero zvakaitwa muChina.

Iko kushandisirwa kweGMP Mitemo muChina iseti yeGMP Mirairo inoshanda kune nyika dzichiri kusimudzira neiyo, neimwe nzira pane izvo zvinodiwa kuti zviitwe zvigadzirwa zvakadai sekugadzira zvigadzirwa.

CGMm yakaitwa nenyika dzakadai seUnited States, Europe, neJapan inotarisa kugadzirwa kwesoftware, yakadai sekutora zviito zvevashandi uye maitiro ekugadzirisa zviitiko zvisingatarisirwi mukugadzira maitiro.

. Kune zvinhu zvitatu mukugadzira zvinodhaka maitiro - Hardware masisitimu, software masisitimu, uye vashandi veUnited States iri nyore uye ine zvitsauko zvishoma pane GMP muChina. Nekudaro, pane misiyano yakakosha mune izvo zvinowanikwa zvinodiwa kune izvi zvitatu zvinhu. China GMP ine zvimwe zvinodiwa zveHardware, nepo United States 'cGMm ine zvimwe zvinodikanwa zve software nevashandi. Izvi zvinodaro nekuti hunhu hwekugadzira zvinodhaka zvinoenderana nekushanda kwemushandi, saka basa revashandi veGMP muUnited States yakakosha kupfuura iyo yemidziyo yemafekitori.

(2) kuenzanisa kwebasa mabasa. MuChina GMP, pane zvakadzama mitemo pane zvinodiwa MuCGMM system muUnited States, zvinodiwa (mwero wekudzidziswa) wevashandi zvakakombama uye zvakajeka, nepo mabasa evashandi akanyatsotsanangurwa. Iri basa rekutonga rinovimbisa hunhu hwekugadzira zvinodhaka.

(3) Kuenzanisa kwemubatanidzwa wekuunganidza uye kuongorora. Gmp Tsime.

 

Matambudziko mukuita cgmm

Iyo GMP Shanduko yemabhizimusi eChinese emishonga ave akatsiga. Nekudaro, kuchine matambudziko mukuita cgmm, inonyanya kuratidzwa muchokwadi yeruzivo uye maitiro.

Semuenzaniso, kambani yemishonga iri muEurope inoda kupinda mumusika weUS neyekuvimbisa zvinhu zvekushandisa uye zvinoisa chigadzirwa chakasimbiswa kuUS FDA. Pakutanga, panguva yehunhu hwekushandisa synthesis, pakanga paine kutsauka kwakanyatsoita mune imwe yedzimwe tembiricha tembiricha yedzinza reaction. Kunyangwe iyo inoshanda yaiverengera uye yakakumbira mirayiridzo, ivo havana kurekodha zvakadzama pane iyo yekugadzira batch zvinyorwa. Pashure pokunge chigadzirwa chacho chakagadzirwa, vhiziri yemhando yemhando chete yakaongororwa kuchisvibiswa kunozivikanwa panguva ye chromatographic kuongorora, uye hapana matambudziko akawanikwa. Naizvozvo, mushumo unokwanisa wekuongorora wakapihwa. Munguva yekuongorora, fda vakuru vakuru veiyo thermometer haina kuita zvinodiwa, asi hapana zvinyorwa zvinowirirana zvakawanikwa muzvinyorwa zveBatch. Munguva yekusimbiswa kwemhando yemhando yekuongorora, yakawanikwa kuti chromating ongororo haina kuitwa maererano nenguva inodiwa. Zvese kutyorwa kweCGMP hakugone kunzvenga kuongororwa kwevatsiors, uye kudanda uku pakupedzisira kwakatadza kupinda mumusika weUS.

FDA yakafunga kuti kutadza kwayo kutevedzera mitemo yeCGMP kwaizokuvadza hutano hwevatengi veAmerica. Kana paine kutsauka mukujeka maererano nezvinodiwa zveCGM Zvese zvekufunga nezvezvinodhaka zvinongoitika zvisingabvumirwe uye zvinhu zvinozivikanwa, uye zvezvinhu zvisingazivikanwe kana zvisingaenzaniswi, hazvigone kuoneka nenzira dziripo.

Kana uchiongorora kunaka kwemushonga, kazhinji tinoshandisa mhando yekuongorora maitiro kuti ione kana mushonga wacho wakakodzera kana zvichienderana nekubudirira uye kutaridzika kwechigadzirwa. Nekudaro, muCGMm, pfungwa yemhando ndeye maitiro maitiro ayo anomhanya mukati meiyo yese yekugadzira maitiro. Mushonga wakakodzera unokwanisa usingaitike zvinodiwa zveCGMP, sezvo paine mukana wekutsauka mukuita kwayo. Kana pasina zvisingaiti zvinongedzo zvekuita kuti zviitwe zviyero zvese, njodzi dzinogona kuitika hadziwanikwe nemishumo yemhando. Ndokusaka CGMm kuurayiwa haina kupusa senge izvo.