UNOZIVA CHII cGMP?

Chii chinonzi cGMP?

Mushonga wekutanga pasi rose weGMP wakazvarwa muUnited States muna 1963. Mushure mekudzokorora kwakati wandei uye kuenderera mberi kupfumiswa nekuvandudzwa neUS FDA, cGMP (Current Good Manufacturing Practices) muUnited States yave mumwe wevamiriri vehunyanzvi hwepamusoro muGMP. munda, ichiita basa rinowedzera kukosha mukushandiswa kwakachengeteka uye kunobudirira kwezvinodhaka pasi rese. China yakatanga kushambadza mushonga weGMP wepamutemo muna 1988, uye yakanyanya kudzokororwa katatu kubvira 1992, 1998, uye 2010, izvo zvichiri kuda kuvandudzwa. Mukati memakore anopfuura makumi maviri ekusimudzira zvinodhaka GMP basa muChina, kubva pakuunza pfungwa yeGMP kusvika mukusimudzirwa kweGMP certification, budiriro dzakaitwa dzakaitwa. Nekudaro, nekuda kwekunonoka kutanga kweGMP muChina, kwave nezviitiko zvakawanda zvemuchina kushandisa GMP, uye zvinoreva GMP hazvina kunyatsobatanidzwa mukugadzirwa chaiko uye manejimendi emhando.

 

Kuvandudzwa kweCGMP

Izvozvi zvinodikanwa zveGMP muChina zvichiri mu "danho rekutanga" uye zvinongori pamutemo zvinodiwa. Kuti mabhizinesi eChinese apinde mumusika wepasirese nezvigadzirwa zvavo, vanofanirwa kuwiriranisa manejimendi avo ekugadzira nezviyero zvepasirese kuitira kuti vawane kuzivikanwa kwemusika. Kunyangwe hazvo hurumende yeChina haisati yaraira makambani emishonga kuti aite cGMP, izvi hazvireve kuti hapana kukurumidza kuti China iite cGMP. Kusiyana neizvi, kutonga maitiro ese ekugadzira zvinoenderana neCGMP zviyero chinhu chakakosha chekufambisa kuenda kune dzimwe nyika. Sezvineiwo, pari zvino muChina, makambani emishonga ane nzira dzekusimudzira dzemberi akaziva kukosha kwenguva refu kwemutemo uyu uye akauisa mukuita.

Nhoroondo ye cGMP Kubudirira: Iyo cGMP inogamuchirwa pasi rose, ingave muUnited States kana kuEurope, iko zvino cGMP yekuteedzera ongororo munzvimbo dzekugadzira inotevera yakabatana cGMP zvirevo zvezvakagadzirwa zvakagadzirwa neInternational Conference on Harmonization (ICH), inozivikanwawo seICH Q7A. . Tsanangudzo iyi yakabva kuInternational Conference on Harmonization of Raw Materials (ICH yeAPI) kuGeneva, Switzerland munaGunyana 1997. Muna Kurume 1998, ichitungamirwa neUS FDA, yakabatana "cGMP for raw materials", ICH Q7A, yakanyorwa. Mumatsutso a1999, European Union neUnited States dzakasvika pachibvumirano cheGMP chekubatana kwechibvumirano chezvigadzirwa. Mushure mekunge chibvumirano chatanga kushanda, mapato ese akabvumirana kuzivisa mumwe nemumwe cGMP mhedzisiro mukutengesa kwezvigadzirwa. Kune makambani eAPI, cGMP mirau ndizvo chaizvo zvemukati zveICH Q7A.

 

Musiyano uripo pakati pecGMP neGMP

CGMP chiyero cheGMP chinoitwa nenyika dzakaita seUnited States, Europe, neJapan, inozivikanwawo se "international GMP standard". cGMP zviyero hazvina kuenzana neiyo GMP miyero inoshandiswa muChina.

Kuitwa kwemitemo yeGMP muChina seti yemitemo yeGMP inoshanda kune nyika dzichiri kusimukira yakagadzirwa neWHO, ichinyanya kukoshesa zvinodikanwa zvekugadzira zvigadzirwa semidziyo yekugadzira.

Iyo cGMP inoshandiswa munyika dzakaita seUnited States, Europe, neJapan inotarisa pakugadzirwa kwesoftware, sekudzora zviito zvevashandisi uye maitiro ekuita zviitiko zvisingatarisirwe mukugadzira.

(1) Kufananidzwa kwezvitupa zvakatemwa makatalogi. Pazvinhu zvitatu zviri mukugadzirwa kwezvinodhaka - hardware masisitimu, masoftware masisitimu, uye vashandi - cGMP muUnited States iri nyore uye ine zvitsauko zvishoma pane GMP muChina. Nekudaro, pane misiyano yakakura muzvarinodiwa zvezvinhu zvitatu izvi. China's GMP ine zvimwe zvinodiwa zvehardware, nepo United States 'cGMP iine zvimwe zvinodiwa zvesoftware nevashandi. Izvi zvinodaro nekuti kunaka kwekugadzirwa kwemishonga kunoenderana nemashandiro emushandisi, saka basa revashandi mukutarisira GMP muUnited States rakakosha kupfuura remidziyo yemufekitori.

(2) Kuenzaniswa kwezvidzidzo zvebasa. MuChina yeGMP, kune mirairo yakadzama pamusoro pezvikwaniriso (nhanho yedzidzo) yevashandi, asi pane zvipingamupinyi zvishoma pamabasa evashandi; Mune cGMP system muUnited States, zvikwaniriso (chikamu chekudzidziswa) chevashandi chakapfupika uye chakajeka, nepo mabasa evashandi akanyatsotsanangurwa. Iyi hurongwa hwekutarisira inonyanya kuve nechokwadi chekugadzirwa kwemishonga.

(3) Kuenzanisa kwemuenzaniso wekuunganidza uye kuongorora. GMP yeChina inongotaura maitiro ekuongorora anodiwa, nepo cGMP iri kuUnited States ichitsanangura matanho ese ekuongorora uye nzira zvakadzama, kuderedza kuvhiringika uye kusvibiswa kwezvinodhaka pamatanho akasiyana, kunyanya padanho rekushandisa, uye kupa vimbiso yekuvandudza mhando yezvinodhaka kubva. kwakabva.

 

Matambudziko mukuita cGMP

Shanduko yeGMP yemabhizinesi emishonga yeChinese yave yakapfava. Nekudaro, kuchine matambudziko mukuita cGMP, inonyanya kuratidzwa muhuchokwadi hwemashoko uye maitiro.

Semuyenzaniso, kambani inogadzira mishonga muEurope inoda kupinda mumusika weAmerica nemushonga unovimbisa uye inoendesa chigadzirwa chakatendwa kuUS FDA. Pakutanga, panguva yekugadzirwa kwezvinhu zvakasvibirira, pakanga paine kutsauswa kwechokwadi mune imwe yemageji maviri etembiricha etangi rekuita. Kunyangwe mushandisi akagadzirisa uye akakumbira mirairo, ivo havana kuinyora zvakadzama pamarekodhi ekugadzira batch. Mushure mokunge chigadzirwa chacho chagadzirwa, vaongorori vehutano vakangotarisa kusvibiswa kunozivikanwa panguva yekuongorora chromatographic, uye hapana matambudziko akawanikwa. Nokudaro, mushumo wekuongorora wakakodzera wakabudiswa. Munguva yekuongorora, vakuru veFDA vakaona kuti chokwadi cheiyo thermometer haina kuzadzisa zvinodiwa, asi hapana marekodhi anoenderana akawanikwa mumarekodhi ekugadzira batch. Munguva yekusimbiswa kwehupoti yekuongorora kwemhando, zvakaonekwa kuti chromatographic analysis haina kuitwa maererano nenguva yaidiwa. Kutyorwa kwese uku kwecGMP hakugone kutiza kuongororwa kwema censors, uye mushonga uyu wakazotadza kupinda mumusika weUS.

Iyo FDA yakaona kuti kutadza kwayo kutevedzera cGMP mirau kungakuvadza hutano hwevatengi vekuAmerica. Kana paine kutsauswa mukurongeka maererano nezvinodiwa neCGMP, kumwe kuongorora kunofanirwa kurongwa, kusanganisira kutarisa mhedzisiro yekutsauka kwetembiricha kubva pachokwadi, uye kurekodha kutsauka kubva pakutsanangurwa kwemaitiro. Kuongororwa kwese kwemishonga ndeyekusvibiswa kunozivikanwa uye zvinozivikanwa zvakashata zvinhu, uye kune zvisingazivikanwe zvinokuvadza kana zvisina hukama zvikamu, hazvigone kuwonekwa zvizere kuburikidza nemaitiro aripo.

Kana tichiongorora kunaka kwemushonga, tinowanzo shandisa maitiro ekuongorora maitiro ekuona kuti mushonga wacho unokodzera here kana kuti zvichienderana nekubudirira uye kutaridzika kwechigadzirwa. Nekudaro, mucGMP, iyo pfungwa yemhando itsika yemaitiro inomhanya mukati mese maitiro ekugadzira. Mushonga unonyatsokodzera haugone kuzadzisa zvinodiwa zvecGMP, sezvo paine mukana wekutsauka mukuita kwayo. Kana pasina hurongwa hwakasimba hunodiwa hwekuita kwese, njodzi dzinogona kuitika hadzigone kuonekwa nemishumo yemhando. Ichi ndicho chikonzero cGMP kuuraya kusiri nyore seizvo.