Chii chinonzi cGMP?
GMP yekutanga pasi rose yemishonga yakazvarwa muUnited States muna 1963. Mushure mekugadziriswa kwakawanda uye kuwedzerwa nekuvandudzwa neUS FDA, cGMP (Current Good Manufacturing Practices) muUnited States yave imwe yemimiriri yetekinoroji yepamusoro mumunda weGMP, ichiita basa rakakosha mukushandiswa kwakachengeteka uye nemazvo kwemishonga pasi rese. China yakatanga kuburitsa mutemo weGMP yemishonga muna 1988, uye yakanyanya kugadziriswa katatu kubva muna 1992, 1998, na2010, izvo zvichiri kuda kugadziriswazve. Munguva yemakore anopfuura makumi maviri ekusimudzira basa reGMP yemishonga muChina, kubva pakuisa pfungwa yeGMP kusvika pakusimudzira GMP certification, kubudirira kwakaitwa zvishoma nezvishoma. Zvisinei, nekuda kwekutanga kweGMP muChina, kwave nezviitiko zvakawanda zvekushandisa GMP nehunyanzvi, uye zvinoreva GMP hazvina kunyatsobatanidzwa mukugadzirwa chaiko uye manejimendi yemhando.
Kugadzirwa kwe cGMP
Zvinodiwa pari zvino zveGMP muChina zvichiri mu "danho rekutanga" uye zvinongova zvinodiwa zvepamutemo chete. Kuti mabhizinesi ekuChina apinde mumusika wepasi rose nezvigadzirwa zvavo, anofanira kuwiriranisa manejimendi ekugadzira kwavo nezvinodiwa zvepasi rose kuitira kuti vazivikanwe pamusika. Kunyangwe hurumende yeChina isati yaraira makambani emishonga kuti aise cGMP, izvi hazvirevi kuti hapana chikonzero chekukurumidzira chekuti China iise cGMP. Kusiyana neizvi, kutarisira maitiro ese ekugadzira zvinoenderana nezvinodiwa zvecGMP chinhu chakakosha kuti tifambire mberi kune dzimwe nyika. Nerombo rakanaka, parizvino muChina, makambani emishonga ane nzira dzekuvandudza dzinotarisa mberi aona kukosha kwenguva refu kwemutemo uyu uye akaushandisa.
Nhoroondo yekuvandudzwa kwecGMP: Iyo cGMP inogamuchirwa pasi rose, kungave muUnited States kana kuEurope, parizvino kuongororwa kwekutevedzera cGMP panzvimbo dzekugadzira kunotevera humbowo hwakabatana hwe cGMP hwezvinhu zvisina kugadzirwa zvakagadzirwa neInternational Conference on Harmonization (ICH), inozivikanwawo seICH Q7A. Humbowo uhwu hwakatangira paInternational Conference on Harmonization of Raw Materials (ICH for API) muGeneva, Switzerland munaGunyana 1997. MunaKurume 1998, vachitungamirwa neUS FDA, "cGMP yezvinhu zvisina kugadzirwa", ICH Q7A, yakanyorwa. Mumatsutso a1999, European Union neUnited States vakasvika pachibvumirano che cGMP chekuzivana kwezvinhu zvisina kugadzirwa. Mushure mekunge chibvumirano chatanga kushanda, mapato ese akabvumirana kuzivana mhedzisiro ye cGMP yekubvumidzwa mukutengeserana kwezvinhu zvisina kugadzirwa. Kune makambani eAPI, mitemo ye cGMP ndiyo chaiyo iri muICH Q7A.
Musiyano uripo pakati pe cGMP ne GMP
CGMP chiyero cheGMP chinoshandiswa nenyika dzakadai seUnited States, Europe, neJapan, chinozivikanwawo se "international GMP standard". Mitemo yecGMP haina kufanana nemiyero yeGMP inoshandiswa muChina.
Kushandiswa kwemitemo yeGMP muChina ibumbiro remitemo yeGMP inoshanda kunyika dzichiri kusimukira rakagadzirwa neWHO, richinyanya kukoshesa zvinodiwa zvemidziyo yekugadzira zvakaita semidziyo yekugadzira.
Iyo cGMP inoshandiswa munyika dzakadai seUnited States, Europe, neJapan inotarisa pakugadzirwa kwesoftware, senge kutonga zviito zvevashandisi uye maitiro ekugadzirisa zviitiko zvisingatarisirwi mukugadzirwa.
(1) Kuenzanisa makatarogu ezvitupa. Kune zvinhu zvitatu zviri mukugadzirwa kwemishonga - masisitimu ehardware, masisitimu esoftware, uye vashandi - cGMP muUnited States iri nyore uye ine zvitsauko zvishoma pane GMP muChina. Zvisinei, kune misiyano yakakura muzvinodiwa zvezvikamu izvi zvitatu. GMP yeChina ine zvinodiwa zvakawanda zvehardware, nepo cGMP yeUnited States ine zvinodiwa zvakawanda zvesoftware nevashandi. Izvi zvinodaro nekuti mhando yekugadzira mishonga inoenderana zvakanyanya nekushanda kwemushandisi, saka basa revashandi mukutarisira GMP muUnited States rakakosha kupfuura remidziyo yefekitori.
(2) Kuenzanisa zvikwaniriso zvebasa. MuGMP yeChina, kune mitemo yakadzama pamusoro pezvikwaniriso (danho redzidzo) yevashandi, asi pane zvipingamupinyi zvishoma pamabasa evashandi; Muhurongwa hwe cGMP muUnited States, zvikwaniriso (danho rekudzidziswa) kwevashandi zvakapfupikiswa uye zvakajeka, nepo mabasa evashandi akatsanangurwa zvakadzama. Hurongwa uhwu hwezvikwaniriso hunonyanya kusimbisa mhando yekugadzirwa kwemishonga.
(3) Kuenzanisa kuunganidzwa kwesampuro nekutarisa. GMP yeChina inongotaura chete maitiro ekuongorora anodiwa, nepo cGMP muUnited States ichitsanangura matanho ese ekuongorora nenzira dzakadzama, ichideredza kuvhiringidzika nekusvibiswa kwemishonga pamatanho akasiyana-siyana, kunyanya padanho rezvinhu zvakagadziriswa, uye ichipa vimbiso yekuvandudza mhando yemishonga kubva kwainobva.
Matambudziko mukushandisa cGMP
Kuchinja kweGMP mumabhizinesi emishonga ekuChina kwave kuri nyore. Zvisinei, kuchine matambudziko mukushandisa cGMP, kunyanya zvichiratidzwa mukuvimbika kweruzivo nemaitiro.
Semuenzaniso, kambani yemishonga muEurope inoda kupinda mumusika weUS nemushonga wezvinhu zvakabikwa unovimbisa uye inotumira chigadzirwa chakabvumidzwa kuUS FDA. Kare, panguva yekugadzira zvinhu zvakabikwa, pakanga paine kutsauka kwekunyatsojeka mune imwe yematembiricha maviri etangi re reaction. Kunyangwe mushandi akagadzirisa ndokukumbira mirairo, havana kuinyora zvakadzama pamarekodhi ekugadzirwa. Mushure mekunge chigadzirwa chagadzirwa, vaongorori vemhando yepamusoro vaingotarisa tsvina inozivikanwa panguva yekuongorora chromatographic, uye hapana matambudziko akawanikwa. Saka, mushumo wekuongorora wakakodzera wakapihwa. Munguva yekuongorora, vakuru veFDA vakaona kuti kururama kwethermometer hakuna kusangana nezvinodiwa, asi hapana zvinyorwa zvinoenderana zvakawanikwa mumarekodhi ekugadzirwa. Munguva yekusimbisa mushumo wekuongorora kwemhando, zvakaonekwa kuti chromatographic analysis haina kuitwa zvichienderana nenguva inodiwa. Kutyorwa kwese uku kwe cGMP hakugone kutiza kuongororwa kwevadziviriri, uye mushonga uyu wakazopedzisira wakundikana kupinda mumusika weUS.
FDA yakaona kuti kukundikana kwayo kutevedzera mitemo ye cGMP kwaizokanganisa hutano hwevatengi vekuAmerica. Kana paine kutsauka mukururama zvichienderana nezvinodiwa ne cGMP, kuferefeta kwakawedzerwa kunofanira kurongwa, kusanganisira kutarisa mhedzisiro inogona kuitika yekutsauka kwekupisa kubva pakururama, uye kunyora kutsauka kubva patsananguro yemaitiro. Kuongororwa kwese kwemishonga kunongoitirwa chete kusviba kunozivikanwa nezvinhu zvinozivikanwa zvakaipa, uye kune zvinhu zvisingazivikanwe zvinokuvadza kana zvisina hukama, hazvigone kuonekwa zvakakwana kuburikidza nenzira dziripo.
Pakuongorora mhando yemushonga, tinowanzo shandisa nzira dzekuongorora mhando kuti tione kana mushonga wacho wakakodzera kana kuti zvichibva pakushanda uye chitarisiko chechigadzirwa. Zvisinei, mu cGMP, pfungwa yemhando itsika yemaitiro inoshanda mukugadzirwa kwese. Mushonga wakakodzera zvakakwana ungasave uchizadzisa zvinodiwa ne cGMP, sezvo paine mukana wekuti pave nekutsauka mukuita kwawo. Kana pasina mitemo yakasimba yemushonga, njodzi dzinogona kuitika hadzigone kuonekwa nemishumo yemhando. Ndokusaka kushanda kwe cGMP kusiri nyore kudaro.
Nguva yekutumira: Chikunguru-26-2023