Munguva pfupi yapfuura, kambani yemishonga yakaferefetwa uye yakatongwa nevakuru vane chekuita nayo nekuda kwenjodzi dzinogona kuitika muhurongwa hwekutarisira mhando uye yakamanikidza kambani yemishonga kuti imise kugadzirwa kwayo nekukurumidza kuti igadziriswe, uye chitupa chekutanga chekambani che "drug GMP" chakabviswawo.

Zvakangoitikawo kuti, munaGunyana 2020, FDA (US Food and Drug Administration) yakaburitsa tsamba yekunyevera pamusoro pekambani yemishonga inorwisa mabhakitiriya muIndia. Tsamba iyi yakanyevera zvakasimba kuti kambani haina kushandisa nzira dzakajairwa dzekuongorora kuchenesa pakugadzira mushonga wemazuva ano, asi yakatarisana nekubviswa kwehutachiona zviri pamutemo, izvo zvaizotungamira kune njodzi yekusvibiswa kweimwe nzira yekuchenesa uye kusawanikwa kwemhando yemishonga yakagadzirwa. Yakavimbiswa. Saka, zvinosimbiswa kuti FDA haizobvumidze mushonga uyu kuti upinde mumusika wevatengi muUnited States kusvika zvasimbiswa kuti kambani inogona kugadzirisa matambudziko ane chekuita nawo.

Tichitarisa nyaya mbiri dziri pamusoro apa, pane chinhu chimwe chete chakafanana chinofanira kukwezva pfungwa dzeindasitiri, kureva kuti, dambudziko rekusimbisa kuchenesa harina kugadziriswa zvakanaka, uye harina kuzadzisa zvinodiwa zvepamutemo zvechitupa. Nemamwe mashoko: kuchena ndiyo kiyi yekuona kuchengetedzeka kwemishonga, uye kunofamba nenzira yese ye pharmacy.

Kutaura zvazviri, nekushandiswa kweshanduro itsva yeGMP (Good Manufacturing Practice), zvinodiwa zvakanyanya zvakaiswa pamberi pemakambani emishonga maererano nekudzora mhando yemishonga, kunyanya muzvikamu zvakananga zveR&D, kugadzirwa, kudzora mhando, uye kutakura.

Kune kambani yemishonga, GMP mutemo unotevedzwa nenyika yese. Makambani anokundikana kuyera kana kuchengetedza GMP mukati menguva yakatarwa acharangwa zvakasiyana-siyana, kusanganisira yambiro uye kumiswa kwekugadzirwa. Inzira yakaoma kwazvo kuita kuti mhando yemishonga isvike padanho rekukodzera. Pakati pazvo, kuchena ndeimwe yezviratidzo zvakakosha zvekuyera kana makambani emishonga aine kugona kwakasimba kwekugadzira. Makambani mazhinji emishonga haatenderwe kuramba achigadzira mushure mekuongororwa nemadhipatimendi akakodzera. Chikonzero chikuru ndicho chinhu chikuru - midziyo yekuchenesa haina kuchena. Kunyanya, midziyo yerabhoritari yakagadzirwa negirazi, plastiki, nezvimwewo. Haigone kuve nechokwadi chekucheneswa kwakakwana kwetsvina yasara.

Zvakakosha kusimbisa kuti pari zvino, makambani mazhinji emishonga anonyanya kutarisa pakuuraya utachiona nekuuraya utachiona, asi anofuratira imwe nhanho inokosha yekuchenesa. Zviri pachena kuti uku kunzwisisa kusina kunaka. Sezvaunoziva kuti ruzivo rwakakosha rwekuongorora kuchenesa runofanirawo kusanganisira kuuraya utachiona nekuuraya utachiona uye kuchenesa zvakakwana rabhoritari yekambani yemishonga. Kubva pane imwe pfungwa, yekupedzisira inonyanya kukosha kupfuura yekutanga. Chikonzero ndechekuti maitiro ekuongorora kuchenesa anowanzo sanganisira chikamu chekugadzira nzira, chikamu chekugadzirira chirongwa, chikamu chekushandisa chirongwa, uye chikamu chekuchengetedza mamiriro ekusimbisa. Matanho mana aya anenge ese anoitwa akapoteredza zviri mukati meGMP, iyo nzira ye "kuderedza kusvibiswa nekusvibiswa mukugadzirwa kwemishonga". Padanho rega rega rekubatanidza kwekuyedza, hazviparadzanisikewo kubva kune standard yekuwachisa magirazi sechinodiwa chekuwana mhedzisiro chaiyo, inoshanda uye yakavimbika yekuona nekuongorora.

Hazvigoneki kuti marabhoritari emakambani akakodzera ade kuvandudza dambudziko rekuchenesa midziyo uye kuwedzera kuchenesa - zvakakwana kuvandudza nekutsiva nzira yekutanga yekuchenesa nemaoko nehurongwa hwekuchenesa otomatiki. Semuenzaniso, kutanga nekushandisamuchina wekuwachisa magirazi otomatikindeimwe yemhinduro dzakanakisisa.

Iyomuchina wekuwachisa magirazi otomatikiinoshandisa nzira yekuchenesa nepfapfaidzo. Zvasara pamusoro pechinhu zvinogona kubviswa nemvura inopisa nemafuta kuti zvinyike zvinhu zvasara, kuitira kuti chinhu chacho chive chakachena uye chakajeka zvakare. Uchishandisa mvura inoyerera nesimba kubva paruoko rwepfapfaidzo nefuremu yebhasiketi,Muchina wekuwachisa marabhoritariinogona kupfuudza mvura zvakananga kuburikidza nenzvimbo yemukati yekugezesa kuburikidza nepombi yekuwachisa inotenderera kusvika kune chero kona yechinangwa chekugezesa. Kana mvura inopfuura nemuchitofu kuti igadzire tembiricha yakakwira uye ikashandiswa sekoramu yemvura, inogona kuchenesa zvinobudirira masara akasiyana-siyana ekusvibiswa akabatanidzwa pamusoro pemudziyo wekubvisa, nokudaro ichizadzisa chinangwa chekuchenesa nekuomesa. Kwete izvozvo chete, kushandiswa kwenzira yekuwachisa otomatiki yeMuchina wekuwachisa murabhoritariine hunyoro hwekuchenesa hwakanyanya (muchina wekuwachisa magirazi otomatikibasa remabheti, maitiro ekuchenesa anodzokororwa), mwero wakaderera wekupwanyika kwebhodhoro (kugadzirisa kumanikidzwa kwemvura, tembiricha yemukati, nezvimwewo), uye kushanduka-shanduka kwakasiyana-siyana (Inogona kugamuchira machubhu ekuyedza, ndiro dzepetri, maflask evolumetric, maflask econical, masirinda ekuyera, nezvimwewo zvehukuru hwakasiyana uye maumbirwo, uye maitiro ese anoshandiswa nehungwaru, akachengeteka uye akavimbika (pombi yekupinda mvura yakachengeteka yakaiswa kunze kwenyika isingaputike, kuramba kumanikidzwa uye tembiricha, hazvisi nyore kusungirira tsvina, ine vharuvhu yekutarisa inodzivirira kudonha kwemvura, chishandiso chinovhara otomatiki kana vharuvhu yesolenoid ikakundikana). Pamusoro pezvo,muchina wekuwachisa magirazi murabhoritariinogona kupa ruzivo rwakakosha ipapo ipapo senge conductivity, TOC, lotion concentration, nezvimwewo, izvo zviri nyore kuti vashandi vakakodzera vatarise uye vanzwisise kufambira mberi kwekuchenesa uye kubatanidza sisitimu kuti idhindwe uye ichengetedze zvinobatsira zvikuru, zvichiita kuti zvive nyore kuteverwa gare gare.

Muchina wekuwachisa murabhoritariinobatsira makambani emishonga kuderedza kugadzirwa kwehutachiona hwakasiyana, inobatsira kuona kuti chinongedzo chega chega chekuongorora kucheneswa kwekambani yemishonga chinovandudzwa, uye inobatsirawo makambani emishonga kuvandudza huwandu hwese hwekushandiswa kwemidziyo. Inotevedzera zvizere zvinodiwa neGMP munyika dzakasiyana. Inokodzera kutariswa uye kushandiswa nemakambani mazhinji emishonga.