Muva nje, inkampani yezokwelapha iphenywe futhi yaphathwa yiziphathimandla ezifanele ngenxa yezingozi zokuphepha ezingaba khona ohlelweni lokuphathwa kwekhwalithi futhi yaphoqa inkampani yezokwelapha ukuthi imise ngokushesha ukukhiqizwa ukuze kulungiswe, kanti nesitifiketi sokuqala senkampani "se-drug GMP" naso sahoxiswa.

Ngokuqondana nje, ngoSepthemba 2020, i-FDA (US Food and Drug Administration) yakhipha incwadi yesixwayiso ngokumelene nenkampani yemithi yokulwa namagciwane eNdiya. Le ncwadi yaxwayisa ngokungathi sína ukuthi inkampani ayizange isebenzise ngokuqinile izinqubo zokuqinisekisa ukuhlanza ezijwayelekile lapho ikhiqiza umuthi wakamuva, kodwa yagxila ekususweni okusemthethweni kwamagciwane, okwakuzoholela engcupheni yokunye ukungcola komphumela wokuhlanza kanye nokungabikho kwekhwalithi yemithi ekhiqiziwe. Kuqinisekisiwe. Ngakho-ke, kuqinisekisiwe ukuthi i-FDA ngeke ivume umuthi ukuthi ungene emakethe yabathengi e-United States kuze kube yilapho kuqinisekiswa ukuthi inkampani ingazithuthukisa ngempela izinkinga ezihlobene.

Uma sibheka la macala amabili angenhla, kukhona into eyodwa efanayo okumele idonse ukunaka kwemboni, okungukuthi, inkinga yesixhumanisi sokuqinisekisa ukuhlanza ayixazululwanga kahle, futhi ayihlangabezani nezidingo zesitifiketi esisemthethweni. Ngamanye amazwi: inhlanzeko iyisihluthulelo sokunquma ukuphepha kwemithi, futhi idlula yonke inqubo yekhemisi.

Eqinisweni, ngokusetshenziswa kwenguqulo entsha ye-GMP (Good Manufacturing Practice), kuye kwabekwa izidingo eziphakeme ezinkampanini zemithi maqondana nokulawulwa kwekhwalithi yemithi, ikakhulukazi ezicini ezithile ze-R&D, ukukhiqizwa, ukulawulwa kwekhwalithi, kanye nokuthuthwa.

Enkampanini yemithi, i-GMP iyinqubomgomo ephoqelelwa kuzwelonke. Izinkampani ezihluleka ukulinganisa noma ukugcina i-GMP ngaphakathi kwesikhathi esinqunyiwe zizojeziswa ngamazinga ahlukahlukene, okuhlanganisa izixwayiso nokumiswa kokukhiqiza. Kuyinqubo eyinkimbinkimbi kakhulu ukwenza ikhwalithi yemithi ihlangabezane nezinga lokufaneleka. Phakathi kwazo, ukuhlanzeka kungenye yezinkomba ezibalulekile zokulinganisa ukuthi izinkampani zemithi zinamandla okukhiqiza azinzile yini. Izinkampani eziningi zemithi azivunyelwe ukuqhubeka nokukhiqiza ngemva kokuhlolwa yiminyango efanele. Isizathu esiyinhloko yisixhumanisi esiyinhloko - izitsha zokuhlanza azihlanzekile. Ikakhulukazi, izitsha zelebhu ezenziwe ngengilazi, ipulasitiki, njll. Azikwazi ukuqinisekisa ukuhlanzwa okuphelele kwezinto ezisele ezingcolisayo.

Kuhle ukugcizelela ukuthi njengamanje, izinkampani eziningi zemithi zigxila kuphela ekuhlanzeni nasekuhlanzeni amagciwane, kodwa azinaki okunye ukuqinisekiswa okubaluleke kakhulu kokuhlanza ngezinyathelo. Lokhu ngokusobala kuwukuqonda okungalungile. Njengoba wazi ukuthi imininingwane ebalulekile yokuqinisekiswa kokuhlanza kumele ihlanganise nokuhlanza amagciwane kanye nokuhlanza ngokuphelele ilebhu yenkampani yemithi. Ngokombono othile, lokhu kokugcina kubaluleke kakhulu kunokuqala. Isizathu ukuthi inqubo yokuqinisekisa ukuhlanza ivame ukumboza isigaba sokuthuthukiswa kwendlela, isigaba sokulungiselela uhlelo, isigaba sokuqaliswa kohlelo, kanye nesigaba sokugcinwa kwesimo sokuqinisekisa. Lezi zigaba ezine cishe zonke zenziwa ngokuzungeza okuqukethwe okuyinhloko kwe-GMP, okuyindlela "yokunciphisa ukungcola kanye nokungcola okuwela enkambisweni yokukhiqiza imithi". Esigabeni ngasinye sesixhumanisi sokuqinisekisa sokuhlola, asihlukanisiwe nendinganiso yokugeza izingilazi njengemfuneko yokuthola imiphumela enembile, ephumelelayo nethembekile yokutholwa kanye nokuhlaziywa.

Akunakwenzeka ukuthi amalabhorethri ezinkampani ezifanele afune ukuthuthukisa inkinga yokuhlanza izitsha nokuthuthukisa umphumela wokuhlanza - kwanele ukuthuthukisa nokufaka esikhundleni indlela yokuqala yokuhlanza ngesandla ngohlelo lokuhlanza oluzenzakalelayo. Isibonelo, ukwethulwa nokusetshenziswa kwe-umshini wokuwasha izingilazi ozenzakalelayoingenye yezixazululo ezinhle kakhulu.

Iumshini wokuwasha izingilazi ozenzakalelayoisebenzisa indlela yokuhlanza ngokufafaza. Izinsalela ezisebusweni bempahla zingahlutshulwa ngamanzi ashisayo kanye neloshini ukuze kucwiliswe izinto ezisele, ukuze impahla ihlanzeke futhi ikhanye futhi. Isebenzisa ijethi yamanzi enomfutho ophezulu evela engalweni yokufafaza kanye nohlaka lwebhasikidi,Umshini Wokuwasha Ilebhuingadlulisa ukugeleza kwamanzi ngqo endaweni yangaphakathi yokuwasha ngepompo yokuwasha ejikelezayo iye kunoma yiliphi ikona lethagethi yokuwasha. Lapho amanzi edlula esifudumezini ukuze akhe izinga lokushisa eliphezulu futhi esetshenziswa ngesimo sekholomu yamanzi, angageza ngempumelelo izinsalela ezahlukene zokungcola ezinamathele phezulu kwesitsha sokususa, ngaleyo ndlela kufezwe injongo yokuhlanza nokomisa. Akukhona lokho kuphela, ukusetshenziswa kohlelo lokuwasha oluzenzakalelayo lweUmshini Wokuwasha Welebhuinendlela yokuhlanza ephezulu (umshini wokuwasha izingilazi ozenzakalelayoumsebenzi we-batch, inqubo yokuhlanza ephindaphindwayo), izinga eliphansi lokuphuka kwamabhodlela (ukulungiswa okuzivumelanisa nengcindezi yokugeleza kwamanzi, izinga lokushisa langaphakathi, njll.), kanye nokuguquguquka okubanzi (Ingamukela amashubhu okuhlola, izitsha ze-petri, amaflaski evolumu, amaflaski ayindilinga, amasilinda okulinganisa, njll. anobukhulu obuhlukahlukene kanye nezimo, futhi yonke inqubo isebenza ngobuhlakani, iphephile futhi inokwethenjelwa (ipayipi lokungenisa amanzi elivikelekile elingenisiwe elifakwe ngaphambilini elingaqhumi, ukumelana nengcindezi kanye nokushisa, akulula ukulibopha Ukungcola, nge-valve yokuqapha elwa nokuvuza, ithuluzi lizovaleka ngokuzenzakalelayo lapho i-valve ye-solenoid yehluleka). Ngaphezu kwalokho,umshini wokuwasha ingilazi webhubhoratriingaletha ngokushesha idatha ebalulekile efana nokuqhuba, i-TOC, ukuhlushwa kwe-lotion, njll., okulula kubasebenzi abafanele ukuqapha nokuqonda inqubekela phambili yokuhlanza nokuxhuma uhlelo ukuze luphrinte futhi lulondoloze kuwusizo kakhulu, okunikeza lula ukulandelelwa kamuva.

Umshini Wokuwasha Welabhorethrikusiza izinkampani zemithi ukunciphisa ukukhiqizwa kokungcola okuxubile, kusiza ukuqinisekisa ukuthuthukiswa kwesixhumanisi ngasinye sokuqinisekiswa kokuhlanza kwenkampani yemithi, futhi kusiza izinkampani zemithi ukuthuthukisa izinga lokusetshenziswa kwemishini iyonke. Ihambisana ngokugcwele nezidingo zomthetho ezibekwe yi-GMP emazweni ahlukahlukene. Ifanele ukubhekisela nokusetshenziswa yiningi lezinkampani zemithi.