Muva nje, inkampani eyenza imithi yaphenywa futhi yasingathwa yiziphathimandla ezifanele ngenxa yezingozi ezingase zibe khona ohlelweni lokuphathwa kwekhwalithi futhi yaphoqelela inkampani eyenza imithi ukuthi imise ngokushesha ukukhiqizwa ukuze kulungiswe, nesitifiketi sokuqala senkampani “sezidakamizwa GMP” saphinde sahoxiswa.

Ngokuqondana nje, ngoSepthemba 2020, i-FDA (US Food and Drug Administration) yakhipha incwadi yesexwayiso ngokumelene nenkampani yezidakamizwa ezilwa namagciwane e-India. igxile ekuqedweni okusemthethweni kwamagciwane, okungaholela engcupheni yokunye ukungcoliswa komphumela wokuhlanza kanye nokungatholakali kwekhwalithi yemithi ekhiqiziwe.Kuqinisekisiwe.Ngakho-ke, kuqinisekiswa ukuthi i-FDA ngeke ivume umuthi ukuthi ungene emakethe yabathengi e-United States kuze kube yilapho kuqinisekiswa ukuthi inkampani ingakwazi ngempela ukuthuthukisa izinkinga ezihlobene.

Uma ubheka amacala amabili angenhla, kukhona into eyodwa efanayo okufanele idonse ukunaka kwemboni, okungukuthi, inkinga yesixhumanisi sokuqinisekisa ukuhlanza ayizange ixazululwe kahle, futhi ayihlangabezani nezidingo zesitifiketi esisemthethweni.Ngamanye amazwi: inhlanzeko iyisihluthulelo sokunquma ukuphepha kwezidakamizwa, futhi isebenza kuyo yonke inqubo yekhemisi.

Eqinisweni, ngokuqaliswa kwenguqulo entsha ye-GMP (Umkhuba Omuhle Wokukhiqiza), izidingo eziphakeme ziye zabekwa phambili ezinkampanini ezithaka imithi ngokokulawulwa kwekhwalithi yezemithi, ikakhulukazi ezicini ezithile ze-R&D, ukukhiqizwa, ukulawulwa kwekhwalithi, nezokuthutha.

Enkampanini eyenza imithi, i-GMP iyinqubomgomo ephoqelelwe kuzwelonke.Izinkampani ezehlulekayo ukulinganisa noma ukunakekela i-GMP phakathi nesikhathi esinqunyiwe zizojeziswa ngamazinga ahlukahlukene, okuhlanganisa izexwayiso nokumiswa kokukhiqiza.Kuyinqubo enzima kakhulu ukwenza ikhwalithi yemithi ihlangabezane nezinga lokufaneleka.Phakathi kwazo, inhlanzeko ingenye yezinkomba ezibalulekile zokulinganisa ukuthi izinkampani ezithaka imithi zinawo yini amandla okukhiqiza azinzile.Izinkampani eziningi ezithaka imithi azigunyazwanga ukuqhubeka nokukhiqiza ngemva kokuhlolwa yiminyango efanele.Isizathu esibalulekile isixhumanisi esiyinhloko - izitsha zokuhlanza azihlanzekile.Ikakhulukazi, izitsha zaselabhorethri ezenziwe ngengilazi, ipulasitiki, njll. Azikwazi ukuqinisekisa ukuhlanzwa okuphelele kokungcola okusele.

Kuyafaneleka ukugcizelela ukuthi okwamanje, izinkampani eziningi zemithi zigxila kuphela ekubulaleni amagciwane kanye nokuvalwa inzalo, kodwa zikushaya indiva okunye ukuqinisekiswa kwesinyathelo esibaluleke kakhulu sokuhlanza.Lokhu ngokusobala ukuqonda okungalungile.Njengoba nazi ukuthi imininingwane ebalulekile yokuqinisekisa yokuhlanza kufanele futhi ifake ukubulawa kwamagciwane kanye nokuvala inzalo kanye nokuhlanzwa okuphelele kwelabhorethri yenkampani eyenza imithi.Ngokombono othile, lokhu kwakamuva kubaluleke kakhulu kunokuqala.Isizathu siwukuthi inqubo yokuqinisekisa yokuhlanza ngokuvamile ihlanganisa isigaba sokuthuthukisa indlela, isigaba sokulungiselela uhlelo, isigaba sokuqalisa uhlelo, kanye nesigaba sokugcinwa kwesimo sokuqinisekisa.Lezi zigaba ezine cishe zonke zenziwa mayelana nokuqukethwe okuyinhloko kwe-GMP, okuyindlela "yokunciphisa ukungcola kanye nokungcoliswa okuphambene nenqubo yokukhiqiza izidakamizwa".Esigabeni ngasinye sesixhumanisi sokuqinisekisa sokuhlola, futhi asinakuhlukaniswa nezinga lokuwasha i-glassware njengemfuneko yokuthola imiphumela enembile, ephumelelayo nethembekile yokutholwa nokuhlaziya.

Akunakufinyeleleka ukuthi amalabhorethri ezinkampani ezifanele afune ukuthuthukisa inkinga yokuhlanza izitsha futhi athuthukise umphumela wokuhlanza-kwanele ukuthuthukiswa nokushintsha indlela yokuqala yokuhlanza ngesandla ngesistimu yokuhlanza okuzenzakalelayo.Isibonelo, isingeniso kanye nokusetshenziswa kwe-aothomathikhi glassware washeringenye yezixazululo ezinhle kakhulu.

Iothomathikhi glassware washerisebenzisa indlela yokuhlanza isifutho.Izinsalela ezingaphezulu kwempahla zingacwecwa ngamanzi ashisayo kanye ne-lotion ukuze kucwiliswe izinto ezisele, ukuze i-ware ihlanzeke futhi ikhanye futhi.Ukusebenzisa ijethi lamanzi elinengcindezi ephezulu evela engalweni yesifutho kanye nohlaka lukabhasikidi, i-Iwasha Labingadlulisa ukugeleza kwamanzi ngokuqondile endaweni yangaphakathi yokuwasha ngokusebenzisa iphampu yokuwasha ejikelezayo ukuya kunoma yiliphi ikhona lethagethi yokugeza.Lapho amanzi edlula ku-heater ukuze enze izinga lokushisa eliphezulu futhi asetshenziswe ngendlela yekholomu yamanzi, angakwazi ukugeza ngokuphumelelayo izinsalela ezihlukahlukene zokungcola ezixhunywe phezulu komkhumbi wokukhipha, ngaleyo ndlela ufeze injongo yokuhlanza nokomisa.Akukhona lokho kuphela, ukusetshenziswa kwe-othomathikhi yokuwasha uhlelo lweIwasha Labhorethriinokuhlanza okuphezulu (othomathikhi glassware washerumsebenzi we-batch, inqubo yokuhlanza okuphindaphindiwe), izinga eliphansi lokuphulwa kwebhodlela (ukulungiswa okuguquguqukayo kumfutho wokugeleza kwamanzi, izinga lokushisa langaphakathi, njll.), kanye nokuguquguquka okubanzi (Ingakwazi ukufaka amashubhu okuhlola, izitsha ze-petri, ama-volumetric flasks, ama-conical flasks, amasilinda okulinganisa, njll. enobukhulu obuhlukahlukene nobujamo, futhi yonke le nqubo isetshenziswa ngobuhlakani, iphephile futhi inokwethenjelwa (ipayipi elingenisa amanzi aphephile elifakwe ngaphandle elifakwe ngaphambi kokuqhuma, ukumelana nokucindezela kanye nezinga lokushisa, akulula ukuhlanganisa Ukungcola, okune-valve yokuqapha evimbela ukuvuza, insimbi izovala ngokuzenzakalelayo lapho i-valve ye-solenoid ihluleka).ilabhorethri glassware washeringakwazi ukwethula ngokushesha idatha ebalulekile efana ne-conductivity, i-TOC, i-lotion concentration, njll., elungele izisebenzi ezifanele ukuqapha nokuphatha kahle inqubekelaphambili yokuhlanza futhi ixhume isistimu ukuze iphrinte futhi ilondoloze kuzuzisa kakhulu, okuhlinzeka kalula ukuze kulandeleke kamuva .

Lab Washing Machineisiza izinkampani ezenza imithi ukunciphisa ukukhiqizwa kokungcola, kusiza ukuqinisekisa ukuthuthukiswa kwesixhumanisi ngasinye sokuqinisekiswa kokuhlanza kwenkampani eyenza imithi, futhi kusiza izinkampani ezithaka imithi ukuthi zithuthukise izinga lonke lokusetshenziswa kwemishini.Ihambisana ngokugcwele nezidingo zokulawula ezibekwe yi-GMP emazweni ahlukahlukene.Ifanele ukubhekisiswa futhi isetshenziswe iningi lezinkampani ezithaka imithi.