Kutshanje, inkampani yoxubo-mayeza iye yaphandwa kwaye yasingathwa ngabasemagunyeni abafanelekileyo ngenxa yeengozi ezinokubakho zokhuseleko kwinkqubo yolawulo lomgangatho kwaye inyanzelise inkampani yoxubo-mayeza ukuba iyimise ngoko nangoko imveliso ukuze ilungiswe, kunye nesiqinisekiso sokuqala senkampani “seGMP” yeziyobisi sarhoxiswa.

Ngokuzenzekelayo, ngoSeptemba ka-2020, i-FDA (i-US Food and Drug Administration) yakhupha ileta yesilumkiso ngokuchasene nenkampani yamachiza e-antibacterial eIndiya. kugxininise ekuphelisweni okusesikweni kweebhaktheriya, okuya kubangela umngcipheko wolunye ungcoliseko lwesiphumo sokucoca kunye nokungafumaneki komgangatho wamachiza awenziweyo.Iqinisekisiwe.Ngoko ke, kuqinisekisiwe ukuba i-FDA ayiyi kuvuma ichiza ukuba lingene kwimarike yabathengi e-United States de kube kuqinisekiswe ukuba inkampani inokuphucula ngokwenene iingxaki ezinxulumene nazo.

Ukujonga ezi meko zimbini zingasentla, kukho into enye efanayo ekufuneka itsalele ingqalelo kwishishini, oko kukuthi, ingxaki yekhonkco lokuqinisekisa ukucoca ayizange isombululwe kakuhle, kwaye ayihambelani neemfuno zesitifiketi esisemthethweni.Ngamanye amazwi: ucoceko lungundoqo ekuqinisekiseni ukhuseleko lweziyobisi, kwaye luqhuba yonke inkqubo yekhemesti.

Enyanisweni, ngokuphunyezwa kwenguqu entsha ye-GMP (i-Good Manufacturing Practice), iimfuno eziphezulu zibekwe phambili kwiinkampani zamachiza ngokubhekiselele kulawulo lomgangatho wamachiza, ngokukodwa kwimiba ethile ye-R & D, imveliso, ukulawula umgangatho, kunye nokuthutha.

Kwinkampani yamayeza, i-GMP ngumgaqo-nkqubo onyanzeliswe kuzwelonke.Iinkampani ezisilelayo ukulinganisa okanye ukugcina i-GMP ngaphakathi kwexesha elimiselweyo ziya kohlwaywa ngamaqondo ahlukeneyo, kubandakanywa izilumkiso kunye nokunqunyanyiswa kwemveliso.Yinkqubo enzima kakhulu ukwenza umgangatho wamayeza ufikelele kumgangatho wokufaneleka.Phakathi kwazo, ukucoceka sesinye sezibonakaliso ezibalulekileyo zokulinganisa ukuba iinkampani zamachiza zinemveliso ezinzileyo.Isizathu esisisiseko sisikhonkco esiphambili-izixhobo zokucoca azicocekanga.Ngokukodwa, izixhobo zebhubhoratri ezenziwe ngeglasi, iplastiki, njl.

Kuyafaneleka ukuba kugxininiswe ukuba okwangoku, iinkampani ezininzi zamachiza zijolise kuphela kwi-disinfection kunye nokuvala inzala, kodwa zityeshela enye inyathelo elibaluleke ngakumbi lokuqinisekisa ukucoca.Oku ngokucacileyo ukuqonda okungalunganga.Njengoko usazi ukuba iinkcukacha ezibalulekileyo zokuqinisekisa ukucoca kufuneka kwakhona zibandakanye ukubulawa kweentsholongwane kunye nokubulala inzala kunye nokucocwa ngokucokisekileyo kwebhubhoratri yenkampani yoxubo-mayeza.Ukusuka kwimbono ethile, le yokugqibela ibaluleke ngakumbi kuneyangaphambili.Isizathu kukuba inkqubo yokuqinisekisa ukucoca ngokuqhelekileyo ibandakanya isigaba sophuhliso lwendlela, isigaba sokulungiselela inkqubo, isigaba sokuphunyezwa kweprogram, kunye nesigaba sokugcinwa kwemeko yokuqinisekisa.Ezi zigaba zine phantse zonke ziqhutywa malunga nomxholo ophambili we-GMP, yindlela "yokunciphisa ungcoliseko kunye nokungcoliseka okunqamlezayo kwinkqubo yokuvelisa iziyobisi".Kwinqanaba ngalinye lekhonkco lokuqinisekiswa kovavanyo, likwangenakuhlukaniswa kumgangatho wokuhlamba i-glassware njengento efunekayo yokufumana iziphumo ezichanekileyo, ezisebenzayo kunye nezithembekileyo zokufumanisa kunye nokuhlalutya.

Akunakwenzeka ukuba ii-laboratories zeenkampani ezichaphazelekayo zifuna ukuphucula ingxaki yokucoca izixhobo kunye nokuphucula umphumo wokucoca-kukwanele ukuhlaziya kunye nokutshintsha indlela yokucoca incwadi yokuqala kunye nenkqubo yokucoca ngokuzenzekelayo.Umzekelo, intshayelelo nokusetyenziswa kwe-aiwasha glassware oluzenzekelayosesinye sezona zisombululo.

Iiwasha glassware oluzenzekelayowamkela indlela yokucoca isitshizi.Iintsalela phezu komphezulu we-ware zinokuxotyulwa ngamanzi ashushu kunye ne-lotion ukucwina izinto ezishiyekileyo, ukuze i-ware icoceke kwaye ikhanyise kwakhona.Ukusebenzisa ijethi yamanzi yoxinzelelo oluphezulu ukusuka kwingalo yokutshiza kunye nesakhelo sebhaskithi, iLab Ukuhlambainokudlulisa amanzi ahamba ngokuthe ngqo kwindawo yangaphakathi yokuhlamba ngepompo yokuhlamba ejikelezayo kuyo nayiphi na ikona ekujoliswe kuyo kokuhlamba.Xa amanzi edlula kwi-heater ukuze enze ubushushu obuphezulu kwaye isetyenziswe ngendlela yoluhlu lwamanzi, inokuhlamba ngokufanelekileyo iintsalela zokungcola ezahlukeneyo eziqhotyoshelwe phezulu kwisitya sokususa, ngaloo ndlela sifezekise injongo yokucoca kunye nokomisa.Akunjalo kuphela, ukusetyenziswa kwenkqubo yokuhlamba ngokuzenzekelayo kwiIwasha yeLabhoratriinokucoca okuphezulu (iwasha glassware oluzenzekelayoumsebenzi we-batch, inkqubo yokucoca ngokuphindaphindiweyo), izinga eliphantsi lokuqhawula ibhotile (uhlengahlengiso oluguquguqukayo kuxinzelelo lokuhamba kwamanzi, ukushisa kwangaphakathi, njl.) zobukhulu obahlukeneyo kunye neemilo, kwaye yonke inkqubo iqhutywa ngobukrelekrele, ikhuselekile kwaye ithembekile (ifakelwe kwangaphambili umbhobho wokungena wamanzi akhuselekileyo, uxinzelelo kunye nobushushu, akukho lula ukwenza iqhina Ukungcola, kunye nevalve yokubeka iliso echasene nokuvuza, isixhobo siya kuvala ngokuzenzekelayo xa ivalve ye-solenoid isilela) Ukongeza, iIwasha yeglasi yelabhoratriinokubonisa ngokukhawuleza idatha ebalulekileyo efana ne-conductivity, i-TOC, i-concentration ye-lotion, njl., efanelekileyo kubasebenzi abafanelekileyo ukuba babeke iliso kwaye badibanise inkqubela phambili yokucoca kunye nokudibanisa inkqubo yokuprinta kunye nokugcina kuluncedo kakhulu, ukubonelela ngokulula ukulandeleka kamva.

Umatshini wokuhlamba weLabinceda iinkampani zamachiza ukunciphisa ukuveliswa kwe-cross-contamination, inceda ekuqinisekiseni ukuphuculwa kwekhonkco nganye yokuqinisekiswa kokucoca kwenkampani yamachiza, kwaye ikwanceda iinkampani zamachiza ukuba ziphucule umgangatho wesicelo sezixhobo.Ithobela ngokupheleleyo iimfuno zolawulo ezibekwe yi-GMP kumazwe ahlukeneyo.Ifanelekile ireferensi kunye nokusetyenziswa luninzi lweenkampani zamachiza.