Kutshanje, inkampani yamayeza iphandwe kwaye yajongwa ziigunya ezifanelekileyo ngenxa yeengozi zokhuseleko ezinokubakho kwinkqubo yolawulo lomgangatho kwaye yanyanzela inkampani yamayeza ukuba imise ngoko nangoko imveliso ukuze ilungiswe, kwaye nesatifikethi sokuqala senkampani "se-GMP yeziyobisi" naso sarhoxiswa.

Ngethamsanqa, ngoSeptemba 2020, i-FDA (US Food and Drug Administration) yakhupha ileta yesilumkiso nxamnye nenkampani yamayeza okulwa neentsholongwane eIndiya. Le leta yalumkisa ngokunzulu ukuba inkampani ayizange isebenzise ngokungqongqo iinkqubo zokuqinisekisa ukucoca ezisemgangathweni xa ivelisa amayeza amva nje, kodwa yagxila ekuphelisweni ngokusesikweni kweebhaktheriya, nto leyo eya kukhokelela kumngcipheko wokungcola okunye kwesiphumo sokucoca kunye nokungabikho komgangatho wamayeza enziweyo. Kuqinisekisiwe. Ke ngoko, kuyaqinisekiswa ukuba i-FDA ayizukuvuma ukuba eli yeza lingene kwimarike yabathengi e-United States de kuqinisekiswe ukuba inkampani inokuziphucula ngokwenene iingxaki ezinxulumene noko.

Ukujonga ezi meko zimbini zingasentla, kukho into enye efanayo ekufuneka itsale ingqalelo yeshishini, oko kukuthi, ingxaki yonxibelelwano lokuqinisekisa ukucoca ayisonjululwanga kakuhle, kwaye ayihlangabezani neemfuno zesatifikethi esisemthethweni. Ngamanye amazwi: ucoceko lubalulekile ekuqinisekiseni ukhuseleko lwamayeza, kwaye luhamba kuyo yonke inkqubo yekhemesti.

Enyanisweni, ngokuphunyezwa kwenguqulelo entsha ye-GMP (iGood Manufacturing Practice), kuye kwabekwa iimfuno eziphezulu kwiinkampani zamayeza ngokubhekiselele kulawulo lomgangatho wamayeza, ingakumbi kwiinkalo ezithile ze-R&D, imveliso, ulawulo lomgangatho, kunye nothutho.

Kwinkampani yamayeza, i-GMP ngumgaqo-nkqubo onyanzeliswayo kuzwelonke. Iinkampani ezingaphumeleliyo ukulinganisa okanye ukugcina i-GMP ngaphakathi kwexesha elimiselweyo ziya kohlwaywa ngamanqanaba ahlukeneyo, kubandakanya izilumkiso kunye nokumiswa kwemveliso. Yinkqubo enzima kakhulu ukwenza umgangatho wamayeza uhlangabezane nomgangatho wokufaneleka. Phakathi kwazo, ucoceko lolunye lwezona zibonakaliso zibalulekileyo zokulinganisa ukuba iinkampani zamayeza zinamandla okuvelisa azinzileyo na. Iinkampani ezininzi zamayeza azivunyelwanga ukuqhubeka nemveliso emva kokuhlolwa ngamasebe afanelekileyo. Isizathu esiyintloko sikhonkco eliphambili - izixhobo zokucoca azicocekanga. Ngokukodwa, izixhobo zelebhu ezenziwe ngeglasi, iplastiki, njl. Ayinakuqinisekisa ukucocwa ngokupheleleyo kwezinto ezisele zingcolileyo.

Kuyafaneleka ukugxininisa ukuba okwangoku, iinkampani ezininzi zamayeza zigxila kuphela ekubulaleni nasekubulaleni iintsholongwane, kodwa zingayinaki enye ingqinisiso ebaluleke ngakumbi yokucoca amanyathelo. Oku ngokucacileyo kukuqonda okungalunganga. Njengoko usazi ukuba iinkcukacha ezibalulekileyo zokuqinisekiswa kokucoca kufuneka zibandakanye ukubulala iintsholongwane kunye nokubulala iintsholongwane kunye nokucoca ngokupheleleyo ilebhu yenkampani yamayeza. Ngokwembono ethile, le yokugqibela ibaluleke ngakumbi kuneyokuqala. Isizathu kukuba inkqubo yokuqinisekiswa kokucoca idla ngokugubungela isigaba sophuhliso lwendlela, isigaba sokulungiselela inkqubo, isigaba sokuphunyezwa kwenkqubo, kunye nesigaba sokugcinwa kwesimo sokuqinisekisa. La manqanaba mane phantse onke enziwa malunga nomxholo oyintloko we-GMP, okuyindlela "yokunciphisa ungcoliseko kunye nokungcola okunqamlezileyo kwinkqubo yokuvelisa amayeza". Kwinqanaba ngalinye lonxibelelwano lovavanyo lokuqinisekisa, akwahlukani nomgangatho wokuhlamba iiglasi njengemfuneko yokufumana iziphumo ezichanekileyo, ezisebenzayo nezithembekileyo zokufumanisa kunye nohlalutyo.

Akunakwenzeka ukuba iilabhoratri zeenkampani ezifanelekileyo zifune ukuphucula ingxaki yokucoca izitya kunye nokuphucula isiphumo sokucoca - kwanele ukuphucula nokutshintsha indlela yokuqala yokucoca ngesandla ngenkqubo yokucoca ngokuzenzekelayo. Umzekelo, ukuqaliswa nokusetyenziswa kweumatshini wokuhlamba izinto zeglasi ozenzekelayoyenye yezona zisombululo zibalaseleyo.

Iumatshini wokuhlamba izinto zeglasi ozenzekelayoisebenzisa indlela yokucoca ngokutshiza. Iintsalela ezikumphezulu wempahla zinokuxotyulwa ngamanzi ashushu kunye neloshini ukuze zimanzise izinto eziseleyo, ukuze impahla icoceke kwaye ikhanye kwakhona. Ukusebenzisa ijethi yamanzi enoxinzelelo oluphezulu evela kwingalo yokutshiza kunye nesakhelo sebhasikithi,Umatshini wokuhlamba iilebhuinokudlulisa amanzi ngokuthe ngqo kwindawo yangaphakathi yokuhlamba ngepompo yokuhlamba ejikelezayo ukuya nakweyiphi na ikona yendawo yokuhlamba. Xa amanzi edlula kwi-heater ukuze enze ubushushu obuphezulu kwaye asetyenziswe njengekholamu yamanzi, anokususa ngokufanelekileyo iintsalela ezahlukeneyo zongcoliseko ezinamathele phezulu kwesitya sokususa, ngaloo ndlela kufezekiswa injongo yokucoca nokomisa. Akupheleli apho, ukusetyenziswa kwenkqubo yokuhlamba ezenzekelayoUmatshini wokuhlamba iLebhuicoceka kakuhle kakhulu (umatshini wokuhlamba izinto zeglasi ozenzekelayoumsebenzi webhetshi, inkqubo yokucoca ephindaphindwayo), izinga eliphantsi lokuqhekeka kwebhotile (uhlengahlengiso oluhambelana noxinzelelo lokuhamba kwamanzi, ubushushu bangaphakathi, njl.njl.), kunye nokuguquguquka okubanzi (Ingamkela iityhubhu zovavanyo, izitya zepetri, iiflaski zevolumu, iiflaski zekhonikhi, iisilinda zokulinganisa, njl.njl. zobukhulu obahlukeneyo kunye neemilo, kwaye yonke le nkqubo isebenza ngobuchule, ikhuselekile kwaye ithembekile (ipayipi yokungena yamanzi ekhuselekileyo engeniswayo engeniswa kwangaphambili engaqhumiyo, ukumelana noxinzelelo kunye nobushushu, akukho lula ukuyibopha Ukungcola, kunye nevalvu yokujonga echasene nokuvuza, isixhobo siya kuvala ngokuzenzekelayo xa ivalvu yesolenoid ingaphumeleli). Ukongeza,umatshini wokuhlamba iiglasi zelebhuinokubonisa ngoko nangoko idatha ebalulekileyo efana nokuqhuba umbane, i-TOC, uxinaniso lweloshini, njl.njl., nto leyo elula kubasebenzi abafanelekileyo ukujonga nokuqonda inkqubela yokucoca kunye nokudibanisa inkqubo ukuze iprintwe kwaye igcinwe iluncedo kakhulu, inika lula ukulandeleka kamva.

Umatshini wokuhlamba iilebhuInceda iinkampani zamayeza ukunciphisa ukuveliswa kongcoliseko oludibanisayo, inceda ukuqinisekisa ukuphuculwa kwekhonkco ngalinye lokuqinisekiswa kokucoca kwenkampani yamayeza, kwaye ikwanceda iinkampani zamayeza ukuphucula umgangatho wokusetyenziswa kwezixhobo. Ihambelana ngokupheleleyo neemfuno zomthetho ezibekwe yi-GMP kumazwe ahlukeneyo. Ifanelekile ukubhekiswa kwaye isetyenziswe luninzi lweenkampani zamayeza.