• iphepha_ibhena

INGABA INKQUBO YOKUPHUMULA INGXAKI YEGUMBI LE-GMP IYAKUCINYWA NGOBUSUKU?

gmp igumbi elicocekileyo
igumbi elicocekileyo

Iinkqubo zokungenisa umoya zeerowu ezicocekileyo zisebenzisa amandla amaninzi, ngakumbi amandla efeni yokufaka umoya, amandla okukhenkceza ukuze kuphole kwaye kususwe umswakama ehlotyeni kunye nezifudumezi zokufudumeza kunye nomphunga ukulungiselela ukufuma ebusika. Ngoko ke, umbuzo uvela ngokuphindaphindiweyo ukuba umntu unokucima umoya wamagumbi ebusuku okanye xa engasetyenziselwanga ukugcina amandla.

Akucetyiswa ukuba ucime ngokupheleleyo inkqubo yokungena umoya, kunoko kucetyiswa ukuba ungakwenzi. Iindawo, iimeko zoxinzelelo, i-microbiology, yonke into iya kuba ingalawuleki ngelo xesha. Oku kuya kwenza ukuba amanyathelo alandelayo okubuyiselwa korhulumente othobela i-GMP abe nzima kakhulu kuba ixesha ngalinye ukufaneleka kuya kuba yimfuneko ukufikelela kwimeko yesiqhelo ethobela i-GMP.

Kodwa ukunciphisa ukusebenza kweenkqubo zokungenisa umoya (ukunciphisa umthamo womoya ngokunciphisa ukusebenza kwenkqubo yokuphefumula) kunokwenzeka, kwaye sele iqhutywe kwezinye iinkampani. Nalapha, nangona kunjalo, imeko ehambelana ne-GMP kufuneka iphunyezwe ngaphambi kokusebenzisa igumbi elicocekileyo kwakhona kwaye le nkqubo kufuneka iqinisekiswe.

Ngale njongo kufuneka kuqatshelwe ezi ngongoma zilandelayo:

Ukunciphisa kunokuqhutywa kuphela ngoku ukuba imida ethile yegumbi ecocekileyo emiselweyo kwimeko echaphazelekayo ayiphulwanga ngokubanzi. Le mida kufuneka ichazwe kwimeko nganye yesimo sokusebenza kunye nemodi yokunciphisa kubandakanywa ubuncinci obuvumelekileyo kunye namaxabiso aphezulu, njengeklasi yegumbi elicocekileyo (i-particle count count with a particle size), amaxabiso athile emveliso (iqondo lokushisa, umswakama ohambelanayo), iimeko zoxinzelelo (ukwahlukana koxinzelelo phakathi kwamagumbi). Qaphela ukuba amaxabiso kwimodi yokunciphisa kufuneka akhethwe ngendlela yokuba isibonelelo sifikelele kwisimo esihambelana ne-GMP ngexesha elifanelekileyo ngaphambi kokuba imveliso iqale (ukuhlanganiswa kwenkqubo yexesha). Lo mbuso uxhomekeke kwiiparamitha ezahlukeneyo ezifana nezinto zokwakha kunye nokusebenza kwenkqubo njl njl. Iimeko zoxinzelelo kufuneka zigcinwe rhoqo, oku kuthetha ukuba ukuguqulwa kolwalathiso lokuhamba akuvumelekanga.

Ngaphezu koko, ukufakelwa kwenkqubo yokubeka iliso yegumbi elizimeleyo elicocekileyo kuyacetyiswa kuyo nayiphi na imeko ukuze kubekwe iliso rhoqo kwaye kubhalwe phantsi iiparamitha ezithile zegumbi elicocekileyo elikhankanywe ngasentla. Ngaloo ndlela, iimeko zommandla ochaphazelekayo zinokujongwa kwaye zibhalwe nangaliphi na ixesha. Kwimeko yokuphambuka (ukufikelela kumda) kwaye kwimeko nganye kunokwenzeka ukufikelela kumlinganiselo kunye nokulawula iteknoloji yenkqubo yokuphefumula umoya kunye nokwenza uhlengahlengiso olufanelekileyo.

Ngexesha lokunciphisa ingqalelo kufuneka ihlawulwe ekuqinisekiseni ukuba akukho zimpembelelo eziphazamisayo zangaphandle ezingalindelekanga ezifana nokungena kwabantu kuvunyelwe. Kule nto kucetyiswa ukuba kufakwe ulawulo lokungena oluhambelanayo. Kwimeko yenkqubo yokutshixa nge-elektroniki ugunyaziso lokungena lunokudityaniswa neprogram yexesha elikhankanywe ngasentla kunye nenkqubo yokubeka iliso ezimeleyo yegumbi elicocekileyo ukuze ukungena kugunyaziswe kuphela ngokuthotyelwa kweemfuno ezichazwe kwangaphambili.

Kwinqununu, omabini la mazwe kufuneka afaneleke kuqala aze emva koko aqinisekiswe ngamaxesha athile kwaye imilinganiselo yesiNtu yemeko yokusebenza eqhelekileyo enjengomlinganiselo wexesha lokubuyisela kwimeko yokungaphumeleli ngokupheleleyo kweso sakhiwo. Kwimeko apho kukho inkqubo yokubeka esweni igumbi elicocekileyo, inqununu ayifunwa - njengoko kukhankanyiwe ngasentla - ukuba yenze eminye imilinganiselo ekuqaleni komsebenzi emva kwemowudi yokunciphisa ukuba inkqubo iqinisekisiwe. Ugxininiso olulodwa kufuneka lubekwe kwinkqubo yokuqaliswa kwakhona njengoko ukuguqulwa okwethutyana kwendlela yokuhamba kunokwenzeka, umzekelo.

Lilonke malunga ne-30% yeendleko zamandla zinokugcinwa ngokuxhomekeke kwindlela yokusebenza kunye nemodeli yeshifti kodwa iindleko ezongezelelweyo zotyalo-mali zingafuneka zilungiswe.


Ixesha lokuposa: Sep-26-2025