Imikhuba Emihle Yokukhiqiza noma i-GMP iwuhlelo oluhlanganisa izinqubo, izinqubo kanye nemibhalo eqinisekisa ukuthi imikhiqizo ekhiqizwayo, efana nokudla, izimonyo, nempahla yemithi, ikhiqizwa ngokuqhubekayo futhi ilawulwa ngokuvumelana nezindinganiso ezimisiwe zekhwalithi.Ukusebenzisa i-GMP kungasiza ukunciphisa ukulahlekelwa nokumosha, ukugwema ukukhumbula, ukubanjwa, inhlawulo kanye nesikhathi sokuboshwa.Sekukonke, ivikela kokubili inkampani nomthengi ezenzakalweni ezingezinhle zokuphepha kokudla.
Ama-GMP ahlola futhi amboze zonke izici zenqubo yokukhiqiza ukuze aqaphe noma yiziphi izingozi ezingaba inhlekelele emikhiqizweni, njengokungcoliswa okuphambene, ukuphinga, nokubhala kabi.Ezinye izindawo ezingaba nomthelela ekuphepheni kanye nekhwalithi yemikhiqizo umhlahlandlela we-GMP kanye namakheli okulawula yilezi ezilandelayo:
·Ukuphathwa kwekhwalithi
·Ukuthuthwa kwendle kanye nenhlanzeko
·Izakhiwo kanye nezinsiza
·Izisetshenziswa
·Ama-Raw material
·Abasebenzi
·Ukuqinisekisa kanye neziqu
·Izikhalazo
·Amadokhumenti nokugcinwa kwamarekhodi
·Ukuhlolwa nokuhlolwa kwekhwalithi
Uyini umehluko phakathi kwe-GMP ne-cGMP?
Imikhuba Emihle Yokukhiqiza (GMP) kanye Nemikhuba Yamanje Yokukhiqiza Okuhle (cGMP), ezimweni eziningi, iyashintshana.I-GMP ingumthethonqubo oyisisekelo omenyezelwe yi-US Food and Drug Administration (FDA) ngaphansi kwegunya le-Federal Food, Drug, and Cosmetic Act ukuze kuqinisekiswe ukuthi abakhiqizi bathatha izinyathelo ezisheshayo zokuqinisekisa ukuthi imikhiqizo yabo iphephile futhi iyasebenza.I-cGMP, ngakolunye uhlangothi, yasetshenziswa yi-FDA ukuze kuqinisekiswe ukuthuthuka okuqhubekayo endleleni abakhiqizi abasondela ngayo kwikhwalithi yomkhiqizo.Kusho ukuzibophezela okuqhubekayo kumazinga aphezulu atholakalayo wekhwalithi ngokusebenzisa amasistimu nobuchwepheshe obukamuva.
Yiziphi Izingxenye Eziyisi-5 Eziyinhloko Zomkhuba Omuhle Wokukhiqiza?
Kubaluleke kakhulu embonini yokukhiqiza ukulawula i-GMP emsebenzini ukuze kuqinisekiswe ikhwalithi engaguquki nokuphepha kwemikhiqizo.Ukugxila kuma-5 P alandelayo we-GMP kusiza ukuthobela izindinganiso eziqinile kuyo yonke inqubo yokukhiqiza.
Ama-5 P we-GMP
1. Abantu
Bonke abasebenzi kulindeleke ukuthi balandele ngokuqinile izinqubo nemithethonqubo yokukhiqiza.Ukuqeqeshwa kwamanje kwe-GMP kufanele kwenziwe yibo bonke abasebenzi ukuze baqonde ngokugcwele izindima zabo nezibopho zabo.Ukuhlola ukusebenza kwabo kusiza ukukhulisa ukukhiqiza kwabo, ukusebenza kahle, kanye nekhono.
2. Imikhiqizo
Yonke imikhiqizo kufanele ihlolwe njalo, iqhathaniswe, futhi iqinisekiswe ikhwalithi ngaphambi kokusatshalaliswa kubathengi.Abakhiqizi kufanele baqinisekise ukuthi izinto zokuqala ezihlanganisa imikhiqizo eluhlaza nezinye izingxenye zinemininingwane ecacile kuzo zonke izigaba zokukhiqiza.Indlela ejwayelekile kufanele ibhekwe lapho kupakishwa, kuhlolwe futhi kwabiwe imikhiqizo eyisampula.
3. Izinqubo
Izinqubo kufanele zibhalwe kahle, zicace, zingaguquguquki futhi zisatshalaliswe kubo bonke abasebenzi.Ukuhlola okuvamile kufanele kwenziwe ukuze kuqinisekiswe ukuthi bonke abasebenzi bathobela izinqubo zamanje futhi bayahlangabezana namazinga adingekayo enhlangano.
4. Izinqubo
Inqubo iyisethi yezinkombandlela zokwenza inqubo ebucayi noma ingxenye yenqubo ukuze kuzuzwe umphumela ongaguquki.Kufanele ibekwe kubo bonke abasebenzi futhi ilandelwe ngokungaguquki.Noma yikuphi ukuchezuka enqubweni evamile kufanele kubikwe ngokushesha futhi kuphenywe.
5. Izakhiwo
Izakhiwo kufanele zikhuthaze ukuhlanzeka ngaso sonke isikhathi ukuze kugwenywe ukungcoliswana, izingozi, ngisho nokufa.Zonke izinto ezisetshenziswayo kufanele zibekwe noma zigcinwe ngendlela efanele futhi zilinganiswe njalo ukuze kuqinisekiswe ukuthi zilungele inhloso yokukhiqiza imiphumela engaguquki ukuvikela ubungozi bokungasebenzi kahle kwemishini.
Yiziphi Izimiso eziyi-10 ze-GMP?
1. Dala Izinqubo Ezijwayelekile Zokusebenza (ama-SOP)
2. Sebenzisa / Sebenzisa ama-SOP kanye neziyalezo zomsebenzi
3. Izinqubo nezinqubo zemibhalo
4. Qinisekisa ukusebenza kwama-SOP
5. Dizayina futhi usebenzise izinhlelo zokusebenza
6. Gcina izinhlelo, izinsiza, kanye nemishini
7. Ukuthuthukisa ikhono lomsebenzi wabasebenzi
8. Vimbela ukungcola ngokuhlanzeka
9. Beka phambili ikhwalithi futhi uyihlanganise ekuhambeni komsebenzi
10.Yenza ukuhlolwa kwe-GMP njalo
Ungavumelana kanjani ne-GI-MP standard
Imihlahlandlela nemithetho ye-GMP ibhekana nezindaba ezahlukene ezingaba nomthelela ekuphepheni nekhwalithi yomkhiqizo.Ukuhlangabezana namazinga e-GMP noma e-cGMP kusiza inhlangano ukuthi ithobele imiyalo yomthetho, ikhulise ikhwalithi yemikhiqizo yayo, ithuthukise ukwaneliseka kwamakhasimende, ikhulise ukuthengisa, futhi ithole imbuyiselo enenzuzo yokutshalwa kwezimali.
Ukuqhuba ukuhlolwa kwe-GMP kudlala indima enkulu ekuhloleni ukuthobela kwenhlangano kuzivumelwano nemihlahlandlela yokukhiqiza.Ukuhlola njalo kunganciphisa ingcuphe yokuphinga kanye ne-misbrand.Ukuhlolwa kwe-GMP kusiza ukuthuthukisa ukusebenza okuphelele kwamasistimu ahlukene kufaka phakathi lokhu okulandelayo:
·Izakhiwo kanye nezinsiza
·Ukuphathwa kwezinto
·Amasistimu okulawula izinga
·Ukukhiqiza
·Ukupakishwa nokulebula kokuhlonza
·Amasistimu okuphatha izinga
·Ukuqeqeshwa kwabasebenzi kanye ne-GMP
·Ukuthenga
·Insizakalo yekhasimende
Isikhathi sokuthumela: Mar-29-2023