Imikhuba Emihle Yokukhiqiza noma i-GMP uhlelo oluqukethe izinqubo, izinqubo kanye nemibhalo eqinisekisa ukuthi imikhiqizo yokukhiqiza, njengokudla, izimonyo, kanye nezimpahla zemithi, ikhiqizwa futhi ilawulwa njalo ngokwezindinganiso zekhwalithi ezibekiwe. Ukusebenzisa i-GMP kungasiza ekunciphiseni ukulahlekelwa kanye nokulahlwa, ukugwema ukukhunjulwa, ukuthunjwa, izinhlawulo kanye nesikhathi sokuboshwa. Sekukonke, kuvikela inkampani kanye nomthengi ezenzakalweni ezimbi zokuphepha kokudla.
Ama-GMP ahlola futhi amboze zonke izici zenqubo yokukhiqiza ukuze avikele kunoma yiziphi izingozi ezingaba yinhlekelele emikhiqizweni, njengokungcoliswa, ukungcoliswa, kanye nokulebula okungalungile. Ezinye izindawo ezingathinta ukuphepha kanye nekhwalithi yemikhiqizo okukhulunywa ngayo yiziqondiso kanye nomthethonqubo we-GMP yilezi ezilandelayo:
·Ukuphathwa kwekhwalithi
·Ukuhlanzeka kanye nokuhlanzeka
·Izakhiwo kanye nezinsiza
·Imishini
·Ama-Raw material
·Abasebenzi
·Ukuqinisekiswa kanye neziqu
·Izikhalazo
·Ukubhala imibhalo nokugcina amarekhodi
·Ukuhlolwa kanye nokuhlolwa kwekhwalithi
Uyini umehluko phakathi kwe-GMP ne-cGMP?
Imikhuba Emihle Yokukhiqiza (i-GMP) kanye nemikhuba Emihle Yokukhiqiza (i-cGMP) yamanje, ezimweni eziningi, iyashintshana. I-GMP iwumthetho oyisisekelo okhishwe yi-US Food and Drug Administration (FDA) ngaphansi kwegunya le-Federal Food, Drug, and Cosmetic Act ukuqinisekisa ukuthi abakhiqizi bathatha izinyathelo zokuqinisekisa ukuthi imikhiqizo yabo iphephile futhi isebenza kahle. I-cGMP, ngakolunye uhlangothi, yaqaliswa yi-FDA ukuqinisekisa ukuthuthuka okuqhubekayo endleleni abakhiqizi abafinyelela ngayo ikhwalithi yomkhiqizo. Kusho ukuzibophezela okuqhubekayo ezindinganisweni zekhwalithi eziphezulu ezitholakalayo ngokusebenzisa izinhlelo nobuchwepheshe obusha.
Yiziphi Izingxenye Ezi-5 Eziyinhloko Zomkhuba Omuhle Wokukhiqiza?
Kubaluleke kakhulu embonini yokukhiqiza ukulawula i-GMP endaweni yokusebenza ukuqinisekisa ikhwalithi nokuphepha kwemikhiqizo okuqhubekayo. Ukugxila ku-5 P elandelayo ye-GMP kusiza ukuhambisana nezindinganiso eziqinile kuyo yonke inqubo yokukhiqiza.
Ama-P angu-5 e-GMP
1. Abantu
Bonke abasebenzi kulindeleke ukuthi balandele ngokuqinile izinqubo nemithethonqubo yokukhiqiza. Ukuqeqeshwa kwe-GMP kwamanje kumele kwenziwe yibo bonke abasebenzi ukuze baqonde ngokugcwele imisebenzi yabo. Ukuhlola ukusebenza kwabo kusiza ekukhuliseni umkhiqizo wabo, ukusebenza kahle, kanye nekhono.
2. Imikhiqizo
Yonke imikhiqizo kumele ihlolwe njalo, iqhathaniswe, futhi iqinisekiswe ikhwalithi ngaphambi kokuyisabalalisa kubathengi. Abakhiqizi kufanele baqinisekise ukuthi izinto eziyinhloko ezifaka phakathi imikhiqizo eluhlaza nezinye izingxenye zinemininingwane ecacile kuzo zonke izigaba zokukhiqiza. Indlela ejwayelekile kumele ilandelwe ekupakisheni, ekuhloleni, nasekwabeni imikhiqizo yesampula.
3. Izinqubo
Izinqubo kufanele zibhalwe phansi kahle, zicace, zihambisane, futhi zisakazwe kubo bonke abasebenzi. Ukuhlolwa okuvamile kufanele kwenziwe ukuqinisekisa ukuthi bonke abasebenzi bayahambisana nezinqubo zamanje futhi bahlangabezana nezindinganiso ezidingekayo zenhlangano.
4. Izinqubo
Inqubo iyiqoqo leziqondiso zokwenza inqubo ebalulekile noma ingxenye yenqubo ukuze kutholakale umphumela ohambisanayo. Kumele ichazwe kubo bonke abasebenzi futhi ilandelwe njalo. Noma yikuphi ukuphambuka enkambisweni ejwayelekile kufanele kubikwe ngokushesha futhi kuphenywe.
5. Indawo
Izindawo kufanele zikhuthaze ukuhlanzeka ngaso sonke isikhathi ukuze kugwenywe ukungcoliswa okuhlukahlukene, izingozi, noma ngisho nokufa. Yonke imishini kufanele ibekwe noma igcinwe kahle futhi ilinganiswe njalo ukuqinisekisa ukuthi ifaneleka ngenhloso yokukhiqiza imiphumela efanayo ukuvimbela ingozi yokwehluleka kwemishini.
Yiziphi Izimiso Eziyi-10 ze-GMP?
1. Dala Izinqubo Zokusebenza Ezijwayelekile (ama-SOP)
2. Ukuphoqelela / ukusebenzisa ama-SOP kanye nemiyalelo yomsebenzi
3. Bhala phansi izinqubo nezinqubo
4. Qinisekisa ukusebenza kahle kwama-SOP
5. Yakha futhi usebenzise izinhlelo zokusebenza
6. Ukunakekela izinhlelo, izikhungo, kanye nemishini
7. Thuthukisa ikhono lomsebenzi labasebenzi
8. Vimbela ukungcola ngokuhlanzeka
9. Beka phambili ikhwalithi bese uyihlanganisa nomsebenzi
10. Yenza ukuhlolwa kwe-GMP njalo
Indlela Yokuthobela U-GIzinga le-MP
Iziqondiso nemithethonqubo ye-GMP zibhekana nezinkinga ezahlukene ezingathinta ukuphepha nekhwalithi yomkhiqizo. Ukuhlangabezana nezindinganiso ze-GMP noma ze-cGMP kusiza inhlangano ukuthi ihambisane nemiyalelo yezomthetho, inyuse ikhwalithi yemikhiqizo yayo, ithuthukise ukwaneliseka kwamakhasimende, inyuse ukuthengisa, futhi ithole inzuzo yokutshalwa kwezimali.
Ukwenza ukuhlolwa kwe-GMP kudlala indima enkulu ekuhloleni ukuthobela kwenhlangano imigomo neziqondiso zokukhiqiza. Ukwenza ukuhlolwa okuvamile kunganciphisa ingozi yokuguqulwa kanye nokwehliswa kwegama. Ukuhlolwa kwe-GMP kusiza ukuthuthukisa ukusebenza okuphelele kwezinhlelo ezahlukene okuhlanganisa okulandelayo:
·Izakhiwo kanye nezinsiza
·Ukuphathwa kwezinto zokwakha
·Izinhlelo zokulawula ikhwalithi
·Ukukhiqiza
·Ukupakisha kanye nokulebula ukuhlonza
·Izinhlelo zokuphatha ikhwalithi
·Ukuqeqeshwa kwabasebenzi kanye ne-GMP
·Ukuthenga
·Insizakalo yekhasimende
Isikhathi sokuthunyelwe: Mashi-29-2023