Imikhuba yokukhiqiza enhle noma i-GMP uhlelo oluqukethe izinqubo, izinqubo kanye nemibhalo eqinisekisa imikhiqizo yokukhiqiza, njengokudla, izimonyo kanye nezimpahla zemithi, kukhiqizwa ngokungaguquki ngokuya ngezilinganiso ezisezingeni eliphakeme. Ukuqalisa ukusebenzisa i-GMP kungasiza ukunciphisa ukulahleka kanye nokungcola, gwema ukukhumbula, ukuthathwa, inhlawulo nesikhathi sejele. Sekukonke, kuvikela zombili inkampani nomthengi kusuka emicimbini engemihle yokuphepha kokudla.
Ama-GMPs ahlole futhi amboze zonke izici zenqubo yokukhiqiza ukuqapha noma yiziphi izingozi ezingaba yinhlekelele yemikhiqizo, njengokungcola kokuwela, ukuphinga, kanye nokungcola kwe-mislabele. Ezinye izindawo ezingathonya ukuphepha nekhwalithi yemikhiqizo eyenziwa yikheli lesiqondisi se-GMP umhlahlandlela kanye nalokhu okulandelayo:
Ukuphathwa Kwekhwalithi
· Ukuthuthwa kanye nenhlanzeko
· Ukwakha nezinsizakusebenza
· Equip
·Ama-Raw material
· Abasebenzi
· Ukuqinisekiswa kanye neziqu
Izikhalazo
· Imibhalo nokurekhoda ukugcinwa
· Ukuhlola nokuhlolwa kwekhwalithi
Uyini umehluko phakathi kwe-GMP ne-CGMP?
Izindlela zokukhiqiza ezinhle (GMP) kanye nezindlela zokukhiqiza ezinhle zamanje (CGMP) zikhona, ezimweni eziningi, ziyashintshana. I-GMP ngumthethosisekelo oyisisekelo oshukunyiswe yi-US Food Food and Drug Administration (FDA) ngaphansi kwegunya lokudla, izidakamizwa, kanye noMthetho wezimonyo ukuqinisekisa ukuthi abakhiqizi bathatha izinyathelo ezisebenzayo zokuphepha futhi zisebenza. I-CGMP, ngakolunye uhlangothi, yaqaliswa yi-FDA ukuqinisekisa ukuthuthuka okuqhubekayo ekusondelweni kwabakhiqizi ngekhwalithi yomkhiqizo. Kusho ukuzibophezela okungapheli kumazinga aphezulu atholakalayo wekhwalithi ngokusetshenziswa kwezinhlelo zakamuva kanye nobuchwepheshe.
Yiziphi izingxenye ezi-5 eziphambili zokuzijwayeza okuhle kokukhiqiza?
Kubaluleke kakhulu embonini yezokukhiqiza ukulawula i-GMP Endaweni yokusebenza ukuze kuqinisekiswe ikhwalithi nokuphepha kwemikhiqizo. Ukugxila kokulandelayo kwe-5 PS ye-GMP kusiza ukulandela amazinga aqinile kuyo yonke inqubo yokukhiqiza.
Ama-5 p we-GMP
1. Abantu
Bonke abasebenzi kulindeleke ukuthi babambelele ngokuqinile ekukhiqizweni kwezinqubo nemigomo. Ukuqeqeshwa kwamanje kwe-GMP kumele kwenziwe yibo bonke abasebenzi ukuze baqonde ngokugcwele izindima zabo nezibopho zabo. Ukuhlola ukusebenza kwabo kusiza ukukhulisa umkhiqizo wabo, ukusebenza kahle, kanye nekhono.
2. Imikhiqizo
Yonke imikhiqizo kufanele ibhekane njalo, ukuqhathanisa, nokuqinisekiswa kwekhwalithi ngaphambi kokusabalalisa kubathengi. Abakhiqizi kufanele baqinisekise ukuthi izinto eziphambili kufaka phakathi imikhiqizo eluhlaza nezinye izinto zinokucaciswa okucacile esigabeni sonke sokukhiqiza. Indlela ejwayelekile kufanele ibonwe ngokupakisha, ukuhlola, nokwabiwa kwemikhiqizo yesampula.
3. Izinqubo
Izinqubo kufanele zibhalwe kahle, zicacile, zingaguquguquki futhi zisatshalaliswa kubo bonke abasebenzi. Ukuhlolwa njalo kufanele kwenziwe ukuqinisekisa ukuthi bonke abasebenzi bahambisana nezinqubo zamanje futhi bahlangabezana namazinga adingekayo enhlangano.
4. Izinqubo
Inqubo iqoqo lezinkombandlela zokwenza inqubo ebalulekile noma ingxenye yenqubo yokufeza umphumela ongaguquguquki. Kufanele ibekwe kubo bonke abasebenzi futhi ilandelwe njalo. Noma yikuphi ukuphambuka kwenqubo evamile kufanele kubikwe ngokushesha futhi kuphenywe.
I-5. Izakhiwo
Izakhiwo kufanele zikhuthaze inhlanzeko ngaso sonke isikhathi ukuze zigweme ukungcoliswa kwezingozi, izingozi, noma ukubulawa kwabantu. Yonke imishini kufanele ibekwe noma igcinwe kahle futhi ilinganiswe njalo ukuze iqinisekise ukuthi ilungele inhloso yokukhiqiza imiphumela engaguquki ukuvikela ingozi yokuhluleka kwemishini.
Yiziphi izimiso eziyi-10 ze-GMP?
1. Dala izinqubo zokusebenza ezijwayelekile (Sops)
2. Ukuphoqelela / Sebenzisa ama-SOPs nemiyalo yomsebenzi
3. Izinqubo nezinqubo nezinqubo
4. Qinisekisa ukusebenza kwe-SoPS
5. Design futhi usebenzise izinhlelo zokusebenza
6. Gcina izinhlelo, izikhungo, kanye nemishini
7. Ukwakha amandla okusebenza kwabasebenzi
8. Vimbela ukungcoliswa kokuhlanzeka
9. Phakamisa ikhwalithi ebeka phambili futhi uhlanganiswe ekuhambeni komsebenzi
10.Constict GMP Ukucwaningwa kwamabhuku njalo
Ungayilandela kanjani i-GI-MP Standard
Imihlahlandlela ye-GMP Imihlahlandlela Nezimiso Izinkinga ezahlukahlukene ezingathonya ukuphepha nekhwalithi yomkhiqizo. Ukuhlangana namazinga we-GMP noma we-CGMP kusiza inhlangano ukuthi ihambisane nemiyalo yomthetho, yandise ikhwalithi yemikhiqizo yayo, yenza ngcono ukwaneliseka kwamakhasimende, yandise ukuthengisa, futhi uthole ukubuyiselwa kwemali okunenzuzo.
Ukwenza ukucwaningwa kwamabhuku kwe-GMP kudlala indima enkulu ekuhlolweni kokuthobela inhlangano ukukhiqiza ama-protocols kanye nemihlahlandlela. Ukwenza amasheke ajwayelekile kunganciphisa ubungozi bokuphinga kanye nephutha. Ukucwaningwa kwamabhuku we-GMP kusiza ukuthuthukisa ukusebenza okuphelele kwezinhlelo ezahlukene kufaka phakathi okulandelayo:
· Ukwakha nezinsizakusebenza
Ukuphathwa Kwezezimali
Amasistimu Wokulawula Wekhwalithi
· Ukukhiqiza
· Ukupakisha nokubhalwa kokubhalwa
Amasistimu Wokuphathwa Kwekhwalithi
Ukuqeqeshwa kwabasebenzi kanye ne-GMP
· Ukuthenga
·Insizakalo yekhasimende
Isikhathi sePosi: Mar-29-2023