Good Manufacturing Practices kapena GMP ndi dongosolo lomwe lili ndi njira, njira ndi zolemba zomwe zimatsimikizira kuti zinthu zopangira, monga chakudya, zodzoladzola, ndi mankhwala, zimapangidwa ndikuwongoleredwa nthawi zonse motsatira miyezo yapamwamba. Kugwiritsa ntchito GMP kungathandize kuchepetsa kutayika ndi kutayika, kupewa kubweza, kulanda, chindapusa ndi nthawi yandende. Ponseponse, kumateteza kampani ndi ogula ku zochitika zoyipa zokhudzana ndi chitetezo cha chakudya.
Ma GMP amafufuza ndikuphimba mbali iliyonse ya njira zopangira kuti ateteze ku zoopsa zilizonse zomwe zingakhale zoopsa pa zinthu, monga kuipitsidwa, kusinthidwa, ndi kulemba zilembo molakwika. Madera ena omwe angakhudze chitetezo ndi mtundu wa zinthu zomwe malangizo ndi malamulo a GMP amayang'ana ndi awa:
·Kuyang'anira khalidwe labwino
·Ukhondo ndi ukhondo
·Nyumba ndi zinthu zina zofunika
· Zipangizo
·Zida zogwiritsira ntchito
·Antchito
· Kutsimikizira ndi kuyenereza
·Madandaulo
· Kulemba ndi kusunga zolemba
· Kuyang'anira ndi kuwunika kwa khalidwe
Kodi kusiyana pakati pa GMP ndi cGMP ndi kotani?
Njira Zabwino Zopangira Zinthu (GMP) ndi Njira Zabwino Zopangira Zinthu (cGMP) nthawi zambiri zimasinthasintha. GMP ndiye lamulo loyambira lomwe lakhazikitsidwa ndi US Food and Drug Administration (FDA) motsogozedwa ndi Federal Food, Drug, and Cosmetic Act kuti atsimikizire kuti opanga akutenga njira zodzitetezera kuti zinthu zawo zikhale zotetezeka komanso zogwira ntchito. Komabe, cGMP idakhazikitsidwa ndi FDA kuti iwonetsetse kuti opanga akupitilizabe kusintha momwe amagwirira ntchito kuti akwaniritse mtundu wa zinthu. Izi zikutanthauza kudzipereka kosalekeza ku miyezo yapamwamba kwambiri yomwe ilipo pogwiritsa ntchito machitidwe ndi ukadaulo waposachedwa.
Kodi ndi Zigawo Ziti Zikuluzikulu 5 za Makhalidwe Abwino Opangira Zinthu?
Ndikofunikira kwambiri kuti makampani opanga zinthu azilamulira GMP kuntchito kuti zinthu ziziyenda bwino komanso kuti zinthu ziziyenda bwino. Kuyang'ana kwambiri pa ma P 5 otsatirawa a GMP kumathandiza kutsatira miyezo yokhwima panthawi yonse yopanga.
Ma P 5 a GMP
1. Anthu
Antchito onse akuyembekezeka kutsatira mosamalitsa njira zopangira ndi malamulo. Maphunziro a GMP omwe alipo pano ayenera kuchitidwa ndi antchito onse kuti amvetsetse bwino ntchito ndi maudindo awo. Kuwunika momwe amagwirira ntchito kumathandiza kukulitsa zokolola zawo, kuchita bwino, komanso luso lawo.
2. Zogulitsa
Zinthu zonse ziyenera kuyesedwa nthawi zonse, kufananizidwa, komanso kutsimikiziridwa bwino musanapereke kwa ogula. Opanga ayenera kuwonetsetsa kuti zinthu zoyambira kuphatikiza zinthu zopangira ndi zinthu zina zili ndi zofunikira zomveka bwino pagawo lililonse lopanga. Njira yokhazikika iyenera kutsatiridwa polongedza, kuyesa, ndi kugawa zinthu zachitsanzo.
3. Njira
Njira ziyenera kulembedwa bwino, zomveka bwino, zogwirizana, komanso kugawidwa kwa antchito onse. Kuwunika nthawi zonse kuyenera kuchitika kuti zitsimikizire kuti antchito onse akutsatira njira zomwe zikuchitika pano komanso akukwaniritsa miyezo yofunikira ya bungwe.
4. Njira Zochitira
Ndondomeko ndi malangizo oyendetsera njira yofunika kwambiri kapena gawo la ndondomeko kuti mupeze zotsatira zofanana. Iyenera kufotokozedwa kwa ogwira ntchito onse ndikutsatiridwa mosalekeza. Kupatuka kulikonse kuchokera ku ndondomeko yokhazikika kuyenera kufotokozedwa nthawi yomweyo ndikufufuzidwa.
5. Malo
Malo ayenera kulimbikitsa ukhondo nthawi zonse kuti apewe kuipitsidwa, ngozi, kapena imfa. Zipangizo zonse ziyenera kuyikidwa kapena kusungidwa bwino ndikuyesedwa nthawi zonse kuti zitsimikizire kuti zili bwino kuti zipereke zotsatira zabwino nthawi zonse kuti zipewe kulephera kwa zida.
Kodi mfundo 10 za GMP ndi ziti?
1. Pangani Njira Zoyendetsera Ntchito (SOPs)
2. Kukhazikitsa/Kukhazikitsa ma SOP ndi malangizo a ntchito
3. Lembani njira ndi njira zomwe zagwiritsidwira ntchito
4. Tsimikizirani momwe ma SOP amagwirira ntchito
5. Pangani ndi kugwiritsa ntchito machitidwe ogwirira ntchito
6. Kusamalira machitidwe, malo, ndi zida
7. Kukulitsa luso la ogwira ntchito pantchito
8. Pewani kuipitsidwa ndi ukhondo
9. Ikani patsogolo khalidwe ndikuphatikiza mu ntchito
10. Kuchita ma audit a GMP nthawi zonse
Momwe Mungatsatire GMuyezo wa MP
Malangizo ndi malamulo a GMP amathetsa mavuto osiyanasiyana omwe angakhudze chitetezo ndi ubwino wa chinthu. Kukwaniritsa miyezo ya GMP kapena cGMP kumathandiza bungwe kutsatira malamulo, kuwonjezera ubwino wa zinthu zawo, kukweza kukhutitsidwa kwa makasitomala, kuwonjezera malonda, ndikupeza phindu lopindulitsa la ndalama zomwe zayikidwa.
Kuchita ma audit a GMP kumathandiza kwambiri poyesa kutsata kwa bungweli kutsata ndondomeko ndi malangizo opanga zinthu. Kuchita ma audit nthawi zonse kungachepetse chiopsezo cha kusokonekera ndi kusokoneza dzina la kampani. Kuwunika kwa GMP kumathandiza kukonza magwiridwe antchito onse a machitidwe osiyanasiyana kuphatikiza izi:
·Nyumba ndi zinthu zina zofunika
·Kuyang'anira zinthu
·Machitidwe owongolera khalidwe
· Kupanga
· Kulemba ndi kulemba zilembo zozindikiritsa
·Machitidwe oyang'anira abwino
· Maphunziro a ogwira ntchito ndi GMP
· Kugula
·Thandizo lamakasitomala
Nthawi yotumizira: Marichi-29-2023