I-PCAB isetshenziselwa izindlela zokukhomba izakhi ezidakamizwa eziphezulu
Okwenzeka ngokushesha ngokushesha kusukela ekuhloleni kwe-US Food and Drug Administration kanye nophenyo lombuso wekhemisi, kodwa kwakungenxa yokuthi abasebenzi be-NECC babengathobeli imithetho elawula ikhemisi ehlanganiswayo, futhi abambelele emikhondweni enhle yokuqinisekisa ikhwalithi ye-drug compound kanye nobungqabavu.
Abalobi kanye neziguli bekungaba nokuhlukumezeka mayelana nawo wonke ama-pharmacy ahlanganisayo. Ukuqinisekisa lokho okukhathazayo kudinga amakhemikhali, amakhemikhali abafundi, kanye nochwepheshe bekhemisi ukuzibamba emazingeni aphakeme kakhulu ekuhlanganiseni. Indlela enhle kakhulu yokubonisa izwe wena nabalingani bakho okwenza kanjalo ukuthola ukuthola imvume yokuhlanganisa izidakamizwa.
Isingeniso se-PCAB Isiqinisekiso
I-Pharmacy Compounding Accreditation Board ibuyekeze futhi iqinisekisile abasebenzi, izakhiwo, nezinqubo ezingaphezu kuka-100 Pharmacy ezihlanganisayo zaseMelika ezilandeleni ezingu-38 kusukela ngo-2006. Iveza ulwazi nobuchwepheshe kusukela
- I-American College of Pharmacy
- Umphakathi Wamazwe Omphakathi Wabahlengikazi
- Association Pharmacy American
- I-National Alliance of State Pharmacy Associations
- I-International Academy of Compounding Pharmacists
- I-National Home Infusion Association
- I-National Association of Boards of Pharmacy
- I-United States Pharmacopeia
Ukubambisana kwe-PCAB kubonisa ukuthi abasebenzi abathintekayo ekuhlanganiseni babe nokuqeqeshwa okufanele nokuqhubekayo ekulungiseleleni izilinganiso ezenziwe ngokwezifiso; ukuthi ikhemisi isebenzisa izithako ezisebenzayo zokusebenza imithi ephezulu futhi izinto ezingasebenzi; nokuthi zonke izinqubo eziyinkimbinkimbi zibhalwe ngokugcwele futhi zenziwe ngokuhambisana namafomula amisiwe.
Okuphawulekayo, izikhungo zezokwelapha ze-Veterans zingakwazi ukuthenga kuphela ngama-pharmacy aqinisekiswe yi-PCAB.
I-PCAB yemvume yokubopha izidakamizwa eziyimpoqo futhi engekho emthethweni kodwa ayifuni imikhuba ye-pharmacy yenuzi noma ama-pharmacy ngaphandle kwe-United States.
I-NECC ayizange iqinisekiswe i-PCAB.
Abafundi bakholelwa ukuthi nabo kanye nabaqondisi neziguli abakhonza kuzozuza ngokuthola imvume yokungena kwi-PCAB manual kanye nesicelo se-intanethi.
Iqala Ngabantu Abalungile
I-pharmacy eqinisekisiwe ye-PCAB, ngokusho kwebhodi, kumele ikhombise ukuthi "bonke abasebenzi abathintekayo nokuhlanganiswa ... bayakwazi ukwenza imisebenzi yabo abelwe yona." Lokhu kusebenza ekuqondiseni abakwa-pharmacy, abakwa-pharmacy abasebenzi, abakwa-pharmacy abafundi abanikeza umsebenzi wokuhlanganisa imisebenzi kanye nabachwepheshe bekhemisi. Ukubonisa ukukhishwa kwamakhono kudinga ukubonisa ukuthi abasebenzi baphethe amalayisense afanele, izitifiketi, iziqinisekiso, nokubhalisa. Ngomhla ka-Jan. 1, 2015, bonke ochwepheshe abahlanganisayo kuma-pharmacy avunyelwe kufanele baqinisekiswe.
Khona-ke Udinga Amazinga, Izinsiza, Namadokhumenti
Izisebenzi ze-Pharmacy nazo zidinga ukuloba ukuthobela ama-USP 795 okungahlanganiswa okungahlanganiswa kwama-nonsterile nama-USP 797 amazinga okuhlanganiswa oyinyumba. Lokhu kusho ukuqopha izinqubo ezijwayelekile zokusebenza ephepheni noma kuma-computer nokugcina amarekhodi avumela amavaysi afanelana neziguli ngabanye.
Ikhemisi kumele futhi ibe nezinodo zokuthi isitokisi sijikelezwa kanjani futhi nini, imishini ihlanzwa futhi iyalinganiswa, futhi izinto zivivinywa ngezinga eliphezulu nokuhlanzeka. Ama-Pharmacy afuna ukugunyazwa kwe-PCAB nawo adinga ukufakazela ukuthi ahlanganiswe kuphela nama-API nezinye izinto ezihlangabezana namazinga we- USP nama- Formule kazwelonke, uhlonzi wonke ama-API kumalebula womkhiqizo futhi ugcine izitifiketi zokuhlaziywa kanye namaphepha okuphepha okuphepha kwento ngayinye ayisebenzisayo.
Imfuneko ebalulekile yokuhambisana nokugcwele kwe-USP 797 kanye ne-PCAB yokugunyazwa yilokho ama-pharmacy akha izidakamizwa ezibeka izingozi eziphezulu empilweni yeziguli uma zihlambulukile kumele zibe nezindlu zokuhlanza ezihlangabezana nezindinganiso ze-ISO-8. I-PCAB igcizelela ukuthi ukusebenzisa imishini ejwayelekile-efana nokuhlanganiswa kwama-isolat aseptic akusilo ngaso sonke isikhathi okwanele ukuqinisekisa ukuthi inzalo.
Kudingeka Imali Yonyaka
Ukuqinisekiswa kwe-PCAB kuxhomeke ngokuyinhloko emiphumeleni yokuhlolwa kwesayithi ngesikhathi ababuyekezi beqinisekisa iziqu zabasebenzi, ukuhlola imishini kanye nezinsiza, nokuqinisekisa ukunemba kwamarekhodi namadokhumenti. Ama-pharmacy afaka isicelo sokugunyazwa kokuqala noma ukuvuselela kabusha akhokhela izindleko ezigcwele zokuhlola ngamunye.
Ama-Pharmacy akhokhela imali yesicelo sesikhathi esisodwa kanye nemali ekhokhwa minyaka yonke ngokususelwa kumthamo wokuhlanganisa.