Posachedwapa, kampani yopanga mankhwala inafufuzidwa ndi kuthandizidwa ndi akuluakulu oyenerera chifukwa cha zoopsa zomwe zingachitike pa kayendetsedwe ka khalidwe ndipo inakakamiza kampani yopanga mankhwala kuyimitsa nthawi yomweyo kupanga kuti ikonzedwe, ndipo satifiketi yoyambirira ya "mankhwala a GMP" ya kampaniyo inachotsedwanso.

Mwamwayi, mu Seputembala 2020, FDA (US Food and Drug Administration) idapereka kalata yochenjeza kampani yogulitsa mankhwala opha mabakiteriya ku India. Kalatayo idachenjeza mwamphamvu kuti kampaniyo sinatsatire njira zovomerezeka zoyeretsera popanga mankhwala atsopano, koma idayang'ana kwambiri pakuchotsa mabakiteriya mwalamulo, zomwe zingayambitse kuipitsidwa kwina kwa zotsatira zoyeretsa komanso kusowa kwa mtundu wa mankhwala opangidwa. Chotsimikizika. Chifukwa chake, zatsimikiziridwa kuti FDA sidzavomereza mankhwalawa kuti alowe mumsika wa ogula ku United States mpaka atatsimikiziridwa kuti kampaniyo ikhoza kukonza mavuto okhudzana nawo.

Poganizira milandu iwiri yomwe ili pamwambapa, pali chinthu chimodzi chofanana chomwe chiyenera kukopa chidwi cha makampaniwa, ndiko kuti, vuto la ulalo wotsimikizira kuyeretsa silinathetsedwe bwino, ndipo silikukwaniritsa zofunikira zovomerezeka za satifiketi. Mwanjira ina: ukhondo ndiye chinsinsi chodziwira chitetezo cha mankhwala, ndipo umadutsa munjira yonse ya pharmacy.

Ndipotu, ndi kukhazikitsidwa kwa mtundu watsopano wa GMP (Good Manufacturing Practice), makampani opanga mankhwala apereka zofunikira zapamwamba pankhani yowongolera khalidwe la mankhwala, makamaka pankhani ya kafukufuku ndi chitukuko, kupanga, kuwongolera khalidwe, ndi mayendedwe.

Kwa kampani yopanga mankhwala, GMP ndi mfundo yokhazikika mdziko lonse. Makampani omwe alephera kutsata kapena kusunga GMP mkati mwa nthawi yoikika adzalangidwa mosiyanasiyana, kuphatikizapo machenjezo ndi kuyimitsa kupanga. Ndi njira yovuta kwambiri kuti ubwino wa mankhwala ukwaniritse muyezo woyenera. Pakati pawo, ukhondo ndi chimodzi mwa zizindikiro zofunika kwambiri kuti aone ngati makampani opanga mankhwala ali ndi mphamvu yokhazikika yopanga. Makampani ambiri opanga mankhwala savomerezedwa kupitiliza kupanga atayang'aniridwa ndi madipatimenti oyenerera. Chifukwa chachikulu ndi ulalo wofunikira - ziwiya zotsukira sizoyera. Makamaka, ziwiya za labotale zopangidwa ndi galasi, pulasitiki, ndi zina zotero sizingatsimikizire kuti zotsalira zodetsedwa zimatsukidwa bwino.

Ndikoyenera kutsindika kuti pakadali pano, makampani ambiri opanga mankhwala amangoyang'ana kwambiri pa kuyeretsa ndi kuyeretsa, koma amanyalanyaza kutsimikizira kwina kofunikira kwambiri pakuyeretsa. Izi mwachionekere ndi kusamvetsetsa kolakwika. Monga mukudziwa, tsatanetsatane wofunikira pakutsimikizira kuyeretsa uyeneranso kuphatikizapo kuyeretsa ndi kuyeretsa bwino labotale ya kampani yopanga mankhwala. Kuchokera pamalingaliro ena, chomalizachi ndi chofunikira kwambiri kuposa choyamba. Chifukwa chake ndikuti njira yotsimikizira kuyeretsa nthawi zambiri imakhudza gawo lopanga njira, gawo lokonzekera pulogalamu, gawo lokhazikitsa pulogalamu, ndi gawo lokonzanso momwe zinthu zilili. Magawo anayi awa pafupifupi onse amachitidwa mozungulira zomwe zili mu GMP, zomwe ndi momwe "mungachepetsere kuipitsa ndi kuipitsidwa kwa mankhwala". Pa gawo lililonse la ulalo wotsimikizira woyeserera, sichingalekanitsidwenso ndi muyezo wotsuka magalasi ngati chofunikira kuti mupeze zotsatira zolondola, zogwira mtima komanso zodalirika zozindikirika ndi kusanthula.

Sizotheka kuti ma laboratories a makampani oyenerera akufuna kukonza vuto loyeretsa ziwiya ndikuwonjezera mphamvu yoyeretsa - ndikokwanira kukweza ndikusintha njira yoyambirira yoyeretsera pamanja ndi makina oyeretsera okha. Mwachitsanzo, kuyambitsa ndi kugwiritsa ntchitochotsukira magalasi chokhandi imodzi mwa njira zabwino kwambiri zothetsera mavuto.

Thechotsukira magalasi chokhaimagwiritsa ntchito njira yotsukira ndi spray. Zotsalira pamwamba pa chidebecho zimatha kuchotsedwa ndi madzi otentha ndi mafuta odzola kuti zilowerere zinthu zotsalazo, kuti chidebecho chikhale choyera komanso chowala kachiwiri. Pogwiritsa ntchito madzi othamanga kwambiri ochokera ku dzanja lopopera ndi chimango cha dengu,Chotsukira labuMadzi amatha kudutsa mwachindunji m'malo otsukira mkati kudzera pa pampu yozungulira yotsukira kupita ku ngodya iliyonse ya chotsukira. Madzi akadutsa mu chotenthetsera kuti apange kutentha kwakukulu ndipo amagwiritsidwa ntchito ngati mzere wamadzi, amatha kutsuka bwino zotsalira zosiyanasiyana zodetsa zomwe zimayikidwa pamwamba pa chotsukira, motero kukwaniritsa cholinga choyeretsa ndi kuumitsa. Sikuti zokhazo, kugwiritsa ntchito makina otsukira okha paChotsukira Cha Laboratoryili ndi ntchito yabwino kwambiri yoyeretsa (chotsukira magalasi chokhantchito ya batch, njira yoyeretsera mobwerezabwereza), kuchuluka kochepa kwa mabotolo (kusintha kosinthika ndi kuthamanga kwa madzi, kutentha kwamkati, ndi zina zotero), komanso kusinthasintha kwakukulu (Imatha kukhala ndi machubu oyesera, mbale za petri, ma flasks odzaza, ma flasks okhala ndi mawonekedwe ofanana, masilinda oyezera, ndi zina zotero za kukula ndi mawonekedwe osiyanasiyana, ndipo njira yonseyi imagwira ntchito mwanzeru, yotetezeka komanso yodalirika (chitoliro cholowera madzi chotetezeka chomwe chimayikidwa kale chomwe sichimaphulika, kukana kuthamanga ndi kutentha, sikophweka kulumikiza Dothi, ndi valavu yowunikira yoletsa kutuluka, chidacho chidzatseka chokha valavu ya solenoid ikalephera). Kuphatikiza apo,chotsukira magalasi cha labotaleimatha kupereka nthawi yomweyo deta yofunika monga conductivity, TOC, kuchuluka kwa mafuta odzola, ndi zina zotero, zomwe zimakhala zosavuta kwa ogwira ntchito oyenerera kuyang'anira ndikudziwa bwino momwe kuyeretsa kukuyendera ndikulumikiza makinawo kuti asindikize ndikusunga ndikuthandizira kwambiri, zomwe zimapangitsa kuti zikhale zosavuta kutsatira pambuyo pake.

Makina Ochapira a LabuZimathandiza makampani opanga mankhwala kuchepetsa kupanga zinthu zodetsa, zimathandiza kuonetsetsa kuti ulalo uliwonse wa kampani yopanga mankhwala ukukonzedwa bwino, komanso zimathandiza makampani opanga mankhwala kukonza momwe zipangizo zimagwiritsidwira ntchito. Zimatsatira malamulo onse omwe GMP imakhazikitsa m'maiko osiyanasiyana. Ndi yoyenera kugwiritsidwa ntchito ndi makampani ambiri opanga mankhwala.