Posachedwapa, kampani yopanga mankhwala idafufuzidwa ndikuthandizidwa ndi akuluakulu oyenerera chifukwa cha ngozi zomwe zingachitike pachitetezo chaukadaulo ndikukakamiza kampani yopanga mankhwala kuyimitsa nthawi yomweyo kupanga kuti ikonzenso, ndipo satifiketi yoyambirira ya "mankhwala a GMP" idachotsedwanso.

Mwachidziwitso, mu Seputembala 2020, a FDA (US Food and Drug Administration) adapereka kalata yochenjeza motsutsana ndi kampani yopanga mankhwala oletsa mabakiteriya ku India. inayang'ana pa kuchotseratu mabakiteriya, zomwe zingapangitse chiopsezo cha kuipitsidwa kwina kwa zotsatira zoyeretsa komanso kusapezeka kwa khalidwe la mankhwala opangidwa.Zotsimikizika.Choncho, zimatsimikiziridwa kuti a FDA sangavomereze mankhwalawa kuti alowe mumsika wa ogula ku United States mpaka atatsimikiziridwa kuti kampaniyo ikhoza kuthetsa mavuto okhudzana nawo.

Kuyang'ana milandu iwiri yomwe ili pamwambayi, pali chinthu chimodzi chofanana chomwe chiyenera kukopa chidwi cha makampani, ndiko kuti, vuto la ulalo wotsimikizira kuyeretsa silinathetsedwe bwino, ndipo silikukwaniritsa zofunikira zovomerezeka.Mwanjira ina: ukhondo ndiye chinsinsi chodziwira chitetezo cha mankhwala, ndipo chimadutsa munjira yonse ya pharmacy.

M'malo mwake, pakukhazikitsidwa kwa mtundu watsopano wa GMP (Good Manufacturing Practice), zofunikira zapamwamba zaperekedwa kwa makampani opanga mankhwala potengera kuwongolera kwabwino kwamankhwala, makamaka pankhani ya R&D, kupanga, kuwongolera bwino, ndi kayendedwe.

Kwa kampani yopanga mankhwala, GMP ndi mfundo yokhazikitsidwa ndi dziko lonse.Makampani omwe amalephera kuyika chizindikiro kapena kusunga GMP mkati mwa nthawi yoikidwiratu adzalangidwa mosiyanasiyana, kuphatikiza machenjezo ndi kuyimitsidwa kwa kupanga.Ndizovuta kwambiri kuti mtundu wamankhwala ukhale woyenerera.Pakati pawo, ukhondo ndi chimodzi mwa zizindikiro zofunika kuyesa ngati makampani opanga mankhwala ali ndi mphamvu zokhazikika zopanga.Chifukwa chachikulu ndicho kulumikizana kwenikweni - ziwiya zoyeretsera sizoyera.Makamaka, zipangizo za labotale zopangidwa ndi galasi, pulasitiki, ndi zina zotero.

Ndikoyenera kutsindika kuti pakali pano, makampani ambiri opanga mankhwala amangoganizira zakupha tizilombo toyambitsa matenda ndi kulera, koma amanyalanyaza kutsimikizira kwina kofunikira kwambiri.Izi mwachiwonekere ndikumvetsetsa kolakwika.Monga mukudziwira kuti tsatanetsatane wofunikira pakutsimikizira koyeretsera kuyeneranso kuphatikizira kupha tizilombo toyambitsa matenda ndi kuthirira komanso kuyeretsa bwino labotale yamakampani opanga mankhwala.Kuchokera pamalingaliro ena, chotsiriziracho ndi chofunikira kwambiri kuposa choyambirira.Chifukwa chake ndikuti njira yotsimikizira kuyeretsa nthawi zambiri imakhudza gawo la chitukuko cha njira, gawo lokonzekera pulogalamu, gawo lokhazikitsa pulogalamuyo, ndi gawo lotsimikiziranso.Magawo anayiwa pafupifupi onse amachitidwa mozungulira zomwe zili mu GMP, momwe mungachepetsere kuipitsidwa ndi kuipitsidwa pakupanga mankhwala.Pa gawo lililonse la ulalo wotsimikizika woyeserera, umakhalanso wosasiyanitsidwa ndi muyezo wotsuka magalasi ngati chofunikira kuti mupeze zotsatira zolondola, zogwira mtima komanso zodalirika zowunikira ndikuwunika.

Ndizosatheka kuti ma laboratories amakampani oyenerera afune kukonza vuto loyeretsa ziwiya ndikuwongolera kuyeretsa - ndikokwanira kukweza ndikusintha njira yoyeretsera pamanja ndi makina oyeretsera okha.Mwachitsanzo, mawu oyamba ndi kugwiritsa ntchito amakina ochapira magalasindi imodzi mwamayankho abwino kwambiri.

Themakina ochapira magalasiamatengera njira yoyeretsera spray.Zotsalira pamwamba pa ware zimatha kusungunuka ndi madzi otentha ndi mafuta odzola kuti zilowerere zinthu zotsalira, kotero kuti ware akhoza kukhala oyera ndi owala kachiwiri.Kugwiritsa ntchito jeti yamadzi yothamanga kwambiri kuchokera ku mkono wopopera ndi chimango cha dengu, theLab Washerakhoza kudutsa madzi akuyenda molunjika kudera lakutsuka lamkati kudzera papampu yotsuka yozungulira kupita ku ngodya iliyonse ya chandamale chotsuka.Madzi akadutsa mu chowotcha kuti apange kutentha kwakukulu ndipo amagwiritsidwa ntchito ngati mzati wamadzi, amatha kutsuka zotsalira zosiyanasiyana zowonongeka zomwe zimayikidwa pamwamba pa chotengera chochotsamo, potero kukwaniritsa cholinga choyeretsa ndi kuyanika.Osati kokha, kugwiritsa ntchito makina ochapira okha kwaWasher wa Laboratoryali ndi ntchito yoyeretsa kwambiri (makina ochapira magalasintchito ya batch, kuyeretsa mobwerezabwereza), kutsika kwa botolo lotsika (kusintha kosinthika kwa kuthamanga kwa madzi, kutentha kwamkati, ndi zina), komanso kusinthasintha kwakukulu (Itha kukhala ndi machubu oyesera, mbale za petri, ma flasks a volumetric, ma flasks a conical, masilindala oyezera, etc. za kukula ndi mawonekedwe osiyanasiyana, ndipo ndondomeko yonseyi ikugwiritsidwa ntchito mwanzeru, yotetezeka komanso yodalirika (yomwe inayikiratu kuphulika-umboni wamadzi otetezera chitoliro, kuthamanga ndi kukana kutentha, kosavuta kulumikiza Dirt, ndi anti-leak monitoring valve, the Chida chimangotseka valavu ya solenoid ikalephera).labotale glassware washerimatha kuwonetsa nthawi yomweyo zofunikira monga ma conductivity, TOC, mafuta odzola, ndi zina zotero, zomwe ndi zabwino kwa ogwira ntchito kuti aziyang'anira ndikuwongolera momwe akuyeretsera ndikulumikiza makinawo kuti asindikize ndikusunga ndizopindulitsa kwambiri, kukupatsani mwayi wopezeka pambuyo pake.

Makina Ochapira a Labimathandizira makampani opanga mankhwala kuti achepetse kufalikira kwa kachilomboka, amathandizira kuwongolera ulalo uliwonse wa kutsimikizira kuyeretsa kwa kampani yamankhwala, komanso amathandizira makampani opanga mankhwala kukonza kuchuluka kwa zida zogwiritsira ntchito.Ikutsata kwathunthu zofunikira zamalamulo zokhazikitsidwa ndi GMP m'maiko osiyanasiyana.Ndikoyenera kutchulidwa ndikugwiritsidwa ntchito ndi makampani ambiri opanga mankhwala.