Nkhani

Pharmaceutical making quality management standard (GMP) yomwe tikuidziwa bwino, kuphatikizidwa kwapang'onopang'ono kwa EHS mu GMP, ndizomwe zimachitika.

Pachimake cha GMP, sikuti chimangofunika kuti chomaliza chomaliza chikwaniritse miyezo yapamwamba, komanso njira yonse yopanga iyenera kukwaniritsa zofunikira za GMP, kasamalidwe kaukadaulo waukadaulo, kasamalidwe ka batch / batch number, linanena bungwe ndi kuyang'anira zinthu moyenera, kasamalidwe kaumoyo, kasamalidwe ka chizindikiritso, kasamalidwe kopatuka ngati cholinga.Kwa njira iliyonse yomwe imakhudza zinthu zazikulu zamtengo wapatali (mphete ya munthu-makina) kuti itenge mitundu yonse ya njira zothandizira kupewa kuipitsidwa ndi kuipitsidwa kwa mtanda, chisokonezo ndi zolakwika zaumunthu, kuonetsetsa chitetezo cha kupanga mankhwala, kuonetsetsa ubwino wa mankhwala.Mu Meyi 2019, WHO idasindikiza Zachilengedwe Zazinthu Zabwino Zopanga Zopanga: Zolingalira kwa Opanga ndi Oyang'anira popewa kukana kwa maantibayotiki, kuphatikiza zinyalala ndi kuthira madzi oyipa ngati poyang'ana GMP.Nkhani ya chitetezo cha ogwira ntchito ikunenedwanso kuti ilembedwe mu GMP yatsopano.Chitetezo cha Occupational Exposure Level (OEB), chiyenera kuyambitsa chidwi chamakampani azamankhwala!

Zowopsa zapantchito zomwe zimayambitsidwa ndi zosakaniza zogwiritsira ntchito mankhwala (API) ndiye mfundo zazikulu komanso zovuta zopewera ngozi zapantchito ndi kasamalidwe kaulamuliro m'mabizinesi azachipatala.Malingana ndi chiopsezo, mankhwala atsopano ndi mankhwala okhudzidwa kwambiri, monga mankhwala a khansa ndi penicillin, amakopa chidwi kwambiri, koma mankhwala osokoneza bongo samakopa chidwi kwambiri kunyumba ndi kunja.Chovuta kwambiri ndikuti mtengo wa "industrial hygiene (IH)" wa chinthu chogwira ntchito ndizovuta kudziwa ndipo uyenera kuyamba kuchokera ku toxicology ndi zachipatala.Mulingo wowongolera wa OEB nthawi zambiri umasinthidwa malinga ndi zotsatira zafunso za MSDS zamagulu.Ngati mukugwiritsa ntchito mankhwala osokoneza bongo, mungafunike kugwiritsa ntchito ndalama zanu ndi mphamvu zanu kuti muyese kuyesa kogwirizana;Kwa mankhwala amtundu uliwonse, malire ndi magiredi a OEL/OEB amatha kupezeka pofunsa zambiri za MSDS zapawiri.Njira zowongolera uinjiniya nthawi zambiri zimagawidwa kukhala: 1. Ntchito yotseguka;2. Ntchito yotsekedwa;3. Mpweya wonse;4. Utsi wa m'deralo;5. Kutuluka kwa laminar;6. Wodzipatula;7. Alpha beta valve, etc. Ndipotu, tonsefe timadziwa izi kuchokera ku GMP, koma poyambira kuganizira nthawi zambiri ndi njira yopewera kuipitsidwa ndi kuipitsidwa, ndipo kawirikawiri kuchokera ku ukhondo wa mafakitale.

Mabizinesi apakhomo apakhomo akuyenera kulimbikitsa chitetezo cha ogwira ntchito ku EHS ndikuyambitsa zida zopangira zofananira ndi API OEB.Ndikoyenera kutengerapo phunziro kuti ogulitsa zida za ku Europe ndi America achita bwino kwambiri poteteza antchito awo, zomwe zimafunikira mafayilo ofananira a MSDS ndi chitetezo chofananira chikutanthauza zikalata zokonzekera zoyeserera.M'mbuyomu, pamene mabizinesi apanyumba amapanga zinthu zosiyanasiyana monga mankhwala oletsa kupweteka komanso kutulutsa poizoni, chitetezo cha OEB sichinali m'malo, zomwe zidapangitsa kuti thanzi la ogwira ntchito akutsogolo likhudzidwe.Pazifukwa zomwe kuzindikira kwalamulo kwa ogwira ntchito kunalimbikitsidwa pang'onopang'ono, mabizinesi sakanatha kuthawa udindo wa ngozi zofananira zantchito.

Kupyolera mu kusanthula zoopsa za API, ndondomeko yowerengera ya occupational exposure limit (OEL) imaperekedwa, API ya hazard classification system PBOEL imayambitsidwa, ndipo malamulo omwe ayenera kutsatiridwa pofuna kupewa ndi kuwongolera amaperekedwa patsogolo.M'tsogolomu, tidzasanthula njira yolamulira mozama.Dzimvetserani!