Amakuru

Imiti yimiti yubuyobozi bwiza (GMP) tumenyereye, kwinjiza buhoro buhoro EHS muri GMP, nicyerekezo rusange.

Intandaro ya GMP, ntabwo isaba gusa ibicuruzwa byanyuma kugirango byuzuze ubuziranenge, ariko kandi inzira yose yumusaruro igomba kuba yujuje ibisabwa na GMP, imiyoborere yikoranabuhanga, gucunga umubare / icyiciro, gucunga no kugenzura ibintu, kugenzura ubuzima, imiyoborere iranga, gucunga gutandukana nkibyingenzi.Kuri gahunda iyo ari yo yose igira ingaruka ku bintu nyamukuru by’ibicuruzwa (impeta y’ibikoresho bya man-man) gufata ingamba zose zifatika zo gukumira umwanda n’umwanda wanduye, urujijo n’amakosa y’abantu, kugira ngo umutekano w’ibicuruzwa bikorwe, kugira ngo ubuziranenge bwabyo ibiyobyabwenge.Muri Gicurasi 2019, OMS yashyize ahagaragara Ibidukikije ku bikorwa byiza byo gukora: Ibitekerezo ku bakora inganda n'abagenzuzi mu rwego rwo kwirinda antibiyotike, harimo imyanda no gutunganya amazi mabi nka bariyeri ya GMP.Ikibazo cyo kurengera abakozi nacyo kivugwa ko cyanditswe muri GMP nshya.Urwego rwo kurinda akazi (OEB) kurinda, bigomba gutera kwitabwaho ninganda zimiti!

Ingaruka ziterwa nakazi ziterwa nibikoresho bikoreshwa mu bya farumasi (API) ningingo zingenzi kandi zigoye zo gukumira no kugenzura ingaruka ziterwa nakazi ku miti yimiti.Bishingiye ku kaga, imiti rusange n’ibiyobyabwenge bikora cyane, nk'imiti ya kanseri na penisiline, bikurura abantu benshi, ariko imiti rusange ntabwo ikurura abantu cyane mu gihugu no mu mahanga.Ikigoye cyane ni uko "isuku yinganda (IH)" agaciro k'ibigize ingirakamaro bigoye kumenya kandi bigomba guhera kuri toxicology na clinique.Urwego rwo kugenzura OEB rushyizwe mubyiciro ukurikije ibisubizo bya MSDS ibisubizo byibintu.Niba ukora ibiyobyabwenge bishya, ushobora gukenera gukoresha amafaranga n'imbaraga zawe kugirango ukore ibizamini bifitanye isano;Ku biyobyabwenge rusange, imipaka n amanota ya OEL / OEB mubisanzwe ushobora kuboneka mubajije amakuru ya MSDS yikigo.Ingamba zijyanye no kugenzura ibijyanye nubuhanga muri rusange zigabanijwemo: 1. Gufungura ibikorwa;2. Igikorwa gifunze;3. Muri rusange gutanga ikirere;4. Umunaniro waho;5. Laminar itemba;6. Kwigunga;7. Alpha beta valve, nibindi. Mubyukuri, twese turabizi duhereye kuri GMP, ariko aho twatangirira kubitekerezaho ni muburyo bwo gukumira umwanda no kwanduzanya, kandi ni gake duhereye kubisuku byinganda.

Ibigo bikorerwamo ibya farumasi bigomba gushimangira kurinda abakozi ba EHS no kumenyekanisha ibikoresho bitanga umusaruro hamwe na API OEB ihuye.Birakwiye ko dukura amasomo kuberako abatanga ibikoresho byabanyaburayi n’abanyamerika bakoze neza cyane mukurinda akazi kubakozi babo, bisaba amadosiye ya MSDS ajyanye no kurinda bisobanura ibyangombwa byo gutegura ibicuruzwa.Mu bihe byashize, igihe uruganda rukora imiti yo mu gihugu rwakoraga ibicuruzwa bitandukanye nka anesthesia nziza no kurekura uburozi, kurinda OEB ntibyari bihari, ibyo bikaba byaratumye ubuzima bw’abakozi benshi bo ku murongo bugira ingaruka.Mu gihe ubumenyi bw’abakozi bwarushijeho gushimangirwa buhoro buhoro, ibigo ntibishobora guhunga inshingano z’ingaruka ziterwa n’akazi.

Binyuze mu isesengura ry’ibyago bya API, hashyizweho uburyo bwo kubara imipaka ntarengwa y’akazi (OEL), hashyizweho uburyo bwa API bwo gushyira mu byiciro PBOEL, kandi amategeko rusange agomba gukurikizwa mu rwego rwo gukumira no kugenzura ashyirwa imbere.Mugihe kizaza, tuzasesengura ingamba zo kugenzura byimbitse.Komeza ukurikirane!