Ibinyabuzima bivuga imiti bivura hakoreshejwe ikoranabuhanga ry’ibinyabuzima, nk'imyiteguro y’ibinyabuzima, ibikomoka ku binyabuzima, imiti y’ibinyabuzima, n’ibindi. Kubera ko isuku, ibikorwa n’umutekano w’ibicuruzwa bigomba gukenerwa mu gihe cyo gukora ibinyabuzima, imiti y’ibyumba isukuye igomba gukoreshwa mu musaruro inzira yo kwemeza ubuziranenge n'umutekano. Igishushanyo mbonera, kubaka no gukoresha icyumba gisukuye cya biofarmaceutical GMP bisaba kubahiriza byimazeyo ibisobanuro bya GMP, harimo kugenzura isuku y’ikirere cy’icyumba gisukuye, ubushyuhe, ubushuhe, itandukaniro ry’umuvuduko n’ibindi bipimo, ndetse no gucunga abakozi, ibikoresho, ibikoresho n’imyanda mu cyumba gisukuye. Muri icyo gihe, tekinoroji n’ibikoresho bigezweho byo mu cyumba bisukuye, nka filteri ya hepa, kwiyuhagira mu kirere, intebe isukuye, n’ibindi birakenewe kugira ngo ubwiza bw’ikirere hamwe na mikorobe mu cyumba gisukuye byujuje ibisabwa.
Igishushanyo cya gmp farumasi yicyumba gisukuye
1. Igishushanyo mbonera cyicyumba ntigishobora guhaza ibikenewe byumusaruro. Kubikorwa bishya byibyumba bisukuye cyangwa imishinga minini yo kuvugurura ibyumba bisukuye, ba nyirubwite bakunda gukoresha ibigo byubushakashatsi byemewe. Ku mishinga mito n'iciriritse isukuye ibyumba bisukuye, urebye ikiguzi, nyirubwite azasinyana amasezerano nisosiyete yubwubatsi, kandi uruganda rukora imirimo rushinzwe imirimo yo gushushanya.
. iyo kubaka icyumba gisukuye birangiye. Ikizamini cyo kwemererwa kirimo ibyiciro bibiri: gutangiza komisiyo no gusuzuma byimazeyo imikorere yicyumba gisukuye.
3. Ibibazo mu mikorere yicyumba gisukuye
QualityUbuziranenge bwabwo ntabwo bugera kubisanzwe
OperationImikorere y'abakozi idasanzwe
Kubungabunga ibikoresho ntabwo ari igihe
CleaningIsuku ryuzuye
OsalKwirukana imyanda idakwiye
F Ingaruka z'ibidukikije
Hariho ibintu byinshi byingenzi ugomba kwitondera mugihe dushushanya icyumba cya farumasi cya GMP.
1. Isuku yo mu kirere
Ikibazo cyukuntu wahitamo neza ibipimo mumahugurwa yubukorikori. Ukurikije ibicuruzwa bitandukanye byubukorikori, uburyo bwo guhitamo neza ibipimo byubushakashatsi nikibazo cyibanze mugushushanya. GMP ishyira imbere ibipimo byingenzi, ni ukuvuga urwego rwisuku yikirere. Imbonerahamwe ikurikira irerekana urwego rw’isuku ry’ikirere rwerekanwe muri GMP y’igihugu cyanjye mu 1998: Muri icyo gihe, OMS (Umuryango w’ubuzima ku isi) n’ubumwe bw’ibihugu by’Uburayi (Umuryango w’ubumwe bw’ibihugu by’Uburayi) byombi bifite ibisabwa bitandukanye ku rwego rw’isuku. . Inzego zavuzwe haruguru zerekanye neza umubare, ingano, na leta y'ibice.
Birashobora kugaragara ko isuku yibintu byinshi byumukungugu ari muke, kandi isuku yubushyuhe buke buri hejuru. Urwego rwisuku yikirere nicyo kintu cyibanze cyo gusuzuma ikirere cyiza. Kurugero, urwego 300.000 urwego ruva muburyo bushya bwo gupakira bwatanzwe na Biro yubuvuzi. Kugeza ubu ntibikwiye gukoreshwa mubikorwa byingenzi byibicuruzwa, ariko birakora neza iyo bikoreshejwe mubyumba bimwe byubufasha.
2. Guhana ikirere
Umubare w'imihindagurikire y’ikirere muri sisitemu rusange yo guhumeka ni inshuro 8 kugeza 10 gusa mu isaha, mu gihe umubare w’imihindagurikire y’ikirere mu cyumba gisukuye mu nganda wikubye inshuro 12 ku rwego rwo hasi kandi inshuro magana ku rwego rwo hejuru. Ikigaragara ni uko itandukaniro ryumubare wimihindagurikire y’ikirere ritera ubwinshi bw’ikirere Itandukaniro rinini mu gukoresha ingufu. Mu gishushanyo, hashingiwe ku mwanya uhagije w’isuku, hagomba kubaho igihe gihagije cyo guhanahana ikirere. Bitabaye ibyo, ibisubizo by'ibikorwa ntibizaba bigera ku gipimo gisanzwe, icyumba gisukuye cyo kurwanya-kwivanga kizaba gikennye, ubushobozi bwo kwiyeza bizagenda byiyongera, kandi ibibazo byinshi bizarenza inyungu.
3. Itandukaniro ryumuvuduko uhagaze
Hano hari urukurikirane rwibisabwa nkintera iri hagati yibyumba bisukuye byinzego zitandukanye nibyumba bidafite isuku ntibishobora kuba munsi ya 5Pa, kandi intera iri hagati yibyumba bisukuye no hanze ntishobora kuba munsi ya 10Pa. Uburyo bwo kugenzura itandukaniro ryumuvuduko uhagaze ni ugutanga urugero rwiza rwumuvuduko mwinshi. Ibikoresho byiza byumuvuduko ukunze gukoreshwa mubishushanyo mbonera ni ibisigisigi byumuvuduko usigaye, umuvuduko ukabije wumuyagankuba wumuvuduko wamashanyarazi hamwe nuburyo bwo kugabanya ikirere byashyizwe kumasoko agaruka. Mu myaka yashize, uburyo bwo kudashyiraho igikoresho cyumuvuduko mwiza ariko bigatuma ubwinshi bwumwuka utanga ubunini burenze ubwinshi bwikirere bwagarutse hamwe nubunini bwumwuka mwinshi mugihe cyo gutangira kwambere bukoreshwa mugushushanya, kandi sisitemu yo kugenzura byikora nayo irashobora kugera kuri Ingaruka imwe.
4. Ishirahamwe ryo mu kirere
Imiterere yimyuka yicyumba gisukuye nikintu cyingenzi mukugirango isuku igerweho. Ifishi yumuryango uhumeka ikunze gukoreshwa mubishushanyo mbonera bigenwa hashingiwe kurwego rwisuku. Kurugero, ibyumba 300,000 byicyumba gisukuye akenshi bikoresha hejuru-kugaburira no kugaruka hejuru, ibyiciro 100000 hamwe nicyiciro 10000 cyogukora isuku mubisanzwe bikoresha umuyaga wo hejuru wo hejuru hamwe nu gice cyo hasi cyo kugaruka, kandi ubwiherero bwo murwego rwohejuru bukoresha inzira itambitse cyangwa ihagaritse .
5. Ubushyuhe n'ubukonje
Usibye ikoranabuhanga ridasanzwe, duhereye ku gushyushya, guhumeka no guhumeka, bikomeza cyane cyane ibikorwa byabakozi, ni ukuvuga ubushyuhe bukwiye nubushuhe. Mubyongeyeho, hari ibipimo byinshi bigomba kudukururira ibitekerezo, nkumuvuduko wumuyaga wambukiranya umuyaga wa tuyere, urusaku, umuvuduko wumuyaga uhuza umuyaga wa tuyere, urusaku, kumurika, hamwe nikigereranyo cyumuyaga mwiza, nibindi. Izi ngingo ntizishobora kwirengagizwa mugushushanya. tekereza.
Igishushanyo mbonera cya biofarmaceutical
Ibyumba bisukuye biologiya bigabanijwemo ibyiciro bibiri; rusange ibyumba bisukuye biologiya nibyumba bisukura umutekano wibinyabuzima. Abashakashatsi ba HVAC mubusanzwe bahura nibyambere, bigenzura cyane cyane umwanda wumukoresha nuduce duto. Ku rugero runaka, ni icyumba gisukuye mu nganda cyongera uburyo bwo kuboneza urubyaro. Ku byumba bisukuye mu nganda, mubishushanyo mbonera bya sisitemu ya HVAC, uburyo bwingenzi bwo kugenzura urwego rwisuku ni ukuyungurura nigitutu cyiza. Ku byumba bisukuye biologiya, usibye gukoresha uburyo bumwe n’ibyumba bisukuye mu nganda, birakenewe kandi gutekereza ku bijyanye n’umutekano w’ibinyabuzima. Rimwe na rimwe, birakenewe gukoresha igitutu kibi kugirango wirinde ibicuruzwa kwanduza ibidukikije.
Igihe cyo kohereza: Ukuboza-25-2023