I-Biopharmaoruticals ibhekisela kumayeza aveliswayo besebenzisa i-biotechnology, njengamalungiselelo ebhayoloji, amachiza ebhayoloji, njl. Inkqubo yokuqinisekisa umgangatho wemveliso kunye nokhuseleko. Uyilo, ukwakhiwa nokusebenza kwe-biopharmacerutical gmp igumbi lokucoca i-GMP kunye ne-GMP yokucoceka komoya, ubushushu, umahluko kunye nolawulo lwabasebenzi, izixhobo, izixhobo kunye nenkunkuma kunye nenkunkuma kunye nenkunkuma kwigumbi elicocekileyo. Kwangelo xesha, iteknoloji yegumbi elicocekileyo ecocekileyo kunye nezixhobo, ezinjenge-HOP, ishawa yomoya, iBish ecocekileyo, njl njl kuyafuneka ukuqinisekisa ukuba umgangatho womoya kunye namanqanaba amantshontsho egumbi elicocekileyo ahlangabezana neemfuno.
Uyilo lwegumbi elicocekileyo le-GMP
1. Ukucoca igumbi akunakuhlangabezana neemfuno zemveliso. Ngeeprojekthi ezintsha zegumbi elicocekileyo okanye iiprojekthi ezinkulu zegumbi lokuhlaziya, abanini zithambekele ekuqeshisweni kweziko loyilo olusesikweni. Kwiiprojekthi zegumbi elincinci neliphakathi, eziqwalasele iindleko, umniniyo uya kuthi asayine imvumelwano yenkampani yobunjineli, kunye nenkampani yobunjineli ziya kuba noxanduva lomsebenzi woyilo.
2. Ukudidanisa injongo yovavanyo lwegumbi lokucoca igumbi, uvavanyo lwegumbi lokusebenza kwegumbi elicocekileyo linyathelo eliyimfuneko lokulinganisa ukuba ngaba iimfuno zoyilo ziyafezekiswa ukuba igumbi lokusebenza lifezekisiwe (uvavanyo rhoqo) Xa kugqitywa ukwakhiwa kwegumbi elicocekileyo. Uvavanyo lolwamkelo lubandakanya amanqanaba amabini: UkuGqibezela ukuGqibezela ukuHamba nokuHlola ngokugqibeleleyo kwegumbi elihle le-HORD.
I-3. Iingxaki kwigumbi lokusebenza elicocekileyo
Umgangatho we-①air akapheleli kumgangatho
Umsebenzi we-②irbhoji
Ukulungiswa kwe-③quippy akunaxesha elifanelekileyo
Ukucoca
Ukulahla inkunkuma
I-⑥innoight yezinto zokusingqongileyo
Kukho iiparamitha ezininzi ezibalulekileyo ukuba zinikele ingqalelo xa uyilo lwegumbi elicocekileyo le-GMP.
1. Ukucoceka komoya
Ingxaki yendlela yokukhetha ngokufanelekileyo iiparameters kwindibano ye-craft. Ngokweemveliso ezahlukeneyo zobugcisa, indlela yokukhetha ngokuchanekileyo iparameter ngendlela eyiyo kuyilo. I-GMP ibeka izalathisi ezibalulekileyo, oko kukuthi, amanqanaba okucoceka komoya. Le theyibhile ilandelayo ibonisa ukuba amanqanaba okucoceka komoya okuchazwe kwi-GMP yam yelizwe le-1998: Kwangelo xesha, ngubani (i-World Heal) kunye ne-EU (i-European Union) zombini zineemfuno ezahlukeneyo zokucoceka. . Eli nqanaba lingentla libonise ngokucacileyo inani, ubukhulu, kunye nemeko yamasuntswana.
Ingabonwa ukuba ukucoceka konxibelelwano oluphakamileyo kuphantsi, kwaye ukucoceka kothuli oluphantsi kuphakamile. Inqanaba lokucoceka lomoya luyinto ephambili yokuvavanya imeko yomoya ococekileyo. Umzekelo, inqanaba lama-300,000 inqanaba livela kwinkcazo entsha yokupakisha ekhutshwe yi-ofisi yezonyango. Okwangoku ayifanelekanga ukuba isetyenziswe kwinkqubo yemveliso ephambili, kodwa isebenza kakuhle xa isetyenziswa kumagumbi amanye amagumbi ancedileyo.
I-2. Ukutshintshiselana ngomoya
Inani lotshintsho lomoya kwiNkqubo yokuPhakanyiswa koMoya ngokubanzi zizihlandlo ezi-8 ukuya kweli-10 ngeyure, ngelixa inani lotshintsho lomoya kwigumbi elicocekileyo lemizi-mveliso lilikhulu kunye namakhulu ali-12 kwinqanaba eliphezulu. Ngokucacileyo, umahluko kwinani lotshintsho lomoya lubangela umohluko omkhulu umahluko omkhulu ekusebenziseni amandla. Kuyilo, kwisiseko sendawo echanekileyo yokucoceka, amaxesha otshintshiselwano olwaneleyo lomoya kufuneka aqinisekiswe. Ngaphandle koko, iziphumo zomsebenzi aziyi kuba semgangathweni, igumbi lokuphazamiseka licocekile liya kuba lihlwempu, umthamo wokuzihlambuluka uyakomeleza ngokuhambelana, kwaye uthotho lweengxaki luya kuyicima.
3. Umahluko woxinzelelo
Kukho uthotho lweemfuno ezifana nomgama phakathi kwamagumbi acocekileyo amagumbi ahlukeneyo kunye namagumbi angacocekanga ayinakuba ngaphantsi kwe-5PA, kwaye umgama phakathi kwamagumbi acocekileyo kunye nokuphuma ngaphandle akunakuba ngaphantsi kwe-10PA. Indlela yokulawula umahluko woxinzelelo oluninzi kukubonelela ngequmrhu elithile lomoya. Izixhobo ezilungileyo zoxinzelelo eziqhele ukusetyenziswa kuyilo ziivalves zoxinzelelo, oovimba boMyiki boMbane woMbane kunye neendawo zokudabe zomoya ezifakelweyo ezifakwe kwiindawo zokubuya. Kwiminyaka yakutshanje, indlela yokufaka isixhobo soxinzelelo esifanelekileyo kodwa esenza ivolumu yomoya eninzi kunevolumu yomoya kunye nevolumu yokuthintela umoya ngexesha lokulawula idla ngokusetyenziswa kwakhona isiphumo esifanayo.
4. Umbutho womoya
Ipateni yombutho we-Airflow yegumbi elicocekileyo yinto ephambili ekuqinisekiseni inqanaba lokucoca. Umbutho woMbutho we-Airflow Fowumu uhlala kwiyilo lwangoku lugqitywe ngokusekwe kwinqanaba lokucoca. Umzekelo, iklasi igumbi elicocekileyo lihlala lisebenzisa i-oirflow yokutya okuphezulu kunye ne-100000 kunye neklasi yegumbi elicocekileyo eliphantsi kunye nendawo ecocekileyo ye-floclow kunye nendawo ecocekileyo yendawo ephantsi, kunye nokuhamba kwamanqanaba aphezulu asebenzisa ukuhamba ngokuthe tyaba okanye nkqo. .
I-5. Ubushushu kunye nokufuma
Ukongeza kwitekhnoloji ekhethekileyo, ukusuka kwimbono yendlela yokufudumeza, umoya ovuthuzayo kunye nemeko yomoya, oko kukuthi, ubushushu obufanelekileyo kunye nokufuma ngokufanelekileyo kunye nokufuma ngokufanelekileyo kunye nokufuma ngokufanelekileyo. Ukongeza, zininzi izikhombisi ezifanele zitsalele ingqalelo yethu, njengesantya somoya esinecandelo le-Tuyeyere, ingxolo, isantya somoya esinqamlezayo se-Tuyeyere, ingxolo, kunye nomyinge wevolumu yomoya omtsha, njl njl. qwalasela.
Uyilo lwegumbi lokucoca i-biopharmacetutical
Amagumbi acocekileyo ebhayoloji ikakhulu ahlulwe ngokwamanqanaba amabini; Amagumbi acocekileyo acocekileyo acocekileyo kunye namagumbi ococeko olucocekileyo. Abayili beenjini ye-HVAC zihlala zivezwa kuye ngaphambili, elawula ubutshijolo bomsebenzi ngamasuntswana aphilayo. Ukuya kuthi ga kwinqanaba elithile, ligumbi elicocekileyo lemizi-mveliso elongeza iinkqubo zokutsala. Kwigumbi lokucoca amashishini, ngoyilo lobungcali lwenkqubo ye-HVAC, indlela ebalulekileyo yokulawula inqanaba lokucoca i-slight kunye nengcinezelo efanelekileyo. Kumagumbi acocekileyo, ukongeza ekusebenziseni iindlela ezifanayo njengeendawo zokucoca amashishini, kuyayimfuneko ukuqwalasela umcimbi wento yendalo. Ngamanye amaxesha kuyimfuneko ukusebenzisa uxinzelelo olubi ukuthintela iimveliso ukuba zingcolise indalo esingqongileyo.
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