Ii-Biopharmaceuticals zibhekisa kumayeza aveliswe kusetyenziswa i-biotechnology, afana namalungiselelo ebhayoloji, iimveliso zebhayoloji, amayeza ebhayoloji, njl. Njengoko ubunyulu, umsebenzi kunye nokuzinza kwemveliso kufuneka kuqinisekiswe ngexesha lokuveliswa kwe-biopharmaceuticals, iteknoloji yegumbi elicocekileyo kufuneka isetyenziswe kwinkqubo yemveliso ukuqinisekisa umgangatho kunye nokhuseleko lwemveliso. Uyilo, ukwakhiwa kunye nokusebenza kwegumbi elicocekileyo le-biopharmaceutical GMP kufuna ukuthotyelwa ngokungqongqo kweenkcukacha ze-GMP, kubandakanya ulawulo lokucoceka komoya kwigumbi elicocekileyo, ubushushu, ukufuma, umahluko woxinzelelo kunye nezinye iiparameter, kunye nolawulo lwabasebenzi, izixhobo, izixhobo kunye nenkunkuma kwigumbi elicocekileyo. Kwangaxeshanye, ubuchwepheshe obuphambili begumbi elicocekileyo kunye nezixhobo, ezifana nesihluzi se-hepa, ishawa yomoya, ibhentshi ecocekileyo, njl. nazo ziyafuneka ukuqinisekisa ukuba umgangatho womoya kunye namanqanaba eentsholongwane kwigumbi elicocekileyo ayahlangabezana neemfuno.
Uyilo lwegumbi lokucoca amayeza le-gmp
1. Uyilo lwegumbi elicocekileyo alunakwanelisa iimfuno zokwenyani zemveliso. Kwiiprojekthi ezintsha zegumbi elicocekileyo okanye kwiiprojekthi ezinkulu zokuhlaziya amagumbi acocekileyo, abanini badla ngokuqesha amaziko oyilo asemthethweni ukuze bayile. Kwiiprojekthi zegumbi elicocekileyo elincinci neliphakathi, kujongwa iindleko, umnini uhlala esayina isivumelwano nenkampani yobunjineli, kwaye inkampani yobunjineli iya kuba noxanduva lomsebenzi woyilo.
2. Ukuze kudideke injongo yovavanyo lwegumbi elicocekileyo, uvavanyo lokusebenza kwegumbi elicocekileyo kunye nomsebenzi wovavanyo linyathelo elifunekayo kakhulu lokulinganisa ukuba iimfuno zoyilo ziyafezekiswa na (uvavanyo lokwamkelwa) kunye nokuqinisekisa imeko yokusebenza eqhelekileyo yegumbi elicocekileyo (uvavanyo oluqhelekileyo) xa ulwakhiwo lwegumbi elicocekileyo lugqityiwe. Uvavanyo lokwamkelwa luquka amanqanaba amabini: ukugqitywa kokugunyaziswa kunye novavanyo olupheleleyo lokusebenza okubanzi kwegumbi elicocekileyo.
3. Iingxaki ekusebenzeni kwegumbi elicocekileyo
①Umgangatho womoya awukho semgangathweni
②Ukusebenza kwabasebenzi ngokungacwangciswanga
③Ukugcinwa kwezixhobo akufikeleli ngexesha elifanelekileyo
④Ukucoca okungaphelelanga
⑤Ukulahlwa kwenkunkuma okungafanelekanga
⑥Impembelelo yezinto ezisingqongileyo
Kukho iiparameter ezibalulekileyo ekufuneka ziqwalaselwe xa kusenziwa uyilo lwegumbi lokucoca amayeza le-GMP.
1. Ucoceko lomoya
Ingxaki yokuba ungayikhetha njani ngokuchanekileyo iparameters kwindawo yokusebenzela yemveliso yobugcisa. Ngokweemveliso ezahlukeneyo zobugcisa, indlela yokukhetha ngokuchanekileyo iparameters yoyilo yingxaki ebalulekileyo kuyilo. I-GMP ibeka phambili izalathisi ezibalulekileyo, oko kukuthi, amanqanaba okucoceka komoya. Le theyibhile ilandelayo ibonisa amanqanaba okucoceka komoya achazwe kwi-GMP yelizwe lam ka-1998: Kwangaxeshanye, i-WHO (i-World Health Organization) kunye ne-EU (i-European Union) zombini zinemfuno ezahlukeneyo zamanqanaba okucoceka. . Amanqanaba angentla abonise ngokucacileyo inani, ubungakanani, kunye nemeko yamasuntswana.
Kuyabonakala ukuba ucoceko lothuli oluphezulu luphantsi, kwaye ucoceko lothuli oluphantsi luphezulu. Inqanaba lokucoceka komoya luphawu oluphambili lokuvavanya imeko-bume yomoya ococekileyo. Umzekelo, umgangatho wamanqanaba angama-300,000 uvela kwinkcazo entsha yokupakisha ekhutshwe yiMedical Bureau. Okwangoku akufanelekanga ukusetyenziswa kwinkqubo yemveliso ephambili, kodwa isebenza kakuhle xa isetyenziswa kumagumbi athile ancedisayo.
2. Utshintshiselwano lomoya
Inani lotshintsho lomoya kwinkqubo yomoya jikelele liphindwe ka-8 ukuya ku-10 ngeyure, ngelixa inani lotshintsho lomoya kwigumbi elicocekileyo lemizi-mveliso liphindwe ka-12 kwinqanaba eliphantsi kwaye amaxesha amaninzi kwinqanaba eliphezulu. Ngokucacileyo, umahluko kwinani lotshintsho lomoya ubangela umthamo womoya Umahluko omkhulu ekusetyenzisweni kwamandla. Kuyilo, ngokusekelwe kwindawo echanekileyo yococeko, amaxesha otshintshiselwano lomoya aneleyo kufuneka aqinisekiswe. Ngaphandle koko, iziphumo zokusebenza aziyi kufikelela kwinqanaba eliqhelekileyo, amandla okulwa nokuphazamiseka kwegumbi elicocekileyo aya kuba mancinci, amandla okuzicoca ngokwawo aya kwandiswe ngokufanayo, kwaye uthotho lweengxaki luya kudlula inzuzo.
3. Umahluko woxinzelelo oluqinileyo
Kukho uthotho lweemfuno ezifana nomgama phakathi kwamagumbi acocekileyo amanqanaba ahlukeneyo kunye namagumbi angacocekanga awanakubakho ngaphantsi kwe-5Pa, kwaye umgama phakathi kwamagumbi acocekileyo nangaphandle awanakubakho ngaphantsi kwe-10Pa. Indlela yokulawula umahluko woxinzelelo oluzinzileyo ikakhulu kukubonelela ngomthamo othile womoya oxinzelelo oluchanekileyo. Izixhobo zoxinzelelo oluchanekileyo ezisetyenziswa rhoqo kuyilo ziivalvu zoxinzelelo ezisele, iilawuli zombane zoxinzelelo oluhlukileyo kunye neeleya zomoya ezifakelwe kwiindawo zomoya ezibuyayo. Kwiminyaka yakutshanje, indlela yokungafaki isixhobo soxinzelelo oluchanekileyo kodwa ukwenza umthamo womoya obonelelwayo ube mkhulu kunomthamo womoya obuyayo kunye nomthamo womoya ophumayo ngexesha lokuqaliswa kokuqala idla ngokusetyenziswa kuyilo, kwaye inkqubo yolawulo oluzenzekelayo ehambelanayo nayo inokufezekisa isiphumo esifanayo.
4. Umbutho wokuhamba komoya
Ipateni yolungiselelo lokuhamba komoya kwigumbi elicocekileyo yinto ebalulekileyo ekuqinisekiseni inqanaba lokucoceka. Uhlobo lolungiselelo lokuhamba komoya oludla ngokusetyenziswa kuyilo lwangoku lumiselwa ngokusekelwe kwinqanaba lokucoceka. Umzekelo, igumbi elicocekileyo leklasi yama-300,000 lidla ngokusebenzisa ukutyiwa komoya okuphezulu kunye nokubuya komoya okuphezulu, uyilo lweklasi ye-100000 kunye neklasi ye-10000 ludla ngokusebenzisa ukugeleza komoya okuphezulu kunye nokubuya komoya okusezantsi, kwaye amagumbi acocekileyo aphezulu asebenzisa ukugeleza okuthe tye okanye okuthe nkqo.
5. Ubushushu kunye nokufuma
Ukongeza kwitekhnoloji ekhethekileyo, ngokwembono yokufudumeza, ukuphefumla kunye ne-air conditioning, igcina intuthuzelo yomqhubi, oko kukuthi, ubushushu obufanelekileyo kunye nokufuma. Ukongeza, kukho izalathisi ezininzi ekufuneka zitsale ingqalelo yethu, ezifana nesantya somoya esinqamlezileyo se-duct ye-tuyere, ingxolo, isantya somoya esinqamlezileyo se-duct ye-tuyere, ingxolo, ukukhanya, kunye nomlinganiselo womthamo womoya omtsha, njl. Ezi nkalo azinakungahoywa kuyilo. cinga.
Uyilo lwegumbi elicocekileyo le-biopharmaceutical
Amagumbi acocekileyo ngokwebhayoloji ahlulwe kakhulu abe ngamacandelo amabini; amagumbi acocekileyo ngokwebhayoloji kunye namagumbi acocekileyo ngokwebhayoloji. Abayili beenjineli ze-HVAC badla ngokuchatshazelwa yile yokuqala, elawula kakhulu ungcoliseko lwabaqhubi ngamasuntswana aphilayo. Ukuya kwinqanaba elithile, ligumbi elicocekileyo lemizi-mveliso elongeza iinkqubo zokubulala iintsholongwane. Kumagumbi acocekileyo kwimizi-mveliso, kuyilo lobungcali lwenkqubo ye-HVAC, indlela ebalulekileyo yokulawula inqanaba lococeko kukucoca kunye noxinzelelo oluhle. Kumagumbi acocekileyo ngokwebhayoloji, ukongeza ekusebenziseni iindlela ezifanayo namagumbi acocekileyo kwimizi-mveliso, kuyafuneka ukuba kuqwalaselwe ukhuseleko lwebhayoloji. Ngamanye amaxesha kuyimfuneko ukusebenzisa uxinzelelo olubi ukuthintela iimveliso ekungcoliseni okusingqongileyo.
Ixesha lokuthumela: Disemba-25-2023