I-Biopharmaceuticals ibhekisela emithini ekhiqizwa kusetshenziswa i-biotechnology, njengezinto eziphilayo ezilungiselelwe, imikhiqizo yezinto eziphilayo, imithi yezinto eziphilayo, njll. Njengoba ubumsulwa, umsebenzi kanye nokuzinza komkhiqizo kudingeka kuqinisekiswe ngesikhathi sokukhiqizwa kwe-biopharmaceuticals, ubuchwepheshe begumbi elihlanzekile kudingeka busetshenziswe enqubweni yokukhiqiza ukuqinisekisa ikhwalithi nokuphepha komkhiqizo. Umklamo, ukwakhiwa kanye nokusebenza kwegumbi elihlanzekile le-biopharmaceutical GMP kudinga ukuhambisana ngokuqinile nemininingwane ye-GMP, okuhlanganisa nokulawulwa kokuhlanzeka komoya wegumbi elihlanzekile, izinga lokushisa, umswakama, umehluko wokucindezela kanye neminye imingcele, kanye nokuphathwa kwabasebenzi, imishini, izinto zokwakha kanye nemfucuza ekamelweni elihlanzekile. Ngesikhathi esifanayo, ubuchwepheshe obuthuthukisiwe begumbi elihlanzekile kanye nemishini, njengesihlungi se-hepa, ishawa yomoya, ibhentshi elihlanzekile, njll. nakho kuyadingeka ukuqinisekisa ukuthi ikhwalithi yomoya kanye namazinga e-microbial ekamelweni elihlanzekile ahlangabezana nezidingo.
Umklamo wegumbi lokuhlanza lemithi le-gmp
1. Ukwakhiwa kwegumbi elihlanzekile akukwazi ukuhlangabezana nezidingo zangempela zokukhiqiza. Kumaphrojekthi amasha egumbi elihlanzekile noma amaphrojekthi amakhulu okuvuselela amakamelo ahlanzekile, abanikazi bavame ukuqasha izikhungo zokuklama ezisemthethweni ukuze ziklame. Kumaphrojekthi amancane naphakathi ahlanzekile amakamelo, uma kucatshangelwa izindleko, umnikazi uvame ukusayina inkontileka nenkampani yobunjiniyela, kanti inkampani yobunjiniyela izoba nesibopho somsebenzi wokuklama.
2. Ukuze kudidaniswe injongo yokuhlolwa kwegumbi elihlanzekile, ukuhlolwa kokusebenza kwegumbi elihlanzekile kanye nomsebenzi wokuhlola kuyisinyathelo esibaluleke kakhulu sokulinganisa ukuthi izidingo zokuklama ziyahlangatshezwana yini (ukuhlolwa kokwamukelwa) kanye nokuqinisekisa isimo esijwayelekile sokusebenza segumbi elihlanzekile (ukuhlolwa okuvamile) lapho ukwakhiwa kwegumbi elihlanzekile sekuqediwe. Ukuhlolwa kokwamukelwa kufaka phakathi izigaba ezimbili: ukuqedwa kokusebenza kanye nokuhlolwa okuphelele kokusebenza okuphelele kwegumbi elihlanzekile.
3. Izinkinga ekusebenzeni kwegumbi elihlanzekile
①Ikhwalithi yomoya ayifiki ezingeni elijwayelekile
②Ukusebenza kwabasebenzi okungajwayelekile
③Ukulungiswa kwemishini akusesikhathini
④Ukuhlanza okungaphelele
⑤Ukulahlwa kwemfucuza okungalungile
⑥Ithonya lezici zemvelo
Kunemingcele embalwa ebalulekile okufanele uyinake lapho uklama igumbi lokuhlanza imithi le-GMP.
1. Ukuhlanzeka komoya
Inkinga yokuthi ungazikhetha kanjani kahle imingcele endaweni yokusebenzela yemikhiqizo yobuciko. Ngokusho kwemikhiqizo yobuciko ehlukene, indlela yokukhetha kahle imingcele yokuklama iyinkinga eyisisekelo ekuklanyweni. I-GMP ibeka phambili izinkomba ezibalulekile, okungukuthi, amazinga okuhlanzeka komoya. Ithebula elilandelayo likhombisa amazinga okuhlanzeka komoya achazwe ku-GMP yezwe lami ka-1998: Ngesikhathi esifanayo, i-WHO (World Health Organization) kanye ne-EU (European Union) zombili zinezidingo ezahlukene zamazinga okuhlanzeka. . Amazinga angenhla abonise ngokucacile inani, usayizi, kanye nesimo sezinhlayiya.
Kungabonakala ukuthi ukuhlanzeka kothuli oluningi kuphansi, kanti ukuhlanzeka kothuli oluncane kuphezulu. Izinga lokuhlanzeka komoya liyisibonakaliso esiyinhloko sokuhlola indawo yomoya ohlanzekile. Isibonelo, indinganiso enamazinga angu-300,000 ivela ekucacisweni okusha kokupakisha okukhishwe yi-Medical Bureau. Okwamanje akufaneleki ukusetshenziswa enqubweni yomkhiqizo oyinhloko, kodwa isebenza kahle uma isetshenziswa kwamanye amakamelo asekelayo.
2. Ukushintshana komoya
Inani lokushintsha komoya ohlelweni olujwayelekile lokupholisa umoya liyizikhathi ezingu-8 kuya kwezingu-10 ngehora, kuyilapho inani lokushintsha komoya ekamelweni elihlanzekile lezimboni liyizikhathi ezingu-12 ezingeni eliphansi kakhulu kanye nezikhathi ezingamakhulu eziningana ezingeni eliphezulu kakhulu. Ngokusobala, umehluko enanini lokushintsha komoya ubangela ivolumu yomoya Umehluko omkhulu ekusetshenzisweni kwamandla. Ekwakhiweni, ngokusekelwe ekubekweni okunembile kokuhlanzeka, izikhathi zokushintshana komoya ezanele kumele ziqinisekiswe. Ngaphandle kwalokho, imiphumela yokusebenza ngeke ifinyelele ezingeni elijwayelekile, ikhono lokuvimbela ukuphazamiseka kwegumbi elihlanzekile lizoba libi, amandla okuzihlanza azokwelulwa ngokufanayo, futhi uchungechunge lwezinkinga luzodlula izinzuzo.
3. Umehluko wengcindezi eqinile
Kunezidingo eziningi ezifana nebanga eliphakathi kwamakamelo ahlanzekile anamazinga ahlukene kanye namakamelo angahlanzekile awakwazi ukuba ngaphansi kwama-5Pa, kanti ibanga eliphakathi kwamakamelo ahlanzekile nangaphandle alikwazi ukuba ngaphansi kwama-10Pa. Indlela yokulawula umehluko wengcindezi engaguquki ngokuyinhloko ukunikeza ivolumu ethile yomoya ocindezelekile. Amadivayisi okucindezela okuhle avame ukusetshenziswa ekwakhiweni ama-valve okucindezela asele, izilawuli zomoya kagesi ezicindezelayo ezihlukile kanye nezendlalelo zokunciphisa umoya ezifakwe ezindaweni zomoya ezibuyayo. Eminyakeni yamuva nje, indlela yokungafaki idivayisi yokucindezela okuhle kodwa ukwenza ivolumu yomoya ophakelwayo ibe nkulu kunevolumu yomoya obuyayo kanye nevolumu yomoya okhiphayo ngesikhathi sokuqala ivame ukusetshenziswa ekwakhiweni, futhi uhlelo lokulawula oluzenzakalelayo oluhambisanayo lungaphinde lufinyelele umphumela ofanayo.
4. Inhlangano yokuhamba komoya
Iphethini yokuhlela ukuhamba komoya kwegumbi elihlanzekile iyisici esibalulekile ekuqinisekiseni izinga lokuhlanzeka. Ifomu lokuhlela ukuhamba komoya elivame ukusetshenziswa ekwakhiweni kwamanje linqunywa ngokusekelwe ezingeni lokuhlanzeka. Isibonelo, igumbi elihlanzekile lekilasi 300,000 livame ukusebenzisa ukugeleza komoya okuphezulu nokubuyisela okuphezulu, imiklamo yekilasi 100000 kanye nekilasi 10000 ivame ukusebenzisa ukugeleza komoya okuphezulu nokubuyisela phansi, kanti amakamelo ahlanzekile aphezulu asebenzisa ukugeleza okuvundlile noma okuqondile okuqondile.
5. Izinga lokushisa kanye nomswakama
Ngaphezu kobuchwepheshe obukhethekile, ngokombono wokushisa, ukupholisa umoya kanye nokupholisa umoya, igcina induduzo yomqhubi, okungukuthi, izinga lokushisa elifanele kanye nomswakama. Ngaphezu kwalokho, kunezinkomba eziningana okufanele zidonse ukunaka kwethu, njengejubane lomoya eliwela ingxenye yepayipi le-tuyere, umsindo, ijubane lomoya eliwela ingxenye yepayipi le-tuyere, umsindo, ukukhanya, kanye nesilinganiso somthamo womoya omusha, njll. Lezi zici azinakwa ekwakhiweni. Cabanga.
Umklamo wegumbi lokuhlanza le-biopharmaceutical
Amakamelo ahlanzekile ezinto eziphilayo ahlukaniswe kakhulu ngezigaba ezimbili; amakamelo ahlanzekile ezinto eziphilayo kanye namakamelo ahlanzekile okuphepha ezinto eziphilayo. Abaklami bobunjiniyela be-HVAC bavame ukuchayeka kulokho kokuqala, okulawula kakhulu ukungcola komqhubi yizinhlayiya eziphilayo. Ngezinga elithile, kuyigumbi elihlanzekile lezimboni elengeza izinqubo zokubulala izinambuzane. Kumakamelo ahlanzekile ezimbonini, ekwakhiweni kobuchwepheshe bohlelo lwe-HVAC, indlela ebalulekile yokulawula izinga lokuhlanzeka iwukuhlunga kanye nokucindezela okuhle. Kumakamelo ahlanzekile ezinto eziphilayo, ngaphezu kokusebenzisa izindlela ezifanayo namakamelo ahlanzekile ezimbonini, kuyadingeka futhi ukucabangela isici sokuphepha sezinto eziphilayo. Ngezinye izikhathi kuyadingeka ukusebenzisa ingcindezi engemihle ukuvimbela imikhiqizo ekungcoliseni imvelo.
Isikhathi sokuthunyelwe: Disemba-25-2023