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Ukuhlanganisa I-GMP Ngamathuluzi Okukhokha Kwamathuluzi Okuhlelwa Kwesikhathi Esifanayo
Kubamabiliwe abalwamisa izinto zokuphila nezinkambo zokuzalisa izinto zokuphila, izimo zemvelo kusuka kwezindawo zokucleaniza azikwazi ukuba yizinto yokuthanda kuphela; kuyinto esebenzisa ukuthi iproduct ephakathi yezinye i-sterile ibe yilokho okuhle nokusebenza kahle. Isilinganiso sesandla, isilinganiso sesandla sokusha, nesilinganiso sezinto ezihlukene zokusha kufanele kubekwe ngokuphelele kwezilinganiso ezikhazimulayo, ezisayensi, ukuze kuvunyelwe ubukhulu nobukhulu bezinto zokuphila zokuphakathi. Izinhlanganiswano zokulawula njenge-FDA yaseMericana ne-European Medicines Agency zasetha izinhlangano ezikhazimulayo ezithile okufanele kuzweleke ngazo lezi zindawo. Ukufumana ukuthi kufanele kwenziwa ngokuphelele kungafana nokuqala ukubeka isistimu yesandla nesandla sokusha (HVAC). Kufanele kubekwe isistimu esiphathelene nomkhosi wokulwa kwamakhanda okwenzeka ngokuphelele, okudinga ukuthi kwenziwe ukubhalwa kwezindawo, ukubhalwa kwezindawo zokujabulisa, nokubhalwa kwezindawo zokubonisa ukuthi kwenziwe ngokuphelele. Ukuzwa izinhlangano zokulawula, izilinganiso zokugcinwa, nokuthi kufanele kwenziwe ngokuphelele ukuthi kwenziwe ngokuphelele kuyisisekelo sokuthi isifundo sasendaweni sokuthi kwenziwe ngokuphelele kanye nokuthi kwenziwe ngokuphelele ukuthi kwenziwe ngokuphelele.
Amathuba okukhokha kwemithombo yokuqinisa ukulawula kwezinhlu
Umbono wokugcina imithwalo yezinye zezindaba zokulawula umhlaba kuzalwa kwezilimi zokuphatha izilimi zokubhala amasiko. Kwi-United States, i-FDA ibiza ukuthi izindawo ziyakwamukela izimo ezinokuvimba ukuthi kuzalwe ukungcoliswa okungakwazi ukuthintela ubuhle bokushaya. Lokhu kuchazwa ngokucacile ngamasiko amanqinisekile okuchaza izidingo zokulawula isikhathi, ubunzima bekhanda nezinhlobo zezinto ezingaphansi kwamagama. Kwe-Europe, izidingo ziyisibonelo esincane kakhulu. I-EU GMP Annex 1, eyasebenza kwezilimi ezinamagama, ibiza ukuthi kufanele kwenziwe umthwalo wokulawula ukungcoliswa. Lokhu kufanele kube nesibonelo sokulinganisa umbono wokuthinteka nokuthuthukiswa ngokusebenzisa iziphumo zokulinganisa. Lokhu kuchaza izihlobo ezincane zokulawula isikhathi ne-ubunzima bekhanda. Lezi zihlobo zizichazwa ukuze zivimbe ukuthuthukiswa kwezinhlobo zezinto ezinkulu nezifuna ukuthi zingavimbi izilimi ezinamagama. Ukungcoliswa kwezinto ezingaphansi kwamagama kulawulwa ngokusebenzisa ukuthi kushekelwe ngokuphelele (HEPA), izihlobo zokuguqula amagama okwenzeka, nezihlobo zokulinganisa ukuthi amagama ayoflowa kusuka emaphakathini amahle kumaqondana amancane.
Ukuqonda Imithambo Yokuhlinzeka Kwemikhumbi Yokuhlola
Ubukhulu bekuphakanyiswa kwezinkinga zokulawula izinyathelo zokulawula umhlaba ozidingekayo kubhekwa ngokulinganisa kwakho. Isistimu sokulinganisa ISO 14644-1 sibhekisela ubukhulu bekuphakanyiswa kwezinkinga zokulawula ngokulinganisa kwezinkinga zokuphakanyiswa kwezinto ezingaphakathi kwezinye zezinyathelo zokulawula. Lezi zilinganiso zihambisana ngqo nezilinganiso zase-EU GMP Annex 1, ezibhekisela kuma-Grade A kuya kuma-Grade D. I-Grade A ibhekisa ekhaya elikhulu kakhulu, elingana ne-ISO 5 lapho isikhathi esilungile. Kule ndawo, ukuphakanyiswa kwezinkinga kufanele kubhekwe ngokuchaza kakhulu futhi kubhalwe ngokuphakanyiswa kahle. Ukugxila phakathi kwezimo zokuhlala ngaphandle kwezinye zezinkinga nokuhlala ngaphandle kwezinye zezinkinga kuyizindlela ezinkulu kuzokwenza ukulinganisa kwezinye zezinkinga. Ukulinganisa okuhlala ngaphandle kwezinye zezinkinga kufana noma isikhathi esilungile, noma kunezinye zezinkinga ezilungile, futhi kubonisa ukuthi izinye zezinkinga ziyakwazi ukufikwa kwezinkinga zokulinganisa. Ukulinganisa okuhlala ngaphandle kwezinye zezinkinga kufana noma kunezinye zezinkinga zokusebenza ngokuphelele, noma kunezinye zezinkinga zokusebenza ngokuphelele. Ukulinganisa okuhlala ngaphandle kwezinye zezinkinga kuyizindlela ezinkulu zokulinganisa ukuthi izinye zezinkinga ziyakwazi ukufikwa kwezinkinga zokulinganisa, ngoba kubonisa ukuthi kunezinkinga zokuphakanyiswa kwezinye zezinkinga zokusebenza.
Umlingelwane we-HVAC kubukhokho bekuphatha ukuthi kungcono
Isistemu se-HVAC yilungelo lokugcina phakathi lwesikhumba esihlanu. Iyasebenza ukuthumela amafutha okunqamuka, okufilta ngokuphelele, ngokulinganisa okuhlanganisa nokuphakanyiswa kuzo zonke izindawo ezitholakala. Ukudesigna kwe-HVAC kufanele kusisupporta izinkinga zezindawo zonke. Isibonelo, indawo yegreidi B, eyayisibopho sesikhumba segreidi A sokuthumela amafutha, ikhuluma ngokuphakanyiswa kwezinhlobo zemifutha ukuze kuvulekwe ngokushesha nokususa izinto ezingaphansi kwamafutha. Isistemu kufanele kakhulu kubeka isikhundla sokuphakanyiswa kwezindawo zokuhlukanisa ukuze kubhekwe ukuthi amafutha ayedlula kusukela kwezindawo eziningi kwezindawo ezingafani. Lokhu kukhokho lokubhekisa ukuthi kungabikho ukuthi kubizwa kwezinye izindawo. Izistemu zesikhumba se-HVAC zasemthwakini zisebenzisa amafan ye-variable-speed nezindawo zokuvimbela ngokuzenzakalelayo ukuze zibekiswe lezi zinkinga. Uma ubisi buvulwa, isistemu iyakwakha ngokushesha ukuthumela amafutha ukuze kubekwe isikhundla sokuphakanyiswa.
Ukuthi Kuyisiphi Sembili Sokubhalwa Kwesilinganiso Sekhaya
Ukubheka phakathi kwesikhathi esifanayo kuyisidingo esingasolwanga ekufundzeni kwe-GMP. Ikhaya kufanele libheke amaphartikili e-“viable” ne-“non-viable”, isilinganiso sesandla, isilinganiso sesigwili, kunye nesiphumela sezimboni zokuphakamisa ngokugcwele. Amaphartikili okukhomba amakhompyutha (optical particle counters) abekwe kwezindawo eziningi ukuthuma izinombolo zamaphartikili ngamazikhathi athiwe. Amasampula okususa amahlobo amahle (active air samplers) ayisebenzisa ukususa amasampula amahle, okwamanje akhululeka ukuthola ukuthi kukhona izinkumbulo zokuhlanganisa (colony-forming units). Lonke lokhu udatha kufanele kusungulwa, kubekwe isikhathi sokusungulwa, kunye nokugcinwa emfashini yokuqondisa enobuchwepheshe. Isistimu kufanele kunezinhloso zokusha izimboni zokusha (alarm functionality) okuzosha abasebenzi ngokwedlulela uma inani elithile livela kwezinhloso zalo. Lokhu udatha lusebenza ngendlela yezimbili. Lunceda ekuboniseni ukuthi kwenziwe ukuthi kufanele kwenziwe ngokwemilayoni yokuqondisa, futhi lunceda ukuphatha ubuchwepheshe ngokweminye yezindlela. Ngokuchazela izintandabuzo zokubheka udatha, ikhaya liyakwazi ukubona izinkinga ezingafika kuqala ngaphambi kokuba zibe yizinkinga ezingavumelekile okanye yisibizo esingafanele.
Ukugxeka Udatha Lokubheka Ngesistimu Yobuchwepheshe
Ukuqiniseka kwempilo yomthwakazi wokubhekisa izinhlanhla kuyafika uma kuhlanganiswa nesistimu yokuphatha ubunzima besifundo esikhulu sesifundaziko. Uma izinombolo zezinkumbi, iziphetho zokulwa kwezinsizakwane, nezindlela zokuthi amandla ayapha kufuna ngokuzenzakalelayo ku-sistimu yokuphatha ubunzima, isibopho sokuchaza izidata ngendlela eyenziwe ngumuntu sivamekile. Lokhu kuvumela ukuthi izirabiso zihlanganiswe ngokuzenzakalelayo. Ukuchaza izinto ezithile nokubhalisa izinto ezingaphansi kwezilinganiso zingahlanganiswa ngokuthanda, ukubika isithembiso esihlukene sokubhekisa izinhlanhla. Uma kusakala isimo esingaphansi kwezilinganiso, isistimu singathatha indlela eyenzekile ngokuzenzakalelayo yokuhlola. Izidata zihlanganiswa futhi nezincwadi zebhacu, ukwenza umthwakazi wokuphatha ubunzima wokusha okwenzekile ngokuzenzakalelayo. Lokhu kubhekisa izinhlanhla ngokuzenzakalelayo kubuyisa ukubhekisa izinhlanhla kusukela ekubeni kuyisibopho sokubona ukuthi kusebenza ngokuphelele kuye kusukela ekubeni kuyisibopho sokubona ukuthi kuyasebenza ngokuzenzakalelayo.
Ukuqiniseka nokubuyisa ngokuzenzakalelayo ukuthi kuyasebenza
Ukufaka isisifundo se-HVAC sokugcina indawo esihle akuyi phakathi yokuphela kwezindlela zokuvumela. Isisifundo kufanele sivunywe ngokuthembekile ngendlela eyenzelwe ukubonisa ukuthi isisifundo sisebenza njani. Le ndlela, eyibizwa ngokuthi IQ/OQ/PQ, inamaphaza amathathu. Ukuvunywa Kwesifundo Kufaka kubonisa ukuthi izinkambo nezinkambo zezinkimba zisafakwe ngokwesiqondiso sesifundo. Ukuvunywa Kwesifundo Lokusebenza kusenza izimini eziningi zokuziphatha kwise sisifundo ngokwesilinganiso sakho sokusebenza, kungakhathalisi ekhaya lokusebenza okuphezulu nokuphezulu kwesilinganiso sokuchitha nokuchitha. Ukuvunywa Kwesifundo Lokusebenza kubonisa ukuthi isisifundo singasebenza ngokuthembekile ngokwesikhathi sokuziphatha kwezinhlangano zokusebenza. Le ndlela yokuvunywa kufanele kwenziwe kabusha ngokuphathelene nesikhathi ukuze kubonakale ukuthi isisifundo sisebenza ngokuthembekile. Le ndlela yokuvunywa kabusha kubonisa ukuthi izinhlaka zokulawula izimo ziyisisekelo esihle futhi siyasebenza ngokuthembekile ngokuphathelene nesikhathi.
Ukuthi Ukusebenza Ngokuthembekile Kusivumela Kanjani Ukuvumela KwesiGMP
Ukuqiniseka kwesistimu yomthwalo wokuphatha amafutha esiklina rume kubona ukuthi kuyasebenza ngokulinganisa nezinkinga zokusebenza ngokuzimisela (GMP) kuyisisekelo esiphakathi kwezinkulungwane zokukhiqiza nokuhlela. Ukuphepha kwezinkampani zokuvula, ukubaluleka kwebhilethi yokuqala kwezinhlobo zokuhlola ukusuka emaphetheni, nokufihla kwezikhumba zokuhlola kwe-HEPA zonke ziyagcina ukuthi isistimu iyasebenza ngokuphelele ngeminyaka. Abakhi abayiqiniseka ngokusebenzisa izindlela zokukhiqiza eziphathelene nezinkinga zokusebenza ezithile njenge-ISO 9001, bayaqhubeka nokuhlola ngokuphelele kwesikhumba phambi kokuthunywa. Bayasebenzisa izinto ezinkulu zokukhiqiza nokusebenzisa izindlela zokukhiqiza eziphelele ukuze bavume ukuthi izikhumba ziyasebenza ngokuphelele ngeminyaka. Kusukela ekubeni umphathi wekhaya uyasebenzisa isiklina rume ukuze akhiwe izinto ezingcono kwezintlungo, ukuxhumana nomkhiqiza owenziwe ngokuphelele nokubaluleka kwezinkulungwane kuyenza ukuthi umphathi aqiniseke ukuthi isistimu yokuphatha imvelo iyasebenza ngokulinganisa nezinkinga zokusebenza zezindaba zokugcina izintlungo.