Kusukela yasungulwa ngo-1992, i-"Good Manufacturing Practice for Drugs" (GMP) embonini yezemithi yaseShayina iye yaqashelwa, yamukelwa, futhi yasetshenziswa kancane kancane yizinkampani zokukhiqiza imithi. I-GMP iyinqubomgomo kazwelonke ephoqelekile yamabhizinisi, futhi amabhizinisi ahluleka ukuhlangabezana nezidingo ngaphakathi komkhawulo wesikhathi esibekiwe azoyeka ukukhiqiza.
Okuqukethwe okuyinhloko kwesitifiketi se-GMP ukulawula ukuphathwa kwekhwalithi kokukhiqizwa kwezidakamizwa. Okuqukethwe kwayo kungafingqwa zibe izingxenye ezimbili: ukuphathwa kwesofthiwe kanye nezinsiza zehadiwe. Isakhiwo segumbi elihlanzekile singenye yezingxenye ezinkulu zokutshalwa kwezimali ezindaweni zehadiwe. Ngemva kokuqedwa kwesakhiwo segumbi elihlanzekile, ukuthi singafinyelela yini imigomo yokuklama futhi sihlangabezane nezidingo ze-GMP kumele kuqinisekiswe ngokuhlolwa.
Ngesikhathi sokuhlolwa kwegumbi elihlanzekile, abanye babo bahlulekile ukuhlolwa kokuhlanzeka, abanye babesendaweni efektri, kanti abanye babeyiphrojekthi yonke. Uma ukuhlolwa kungafaneleki, yize bobabili izinhlangothi befeze izidingo ngokulungiswa, ukulungisa amaphutha, ukuhlanza, njll., kuvame ukuchitha amandla amaningi kanye nezinsizakusebenza, kubambezele isikhathi sokwakha, futhi kubambezele inqubo yokuqinisekiswa kwe-GMP. Ezinye izizathu kanye namaphutha kungagwenywa ngaphambi kokuhlolwa. Emsebenzini wethu wangempela, sithole ukuthi izizathu eziyinhloko kanye nezinyathelo zokuthuthukisa ukuhlanzeka okungafaneleki kanye nokwehluleka kwe-GMP zifaka:
1. Umklamo wobunjiniyela ongenangqondo
Lesi simo asivamile, ikakhulukazi ekwakhiweni kwamakamelo amancane ahlanzekile anezidingo eziphansi zokuhlanzeka. Umncintiswano wobunjiniyela bamakamelo ahlanzekile usukhulu kakhulu manje, futhi amanye amayunithi okwakha anikeze izingcaphuno eziphansi kumabhidi awo ukuze kutholakale iphrojekthi. Esigabeni sokugcina sokwakha, amanye amayunithi asetshenziswa ukunciphisa amakhona nokusebenzisa amayunithi omoya opholile kanye ne-ventilation compressor anamandla aphansi ngenxa yokuntula kwawo ulwazi, okuholele ekungahambelani kwamandla okunikezwa kanye nendawo ehlanzekile, okuholele ekuhlanzekeni okungafanele. Esinye isizathu ukuthi umsebenzisi unezele izidingo ezintsha kanye nendawo ehlanzekile ngemuva kokuqala kokuklama nokwakha, okuzokwenza futhi umklamo wokuqala ungakwazi ukuhlangabezana nezidingo. Lokhu kukhubazeka kokuzalwa kunzima ukukuthuthukisa futhi kufanele kugwenywe ngesikhathi sesigaba sokuklama sobunjiniyela.
2. Ukushintsha imikhiqizo yekhwalithi ephezulu ngemikhiqizo yekhwalithi ephansi
Ekusetshenzisweni kwezihlungi ze-hepa emakamelweni ahlanzekile, izwe libeka ukuthi ekwelashweni kokuhlanza umoya okunezinga lokuhlanzeka elingu-100000 noma ngaphezulu, kufanele kusetshenziswe izihlungi ezintathu ze-primary, medium, kanye ne-hepa. Ngesikhathi senqubo yokuqinisekisa, kwatholakala ukuthi iphrojekthi enkulu yegumbi elihlanzekile isebenzisa isihlungi somoya esincane se-hepa ukuze ithathe indawo yesihlungi somoya se-hepa ezingeni lokuhlanzeka elingu-10000, okwaholela ekuhlanzekeni okungafanele. Ekugcineni, isihlungi esisebenza kahle kakhulu sashintshwa ukuze kuhlangatshezwane nezidingo zesitifiketi se-GMP.
3. Ukuvalwa kabi komsele wokuhambisa umoya noma isihlungi
Lesi simo sibangelwa ukwakhiwa okunzima, futhi ngesikhathi sokwamukelwa, kungase kubonakale sengathi igumbi elithile noma ingxenye yesistimu efanayo ayifaneleki. Indlela yokuthuthukisa ukusebenzisa indlela yokuhlola ukuvuza kwepayipi lokuhambisa umoya, futhi isihlungi sisebenzisa ikhawunta yezinhlayiya ukuskena ingxenye enqamulelayo, iglu yokuvala, kanye nohlaka lokufaka lwesihlungi, ukuhlonza indawo yokuvuza, bese siyivala ngokucophelela.
4. Ukwakheka okubi kanye nokusebenza kabi kwemigudu yomoya ebuyayo noma imigodi yomoya
Ngokuphathelene nezizathu zokuklama, ngezinye izikhathi ngenxa yokulinganiselwa kwesikhala, ukusetshenziswa "kokubuyisela ohlangothini lokunikezwa okuphezulu" noma inani elanele lemifudlana yomoya ebuyayo akunakwenzeka. Ngemva kokuqeda izizathu zokuklama, ukulungisa amafudlana omoya ebuyayo nakho kuyisixhumanisi esibalulekile sokwakha. Uma ukulungisa amafudlana kungalungile, ukumelana komfudlana womoya obuyayo kuphakeme kakhulu, futhi umthamo womoya obuyayo ungaphansi komthamo womoya obuyayo, kuzophinde kubangele ukuhlanzeka okungafanele. Ngaphezu kwalokho, ukuphakama komfudlana womoya obuyayo ovela emhlabathini ngesikhathi sokwakha nakho kuthinta ukuhlanzeka.
5. Isikhathi sokuzihlanza esinganele sohlelo lokuhlanza igumbi ngesikhathi sokuhlolwa
Ngokwezinga likazwelonke, umzamo wokuhlola kufanele uqalwe imizuzu engama-30 ngemuva kokuthi uhlelo lokuhlanza umoya lusebenze ngokujwayelekile. Uma isikhathi sokusebenza sifushane kakhulu, singadala nokuhlanzeka okungafanele. Kulokhu, kwanele ukwandisa isikhathi sokusebenza kohlelo lokuhlanza umoya ngokufanele.
6. Uhlelo lokuhlanza umoya oluhlanzekile aluzange luhlanzwe kahle
Ngesikhathi senqubo yokwakha, lonke uhlelo lokuhlanza umoya, ikakhulukazi amapayipi omoya ahlinzekayo nabuyayo, aluqedwa ngesikhathi esisodwa, futhi abasebenzi bokwakha kanye nendawo yokwakha kungabangela ukungcola kumapayipi omoya kanye nezihlungi. Uma kungahlanzwa kahle, kuzothinta ngqo imiphumela yokuhlolwa. Isinyathelo sokuthuthukisa ukuhlanza ngenkathi kwakhiwa, futhi ngemva kokuba ingxenye yangaphambilini yokufakwa kwepayipi ihlanzwe kahle, ifilimu yepulasitiki ingasetshenziswa ukuyivala ukuze kugwenywe ukungcola okubangelwa yizici zemvelo.
7. Indawo yokusebenzela ehlanzekile engahlanzwanga kahle
Akungabazeki ukuthi indawo yokusebenzela ehlanzekile kumele ihlanzwe kahle ngaphambi kokuba kuqhubeke ukuhlolwa. Cela abasebenzi bokugcina bokusula ukuthi bagqoke izingubo zokusebenza ezihlanzekile zokuhlanza ukuze kuqedwe ukungcola okubangelwa umzimba womuntu wabasebenzi bokuhlanza. Izinto zokuhlanza zingaba amanzi ompompi, amanzi ahlanzekile, izinyibilikisi eziphilayo, insipho engathathi hlangothi, njll. Kulabo abanezidingo zokulwa nokuqina, sula kahle ngendwangu ecwiliswe kuketshezi olulwa nokuqina.
Isikhathi sokuthunyelwe: Julayi-26-2023