Ukusukela ekubhengezweni kwayo ngo-1992, i- "Good Manufacturing Practice for Drugs" (GMP) kwishishini lamayeza laseTshayina liye laqatshelwa ngokuthe ngcembe, lamkelwa, kwaye laphunyezwa ngamashishini okuvelisa amayeza.I-GMP ngumgaqo-nkqubo ogunyazisiweyo wesizwe kumashishini, kwaye amashishini angaphumeleliyo ukuhlangabezana neemfuno ngexesha elibekiweyo aya kuyeka ukuvelisa.
Umxholo ophambili wesiqinisekiso se-GMP lulawulo lomgangatho wolawulo lwemveliso yeziyobisi.Umxholo wayo unokushwankathelwa ube ngamacandelo amabini: ulawulo lwesoftware kunye nezixhobo zehardware.Isakhiwo esicocekileyo segumbi lelinye lamacandelo otyalo-mali oluphambili kuncedo lwehardware.Emva kokugqitywa kwesakhiwo segumbi elicocekileyo, nokuba sinokufikelela kwiinjongo zokuyila kunye nokuhlangabezana neemfuno ze-GMP kufuneka ekugqibeleni kuqinisekiswe ngovavanyo.
Ebudeni bokuhlolwa kwegumbi elicocekileyo, abanye babo abazange baluphumeze ucoceko, abanye babengabasekuhlaleni kumzi-mveliso, yaye abanye baba ngumsebenzi wonke.Ukuba ukuhlolwa akufanelekile, nangona amaqela omabini afezekise iimfuno ngokulungiswa, ukuchithwa, ukucocwa, njl., kudla ngokuchitha amandla amaninzi kunye nezinto eziphathekayo, ukulibaziseka kwexesha lokwakha, kunye nokulibazisa inkqubo ye-GMP certification.Ezinye izizathu kunye neziphene zinokuphetshwa phambi kovavanyo.Kumsebenzi wethu wokwenyani, sifumanise ukuba ezona zizathu ziphambili kunye namanyathelo okuphucula ukucoceka okungafanelekanga kunye nokusilela kwe-GMP kubandakanya:
1. Uyilo lobunjineli obungenangqiqo
Le nto inqabile, ngakumbi ekwakhiweni kwamagumbi amancinci acocekileyo aneemfuno eziphantsi zococeko.Ukhuphiswano lobunjineli begumbi elicocekileyo lunzima ngoku, kwaye ezinye iiyunithi zokwakha zibonelele ngeekowuteshini ezisezantsi kwiibhidi zabo zokufumana iprojekthi.Kwinqanaba lamva lolwakhiwo, ezinye iiyunithi zasetyenziselwa ukusika iikona kunye nokusetyenziswa kwe-air conditioning yamandla aphantsi kunye neeyunithi ze-compressor zokungenisa umoya ngenxa yokungabi nalwazi, okubangele amandla okubonelela ngokungafaniyo kunye nommandla ococekileyo, okukhokelela kucoceko olungafanelekanga.Esinye isizathu kukuba umsebenzisi wongeze iimfuno ezintsha kunye nommandla ococekileyo emva koyilo kunye nokwakhiwa kokuqala, okuya kwenza ukuba uyilo lwangaphambili lungakwazi ukuhlangabezana neemfuno.Esi siphene sokuzalwa kunzima ukuphucula kwaye kufuneka sigwenywe ngexesha lesigaba soyilo lobunjineli.
2. Ukutshintsha iimveliso eziphezulu kunye neemveliso eziphantsi
Ekusetyenzisweni kweefilitha ze-hepa kumagumbi acocekileyo, ilizwe lichaza ukuba unyango lokucoca umoya kunye nenqanaba lokucoceka kwe-100000 okanye ngaphezulu, kufuneka kusetyenziswe ukuhluzwa kwamanqanaba amathathu eprayimari, aphakathi, kunye ne-hepa.Ngethuba lenkqubo yokuqinisekisa, kwafunyaniswa ukuba iprojekthi enkulu yegumbi elicocekileyo isebenzisa i-sub hepa yokucoca umoya ukuze ithathe indawo ye-air filter ye-hepa kwinqanaba lokucoceka kwe-10000, okubangelwa ukucoceka okungafanelekanga.Ekugqibeleni, isihluzi esisebenza kakuhle kakhulu satshintshwa ukuze sihlangabezane neemfuno zesatifikethi se-GMP.
3. Ukutywinwa kakubi kombhobho wokuhambisa umoya okanye isihluzo
Esi siganeko sibangelwa ukwakhiwa okunzima, kwaye ngexesha lokwamkelwa, kunokubonakala ngathi igumbi elithile okanye inxalenye yenkqubo efanayo ayifanelekanga.Indlela yokuphucula kukusebenzisa indlela yokuvavanya ukuvuza kombhobho wokubonelela komoya, kwaye isihluzi sisebenzisa ikhawuntala yesuntswana ukuskena icandelo elinqamlezayo, iglue yokutywina, kunye nesakhelo sofakelo lwesihluzi, ukuchonga indawo yokuvuza, kwaye uyitywine ngononophelo.
4. Uyilo olulambathayo kunye nokugunyaziswa kwemibhobho yomoya yokubuyisela okanye i-air vents
Ngokwezizathu zokuyila, ngamanye amaxesha ngenxa yokunciphisa indawo, ukusetyenziswa kwe "top supply side return" okanye inani elingonelanga leevens zomoya ezibuyiswayo akunakwenzeka.Emva kokuphelisa izizathu zoyilo, ukulungiswa kwee-air vents ezibuyiswayo kukwayinxalenye ebalulekileyo yokwakha.Ukuba ukuchithwa kwe-debugging akulungile, ukuchasana kwe-air outlet yokubuya kuphezulu kakhulu, kwaye umthamo womoya wokubuyisela ungaphantsi komthamo womoya wokubonelela, kuya kubangela ukucoceka okungafanelekanga.Ukongezelela, ukuphakama kwe-air outlet yokubuya emhlabeni ngexesha lokwakha kuchaphazela nokucoceka.
5. Ukungonelanga kwexesha lokuzicoca kwisixokelelwano segumbi elicocekileyo ngexesha lovavanyo
Ngokomgangatho wesizwe, umzamo wokuvavanya uya kuqaliswa kwimizuzu engama-30 emva kokuba inkqubo yokucoca umoya isebenza ngokuqhelekileyo.Ukuba ixesha lokuqhuba lifutshane kakhulu, linokubangela ukucoceka okungafanelanga.Kule meko, kwanele ukwandisa ixesha lokusebenza kwenkqubo yokucoca umoya ngokufanelekileyo.
6. Inkqubo yokucoca umoya yokucoca umoya ayizange icocwe ngokucokisekileyo
Ngethuba lenkqubo yokwakha, yonke inkqubo yokucoca umoya wokucoca umoya, ngokukodwa ukubonelela kunye nokubuyisela i-air ducts, ayigqitywanga ngexesha elinye, kwaye abasebenzi bokwakha kunye nommandla wokwakha bangabangela ukungcola kwimigudu yokuphefumula kunye nezihlungi.Ukuba ayicocwanga ngokucokisekileyo, iya kuchaphazela ngokuthe ngqo iziphumo zovavanyo.Indlela yokuphucula kukucoca ngelixa kusakhiwa, kwaye emva kokuba icandelo langaphambili lofakelo lombhobho licocwe ngokucokisekileyo, ifilimu yeplastiki ingasetyenziselwa ukutywina ukuphepha ungcoliseko olubangelwa yimiba yokusingqongileyo.
7. Iworkshop ecocekileyo ayicocwanga ngokupheleleyo
Ngaphandle kwamathandabuzo, iworkshop ecocekileyo kufuneka icocwe ngocoselelo phambi kokuba kuqhutyekwe novavanyo.Funa ukuba abasebenzi bosulelayo bokugqibela banxibe iimpahla ezicocekileyo zokusebenza xa becoca ukuze kupheliswe ungcoliseko olubangelwa ngumzimba womntu wabasebenzi abacocayo.Ii-agent zokucoca zinokuba ngamanzi ompompo, amanzi acocekileyo, i-solvents ye-organic, i-detergents engathathi hlangothi, njl. Kulabo abaneemfuno ezichasene ne-static, sula ngokucokisekileyo ngelaphu elifakwe kwi-anti-static liquid.
Ixesha lokuposa: Jul-26-2023