Ukususela oko yapapashwa ngo-1992, i-"Good Manufacturing Practice for Drugs" (GMP) kwishishini leyeza laseTshayina iye yaqatshelwa, yamkelwe, kwaye yaphunyezwa kancinci kancinci ziinkampani zemveliso yamayeza. I-GMP ngumgaqo-nkqubo onyanzelekileyo wesizwe kwiinkampani, kwaye amashishini angaphumeleliyo ukuhlangabezana neemfuno ngaphakathi kwexesha elimiselweyo aya kuyeka ukuvelisa.
Umxholo ophambili wesatifikethi se-GMP kukulawula umgangatho wokuveliswa kwamayeza. Umxholo wayo ungashwankathelwa kwiindawo ezimbini: ulawulo lwesoftware kunye nezixhobo zehardware. Isakhiwo segumbi elicocekileyo sesinye sezona zinto zibalulekileyo zotyalo-mali kwizixhobo zehardware. Emva kokugqitywa kwesakhiwo segumbi elicocekileyo, ukuba singazifezekisa iinjongo zoyilo kwaye sihlangabezane neemfuno ze-GMP kufuneka ekugqibeleni kuqinisekiswe ngovavanyo.
Ngexesha lokuhlolwa kwegumbi elicocekileyo, abanye babo abaphumelelanga kuhlolo lococeko, abanye babekwindawo yasefektri, kwaye abanye babeyiprojekthi yonke. Ukuba uhlolo alufanelekanga, nangona omabini amaqela efezekisile iimfuno ngokulungiswa, ukulungisa iimpazamo, ukucoca, njl.njl., ludla ngokuchitha amandla amaninzi kunye nezixhobo, lulibazise ixesha lokwakha, kwaye libazise inkqubo yokuqinisekiswa kwe-GMP. Ezinye izizathu kunye neziphene zinokuthintelwa ngaphambi kovavanyo. Kumsebenzi wethu wokwenyani, sifumanise ukuba izizathu eziphambili kunye namanyathelo okuphucula ucoceko olungafanelekiyo kunye nokusilela kwe-GMP ziquka:
1. Uyilo lobunjineli olungenangqiqo
Le nto inqabile, ikakhulu ekwakhiweni kwamagumbi amancinci acocekileyo aneemfuno eziphantsi zococeko. Ukhuphiswano kubunjineli bamagumbi acocekileyo luphezulu ngoku, kwaye amanye amayunithi okwakha anike iikowuteshini eziphantsi kwiibhidi zawo zokufumana le projekthi. Kwinqanaba lokugqibela lokwakha, amanye amayunithi asetyenziselwa ukunciphisa iikona kwaye asebenzise amayunithi omoya opholileyo kunye ne-ventilation compressor anamandla aphantsi ngenxa yokuswela kwawo ulwazi, okubangela umbane ongahambelaniyo kunye nendawo ecocekileyo, okubangela ucoceko olungenamkhethe. Esinye isizathu kukuba umsebenzisi wongeze iimfuno ezintsha kunye nendawo ecocekileyo emva kokuqala koyilo nolwakhiwo, okuya kwenza uyilo lokuqala lungakwazi ukuhlangabezana neemfuno. Esi siphene sokuzalwa kunzima ukusiphucula kwaye kufuneka siphetshwe ngexesha lesigaba soyilo lobunjineli.
2. Ukutshintsha iimveliso ezikumgangatho ophezulu ngeemveliso ezikumgangatho ophantsi
Ekusetyenzisweni kwezihluzi ze-hepa kumagumbi acocekileyo, ilizwe limisela ukuba kunyango lokucoca umoya olunenqanaba lococeko eliyi-100000 nangaphezulu, kufuneka kusetyenziswe ukuhluzwa kwamanqanaba amathathu kwezihluzi zokuqala, eziphakathi, kunye neze-hepa. Ngexesha lenkqubo yokuqinisekisa, kufunyaniswe ukuba iprojekthi enkulu yegumbi elicocekileyo isebenzisa isihluzi somoya esincinci se-hepa ukutshintsha isihluzi somoya se-hepa kwinqanaba lococeko eliyi-10000, nto leyo eyabangela ukucoceka okungafanelekiyo. Ekugqibeleni, isihluzi esisebenza kakuhle satshintshwa ukuze kuhlangatyezwane neemfuno zesatifikethi se-GMP.
3. Ukuvalwa kakubi kwendlela yokuhambisa umoya okanye isihluzi
Le nto ibangelwa kukwakhiwa okunzima, kwaye ngexesha lokwamkelwa, kunokubonakala ngathi igumbi elithile okanye inxalenye yenkqubo efanayo ayifanelekanga. Indlela yokuphucula kukusebenzisa indlela yokuvavanya ukuvuza kwipayipi yokuhambisa umoya, kwaye isihluzi sisebenzisa ikhawuntara yamasuntswana ukuskena icandelo elinqamlezileyo, ukutywina iglu, kunye nesakhelo sokufakela isihluzi, ukuchonga indawo yokuvuza, kunye nokusivala ngononophelo.
4. Uyilo olubi kunye nokusebenza kakubi kweendlela zokungenisa umoya okanye ii-air vents
Ngokuphathelele izizathu zoyilo, ngamanye amaxesha ngenxa yemida yendawo, ukusetyenziswa "kwe-top supply side return" okanye inani elaneleyo lee-return air vents akunakwenzeka. Emva kokususa izizathu zoyilo, ukulungisa ii-return air vents nako kukudibanisa okubalulekileyo kolwakhiwo. Ukuba ukulungisa ii-return air vents akulunganga, ukumelana kwe-return air outlet kuphezulu kakhulu, kwaye i-return air volume ingaphantsi kwe-resource air volume, kuya kubangela ucoceko olungenamkhethe. Ukongeza, ukuphakama kwe-return air outlet evela emhlabeni ngexesha lokwakha nako kuchaphazela ucoceko.
5. Ixesha elaneleyo lokuzihlambulula kwinkqubo yokucoca igumbi ngexesha lovavanyo
Ngokomgangatho wesizwe, umzamo wovavanyo kufuneka uqaliswe emva kwemizuzu engama-30 emva kokuba inkqubo yokucoca umoya isebenza ngokwesiqhelo. Ukuba ixesha lokusebenza lifutshane kakhulu, linokubangela ucoceko olungafanelekiyo. Kule meko, kwanele ukwandisa ixesha lokusebenza kwenkqubo yokucoca umoya ngokufanelekileyo.
6. Inkqubo yokucoca umoya ayizange icocwe kakuhle
Ngexesha lenkqubo yokwakha, yonke inkqubo yokucoca umoya opholileyo, ingakumbi imibhobho yomoya ehambisayo nebuyayo, ayigqitywanga ngaxeshanye, kwaye abasebenzi bokwakha kunye nendawo yokwakha banokubangela ungcoliseko kwimibhobho yomoya kunye nezihluzi. Ukuba ayicocwanga kakuhle, iya kuchaphazela ngqo iziphumo zovavanyo. Indlela yokuphucula kukucoca ngelixa kusakhiwa, kwaye emva kokuba icandelo langaphambili lofakelo lombhobho licociwe kakuhle, ifilimu yeplastiki ingasetyenziselwa ukuyivala ukuze kuthintelwe ungcoliseko olubangelwa zizinto ezingqongileyo.
7. Indawo yokusebenzela ecocekileyo ayicocwanga kakuhle
Ngokungathandabuzekiyo, indawo yokusebenzela ecocekileyo kufuneka icocwe kakuhle ngaphambi kokuba uvavanyo luqhubeke. Kufuneka abasebenzi bokugqibela bokucoca banxibe iimpahla zomsebenzi ezicocekileyo zokucoca ukuze kususwe ungcoliseko olubangelwa ngumzimba womntu wabasebenzi bokucoca. Izinto zokucoca zingaba ngamanzi empompini, amanzi acocekileyo, izinyibilikisi zendalo, isepha ezingathathi cala, njl. Kwabo banemfuno yokulwa nokuqina, sula kakuhle ngelaphu elifakwe kwi-anti-static liquid.
Ixesha lokuthumela: Julayi-26-2023