Kunzima kakhulu ukwakha igumbi elicocekileyo le-GMP. Akufuneki nje kuphela ukuba kubekho ungcoliseko, kodwa kukwafuneka neenkcukacha ezininzi ezingenakwenziwa zibe zingalunganga, nto leyo eza kuthatha ixesha elide kunezinye iiprojekthi. Iimfuno zomthengi, njl.njl. ziya kuchaphazela ngokuthe ngqo ixesha lokwakha.
Kuthatha ixesha elingakanani ukwakha i-GMP workshop?
1. Okokuqala, kuxhomekeke kwindawo iyonke ye-GMP workshop kunye neemfuno ezithile zokwenza izigqibo. Kwabo banommandla omalunga ne-1000 square metres kunye ne-3000 square metres, kuthatha malunga neenyanga ezi-2 ngelixa kwabaninzi kuthatha malunga neenyanga ezi-3-4.
2. Okwesibini, ukwakha indawo yokusebenzela yokuvelisa ukupakisha ye-GMP nako kunzima ukuba ufuna ukonga iindleko. Kucetyiswa ukuba ufumane inkampani yobunjineli begumbi elicocekileyo ukuze ikuncede ucwangcise kwaye uyile.
3. Iiworkshop ze-GMP zisetyenziswa kwishishini lamayeza, kwishishini lokutya, kwiimveliso zokhathalelo lolusu nakwezinye iishishini zokuvelisa. Okokuqala, zonke iiworkshop zemveliso mazihlulwe ngokwenkqubo yokuhamba kwemveliso kunye nemigaqo yemveliso. Ucwangciso lwendawo kufuneka luqinisekise ukuba lusebenza kwaye luncinci ukuze kuthintelwe ukuphazamisa ukuhamba kwabasebenzi kunye nokuhamba kwemithwalo; Cwangcisa uyilo ngokwendlela yokuhamba kwemveliso, kwaye unciphise ukuhamba kwemveliso okujikelezayo.
- Amagumbi acocekileyo eklasi ye-10000 kunye neklasi ye-100000 GMP oomatshini, izixhobo kunye nezixhobo anokulungiswa kwindawo ecocekileyo. Amagumbi acocekileyo eklasi ye-100 kunye neklasi ye-1000 ephezulu kufuneka akhiwe ngaphandle kwendawo ecocekileyo, kwaye umgangatho wawo ococekileyo unokuba kumgangatho omnye ongaphantsi kunowommandla wemveliso; Amagumbi okucoca, ukugcina, kunye nokulungisa izixhobo ezikhethekileyo awafanelekanga ukwakhiwa kwiindawo zemveliso ezicocekileyo; Amagumbi acocekileyo okucoca kunye nokomisa iimpahla zegumbi acocekileyo ngokubanzi anokuba kumgangatho omnye ongaphantsi kunowommandla wemveliso, ngelixa umgangatho ococekileyo wamagumbi okucoca kunye nokubulala iintsholongwane kwiimpahla zokuvavanya ezicocekileyo kufuneka ufane nowommandla wemveliso.
- Akulula ukwakha umzi-mveliso we-GMP opheleleyo, kuba akufuneki nje kuphela ukuqwalasela ubungakanani kunye nommandla womzi-mveliso, kodwa kufuneka kulungiswe ngokweemeko ezahlukeneyo.
Zingaphi izigaba ezikhoyo kwisakhiwo segumbi elicocekileyo le-GMP?
1. Izixhobo zokucwangcisa
Kufuneka kubekho indawo eyaneleyo yefektri ye-GMP ekhoyo yokwenziwa, kunye nokuhlolwa komgangatho ukugcina amanzi, umbane kunye nobonelelo olugqwesileyo lwegesi. Ngokwemigaqo yetekhnoloji yokucubungula kunye nomgangatho, umgangatho ococekileyo wendawo yemveliso ngokubanzi wahlulwe waba yiklasi ye-100, iklasi ye-1000, iklasi ye-10000, kunye neklasi ye-100000. Indawo ecocekileyo kufuneka igcine uxinzelelo oluhle.
2. Iimfuno zemveliso
(1). Uyilo lwesakhiwo kunye nocwangciso lwendawo kufuneka lube namandla okulungelelanisa aphakathi, kwaye igumbi eliphambili le-GMP elicocekileyo alifanelekanga ukukhetha udonga oluthwala umthwalo lwangaphakathi nolwangaphandle.
(2). Iindawo ezicocekileyo kufuneka zixhotyiswe ngezakhelo zobugcisa okanye iindlela zokuhlela imibhobho yomoya kunye nemibhobho eyahlukeneyo.
(3). Ukuhonjiswa kweendawo ezicocekileyo kufuneka kusetyenziswe izinto eziluhlaza ezinentsebenzo entle yokutywina kunye nokuguquguquka okuncinci ngenxa yotshintsho lobushushu kunye nokufuma kokusingqongileyo.
3. Iimfuno zokwakha
(1). Umphezulu wendlela ye-GMP workshop kufuneka ube banzi, ucaba, ungabi nazikhewu, umelane nokukrwela, umelane nokungqubana, ungabi lula ukuqokelela i-electrostatic induction, kwaye kube lula ukususa uthuli.
(2). Ukuhonjiswa komphezulu wangaphakathi weepayipi zokukhupha umoya, iipayipi zomoya ezibuyayo kunye neepayipi zomoya ezibonelela ngomoya kufuneka zihambelane ne-20% nazo zonke iinkqubo zomoya ezibuyisela umoya kunye nokubonelela, kwaye kube lula ukususa uthuli.
(3). Xa ucinga ngemibhobho eyahlukeneyo yangaphakathi, izixhobo zokukhanyisa, iindawo zokungenisa umoya kunye nezinye izibonelelo zikawonke-wonke, kufuneka uphephe indawo engenako ukucocwa ngexesha loyilo nofakelo.
Ngamafutshane, iimfuno zeeworkshop ze-GMP ziphezulu kunezo zesiqhelo. Enyanisweni, inqanaba ngalinye lokwakha lahlukile, kwaye amanqaku abandakanyekayo ahlukile. Kufuneka sigqibezele imigangatho ehambelanayo ngokwenyathelo ngalinye.
Ixesha lokuthumela: Meyi-21-2023