Inqanaba leeNkcukacha
E-USA, imigaqo ye-GMP igutyungelwe kwinxalenye ye-210 kunye nenxalenye ye-211 yekhowudi yemigaqo ye-federal.Ngenxa yokuba le mimiselo kunzima ukuyilungisa okanye ukongeza, i-FDA ikhuphe amaxwebhu ahlukeneyo emigaqo ye-GMP kunye nesikhokelo sokusebenza kumayeza, afanaIsikhokelo kuShishino.Ezi fayile zihlala zilungiswa kwaye zongezwa zibizwa ngokuba zizikhokelo zeCGMP.Ezinye zezi zikhokelo zinxulumene nophando olutsha lwechiza kunye nokubhaliswa, njenge-ICH (Q1-Q10).Indlela yokuqhuba ukuqinisekiswa kwenkqubo, ukuqinisekiswa kwenkqubo kunye nezinye iziqulatho malunga ne-GMP nazo zibandakanyiwe kula maxwebhu, ayimigangatho ethotyelwe kwi-GMP yokuhlolwa kwendawo.Ukongeza, ezinye izikhokelo zikhutshwa kubahloli be-GMP njengezalathisi, ezifanaIsikhokelo soHlolo lweFom yedosi yabavelisi beziyobisi, Isikhokelo sokuHlolwa kweeNkqubo zoMgangatho, Ukuqinisekiswa kweeNkqubo zokuCocanjl. Akunyanzelekanga ukusebenzisa ezi zikhokelo.Ngenxa yokuba ngabahloli be-FDA kuphela abagunyazisiweyo ukuba benze isigqibo sokuba inkqubo yokusebenza yomenzi iyahlangabezana nalo mgangatho "wangoku", abavelisi bamachiza kufuneka balandele i-cGMP yamva nje kunye nezinye izikhokelo kwaye bazihlole ngokwabo ukuze babone ukuba imigangatho yenziwe.Kungenjalo, baya kuthathwa ngokuba "abavunywanga" kwaye bafumane isohlwayo ngenxa yoko.
I-GMP yesiTshayina (uhlelo luka-1998) ilula kakhulu kwaye ayicacanga, ayinazikhokelo ezichaziweyo kunye neemfuno ngokuhambelana nemigaqo ye-GMP.Kwisihlomelo se-GMP ye-1998, iintlobo ezintandathu zamachiza zaziswa kunye nezikhokelo ezimfutshane.Ukuza kuthi ga ngoku, kusekho i-GMP ebonelela ngezalathiso zesikhokelo sokusebenza.Ukufaneleka kwezixhobo kunye nokuqinisekiswa, ukuqinisekiswa kwenkqubo, ukuqinisekiswa kweendlela, ukuqinisekiswa kwe-sterilization kunye nezinye iindlela zokusebenza ezithile ziye zaqhutywa ngaphandle kwemigangatho ecacileyo, ebangela ulawulo lwangasemva.
Thumela umyalezo wakho kuthi:
Ixesha lokuposa: Nov-03-2017