(1) sebenzisa "indlela yobunjineli bexabiso" ekuthengeni izixhobo, iinkqubo ezithile zezi zilandelayo. Iimfuno ezicacileyo, misela izixhobo zokukhetha nokuthenga - ulwazi lweshishini ekujoliswe kulo (ulwazi luquka: umgaqo-nkqubo wokusebenza, injongo yolawulo, ubungakanani bemeko yemveliso nolawulo, njl.njl.) - imveliso ekujoliswe kuyo yahlalutywa, uhlalutyo lweemveliso ekujoliswe kuzo zesohlwayo, oko kukuthi udidi lomsebenzi, umsebenzi othile nocacileyo, emva koko, uhlalutyo lomsebenzi wezixhobo kunye nenqanaba lokufanisa imfuno yokwenyani, kuqwalaselwa ukusebenza kwezixhobo, uhlobo lokugxila olusebenzayo) - iskimu sovavanyo (ngengxoxo yeqela, iingcali zokubonisana kunye nezinye iindlela uhlalutyo malunga neenzuzo kunye nokungalungi kwezixhobo zokwenza uhlalutyo lweendleko, kwaye, emva koko, ukudibanisa into ephambili, kunye nokuhlela), misela injongo yokukhetha nokuthenga.
(2) ukufakwa nokwamkelwa kwezixhobo zamayeza. Ngokuhambelana ngqo neemfuno ze-GMP kunye neenkqubo zokusebenza ezinxulumene noko zokufakelwa nokwamkelwa kwezixhobo zamayeza. Abathathi-nxaxheba baquka: imveliso, ubunjineli, umbane, i-QA kunye neengcali zangaphandle. Inkqubo ethile yile: ukuqinisekiswa kokufakwa, ukuqinisekiswa kokusebenza. I-QA inoxanduva lokuhlola nokuqinisekisa iprojekthi ye-GMP, uphicotho kunye nokuqinisekiswa.
(3) ukwakhiwa kolwazi. Ngokwencwadi yesikhokelo sobuchwephesha bezixhobo kunye ne-GMP, qhagamshelana neengcali ezifanelekileyo, uqokelele itheyibhile yokugcinwa kwezixhobo kunye nencwadi yesikhokelo yobuchwepheshe, kwaye ubhale ngokweenkcukacha idatha yokugcinwa kwangaphambili, iindlela zokugcinwa kunye neziphumo zokugcinwa, ukuze kukhuthazwe ulwazi kunye nokubekwa emgangathweni kolawulo kunye nokugcinwa kwezixhobo zamayeza.
(4) ukusebenzisa inkqubo "yeeseshoni ezimbini". Njengoko ulawulo lwezixhobo zamayeza luphawulwa bubuchule obuqinileyo, iingxaki ezinzima kunye noluhlu olubanzi lweendawo, kunye nokufihlwa kweengxaki zezixhobo ngequbuliso, kufuna ukuba simisele ukusebenza ngokukhawuleza nangokufanelekileyo, indlela yokuphendula kunye nokuphathwa ngexesha elifanelekileyo kweengxaki. Ingcaciso yeShift (ibhekisa ekusebenziseni imizuzu eli-10 ngaphambi kokuya emsebenzini yonke imihla, ukushwankathela nokuxoxa ngosuku olunye ngaphambi komsebenzi kunye nesicwangciso somsebenzi sale mini) kunye nentlanganiso yeveki yesebe (ukuhlolwa, ukuhlaziywa kokusebenza kule veki, kule veki ukuxoxa ngeengxaki eziphambili, ukuxoxa ngesisombululo, kunye nokuseta isicwangciso somsebenzi kwiveki ezayo), esinokuphucula ngokufanelekileyo ukubekwa emgangathweni komsebenzi, kubaluleke kakhulu ekunciphiseni ingozi yokhuseleko efihliweyo.
Ixesha lokuthumela: Feb-27-2020

