Mhinduro kumishonga yemishonga manejimendi uye matambudziko ekugadzirisa

1-(3)

(1) shandisa "kukosha kweinjiniya nzira" kutenga michina, iwo maitiro akajeka anotevera. Bvisa zvinodikanwa, sarudza iyo sarudza uye tenga zvishandiso - tarisa bhizinesi ruzivo (ruzivo rwunosanganisira: mashandiro mutemo, manejimendi chinangwa, chiyero chekugadzira uye manejimendi nyika, nezvimwewo) - chigadzirwa chakanangwa chakaongororwa, kuongororwa kwezvakanangwa zvigadzirwa zvakanaka, zvinoti. basa ratidziro, yakatarwa uye yakajeka basa, ipapo, kuongororwa kwemidziyo mashandiro uye chiyero chakaenzana chechinodikanwa chaicho, tichifunga mashandiro emidziyo, anoshanda anotarisisa mhando) - chirongwa chekuongorora (kuburikidza nekukurukurirana kweboka, kubvunza nyanzvi uye dzimwe nzira dzekuongorora nezve zvakanakira nekuipira yeiyo michina yekuitisa ongororo yemutengo uye, ipapo, kubatanidza chinhu chakakosha, uye kugadzirisa), sarudza tarisiro yekusarudza nekutenga.

(2) kuisirwa uye kugamuchirwa kwemishonga mishonga. Chaizvoizvo zvinoenderana nezvinodiwa neGMP uye zvine chekuita mashandiro ekushandisa ekumisikidza midziyo yemishonga uye kugamuchirwa. Vatori vechikamu vanosanganisira: kugadzirwa, mainjiniya, simba, QA uye nyanzvi dzekunze. Iyo chaiyo maitiro ndeye: kuisirwa simbiso, kushanda kusimbisa. QA inoongorora uye kusimbisa chirongwa cheGMP, kuongorora uye kuongorora.

(3) kuvakwa kwemashoko. Sekureva kwemidziyo yehunyanzvi yekushandisa uye GMP, bvunza nyanzvi nyanzvi, nyora tafura yekugadzirisa michina uye technical manual, uye nyora zvakadzama dhata yekuchengetedza yapfuura, nzira dzekuchengetedza uye mhedzisiro yekugadzirisa, kuitira kusimudzira kugadziriswa uye kusimudzira kweyemishonga michina manejimendi uye kuchengetedza.

(4) kushandisa iyo "zvikamu zviviri" sisitimu. Sezvo manejimendi michina manejimendi inoratidzirwa nehunyanzvi hwakasimba, matambudziko akaomarara uye akasiyana masango, pamwe nekukasira nekuvanda kwekutadza kwemidziyo, zvinoda kuti isu titange kumhanya nekukurumidza kushanda, kupindura maitiro uye kubata kwakakodzera kwekutadza. Shift briefing (zvinoreva kushandiswa kwemaminitsi gumi usati waenda kubasa mazuva ese, kupfupisa nekukurukura 1 d usati waita basa uye chirongwa chebasa chezuva rino) uye musangano wedhipatimendi wevhiki (kuongorora, kuongorora mashandiro svondo rino, vhiki ino kukurukura nezve matambudziko makuru, kurukurai mhinduro, nekumisikidza chirongwa chebasa svondo rinouya), icho chinogona kunyatso kusimudzira kusimudzira kwebasa, chakakosha zvikuru kudzikisira njodzi yakavanzika.


Post nguva: Feb-27-2020