公司突出質(zhi)(zhi)量(liang)(liang)意識，強化(hua)全程(cheng)管理(li)(li)(li)，建立了較完(wan)善的(de)質(zhi)(zhi)量(liang)(liang)管理(li)(li)(li)體(ti)系(xi)，涵蓋生(sheng)產、檢(jian)驗、物(wu)料放行和發運(yun)銷售等(deng)環節的(de)文件系(xi)統；建立了變更控(kong)制(zhi)(zhi)、偏差處理(li)(li)(li)、產品(pin)質(zhi)(zhi)量(liang)(liang)回(hui)顧、自檢(jian)、風險(xian)評(ping)估、糾(jiu)正與(yu)預防(fang)措施、產品(pin)發運(yun)與(yu)召回(hui)等(deng)相關(guan)規程(cheng)；通過變更控(kong)制(zhi)(zhi)、偏差處理(li)(li)(li)、糾(jiu)正與(yu)預防(fang)措施對質(zhi)(zhi)量(liang)(liang)管理(li)(li)(li)體(ti)系(xi)進(jin)行維護及持續改進(jin)；運(yun)用(yong)產品(pin)質(zhi)(zhi)量(liang)(liang)回(hui)顧分析、自檢(jian)、風險(xian)管理(li)(li)(li)等(deng)手(shou)段強化(hua)質(zhi)(zhi)量(liang)(liang)管理(li)(li)(li)體(ti)系(xi)的(de)有效性(xing)。
; 公(gong)司(si)全(quan)面落實(shi)藥(yao)品(pin)上市(shi)(shi)許可持有(you)人制度(du)，深刻領會主體責(ze)任的新內涵(han)，建(jian)立(li)(li)了(le)質量管(guan)理架構，明確了(le)質量管(guan)理體系(xi)(xi)中各級(ji)人員的職責(ze)；公(gong)司(si)對上市(shi)(shi)產品(pin)的質量全(quan)生命(ming)周期負責(ze)，建(jian)立(li)(li)了(le)藥(yao)品(pin)年度(du)報告制度(du)，制定了(le)上市(shi)(shi)后藥(yao)品(pin)風險管(guan)理計劃，建(jian)立(li)(li)藥(yao)物(wu)警戒體系(xi)(xi)及(ji)時發現不良(liang)趨勢(shi)，使產品(pin)及(ji)工藝持續提升(sheng)和(he)改進。
公(gong)司(si)(si)(si)突出法(fa)律(lv)意識，認真落(luo)實《藥品管(guan)(guan)理(li)(li)(li)法(fa)》、《藥品注冊(ce)管(guan)(guan)理(li)(li)(li)辦法(fa)》等法(fa)律(lv)法(fa)規(gui)(gui)(gui)，全面修(xiu)訂公(gong)司(si)(si)(si)文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)體系分層(ceng)進(jin)(jin)行管(guan)(guan)理(li)(li)(li)：一層(ceng)文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)為(wei)政策文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)，包括公(gong)司(si)(si)(si)質(zhi)(zhi)量手(shou)冊(ce)、部門職責書(shu)和(he)崗位說明書(shu)；二層(ceng)文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)為(wei)指(zhi)導文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)，包括質(zhi)(zhi)量標準、工(gong)藝規(gui)(gui)(gui)程以及(ji)與(yu)質(zhi)(zhi)量管(guan)(guan)理(li)(li)(li)相關的各(ge)類管(guan)(guan)理(li)(li)(li)規(gui)(gui)(gui)程；三層(ceng)文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)為(wei)工(gong)作(zuo)標準，包括各(ge)類操作(zuo)規(gui)(gui)(gui)程、確認和(he)驗(yan)證(zheng)文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)；四(si)層(ceng)文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)為(wei)記錄。基于指(zhi)導文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)、管(guan)(guan)理(li)(li)(li)規(gui)(gui)(gui)程、操作(zuo)規(gui)(gui)(gui)程內(nei)容進(jin)(jin)行編訂，文(wen)(wen)(wen)(wen)件(jian)(jian)(jian)系統符合(he)規(gui)(gui)(gui)范(fan)要(yao)求。制度先(xian)行，使公(gong)司(si)(si)(si)內(nei)部的運轉合(he)規(gui)(gui)(gui)、高(gao)效。
