文章來源:中(zhong)國醫藥集團總公(gong)司 發布時間:2009-10-07
以“三鹿奶粉事件”引發的奶制品及食品質量安全問題,引起黨中央、國務院的高度重視。為了積極響應國家開展的專項整治工作,更好地吸取教訓,舉一反三,防微杜淅,確保人民群眾用藥和飲食安全,中國醫藥集團進一步加強藥品生產經營質量安全管理。一是提高認識,開展自查。
中國醫(yi)藥(yao)(yao)(yao)集(ji)(ji)團所屬各(ge)公司(si)要(yao)(yao)提高認(ren)識,吸取(qu)教訓,對(dui)本單(dan)位(wei)生(sheng)產(chan)(chan)(chan)(chan)(chan)和經(jing)營(ying)(ying)(ying)(ying)的(de)(de)(de)(de)藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)進行全(quan)(quan)(quan)(quan)面自(zi)查(cha)(cha),加(jia)強監管(guan),排查(cha)(cha)隱患。以“三鹿奶粉(fen)”嚴重事件(jian)為借鑒,狠抓藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)質(zhi)(zhi)(zhi)(zhi)量(liang)的(de)(de)(de)(de)管(guan)理(li)(li),對(dui)照新修訂的(de)(de)(de)(de)《藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)GMP認(ren)證檢查(cha)(cha)評定標準(zhun)》各(ge)項條款,通過自(zi)查(cha)(cha)抽查(cha)(cha),找準(zhun)問題,清除源(yuan)頭(tou),落實責(ze)任人(ren),做好日常跟蹤檢查(cha)(cha)工作,保(bao)證企業(ye)自(zi)覺嚴格(ge)(ge)執行《藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)質(zhi)(zhi)(zhi)(zhi)量(liang)管(guan)理(li)(li)規范(fan)》(GMP),確(que)(que)保(bao)藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)企業(ye)嚴格(ge)(ge)按照經(jing)批準(zhun)的(de)(de)(de)(de)生(sheng)產(chan)(chan)(chan)(chan)(chan)工藝和處(chu)方(fang)組織生(sheng)產(chan)(chan)(chan)(chan)(chan)。同時(shi),要(yao)(yao)在年底(di)前開展徹底(di)的(de)(de)(de)(de)庫存商品(pin)(pin)(pin)(pin)(pin)清理(li)(li)工作,及時(shi)處(chu)理(li)(li)退換貨,銷(xiao)毀不合格(ge)(ge)商品(pin)(pin)(pin)(pin)(pin),并制(zhi)(zhi)定出滯銷(xiao)商品(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)解決方(fang)案。對(dui)于生(sheng)產(chan)(chan)(chan)(chan)(chan)經(jing)營(ying)(ying)(ying)(ying)的(de)(de)(de)(de)品(pin)(pin)(pin)(pin)(pin)種嚴把質(zhi)(zhi)(zhi)(zhi)量(liang)關(guan),特(te)別關(guan)注藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)、食(shi)品(pin)(pin)(pin)(pin)(pin)、食(shi)品(pin)(pin)(pin)(pin)(pin)添加(jia)劑及化工產(chan)(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)質(zhi)(zhi)(zhi)(zhi)量(liang)情況(kuang),分清所經(jing)營(ying)(ying)(ying)(ying)商品(pin)(pin)(pin)(pin)(pin)的(de)(de)(de)(de)實際用途(tu),嚴格(ge)(ge)履行必要(yao)(yao)的(de)(de)(de)(de)資質(zhi)(zhi)(zhi)(zhi)驗證手續,杜(du)絕超(chao)范(fan)圍經(jing)營(ying)(ying)(ying)(ying);對(dui)于產(chan)(chan)(chan)(chan)(chan)銷(xiao)渠(qu)道進行嚴格(ge)(ge)控制(zhi)(zhi),特(te)別關(guan)注藥(yao)(yao)(yao)店終端(duan)銷(xiao)售,杜(du)絕沒(mei)有(you)質(zhi)(zhi)(zhi)(zhi)量(liang)監督(du)的(de)(de)(de)(de)過票經(jing)營(ying)(ying)(ying)(ying)。醫(yi)藥(yao)(yao)(yao)集(ji)(ji)團將(jiang)在年底(di)按照GSP要(yao)(yao)求檢查(cha)(cha)庫存商品(pin)(pin)(pin)(pin)(pin)情況(kuang)。二是完善制(zhi)(zhi)度(du),快速反應(ying)。醫(yi)藥(yao)(yao)(yao)集(ji)(ji)團所屬藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和經(jing)營(ying)(ying)(ying)(ying)企業(ye)要(yao)(yao)建立并完善藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和經(jing)營(ying)(ying)(ying)(ying)質(zhi)(zhi)(zhi)(zhi)量(liang)安全(quan)(quan)(quan)(quan)事故即時(shi)上報制(zhi)(zhi)度(du),一(yi)(yi)旦(dan)發生(sheng)藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和經(jing)營(ying)(ying)(ying)(ying)質(zhi)(zhi)(zhi)(zhi)量(liang)安全(quan)(quan)(quan)(quan)事故,必須(xu)在第一(yi)(yi)時(shi)間逐(zhu)級(ji)上報至醫(yi)藥(yao)(yao)(yao)集(ji)(ji)團總公司(si),以便于及時(shi)掌握了解情況(kuang),正(zheng)確(que)(que)決策(ce)和處(chu)理(li)(li)。三是明確(que)(que)責(ze)任,嚴格(ge)(ge)管(guan)理(li)(li)。各(ge)分公司(si)要(yao)(yao)完善藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和經(jing)營(ying)(ying)(ying)(ying)質(zhi)(zhi)(zhi)(zhi)量(liang)安全(quan)(quan)(quan)(quan)事故責(ze)任人(ren)追(zhui)究制(zhi)(zhi)度(du),落實各(ge)級(ji)安全(quan)(quan)(quan)(quan)生(sheng)產(chan)(chan)(chan)(chan)(chan)責(ze)任人(ren),明確(que)(que)責(ze)任目(mu)標,一(yi)(yi)旦(dan)發生(sheng)藥(yao)(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和經(jing)營(ying)(ying)(ying)(ying)質(zhi)(zhi)(zhi)(zhi)量(liang)安全(quan)(quan)(quan)(quan)事故,將(jiang)嚴格(ge)(ge)追(zhui)究有(you)關(guan)人(ren)員責(ze)任,絕不姑息遷就。