文章來(lai)源:中國(guo)醫藥集團(tuan)總公司 發布時(shi)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。
中國醫藥(yao)(yao)集(ji)團所(suo)屬各公司(si)要(yao)提(ti)高認識,吸取(qu)教訓(xun),對(dui)本單位生(sheng)產(chan)(chan)(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)的(de)藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)進(jin)行(xing)全(quan)面(mian)自查,加(jia)強監(jian)管(guan),排查隱患。以“三(san)鹿奶(nai)粉”嚴(yan)重事(shi)(shi)件(jian)為借鑒,狠抓(zhua)藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)質(zhi)(zhi)量(liang)的(de)管(guan)理(li),對(dui)照(zhao)新修(xiu)訂的(de)《藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)GMP認證(zheng)(zheng)檢查評(ping)定標(biao)準(zhun)》各項條款,通過自查抽查,找準(zhun)問題,清(qing)除(chu)源頭,落實責(ze)(ze)(ze)任人,做好日常跟蹤檢查工(gong)作,保證(zheng)(zheng)企業(ye)(ye)(ye)自覺嚴(yan)格(ge)(ge)執(zhi)行(xing)《藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)質(zhi)(zhi)量(liang)管(guan)理(li)規范》(GMP),確(que)保藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)企業(ye)(ye)(ye)嚴(yan)格(ge)(ge)按照(zhao)經(jing)(jing)批(pi)準(zhun)的(de)生(sheng)產(chan)(chan)(chan)(chan)(chan)工(gong)藝和(he)處(chu)方(fang)組織(zhi)生(sheng)產(chan)(chan)(chan)(chan)(chan)。同(tong)時,要(yao)在(zai)年底前開(kai)展(zhan)徹底的(de)庫(ku)(ku)存商品(pin)(pin)(pin)(pin)(pin)清(qing)理(li)工(gong)作,及(ji)時處(chu)理(li)退換貨,銷(xiao)毀不合(he)格(ge)(ge)商品(pin)(pin)(pin)(pin)(pin),并(bing)(bing)制(zhi)(zhi)(zhi)定出滯銷(xiao)商品(pin)(pin)(pin)(pin)(pin)的(de)解決方(fang)案(an)。對(dui)于(yu)生(sheng)產(chan)(chan)(chan)(chan)(chan)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)的(de)品(pin)(pin)(pin)(pin)(pin)種嚴(yan)把(ba)質(zhi)(zhi)量(liang)關(guan)(guan),特(te)別關(guan)(guan)注(zhu)藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)、食品(pin)(pin)(pin)(pin)(pin)、食品(pin)(pin)(pin)(pin)(pin)添加(jia)劑(ji)及(ji)化工(gong)產(chan)(chan)(chan)(chan)(chan)品(pin)(pin)(pin)(pin)(pin)的(de)質(zhi)(zhi)量(liang)情(qing)況(kuang)(kuang),分(fen)清(qing)所(suo)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)商品(pin)(pin)(pin)(pin)(pin)的(de)實際(ji)用途,嚴(yan)格(ge)(ge)履行(xing)必(bi)(bi)要(yao)的(de)資質(zhi)(zhi)驗證(zheng)(zheng)手(shou)續,杜絕超范圍經(jing)(jing)營(ying)(ying)(ying)(ying)(ying);對(dui)于(yu)產(chan)(chan)(chan)(chan)(chan)銷(xiao)渠道進(jin)行(xing)嚴(yan)格(ge)(ge)控(kong)制(zhi)(zhi)(zhi),特(te)別關(guan)(guan)注(zhu)藥(yao)(yao)店終端銷(xiao)售(shou),杜絕沒有質(zhi)(zhi)量(liang)監(jian)督(du)的(de)過票經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)。醫藥(yao)(yao)集(ji)團將(jiang)在(zai)年底按照(zhao)GSP要(yao)求檢查庫(ku)(ku)存商品(pin)(pin)(pin)(pin)(pin)情(qing)況(kuang)(kuang)。二是完善制(zhi)(zhi)(zhi)度,快速反應(ying)。醫藥(yao)(yao)集(ji)團所(suo)屬藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)企業(ye)(ye)(ye)要(yao)建(jian)立并(bing)(bing)完善藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)質(zhi)(zhi)量(liang)安(an)全(quan)事(shi)(shi)故即時上報制(zhi)(zhi)(zhi)度,一(yi)(yi)旦(dan)發(fa)生(sheng)藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)質(zhi)(zhi)量(liang)安(an)全(quan)事(shi)(shi)故,必(bi)(bi)須在(zai)第一(yi)(yi)時間(jian)逐級(ji)上報至醫藥(yao)(yao)集(ji)團總公司(si),以便(bian)于(yu)及(ji)時掌握了解情(qing)況(kuang)(kuang),正確(que)決策(ce)和(he)處(chu)理(li)。三(san)是明確(que)責(ze)(ze)(ze)任,嚴(yan)格(ge)(ge)管(guan)理(li)。各分(fen)公司(si)要(yao)完善藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)質(zhi)(zhi)量(liang)安(an)全(quan)事(shi)(shi)故責(ze)(ze)(ze)任人追(zhui)究(jiu)制(zhi)(zhi)(zhi)度,落實各級(ji)安(an)全(quan)生(sheng)產(chan)(chan)(chan)(chan)(chan)責(ze)(ze)(ze)任人,明確(que)責(ze)(ze)(ze)任目標(biao),一(yi)(yi)旦(dan)發(fa)生(sheng)藥(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)產(chan)(chan)(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)(ying)(ying)(ying)(ying)質(zhi)(zhi)量(liang)安(an)全(quan)事(shi)(shi)故,將(jiang)嚴(yan)格(ge)(ge)追(zhui)究(jiu)有關(guan)(guan)人員責(ze)(ze)(ze)任,絕不姑息(xi)遷(qian)就。