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中國醫藥集團加強藥品生產經營質量安全管理

文章來源(yuan):中國(guo)醫藥集團(tuan)總公司  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)(yao)集(ji)團所(suo)屬各(ge)公(gong)司要(yao)(yao)提高認識(shi),吸(xi)取教(jiao)訓,對(dui)本單位生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)和(he)(he)經營(ying)(ying)(ying)的藥(yao)(yao)(yao)(yao)品(pin)進行全面自(zi)查(cha)(cha)(cha)(cha),加強監管,排查(cha)(cha)(cha)(cha)隱患。以“三鹿奶粉(fen)”嚴(yan)(yan)(yan)重事(shi)件為借鑒,狠抓藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)質(zhi)量(liang)的管理(li)(li),對(dui)照(zhao)新修訂的《藥(yao)(yao)(yao)(yao)品(pin)GMP認證檢(jian)查(cha)(cha)(cha)(cha)評(ping)定標準(zhun)》各(ge)項(xiang)條款(kuan),通過自(zi)查(cha)(cha)(cha)(cha)抽查(cha)(cha)(cha)(cha),找準(zhun)問題,清除(chu)源頭,落(luo)實責(ze)(ze)任(ren)(ren)人,做(zuo)好日常(chang)跟蹤檢(jian)查(cha)(cha)(cha)(cha)工(gong)作(zuo),保證企業自(zi)覺嚴(yan)(yan)(yan)格(ge)執行《藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)質(zhi)量(liang)管理(li)(li)規范》(GMP),確保藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)企業嚴(yan)(yan)(yan)格(ge)按照(zhao)經批(pi)準(zhun)的生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)工(gong)藝(yi)和(he)(he)處(chu)方組織生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)。同時(shi)(shi),要(yao)(yao)在年(nian)底(di)(di)前開展(zhan)徹底(di)(di)的庫存商品(pin)清理(li)(li)工(gong)作(zuo),及時(shi)(shi)處(chu)理(li)(li)退(tui)換貨,銷(xiao)(xiao)毀不(bu)合(he)格(ge)商品(pin),并(bing)制定出(chu)滯銷(xiao)(xiao)商品(pin)的解決方案。對(dui)于(yu)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)經營(ying)(ying)(ying)的品(pin)種嚴(yan)(yan)(yan)把(ba)質(zhi)量(liang)關,特別(bie)關注藥(yao)(yao)(yao)(yao)品(pin)、食品(pin)、食品(pin)添加劑(ji)及化工(gong)產(chan)(chan)(chan)品(pin)的質(zhi)量(liang)情況,分清所(suo)經營(ying)(ying)(ying)商品(pin)的實際用途,嚴(yan)(yan)(yan)格(ge)履行必要(yao)(yao)的資質(zhi)驗(yan)證手(shou)續,杜(du)(du)絕超范圍經營(ying)(ying)(ying);對(dui)于(yu)產(chan)(chan)(chan)銷(xiao)(xiao)渠道(dao)進行嚴(yan)(yan)(yan)格(ge)控制,特別(bie)關注藥(yao)(yao)(yao)(yao)店終(zhong)端銷(xiao)(xiao)售,杜(du)(du)絕沒有質(zhi)量(liang)監督的過票經營(ying)(ying)(ying)。醫(yi)藥(yao)(yao)(yao)(yao)集(ji)團將在年(nian)底(di)(di)按照(zhao)GSP要(yao)(yao)求檢(jian)查(cha)(cha)(cha)(cha)庫存商品(pin)情況。二(er)是完善(shan)制度,快速(su)反應。醫(yi)藥(yao)(yao)(yao)(yao)集(ji)團所(suo)屬藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)和(he)(he)經營(ying)(ying)(ying)企業要(yao)(yao)建立并(bing)完善(shan)藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)和(he)(he)經營(ying)(ying)(ying)質(zhi)量(liang)安(an)(an)全事(shi)故(gu)(gu)即時(shi)(shi)上報制度,一(yi)旦發生(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)和(he)(he)經營(ying)(ying)(ying)質(zhi)量(liang)安(an)(an)全事(shi)故(gu)(gu),必須在第一(yi)時(shi)(shi)間(jian)逐級上報至醫(yi)藥(yao)(yao)(yao)(yao)集(ji)團總公(gong)司,以便于(yu)及時(shi)(shi)掌握了(le)解情況,正(zheng)確決策和(he)(he)處(chu)理(li)(li)。三是明確責(ze)(ze)任(ren)(ren),嚴(yan)(yan)(yan)格(ge)管理(li)(li)。各(ge)分公(gong)司要(yao)(yao)完善(shan)藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)和(he)(he)經營(ying)(ying)(ying)質(zhi)量(liang)安(an)(an)全事(shi)故(gu)(gu)責(ze)(ze)任(ren)(ren)人追(zhui)究制度,落(luo)實各(ge)級安(an)(an)全生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)責(ze)(ze)任(ren)(ren)人,明確責(ze)(ze)任(ren)(ren)目標,一(yi)旦發生(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)和(he)(he)經營(ying)(ying)(ying)質(zhi)量(liang)安(an)(an)全事(shi)故(gu)(gu),將嚴(yan)(yan)(yan)格(ge)追(zhui)究有關人員責(ze)(ze)任(ren)(ren),絕不(bu)姑息(xi)遷就(jiu)。

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