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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(zhang)來源:中國醫藥集團(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(guo)醫(yi)(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)所屬各(ge)(ge)公(gong)司(si)(si)要(yao)(yao)提高認識,吸取教訓(xun),對本單位生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和(he)(he)經(jing)(jing)營(ying)的(de)(de)(de)(de)藥(yao)(yao)(yao)(yao)(yao)品(pin)進行(xing)全(quan)(quan)面自查(cha),加(jia)強監管(guan)(guan),排查(cha)隱患。以“三(san)鹿(lu)奶(nai)粉”嚴(yan)重事件為借鑒,狠抓藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)的(de)(de)(de)(de)管(guan)(guan)理,對照新(xin)修訂的(de)(de)(de)(de)《藥(yao)(yao)(yao)(yao)(yao)品(pin)GMP認證檢查(cha)評定標準(zhun)》各(ge)(ge)項(xiang)條(tiao)款,通過自查(cha)抽查(cha),找準(zhun)問題,清(qing)除源頭(tou),落(luo)(luo)實責(ze)(ze)(ze)任(ren)(ren)人(ren),做好日常跟蹤(zong)檢查(cha)工(gong)作,保證企(qi)(qi)(qi)業(ye)自覺(jue)嚴(yan)格(ge)(ge)執(zhi)行(xing)《藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)管(guan)(guan)理規范》(GMP),確保藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)企(qi)(qi)(qi)業(ye)嚴(yan)格(ge)(ge)按(an)照經(jing)(jing)批準(zhun)的(de)(de)(de)(de)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)工(gong)藝和(he)(he)處方組織生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)。同時(shi),要(yao)(yao)在(zai)(zai)年底(di)前(qian)開展(zhan)徹底(di)的(de)(de)(de)(de)庫(ku)存(cun)(cun)商品(pin)清(qing)理工(gong)作,及時(shi)處理退換(huan)貨,銷(xiao)毀不合格(ge)(ge)商品(pin),并制(zhi)(zhi)(zhi)定出滯銷(xiao)商品(pin)的(de)(de)(de)(de)解決方案。對于(yu)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)經(jing)(jing)營(ying)的(de)(de)(de)(de)品(pin)種嚴(yan)把質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)關(guan),特(te)別(bie)關(guan)注(zhu)(zhu)藥(yao)(yao)(yao)(yao)(yao)品(pin)、食品(pin)、食品(pin)添加(jia)劑及化(hua)工(gong)產(chan)(chan)(chan)(chan)品(pin)的(de)(de)(de)(de)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)情(qing)況(kuang),分清(qing)所經(jing)(jing)營(ying)商品(pin)的(de)(de)(de)(de)實際用(yong)途,嚴(yan)格(ge)(ge)履行(xing)必要(yao)(yao)的(de)(de)(de)(de)資質(zhi)(zhi)(zhi)(zhi)(zhi)驗證手續,杜絕(jue)(jue)超范圍經(jing)(jing)營(ying);對于(yu)產(chan)(chan)(chan)(chan)銷(xiao)渠道進行(xing)嚴(yan)格(ge)(ge)控制(zhi)(zhi)(zhi),特(te)別(bie)關(guan)注(zhu)(zhu)藥(yao)(yao)(yao)(yao)(yao)店終端(duan)銷(xiao)售(shou),杜絕(jue)(jue)沒有質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)監督的(de)(de)(de)(de)過票經(jing)(jing)營(ying)。醫(yi)(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)將(jiang)在(zai)(zai)年底(di)按(an)照GSP要(yao)(yao)求(qiu)檢查(cha)庫(ku)存(cun)(cun)商品(pin)情(qing)況(kuang)。二是完(wan)善制(zhi)(zhi)(zhi)度(du),快速反應。醫(yi)(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)所屬藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和(he)(he)經(jing)(jing)營(ying)企(qi)(qi)(qi)業(ye)要(yao)(yao)建立并完(wan)善藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和(he)(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)安(an)全(quan)(quan)事故(gu)即時(shi)上(shang)報(bao)制(zhi)(zhi)(zhi)度(du),一旦(dan)發(fa)生(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和(he)(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)安(an)全(quan)(quan)事故(gu),必須在(zai)(zai)第一時(shi)間逐級上(shang)報(bao)至醫(yi)(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)總公(gong)司(si)(si),以便于(yu)及時(shi)掌握了(le)解情(qing)況(kuang),正確決策和(he)(he)處理。三(san)是明(ming)確責(ze)(ze)(ze)任(ren)(ren),嚴(yan)格(ge)(ge)管(guan)(guan)理。各(ge)(ge)分公(gong)司(si)(si)要(yao)(yao)完(wan)善藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和(he)(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)安(an)全(quan)(quan)事故(gu)責(ze)(ze)(ze)任(ren)(ren)人(ren)追(zhui)究(jiu)制(zhi)(zhi)(zhi)度(du),落(luo)(luo)實各(ge)(ge)級安(an)全(quan)(quan)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)責(ze)(ze)(ze)任(ren)(ren)人(ren),明(ming)確責(ze)(ze)(ze)任(ren)(ren)目標,一旦(dan)發(fa)生(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和(he)(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)安(an)全(quan)(quan)事故(gu),將(jiang)嚴(yan)格(ge)(ge)追(zhui)究(jiu)有關(guan)人(ren)員責(ze)(ze)(ze)任(ren)(ren),絕(jue)(jue)不姑(gu)息遷就。

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