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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:中(zhong)國醫藥集(ji)團總(zong)公司(si)  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(zhong)國(guo)醫(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)(tuan)所(suo)屬各(ge)(ge)公(gong)司要(yao)(yao)(yao)提高認識,吸取教訓,對(dui)(dui)本單位生(sheng)(sheng)產(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)的(de)(de)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)進行(xing)全面自查(cha)(cha)(cha),加強監管(guan),排查(cha)(cha)(cha)隱患。以(yi)“三鹿奶粉”嚴(yan)重事(shi)件為借鑒,狠抓(zhua)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)質(zhi)(zhi)(zhi)量(liang)(liang)(liang)的(de)(de)管(guan)理(li),對(dui)(dui)照(zhao)(zhao)新修(xiu)訂的(de)(de)《藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)GMP認證(zheng)檢(jian)(jian)查(cha)(cha)(cha)評(ping)定(ding)(ding)標準》各(ge)(ge)項條款,通(tong)過自查(cha)(cha)(cha)抽(chou)查(cha)(cha)(cha),找準問(wen)題,清(qing)除源頭,落實責(ze)任(ren)人,做好日常跟蹤檢(jian)(jian)查(cha)(cha)(cha)工作,保證(zheng)企(qi)(qi)業自覺(jue)嚴(yan)格(ge)(ge)執行(xing)《藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)質(zhi)(zhi)(zhi)量(liang)(liang)(liang)管(guan)理(li)規范(fan)》(GMP),確(que)保藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)(qi)業嚴(yan)格(ge)(ge)按(an)照(zhao)(zhao)經(jing)(jing)批(pi)準的(de)(de)生(sheng)(sheng)產(chan)(chan)(chan)工藝和(he)處(chu)方組織生(sheng)(sheng)產(chan)(chan)(chan)。同(tong)時(shi),要(yao)(yao)(yao)在年底(di)前開(kai)展徹底(di)的(de)(de)庫(ku)存商(shang)(shang)品(pin)(pin)(pin)(pin)清(qing)理(li)工作,及時(shi)處(chu)理(li)退換貨,銷(xiao)毀不(bu)合格(ge)(ge)商(shang)(shang)品(pin)(pin)(pin)(pin),并制(zhi)定(ding)(ding)出滯銷(xiao)商(shang)(shang)品(pin)(pin)(pin)(pin)的(de)(de)解(jie)決方案。對(dui)(dui)于(yu)生(sheng)(sheng)產(chan)(chan)(chan)經(jing)(jing)營(ying)的(de)(de)品(pin)(pin)(pin)(pin)種嚴(yan)把質(zhi)(zhi)(zhi)量(liang)(liang)(liang)關(guan)(guan),特別關(guan)(guan)注藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)、食(shi)品(pin)(pin)(pin)(pin)、食(shi)品(pin)(pin)(pin)(pin)添(tian)加劑及化工產(chan)(chan)(chan)品(pin)(pin)(pin)(pin)的(de)(de)質(zhi)(zhi)(zhi)量(liang)(liang)(liang)情(qing)況,分(fen)(fen)清(qing)所(suo)經(jing)(jing)營(ying)商(shang)(shang)品(pin)(pin)(pin)(pin)的(de)(de)實際用途,嚴(yan)格(ge)(ge)履(lv)行(xing)必要(yao)(yao)(yao)的(de)(de)資(zi)質(zhi)(zhi)(zhi)驗證(zheng)手(shou)續,杜絕超范(fan)圍(wei)經(jing)(jing)營(ying);對(dui)(dui)于(yu)產(chan)(chan)(chan)銷(xiao)渠道進行(xing)嚴(yan)格(ge)(ge)控制(zhi),特別關(guan)(guan)注藥(yao)(yao)(yao)(yao)(yao)店終端銷(xiao)售,杜絕沒(mei)有質(zhi)(zhi)(zhi)量(liang)(liang)(liang)監督的(de)(de)過票經(jing)(jing)營(ying)。醫(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)(tuan)將在年底(di)按(an)照(zhao)(zhao)GSP要(yao)(yao)(yao)求檢(jian)(jian)查(cha)(cha)(cha)庫(ku)存商(shang)(shang)品(pin)(pin)(pin)(pin)情(qing)況。二是完(wan)善(shan)制(zhi)度,快速反應。醫(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)(tuan)所(suo)屬藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)企(qi)(qi)業要(yao)(yao)(yao)建立(li)并完(wan)善(shan)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)量(liang)(liang)(liang)安(an)(an)全事(shi)故即時(shi)上報制(zhi)度,一(yi)旦發生(sheng)(sheng)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)量(liang)(liang)(liang)安(an)(an)全事(shi)故,必須在第一(yi)時(shi)間逐級上報至醫(yi)藥(yao)(yao)(yao)(yao)(yao)集團(tuan)(tuan)總公(gong)司,以(yi)便于(yu)及時(shi)掌握(wo)了解(jie)情(qing)況,正確(que)決策(ce)和(he)處(chu)理(li)。三是明(ming)確(que)責(ze)任(ren),嚴(yan)格(ge)(ge)管(guan)理(li)。各(ge)(ge)分(fen)(fen)公(gong)司要(yao)(yao)(yao)完(wan)善(shan)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)量(liang)(liang)(liang)安(an)(an)全事(shi)故責(ze)任(ren)人追究制(zhi)度,落實各(ge)(ge)級安(an)(an)全生(sheng)(sheng)產(chan)(chan)(chan)責(ze)任(ren)人,明(ming)確(que)責(ze)任(ren)目標,一(yi)旦發生(sheng)(sheng)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)和(he)經(jing)(jing)營(ying)質(zhi)(zhi)(zhi)量(liang)(liang)(liang)安(an)(an)全事(shi)故,將嚴(yan)格(ge)(ge)追究有關(guan)(guan)人員責(ze)任(ren),絕不(bu)姑(gu)息遷就。

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