文章來源:中國醫藥集團總公司 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)醫藥(yao)集(ji)(ji)團(tuan)所屬各公(gong)司(si)要提高認識,吸(xi)取教訓,對(dui)本單位生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)和(he)(he)經(jing)營(ying)(ying)(ying)的(de)(de)藥(yao)品(pin)(pin)進行(xing)全(quan)(quan)(quan)面(mian)自(zi)(zi)查(cha),加強監管(guan)(guan),排查(cha)隱(yin)患。以(yi)(yi)“三鹿奶粉”嚴(yan)重事(shi)(shi)(shi)件為借鑒(jian),狠抓藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)質(zhi)量(liang)(liang)的(de)(de)管(guan)(guan)理(li),對(dui)照(zhao)新修訂(ding)的(de)(de)《藥(yao)品(pin)(pin)GMP認證檢(jian)查(cha)評定標準》各項(xiang)條款,通過自(zi)(zi)查(cha)抽查(cha),找準問題(ti),清除源(yuan)頭,落實責任(ren)人,做(zuo)好日(ri)常跟蹤檢(jian)查(cha)工(gong)作,保證企(qi)業(ye)自(zi)(zi)覺嚴(yan)格執行(xing)《藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)質(zhi)量(liang)(liang)管(guan)(guan)理(li)規范》(GMP),確(que)保藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)企(qi)業(ye)嚴(yan)格按照(zhao)經(jing)批準的(de)(de)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)工(gong)藝和(he)(he)處(chu)方(fang)組織生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)。同(tong)時,要在年底(di)前(qian)開展徹底(di)的(de)(de)庫(ku)存商品(pin)(pin)清理(li)工(gong)作,及時處(chu)理(li)退(tui)換貨,銷(xiao)(xiao)毀(hui)不合格商品(pin)(pin),并(bing)制(zhi)(zhi)定出滯銷(xiao)(xiao)商品(pin)(pin)的(de)(de)解(jie)決方(fang)案。對(dui)于生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)經(jing)營(ying)(ying)(ying)的(de)(de)品(pin)(pin)種(zhong)嚴(yan)把質(zhi)量(liang)(liang)關(guan),特(te)別(bie)關(guan)注(zhu)藥(yao)品(pin)(pin)、食品(pin)(pin)、食品(pin)(pin)添加劑(ji)及化工(gong)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)品(pin)(pin)的(de)(de)質(zhi)量(liang)(liang)情(qing)況,分清所經(jing)營(ying)(ying)(ying)商品(pin)(pin)的(de)(de)實際用途,嚴(yan)格履(lv)行(xing)必(bi)(bi)要的(de)(de)資質(zhi)驗證手續,杜(du)絕(jue)超(chao)范圍經(jing)營(ying)(ying)(ying);對(dui)于產(chan)(chan)(chan)(chan)(chan)(chan)(chan)銷(xiao)(xiao)渠道進行(xing)嚴(yan)格控制(zhi)(zhi),特(te)別(bie)關(guan)注(zhu)藥(yao)店終端銷(xiao)(xiao)售,杜(du)絕(jue)沒有質(zhi)量(liang)(liang)監督的(de)(de)過票經(jing)營(ying)(ying)(ying)。醫藥(yao)集(ji)(ji)團(tuan)將在年底(di)按照(zhao)GSP要求(qiu)檢(jian)查(cha)庫(ku)存商品(pin)(pin)情(qing)況。二是完(wan)善(shan)(shan)(shan)制(zhi)(zhi)度,快速反應。醫藥(yao)集(ji)(ji)團(tuan)所屬藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)和(he)(he)經(jing)營(ying)(ying)(ying)企(qi)業(ye)要建立并(bing)完(wan)善(shan)(shan)(shan)藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)和(he)(he)經(jing)營(ying)(ying)(ying)質(zhi)量(liang)(liang)安(an)(an)(an)全(quan)(quan)(quan)事(shi)(shi)(shi)故(gu)即時上(shang)報(bao)(bao)制(zhi)(zhi)度,一(yi)(yi)旦發(fa)生(sheng)(sheng)(sheng)(sheng)藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)和(he)(he)經(jing)營(ying)(ying)(ying)質(zhi)量(liang)(liang)安(an)(an)(an)全(quan)(quan)(quan)事(shi)(shi)(shi)故(gu),必(bi)(bi)須在第一(yi)(yi)時間逐級上(shang)報(bao)(bao)至醫藥(yao)集(ji)(ji)團(tuan)總公(gong)司(si),以(yi)(yi)便于及時掌握了解(jie)情(qing)況,正確(que)決策和(he)(he)處(chu)理(li)。三是明確(que)責任(ren),嚴(yan)格管(guan)(guan)理(li)。各分公(gong)司(si)要完(wan)善(shan)(shan)(shan)藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)和(he)(he)經(jing)營(ying)(ying)(ying)質(zhi)量(liang)(liang)安(an)(an)(an)全(quan)(quan)(quan)事(shi)(shi)(shi)故(gu)責任(ren)人追(zhui)究(jiu)制(zhi)(zhi)度,落實各級安(an)(an)(an)全(quan)(quan)(quan)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)責任(ren)人,明確(que)責任(ren)目標,一(yi)(yi)旦發(fa)生(sheng)(sheng)(sheng)(sheng)藥(yao)品(pin)(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)(chan)和(he)(he)經(jing)營(ying)(ying)(ying)質(zhi)量(liang)(liang)安(an)(an)(an)全(quan)(quan)(quan)事(shi)(shi)(shi)故(gu),將嚴(yan)格追(zhui)究(jiu)有關(guan)人員責任(ren),絕(jue)不姑息遷(qian)就(jiu)。