文章來源(yuan):中國醫(yi)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)(yao)集(ji)團所屬各公(gong)(gong)司要(yao)提高認識,吸取教訓,對(dui)(dui)本單位(wei)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)和(he)(he)經(jing)營(ying)(ying)的(de)(de)(de)藥(yao)(yao)品(pin)進行全面自查(cha)(cha),加強監管,排查(cha)(cha)隱(yin)患。以“三鹿奶粉”嚴重事(shi)件為借鑒,狠(hen)抓藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)質量(liang)(liang)(liang)的(de)(de)(de)管理,對(dui)(dui)照新修訂的(de)(de)(de)《藥(yao)(yao)品(pin)GMP認證檢(jian)查(cha)(cha)評定標(biao)(biao)準》各項條(tiao)款(kuan),通過(guo)(guo)自查(cha)(cha)抽查(cha)(cha),找準問題,清除源頭,落實責(ze)(ze)任(ren)(ren)(ren)人(ren),做好日常(chang)跟蹤檢(jian)查(cha)(cha)工(gong)(gong)作,保證企業(ye)自覺嚴格(ge)執行《藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)質量(liang)(liang)(liang)管理規范》(GMP),確(que)(que)保藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)企業(ye)嚴格(ge)按照經(jing)批準的(de)(de)(de)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)工(gong)(gong)藝和(he)(he)處(chu)(chu)方(fang)組織生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)。同時(shi),要(yao)在年(nian)底(di)前開展徹底(di)的(de)(de)(de)庫(ku)存(cun)商品(pin)清理工(gong)(gong)作,及(ji)時(shi)處(chu)(chu)理退換貨(huo),銷(xiao)(xiao)毀(hui)不(bu)合格(ge)商品(pin),并制定出(chu)滯(zhi)銷(xiao)(xiao)商品(pin)的(de)(de)(de)解(jie)決(jue)方(fang)案。對(dui)(dui)于(yu)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)經(jing)營(ying)(ying)的(de)(de)(de)品(pin)種嚴把(ba)質量(liang)(liang)(liang)關,特別關注藥(yao)(yao)品(pin)、食(shi)品(pin)、食(shi)品(pin)添加劑及(ji)化工(gong)(gong)產(chan)(chan)品(pin)的(de)(de)(de)質量(liang)(liang)(liang)情(qing)況,分清所經(jing)營(ying)(ying)商品(pin)的(de)(de)(de)實際用途,嚴格(ge)履行必要(yao)的(de)(de)(de)資質驗證手續,杜(du)絕超(chao)范圍經(jing)營(ying)(ying);對(dui)(dui)于(yu)產(chan)(chan)銷(xiao)(xiao)渠道進行嚴格(ge)控(kong)制,特別關注藥(yao)(yao)店終端銷(xiao)(xiao)售,杜(du)絕沒有(you)質量(liang)(liang)(liang)監督的(de)(de)(de)過(guo)(guo)票經(jing)營(ying)(ying)。醫藥(yao)(yao)集(ji)團將在年(nian)底(di)按照GSP要(yao)求檢(jian)查(cha)(cha)庫(ku)存(cun)商品(pin)情(qing)況。二是完(wan)(wan)善制度(du),快速反應。醫藥(yao)(yao)集(ji)團所屬藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)和(he)(he)經(jing)營(ying)(ying)企業(ye)要(yao)建立并完(wan)(wan)善藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)和(he)(he)經(jing)營(ying)(ying)質量(liang)(liang)(liang)安(an)(an)全事(shi)故(gu)即(ji)時(shi)上報(bao)制度(du),一旦(dan)發生(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)和(he)(he)經(jing)營(ying)(ying)質量(liang)(liang)(liang)安(an)(an)全事(shi)故(gu),必須(xu)在第一時(shi)間逐級上報(bao)至醫藥(yao)(yao)集(ji)團總公(gong)(gong)司,以便于(yu)及(ji)時(shi)掌握(wo)了解(jie)情(qing)況,正確(que)(que)決(jue)策和(he)(he)處(chu)(chu)理。三是明(ming)確(que)(que)責(ze)(ze)任(ren)(ren)(ren),嚴格(ge)管理。各分公(gong)(gong)司要(yao)完(wan)(wan)善藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)和(he)(he)經(jing)營(ying)(ying)質量(liang)(liang)(liang)安(an)(an)全事(shi)故(gu)責(ze)(ze)任(ren)(ren)(ren)人(ren)追究(jiu)制度(du),落實各級安(an)(an)全生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)責(ze)(ze)任(ren)(ren)(ren)人(ren),明(ming)確(que)(que)責(ze)(ze)任(ren)(ren)(ren)目標(biao)(biao),一旦(dan)發生(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)和(he)(he)經(jing)營(ying)(ying)質量(liang)(liang)(liang)安(an)(an)全事(shi)故(gu),將嚴格(ge)追究(jiu)有(you)關人(ren)員責(ze)(ze)任(ren)(ren)(ren),絕不(bu)姑息遷就。