文章來源:中(zhong)國醫藥集(ji)團總(zong)公司 發(fa)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。
中國醫藥(yao)(yao)(yao)(yao)(yao)集團所(suo)屬各公(gong)司要提高認識(shi),吸取教訓,對本單位生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和經(jing)(jing)(jing)營(ying)(ying)的(de)(de)藥(yao)(yao)(yao)(yao)(yao)品(pin)進(jin)行全(quan)(quan)面自查(cha)(cha)(cha),加強(qiang)監管(guan)(guan),排(pai)查(cha)(cha)(cha)隱患。以(yi)“三(san)(san)鹿奶粉(fen)”嚴(yan)(yan)(yan)重事(shi)(shi)件(jian)為(wei)借(jie)鑒,狠抓藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)質(zhi)量(liang)的(de)(de)管(guan)(guan)理,對照新修(xiu)訂的(de)(de)《藥(yao)(yao)(yao)(yao)(yao)品(pin)GMP認證(zheng)檢查(cha)(cha)(cha)評定標準(zhun)》各項條(tiao)款,通過自查(cha)(cha)(cha)抽查(cha)(cha)(cha),找準(zhun)問題,清除源頭,落實(shi)責(ze)(ze)任(ren)(ren)人(ren)(ren),做好日常(chang)跟蹤檢查(cha)(cha)(cha)工作(zuo),保證(zheng)企業(ye)自覺嚴(yan)(yan)(yan)格(ge)(ge)(ge)執(zhi)行《藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)質(zhi)量(liang)管(guan)(guan)理規范》(GMP),確(que)保藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)企業(ye)嚴(yan)(yan)(yan)格(ge)(ge)(ge)按照經(jing)(jing)(jing)批準(zhun)的(de)(de)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)工藝和處(chu)方組織生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)。同時,要在(zai)年底前開展徹底的(de)(de)庫(ku)存(cun)(cun)商(shang)品(pin)清理工作(zuo),及(ji)時處(chu)理退換(huan)貨,銷(xiao)(xiao)毀不(bu)合格(ge)(ge)(ge)商(shang)品(pin),并(bing)制(zhi)(zhi)定出滯銷(xiao)(xiao)商(shang)品(pin)的(de)(de)解決(jue)方案。對于生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)經(jing)(jing)(jing)營(ying)(ying)的(de)(de)品(pin)種(zhong)嚴(yan)(yan)(yan)把質(zhi)量(liang)關,特別(bie)關注藥(yao)(yao)(yao)(yao)(yao)品(pin)、食品(pin)、食品(pin)添加劑及(ji)化工產(chan)(chan)(chan)(chan)品(pin)的(de)(de)質(zhi)量(liang)情(qing)況(kuang)(kuang),分(fen)清所(suo)經(jing)(jing)(jing)營(ying)(ying)商(shang)品(pin)的(de)(de)實(shi)際用途(tu),嚴(yan)(yan)(yan)格(ge)(ge)(ge)履(lv)行必要的(de)(de)資(zi)質(zhi)驗(yan)證(zheng)手續,杜絕超范圍經(jing)(jing)(jing)營(ying)(ying);對于產(chan)(chan)(chan)(chan)銷(xiao)(xiao)渠道進(jin)行嚴(yan)(yan)(yan)格(ge)(ge)(ge)控制(zhi)(zhi),特別(bie)關注藥(yao)(yao)(yao)(yao)(yao)店終端銷(xiao)(xiao)售,杜絕沒有質(zhi)量(liang)監督的(de)(de)過票(piao)經(jing)(jing)(jing)營(ying)(ying)。醫藥(yao)(yao)(yao)(yao)(yao)集團將在(zai)年底按照GSP要求檢查(cha)(cha)(cha)庫(ku)存(cun)(cun)商(shang)品(pin)情(qing)況(kuang)(kuang)。二是(shi)(shi)完(wan)善(shan)制(zhi)(zhi)度,快(kuai)速反應。醫藥(yao)(yao)(yao)(yao)(yao)集團所(suo)屬藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和經(jing)(jing)(jing)營(ying)(ying)企業(ye)要建立并(bing)完(wan)善(shan)藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和經(jing)(jing)(jing)營(ying)(ying)質(zhi)量(liang)安全(quan)(quan)事(shi)(shi)故(gu)即(ji)時上(shang)報制(zhi)(zhi)度,一旦(dan)發生(sheng)(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和經(jing)(jing)(jing)營(ying)(ying)質(zhi)量(liang)安全(quan)(quan)事(shi)(shi)故(gu),必須在(zai)第一時間逐級上(shang)報至醫藥(yao)(yao)(yao)(yao)(yao)集團總(zong)公(gong)司,以(yi)便(bian)于及(ji)時掌握了解情(qing)況(kuang)(kuang),正確(que)決(jue)策和處(chu)理。三(san)(san)是(shi)(shi)明確(que)責(ze)(ze)任(ren)(ren),嚴(yan)(yan)(yan)格(ge)(ge)(ge)管(guan)(guan)理。各分(fen)公(gong)司要完(wan)善(shan)藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和經(jing)(jing)(jing)營(ying)(ying)質(zhi)量(liang)安全(quan)(quan)事(shi)(shi)故(gu)責(ze)(ze)任(ren)(ren)人(ren)(ren)追(zhui)究(jiu)(jiu)制(zhi)(zhi)度,落實(shi)各級安全(quan)(quan)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)責(ze)(ze)任(ren)(ren)人(ren)(ren),明確(que)責(ze)(ze)任(ren)(ren)目標,一旦(dan)發生(sheng)(sheng)(sheng)(sheng)(sheng)藥(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)和經(jing)(jing)(jing)營(ying)(ying)質(zhi)量(liang)安全(quan)(quan)事(shi)(shi)故(gu),將嚴(yan)(yan)(yan)格(ge)(ge)(ge)追(zhui)究(jiu)(jiu)有關人(ren)(ren)員責(ze)(ze)任(ren)(ren),絕不(bu)姑息遷就。