為進一步加強我市(shi)藥(yao)(yao)品(pin)(pin)生(sheng)產管理(li)，保障藥(yao)(yao)品(pin)(pin)生(sheng)產環節的(de)質(zhi)(zhi)量安全(quan)，近日，營口市(shi)食品(pin)(pin)藥(yao)(yao)品(pin)(pin)監督管理(li)局召開全(quan)市(shi)藥(yao)(yao)品(pin)(pin)生(sheng)產質(zhi)(zhi)量安全(quan)工作會議，市(shi)食品(pin)(pin)藥(yao)(yao)品(pin)(pin)監督管理(li)局副局長秦顯杰、相關科室(shi)人(ren)員、全(quan)市(shi)藥(yao)(yao)品(pin)(pin)生(sheng)產企業的(de)法人(ren)及質(zhi)(zhi)量、生(sheng)產負責人(ren)參加會議。
會議回顧了2012年(nian)(nian)全(quan)市藥(yao)(yao)(yao)(yao)品生(sheng)(sheng)產(chan)(chan)(chan)企業(ye)(ye)(ye)質(zhi)量安(an)全(quan)監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)工作(zuo)，分析了當前的(de)(de)(de)(de)(de)監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)形勢，布置了2013年(nian)(nian)全(quan)市藥(yao)(yao)(yao)(yao)品生(sheng)(sheng)產(chan)(chan)(chan)監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)任(ren)務(wu)。2013年(nian)(nian)重點(dian)做(zuo)好(hao)六(liu)(liu)項工作(zuo)：一(yi)是(shi)以發(fa)現風險為目的(de)(de)(de)(de)(de)，切(qie)實強化現場監(jian)督檢查(cha)；二是(shi)開展(zhan)基本(ben)藥(yao)(yao)(yao)(yao)物生(sheng)(sheng)產(chan)(chan)(chan)企業(ye)(ye)(ye)質(zhi)量管(guan)(guan)(guan)(guan)(guan)(guan)理狀況評估工作(zuo)，提高(gao)監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)水平；三是(shi)全(quan)力做(zuo)好(hao)新版GMP實施工作(zuo)，促進產(chan)(chan)(chan)業(ye)(ye)(ye)升級和藥(yao)(yao)(yao)(yao)品質(zhi)量提高(gao)；四是(shi)進一(yi)步加(jia)(jia)(jia)(jia)強藥(yao)(yao)(yao)(yao)品不(bu)良(liang)反應(ying)監(jian)測(ce)(ce)工作(zuo)，明確企業(ye)(ye)(ye)在監(jian)測(ce)(ce)工作(zuo)中的(de)(de)(de)(de)(de)責任(ren)；五是(shi)切(qie)實加(jia)(jia)(jia)(jia)強特殊藥(yao)(yao)(yao)(yao)品監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)，避免社會危(wei)害；六(liu)(liu)是(shi)認真做(zuo)好(hao)電子監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)工作(zuo)，保證(zheng)賦碼(ma)管(guan)(guan)(guan)(guan)(guan)(guan)理率100%.市局要(yao)求(qiu)安(an)監(jian)科要(yao)緊緊圍繞這六(liu)(liu)項工作(zuo)，加(jia)(jia)(jia)(jia)強對(dui)藥(yao)(yao)(yao)(yao)品生(sheng)(sheng)產(chan)(chan)(chan)企業(ye)(ye)(ye)的(de)(de)(de)(de)(de)監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)，確保完成要(yao)求(qiu)的(de)(de)(de)(de)(de)監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)頻次，提高(gao)監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)質(zhi)量，確保藥(yao)(yao)(yao)(yao)品生(sheng)(sheng)產(chan)(chan)(chan)環節(jie)不(bu)出(chu)現監(jian)管(guan)(guan)(guan)(guan)(guan)(guan)漏(lou)洞，保證(zheng)藥(yao)(yao)(yao)(yao)品質(zhi)量；也要(yao)求(qiu)各藥(yao)(yao)(yao)(yao)品生(sheng)(sheng)產(chan)(chan)(chan)企業(ye)(ye)(ye)要(yao)切(qie)實加(jia)(jia)(jia)(jia)強本(ben)企業(ye)(ye)(ye)的(de)(de)(de)(de)(de)藥(yao)(yao)(yao)(yao)品質(zhi)量管(guan)(guan)(guan)(guan)(guan)(guan)理，落實第(di)一(yi)責任(ren)人意識，規范生(sheng)(sheng)產(chan)(chan)(chan)行為，嚴格按照GMP要(yao)求(qiu)和規定(ding)的(de)(de)(de)(de)(de)處(chu)方工藝(yi)生(sheng)(sheng)產(chan)(chan)(chan)藥(yao)(yao)(yao)(yao)品。會議還對(dui)2013年(nian)(nian)全(quan)市藥(yao)(yao)(yao)(yao)品生(sheng)(sheng)產(chan)(chan)(chan)企業(ye)(ye)(ye)不(bu)良(liang)反應(ying)監(jian)測(ce)(ce)上報和基本(ben)藥(yao)(yao)(yao)(yao)物抽(chou)驗進行了詳細安(an)排。
秦顯(xian)杰副局長代表市局黨(dang)組提(ti)(ti)出五點要(yao)求：一是(shi)生(sheng)產(chan)(chan)企(qi)(qi)業(ye)要(yao)加強(qiang)管(guan)理、依(yi)法(fa)生(sheng)產(chan)(chan)、保(bao)證安(an)(an)全(quan)，嚴格(ge)按照(zhao)法(fa)律法(fa)規進行生(sheng)產(chan)(chan)，原輔料及成品全(quan)項檢驗(yan)；二是(shi)要(yao)扎實(shi)推(tui)行新版GMP,確保(bao)企(qi)(qi)業(ye)認證通(tong)過；三是(shi)市局執法(fa)人員要(yao)依(yi)法(fa)監管(guan)、依(yi)法(fa)服(fu)務(wu)、嚴肅(su)執法(fa)、嚴厲查(cha)處；要(yao)發揚"死(si)看死(si)守"的精神，檢查(cha)計劃要(yao)周到(dao)，任(ren)務(wu)要(yao)明確，職責要(yao)清楚，對于查(cha)出的問(wen)題分析要(yao)到(dao)位，要(yao)有監督、有結果，重點加強(qiang)基本藥(yao)物(wu)及中藥(yao)生(sheng)產(chan)(chan)的監管(guan)，提(ti)(ti)高對輔料企(qi)(qi)業(ye)的監管(guan)力度，確保(bao)安(an)(an)全(quan)；四是(shi)生(sheng)產(chan)(chan)企(qi)(qi)業(ye)應提(ti)(ti)高對PSUR報告的認識，認真填報；五是(shi)加強(qiang)藥(yao)品抽驗(yan)，特別是(shi)要(yao)保(bao)證基本藥(yao)物(wu)抽驗(yan)全(quan)覆蓋，在庫(ku)抽驗(yan)合格(ge)率要(yao)達到(dao)100%.
