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全方位加强兽药生产质量管理 促进兽药产业转型升级 ———农业农村部畜牧兽医局负责人就《兽药生产质量管理规范(2020年修订)》答记者问

发布时间: 2019-05-09 09:55     来源:湖北快3投注_湖北快3下载【信誉平台】

 JINQI,NONGYENONGCUNBUFABU《SHOUYAOSHENGCHANZHILIANGGUANLIGUIFAN(2020NIANXIUDING)》(YIXIAJIANCHENG“XINBANSHOUYAOGMP”)。JIZHEJIUXIANGGUANWENTICAIFANGLENONGYENONGCUNBUCHUMUSHOUYIJUFUZEREN。

  问: 什么是兽药生产质量管理规范?

  DA: SHOUYAOSHENGCHANZHILIANGGUANLIGUIFAN(SHOUYAOGMP)SHISHOUYAOSHENGCHANGUANLIHEZHILIANGKONGZHIDEJIBENYAOQIUHEZHUNZE,SHISHIJIEGEGUODUISHOUYAOSHENGCHANQUANGUOCHENGJIANDUGUANLIPUBIANCAIYONGDEFADINGJISHUGUIFAN。SHOUYAOSHENGCHANSHIYIGESHIFENFUZADEGUOCHENG,SHEJIDAOXUDUOHUANJIEHEGUANLI,RENHEYIGEHUANJIESHUHUDOUYOUKENENGDAOZHICHANPINZHILIANGWENTI。WEIJIAQIANGSHOUYAOSHENGCHANZHILIANGGUANLI,2002NIAN,YUANNONGYEBUBANBUSHISHILESHOUYAOGMP。TONGGUOSHISHISHOUYAOGMP,CONGRENYUAN、CHANGFANG、SHEBEI、WULIAO、WENJIAN、SHENGCHANGUOCHENG、CHANPINXIAOSHOU、ZIJIANDENGQUANGUOCHENG、QUANFANGWEIGUIFANSHOUYAOSHENGCHANXINGWEI,QUEBAOSHOUYAOCHANPINZHILIANGANQUAN,DUICUJINSHOUYAOXINGYEJIANKANGFAZHAN、WEIHUDONGWUCHANPINZHILIANGANQUANFAHUILEZHONGYAOZUOYONG。

  问: 为什么要修订发布新版兽药GMP?

  DA: SHOUYAOGMPZI2002NIANSHISHIYILAI,DUIGUIFANSHOUYAOSHENGCHANQIYEXINGWEI、CUJINSHOUYAOXINGYEJIANKANGFAZHANFAHUILEZHONGYAOBAOZHANGZUOYONG。DANSUIZHEJINGJISHEHUIFAZHANHECHANYEJISHUJINBU,YUANSHOUYAOGMPYIYUELAIYUEBUSHIYINGSHOUYAOCHANYEFAZHANHEXINGYEGUANLIDESHIJIXUYAO,JIXUXIUDINGWANSHAN。

  YISHIZHUNRUMENJIANJIAODI,DISHUIPINGZHONGFUJIANSHEWENTITUCHU。JINGGUODUONIANFAZHAN,WOGUOSHOUYAOCHANYEYIXINGCHENGYIDINGGUIMO,DANSHENGCHANQIYESHULIANGDUO、GUIMOXIAO、XIAOYIDIDEJUMIANSHANGWEIGENBENGAIBIAN。DISHUIPINGZHONGFUJIANSHEZAOCHENGZIYUANLANGFEI、CHANNENGGUOSHENG、CHANYEJIZHONGDUPIANDI,DAOZHICHANPINTONGZHIHUAHEEXINGJINGZHENG,YIXIESHOUYAOCHANPINZHILIANGCANCHABUQI,JIDONGWUCHANPINZHILIANGANQUANDAILAIFENGXIANYINHUAN。

湖北快3投注  ERSHISHOUYAOSHENGCHANCHEJIANJIEJINGDUKONGZHIBIAOZHUNPIANDI,ZHILIANGANQUANCUNZAIYIDINGFENGXIAN。OUMENGYIJIWOGUOXINBAN《YAOPINSHENGCHANZHILIANGGUANLIGUIFAN》DUISHENGCHANCHEJIANKONGQIJIEJINGDUFENLEIFANGFAJUNYISHELILEJINGTAIBIAOZHUNHEDONGTAIBIAOZHUN,YAOQIUDUISHENGCHANHUANJINGSHIXINGDONGTAIJIANCE,JIJIANCEZAISHIJISHENGCHANTIAOJIANXIADEKONGQIJIEJINGSHUIPING。YUANSHOUYAOGMPDUIWOGUOSHOUYAOSHENGCHANKONGQIJIEJINGDUDEGUIDINGJINWEIJINGTAIJIANCEBIAOZHUN,YIBUNENGMANZUSHOUYAOGUIMOHUASHENGCHANDEXUYAO,JIXUJINYIBUWANSHAN。

  SANSHIYUANSHOUYAOGMPDEGUIDINGHEYAOQIUCUNZAIGUANLIKONGBAI,JIXUXIHUAHEWANSHAN。ZHILIANGFENGXIANLIANGHUAGUANLISHIGUONEIWAIYAOPINGUANLITIXIZHONGDETONGXINGZUOFAHEYOUXIAOSHOUDUAN,YUANSHOUYAOGMPQUEFAXIANGGUANYAOQIU,QIYEDUOYIKAOJINGYANJINXINGGUANLI,BULIYUGUANKONGZHILIANGFENGXIAN。SUIZHEJISHUJINBU,DIANZIJILUYIGUANGFANYINGYONGYUSHOUYAOSHENGCHANGUANLI,DANJISUANJIHUAXITONGDEGUANLIYAOQIUYIJIDIANZIJILUDEYOUXIAOXINGDENGNEIRONGZAIYUANSHOUYAOGMPZHONGMEIYOUXIANGYINGDEGUIDINGYAOQIU。CIWAI,YUANSHOUYAOGMPDEGUIDINGHEYAOQIUHAICUNZAIBUGOUXIHUADENGWENTI。

  问: 新版兽药GMP在哪些方面进行了修订完善?

  DA: ZAIXIUDINGXINBANSHOUYAOGMPSHI,HUBEIKUAI3TOUZHUSHIZHONGJIANCHIZONGJIEJIEJIANYULIZUGUOQINGXIANGJIEHE、YINGJIANRUANJIANBINGZHONGYUQIANGHUARENYUANSUZHIXIANGJIEHE、CHANPINZHILIANGANQUANHESHENGWUANQUANXIANGJIEHEDEYUANZE,TIGAOLEXIANGGUANYAOQIUHEBIAOZHUN。XINBANSHOUYAOGMPSHISHIHOUJIANGYOUXIAOEZHIDISHUIPINGZHONGFUJIANSHE,TIGAOCHANYEJIZHONGDU,TISHENGCHANPINZHILIANGKONGZHISHUIPING,GENGHAODIBAOZHANGDONGWUYUANSHIPINANQUANHEGONGGONGWEISHENGANQUAN。XIUDINGNEIRONGZHUYAOSHEJIYIXIASIGEFANGMIAN。

  YISHIYOUHUAJIEGOU,XIHUANEIRONG,TIGAOZHIDAOXINGHEKECAOZUOXING。XINBANSHOUYAOGMPGONG13ZHANG287TIAO,ERYUANSHOUYAOGMPJIN95TIAO。GEZHANGFENJIEBIANXIE,DUIGEXIANGYAOQIUJINKENENGXIHUA,BIANYUSHIYONGZHELIJIEZHANGWO。TONGSHI,GENJUBUTONGLEIXINGSHOUYAODESHENGCHANGONGYIHETEDIAN,HUBEIKUAI3TOUZHUTONGBUZHIDINGLEWUJUNSHOUYAO、FEIWUJUNSHOUYAO、SHOUYONGSHENGWUZHIPIN、YUANLIAOYAO、ZHONGYAOZHIJIDENG5LEISHOUYAOSHENGCHANZHILIANGGUANLIDETESHUYAOQIU,DUIZHENGWENBUFENDEYUANZEXINGGUIDINGJINYIBUXIHUA,ZENGQIANGZHIDAOXINGHEKECAOZUOXING。JIANYUXIANGGUANSHOUYAOSHENGCHANZHILIANGGUANLIYAOQIUSHIDUIZHENGWENDEXIHUA,WEIBIANYUJINHOUJISHIXIUDING,ZHENGWENYIBULINGXINGSHIFABU,XIANGGUANZHILIANGGUANLIDETESHUYAOQIUZUOWEIZHENGWENDEFULUYIGONGGAOXINGSHIFABU。

湖北快3投注  ERSHITIGAOZHUNRUMENJIAN,EZHIDISHUIPINGZHONGFUJIANSHE。ZAIYINGJIANFANGMIAN,TIGAOLEJINGHUAYAOQIUHETESHUSHOUYAOPINZHONGSHENGCHANSHESHIYAOQIU。CANKAOOUMENGHEWOGUOYAOPINSHENGCHANZHILIANGGUANLIGUIFANDUIWUJUNZHIJIKONGQIJIEJINGDUJIBIEDEYAOQIU,JIANGWUJUNSHOUYAOHESHOUYONGSHENGWUZHIPINSHENGCHANHUANJINGJINGHUASHEZHIWEIA、B、C、D SIGEJIBIE,ZENGJIALESHENGCHANHUANJINGDONGTAIJIANCE,DUICHANGFANGJIANSHEHEJINGHUASHEBEIXIANZHUTIGAOLEYAOQIU。DUIGAOSHENGWUHUOXINGDETESHUSHOUYAOSHENGCHAN,YAOQIUSHIYONGZHUANMENDESHENGCHANCHEJIAN、SHEBEIJIKONGDIAOJINGHUAXITONG,BINGYUQITASHOUYAOSHENGCHANQUYANGEFENKAI。ZAIRUANJIANFANGMIAN,TIGAOLEQIYEZHILIANGGUANLIYAOQIU。YINRUZHILIANGFENGXIANGUANLI、BIANGENGKONGZHI、PIANCHACHULI、JIUZHENGHEYUFANGCUOSHI、CHANPINZHILIANGHUIGUFENXI、CHIXUWENDINGXINGKAOCHAJIHUA、SHEJIQUERENDENGZHIDU,ZUIDAXIANDUBAOZHENGSHOUYAOCHANPINZHILIANG。ZAIRENYUANFANGMIAN,TIGAOLEQIYEGUANJIANGUANLIRENYUANYINGDANGJUBEIDEZIZHIHEJINENGYAOQIU。

湖北快3投注  SANSHITIGAOQIYESHENGWUANQUANKONGZHIYAOQIU,QUEBAOSHENGWUANQUAN。DUISHOUYONGSHENGWUZHIPINSHENGCHAN、JIANYANZHONGSHEJISHENGWUANQUANFENGXIANDECHANGFANG、SHESHISHEBEIYIJIFEIQIWU、HUODUFEISHUIHEPAIFANGKONGQIDECHULIDENG,JINYIBUTICHULEYANGEYAOQIU。YOUSHENGWUANQUANSANJIFANGHUYAOQIUDESHOUYONGSHENGWUZHIPINDESHENGCHANSHESHIXUFUHESHENGWUANQUANSANJIFANGHUBIAOZHUN,JIANYANSHESHIXUDADAOSHENGWUANQUANSANJISHIYANSHIBIAOZHUN。

  SISHIWANSHANZERENGUANLIJIZHI,YASHIXIANGGUANZEREN。MINGQUEQIYEFUZERENSHISHOUYAOZHILIANGDEZHUYAOZERENREN。JIANGYUANSHOUYAOGMPGUIDINGDESHENGCHANGUANLIBUMENHEZHILIANGGUANLIBUMENCHENGDANDEZHIZEFENBIEMINGQUEDAOSHENGCHANGUANLIFUZERENHEZHILIANGGUANLIFUZEREN,WEIZHUIJIUSHOUYAOCHANPINZHILIANGSHIGUZERENRENTIGONGYIJU。

  问: 新版兽药GMP什么时候实施?在实施安排上有哪些要求?

  DA: XINBANSHOUYAOGMPJIANGYU2020NIAN6YUE1RIQISHIXING。JINQINONGYENONGCUNBUFABULEDI293HAOGONGGAO,GONGBULESHISHIYAOQIUHEGUODUQIJUTIANPAI。GENJUDI293HAOGONGGAO,SUOYOUSHOUYAOSHENGCHANQIYEJUNYINGZAI2022NIAN6YUE1RIQIANDADAOXINBANSHOUYAOGMPYAOQIU;WEIDADAOXINBANSHOUYAOGMPYAOQIUDESHOUYAOSHENGCHANQIYE(SHENGCHANCHEJIAN),QISHOUYAOSHENGCHANXUKEZHENGHESHOUYAOGMPZHENGSHUYOUXIAOQIZUIZHANGBUCHAOGUO2022NIAN5YUE31RI。ZI2020NIAN6YUE1RIQI,XINJIANSHOUYAOSHENGCHANQIYEYIJISHOUYAOSHENGCHANQIYEGAI、KUOJIANHUOQIANZHIZHONGJIANSHENGCHANCHEJIAN,JUNYINGFUHEXINBANSHOUYAOGMPYAOQIU。ZI2020NIAN6YUE1RIQI,SHENGJICHUMUSHOUYIZHUGUANBUMENSHOULISHOUYAOSHENGCHANQIYEANZHAOXINBANSHOUYAOGMPYAOQIUTICHUDESHENQING,JINGJIANCHAYANSHOUFUHEYAOQIUDE,SHOUYAOSHENGCHANXUKEZHENGHESHOUYAOGMPZHENGSHUYOUXIAOQIWEI5NIAN;SHOULISHOUYAOSHENGCHANQIYEDAOQIHUANZHENGBINGANZHAO2002NIANFABUDESHOUYAOGMPYAOQIUTICHUDESHENQING,JINGJIANCHAYANSHOUFUHEYAOQIUDE,SHOUYAOSHENGCHANXUKEZHENGHESHOUYAOGMPZHENGSHUYOUXIAOQIHEFAZHI2022NIAN5YUE31RI。DUI2020NIAN6YUE1RIQIANYIJINGSHOULIDESHENQING,ANYUANGUIDINGWANCHENGXIANGGUANGONGZUOBINGHEFASHOUYAOSHENGCHANXUKEZHENGHESHOUYAOGMPZHENGSHU,ZHENGSHUYOUXIAOQIHEFAZHI2022NIAN5YUE31RI。

  XINBANSHOUYAOGMPNEIHANFENGFU,YAOQIUJUTI,XIANGGUANBIAOZHUNHENGAO。GESHENGJICHUMUSHOUYIZHUGUANBUMENYAODAITOURENZHENXUEXILINGHUI,QIESHIJIAQIANGDUIXINBANSHOUYAOGMPDEXUANCHUANGUANCHE,GUANGFANKAIZHANDUOZHONGXINGSHIDEXUANCHUANPEIXUN,BANGZHUGUANGDACONGYERENYUANQUANMIANZHANGWOQIJIBENNEIHANHEJINGSHENSHIZHI,QIESHIZUODAOXUANCHUANDAOWEI、ZHIXINGDAOWEI、JIANGUANDAOWEI。GESHOUYAOSHENGCHANQIYEYAOYANGEZUNSHOU、QUANMIANZHIXINGXINBANSHOUYAOGMP,RENZHENLVXINGZHILIANGANQUANZHUTIZEREN,BUDUANTIGAOSHOUYAOCHANPINZHILIANGANQUANSHUIPING,YOUXIAOWEIHUDONGWUCHANPINZHILIANGANQUANHEGONGGONGWEISHENGANQUAN。


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