YUANLI
VHPJISHUSHIZHIJIANGBOTAISHUANGYANGSHUIQIHUAWEIGUOYANGHUAQINGZHENGQI,YUNYONGQIHUADEGUOYANGHUAQINGDUIWUTIBIAOMIANDEDIWENMIEJUNJISHU。
VHPJUYOUGUANGPUSHAJUNXING,NENGYOUXIAOSHAMIEXIJUN,ZHENJUN、MEIJUN、BINGDU、XIJUNYABAODENGSUOYOULEIXINGDEWEISHENGWU,MUQIANFAXIANVHPZUINANSHAMIEDEWEISHENGWUSHISHIREZHIFANGYABAO,SUOYIVHPMIEJUNYANZHENGSUOYONGDESHENGWUZHISHIJIWEISHIREZHIFANGYABAO。
VHPMIEMIAOWUDUWUCANLIU,QIHUAGUOYANGHUAQINGZAIMIEJUNGUOCHENGZHONGKEYIKUAISUSHAMIEWEISHENGWU,MIEMIAOWANCHENGHOUNENGKUAISUJIANGJIEWEIH²OHEO²,WUDUWUCANLIU,QIEGUOYANGHUAQINGDECANLIUNONGDUKEJIANCE。
VHPMIEJUNXIAOGUOKEYANZHENG,ZHENGCHANGDEYIGEYANZHENGZHOUQIBAOKUOCANSHUKAIFA,VHPFENBUYANJIU,SHENGWUTIAOZHANSHIYANHEPAIFENGJIANGJIEYANJIU,INNOVE- HPBQIHUAGUOYANGHUAQINGSHEBEIJUYOUWANZHENGDEGMPYANZHENGWENJIANTIXI。
VHPMIEJUNJIANRONGXINGHAO,INNOVE- HPBXILIEDEQIHUAGUOYANGHUAQINGMIEJUNQICAIYONGTEYOUDEBAOHEDUKONGZHIFA,BAOZHENGZHENGGEMIEJUNGUOCHENGZHONGGUOYANGHUAYUNBUYEHUABULENGNING,CAILIAOJIANRONGXINGGENGHAO。
JIEGOU
SHEBEIZHUTI
VHPCHUANDICHUANGCAIYONGBUXIUGANGZHUTIJIEGOU,NEIQIANGCAIYONG316LBUXIUGANG,KUANGJIAHEWAIBIAOCAIYONG304BUXIUGANGJIEGOU,NEIMUCAIYONGYUANHUJIAOWEIHANSHEJI。CAIYONGRa≤0.6u mPAOGUANGDU。
VHPFASHENGDANWEI
NEIZHISHANRANYUANLIGANFAVHPFASHENGQI,CAIYONGJICHENGKONGZHIFANGSHI,YUVHPCHUANDICHUANGCAIYONGTONGYIKONGZHIFANGSHI, VHPFASHENGNONGDU,QIANGTIWENSHIDUHEBAOHEDUKONGZHIGENGWENDING。
QIDONGMIFENGXITONG
YASUOKONGQIDONGLIXITONGBAOHANCHONGQIMIFENGHEQIDONGFAMENDEKONGZHI。CHONGQIMIFENGHEQIDONGFAKONGZHICAIYONGYILUYASUOKONGQIGUANLU, BAOHANJIANYIFAHEDIANCIYUEKONGZHI。LINGYILUYASUOKONGQICAIYONGDULIDEJIANYAFAHEDIANCIFAKONGZHI,YONGYUQIANGTIBAOHEDUKONGZHI。
KONGZHIXITONG
BIAOZHUNDEKONGZHIXITONGCAIYONGPLCHEHMIKONGZHIFANGSHI,CAIYONGBIAOZHUNDEMOKUAIHUAKONGZHIBAN,WENDINGKEKAO,KONGZHIXITONGSHEJIJINGGUOCHONGFENDEYANZHENGHESHIJIANYINGYONG。WENDINGKEKAO。
JINGHUAGUOLVXITONG
QIANGTISONGFENGHEPAIFENGJUNCAIYONGH14GAOXIAOGUOLVQIGUOCHENG,GONGYIGUANLUHEZHITIJUNCAIYONGJINGHUASHEJI,PEIHEGAOXIAOGUOLVXITONG,KEZAIQIANGTISHIXIANAJIJINGHUA,SHEBEIYULIUZHUANYONGJIANCEKOU,KEDUIJINGHUATIAOJIANSHIXIANZAIXIANCESHIYANZHENG。
DIANQIXITONG
DIANQIJUDESHEJIFUHEANQUANHEFANGHUFAGUIYAOQIU,DIANQIXIANLUBUJUYOUXUHELI,QIANGDIANHERUODIANBIAOSHIMINGXIAN,FUHECEHEENBIAOZHUN。
EHSYAOQIU
RENYUANANQUANFANGHUHECHANPINANQUANFANGHUJUNZAISHEJISHANGZUOLECHONGFENKAOLV,CAIYONGQIANGDIANANQUANBAOHU,BAOZHENGCAOZUORENYUANJIECHUBUDAOQIANGDIAN,LIANGCEJUNYOUJITINGANNIUSHEJI;GAOWENBUJIANCAIQUMINGQUEGAOWENBIAOSHI;QIANGTICAIYONGDIANCIHUSUOZHUANGZHI,BIMIANCHANPINHEQINGJINGSHIDEWURAN;YICHANGZHUANGTAISHENGGUANGBAOJINGXINHAOTISHI,BIMIANANQUANSHIJIANFASHENG。
CHANPINGUIGE
BEIZHU:YISHANGWEIBIAOZHUNCHANPIN,FEIBIAOCHANPINKEZIXUNWOSIXIAOSHOURENYUAN,KEGENJUKEHUYAOQIUTIGONGFEIBIAODINGZHICHANPIN
MIEJUNGUOCHENG
YURE:SHEBEIQIDONGQIANZIDONGDIAOJIEQIANGTIDEWENSHIDUTIAOJIAN,YIDADAOSHEDINGDECHENGXUQIDONGTIAOJIAN。
PINGHENG:QIDONGMIEJUNTIAOJIAN,SHEBEIJINXINGVHPNONGDUHEBAOHEDUDEZIPINGHENGYIDADAOMIEJUNTIAOJIAN。
MIEJUN:KAISHIMIEJUN,LEIJIMIEJUNDELOGZHI,ZHIZHIMIEJUNJIESHU。
JIANGJIE:MIEJUNJIESHUHOU,SHEBEIJINRUPAIFENGJIANGJIEJIEDUAN,JINXINGVHPDEPAICANHEJIANGJIE,ZHIZHICHENGXUJIESHU。
BIAOZHUNCHENGXU
LOGACHENGXU:CAIYONGMIEMIAOWEISHENGWUDZHIHEMIEJUNLOGZHIGUOCHENGKONGZHIFA,DUIMIEJUNGUOCHENGJINXINGWENDINGDIAOJIE,YIDADAOSHEDINGDEMIEJUNTIAOJIAN,- BANSHEDINGWEI6LOGCHENGXU。
LOGBCHENGXU:CAIYONGMIEMIAOWEISHENGWUDZHIHEMIEJUNLOGZHIGUOCHENGKONGZHIFA,DUIMIETAOGUOCHENGJINXINGWENDINGDIAOJIE,YIDADAOSHEDINGDEMIEJUNTIAOJIAN,-BANSHEDINGWEI12LOGGUODUSHAMIECHENGXU。
NONGDUCHENGXU:MIEJUNGUOCHENGCAIYONGNONGDUHESHIJIANKONGZHIFANGSHI,GENJUCANSHUKAIFASUODEDEMIEJUNNONGDUHESHIJIANTIAOJIANSHEDINGCHENGXU,YIDADAOSHEDINGDEMIEJUNTIAOJIAN。
ZIJINGCHENGXU:TONGGUOGAOXIAOGUOLVQIDEGUOLVSHIXIANQIANGTINEIBUDEZIJING,YIZAIWUXUMIEJUNDETIAOJIANXIASHIXIANCHUANDI,YITIDAIZIJINGCHUANDICHUANGDEBUFENGONGNENG。
GONGYONGJIEZHIJIESHAO
YANZHENGTIXI
FUHEcGMPHEGamp5YAOQIUDEYANZHENGWENJIANTIXI,
KETIGONGCONGURS, FS, DQ, FAT, SAT, IQ, OQHEPQDEYANZHENGWENJIANHEFUWU。
BIAOZHUPEIZHI
KEXUANXIANG
1.ASME BPEGONGYIGUANLU:GONGYIGUANLUXUANYONG316LBUXIUGANGCAIZHI,TIGONGFUHEASME BPEDEHANJIERIZHIHEBAOGAO。
2.SHENJIZHUIZONG:XUANYONGXIMENZIAudit trailMOKUAIHESHOUQUAN,SHIXIANFUHEFDADESHENJIZHUIZONGYAOQIU。
3.DIANZIQIANMING:FUHE21CFR Part11DEDIANZIQIANMINGGONGNENG,YIBANZAIFDABIAOZHUNXIANGMUSHANGXUYAO。
4.SHENGWUMIFENG:FUHEBSL -3HUOBSL- 4DESHENGWUMIFENGYAOQIU,ZAISHENGWUANQUANXIANGMUSHANGXUANYONG。
5.GMPYANZHENG(FAT、SAT. DQ、I0PQ) :FUHEGMPYAOQIUDEYANZHENGWENJIANHEFUWU,KEGENJUXUQIUXUANGOU。
6.BEIJIANBAO:YONGYUSHEBEIRICHANGHUODINGQIWEIHUDEBUJIANHEHAOCAI,BAOHANCHONGQIMIFENGQUAN,GUIJIAOGUAN,VHPNONGDUTANTOUDENG。
7.ZHUANGZAICHE: 304BUXIUGANGCAIZHI,YONGYUQIANGTIZHUANGZAIZHIJIADEZHUANYUN,SHIYONGFANGBIAN。
8.VHPDINONGDUTANTOU:ANZHUANGZAIPAIFENGGUANLUSHANG,YONGYUJIANCEMIEJUNJIESHUSHIDEVHPNONGDU。
9.JIEJINGCECAOZUOPING:SHIXIANSHEBEIDESHUANGCECAOZUOHEGUANCHA,YIFANGBIANSHIYONG。
10. TCP/IPWANGKOU:YONGYUDIANZISHUJUCHUANSHUHESHEBEIYUSCADAXITONGDELIANJIE。
11.WENQIULIPENZUI:FUZHUDAQIANGTIVHPCHUANDICHUANGNEIBUDEGUOYANGHUAQINGFENBU,YIDADAOGENGHAODEFENBUXIAOGUO。
YUANLI
VHPJISHUSHIZHIJIANGBOTAISHUANGYANGSHUIQIHUAWEIGUOYANGHUAQINGZHENGQI,YUNYONGQIHUADEGUOYANGHUAQINGDUIWUTIBIAOMIANDEDIWENMIEJUNJISHU。
VHPJUYOUGUANGPUSHAJUNXING,NENGYOUXIAOSHAMIEXIJUN,ZHENJUN、MEIJUN、BINGDU、XIJUNYABAODENGSUOYOULEIXINGDEWEISHENGWU,MUQIANFAXIANVHPZUINANSHAMIEDEWEISHENGWUSHISHIREZHIFANGYABAO,SUOYIVHPMIEJUNYANZHENGSUOYONGDESHENGWUZHISHIJIWEISHIREZHIFANGYABAO。
VHPMIEMIAOWUDUWUCANLIU,QIHUAGUOYANGHUAQINGZAIMIEJUNGUOCHENGZHONGKEYIKUAISUSHAMIEWEISHENGWU,MIEMIAOWANCHENGHOUNENGKUAISUJIANGJIEWEIH²OHEO²,WUDUWUCANLIU,QIEGUOYANGHUAQINGDECANLIUNONGDUKEJIANCE。
VHPMIEJUNXIAOGUOKEYANZHENG,ZHENGCHANGDEYIGEYANZHENGZHOUQIBAOKUOCANSHUKAIFA,VHPFENBUYANJIU,SHENGWUTIAOZHANSHIYANHEPAIFENGJIANGJIEYANJIU,INNOVE- HPBQIHUAGUOYANGHUAQINGSHEBEIJUYOUWANZHENGDEGMPYANZHENGWENJIANTIXI。
VHPMIEJUNJIANRONGXINGHAO,INNOVE- HPBXILIEDEQIHUAGUOYANGHUAQINGMIEJUNQICAIYONGTEYOUDEBAOHEDUKONGZHIFA,BAOZHENGZHENGGEMIEJUNGUOCHENGZHONGGUOYANGHUAYUNBUYEHUABULENGNING,CAILIAOJIANRONGXINGGENGHAO。
JIEGOU
SHEBEIZHUTI
VHPCHUANDICHUANGCAIYONGBUXIUGANGZHUTIJIEGOU,NEIQIANGCAIYONG316LBUXIUGANG,KUANGJIAHEWAIBIAOCAIYONG304BUXIUGANGJIEGOU,NEIMUCAIYONGYUANHUJIAOWEIHANSHEJI。CAIYONGRa≤0.6u mPAOGUANGDU。
VHPFASHENGDANWEI
NEIZHISHANRANYUANLIGANFAVHPFASHENGQI,CAIYONGJICHENGKONGZHIFANGSHI,YUVHPCHUANDICHUANGCAIYONGTONGYIKONGZHIFANGSHI, VHPFASHENGNONGDU,QIANGTIWENSHIDUHEBAOHEDUKONGZHIGENGWENDING。
QIDONGMIFENGXITONG
YASUOKONGQIDONGLIXITONGBAOHANCHONGQIMIFENGHEQIDONGFAMENDEKONGZHI。CHONGQIMIFENGHEQIDONGFAKONGZHICAIYONGYILUYASUOKONGQIGUANLU, BAOHANJIANYIFAHEDIANCIYUEKONGZHI。LINGYILUYASUOKONGQICAIYONGDULIDEJIANYAFAHEDIANCIFAKONGZHI,YONGYUQIANGTIBAOHEDUKONGZHI。
KONGZHIXITONG
BIAOZHUNDEKONGZHIXITONGCAIYONGPLCHEHMIKONGZHIFANGSHI,CAIYONGBIAOZHUNDEMOKUAIHUAKONGZHIBAN,WENDINGKEKAO,KONGZHIXITONGSHEJIJINGGUOCHONGFENDEYANZHENGHESHIJIANYINGYONG。WENDINGKEKAO。
JINGHUAGUOLVXITONG
QIANGTISONGFENGHEPAIFENGJUNCAIYONGH14GAOXIAOGUOLVQIGUOCHENG,GONGYIGUANLUHEZHITIJUNCAIYONGJINGHUASHEJI,PEIHEGAOXIAOGUOLVXITONG,KEZAIQIANGTISHIXIANAJIJINGHUA,SHEBEIYULIUZHUANYONGJIANCEKOU,KEDUIJINGHUATIAOJIANSHIXIANZAIXIANCESHIYANZHENG。
DIANQIXITONG
DIANQIJUDESHEJIFUHEANQUANHEFANGHUFAGUIYAOQIU,DIANQIXIANLUBUJUYOUXUHELI,QIANGDIANHERUODIANBIAOSHIMINGXIAN,FUHECEHEENBIAOZHUN。
EHSYAOQIU
RENYUANANQUANFANGHUHECHANPINANQUANFANGHUJUNZAISHEJISHANGZUOLECHONGFENKAOLV,CAIYONGQIANGDIANANQUANBAOHU,BAOZHENGCAOZUORENYUANJIECHUBUDAOQIANGDIAN,LIANGCEJUNYOUJITINGANNIUSHEJI;GAOWENBUJIANCAIQUMINGQUEGAOWENBIAOSHI;QIANGTICAIYONGDIANCIHUSUOZHUANGZHI,BIMIANCHANPINHEQINGJINGSHIDEWURAN;YICHANGZHUANGTAISHENGGUANGBAOJINGXINHAOTISHI,BIMIANANQUANSHIJIANFASHENG。
CHANPINGUIGE
BEIZHU:YISHANGWEIBIAOZHUNCHANPIN,FEIBIAOCHANPINKEZIXUNWOSIXIAOSHOURENYUAN,KEGENJUKEHUYAOQIUTIGONGFEIBIAODINGZHICHANPIN
MIEJUNGUOCHENG
YURE:SHEBEIQIDONGQIANZIDONGDIAOJIEQIANGTIDEWENSHIDUTIAOJIAN,YIDADAOSHEDINGDECHENGXUQIDONGTIAOJIAN。
PINGHENG:QIDONGMIEJUNTIAOJIAN,SHEBEIJINXINGVHPNONGDUHEBAOHEDUDEZIPINGHENGYIDADAOMIEJUNTIAOJIAN。
MIEJUN:KAISHIMIEJUN,LEIJIMIEJUNDELOGZHI,ZHIZHIMIEJUNJIESHU。
JIANGJIE:MIEJUNJIESHUHOU,SHEBEIJINRUPAIFENGJIANGJIEJIEDUAN,JINXINGVHPDEPAICANHEJIANGJIE,ZHIZHICHENGXUJIESHU。
BIAOZHUNCHENGXU
LOGACHENGXU:CAIYONGMIEMIAOWEISHENGWUDZHIHEMIEJUNLOGZHIGUOCHENGKONGZHIFA,DUIMIEJUNGUOCHENGJINXINGWENDINGDIAOJIE,YIDADAOSHEDINGDEMIEJUNTIAOJIAN,- BANSHEDINGWEI6LOGCHENGXU。
LOGBCHENGXU:CAIYONGMIEMIAOWEISHENGWUDZHIHEMIEJUNLOGZHIGUOCHENGKONGZHIFA,DUIMIETAOGUOCHENGJINXINGWENDINGDIAOJIE,YIDADAOSHEDINGDEMIEJUNTIAOJIAN,-BANSHEDINGWEI12LOGGUODUSHAMIECHENGXU。
NONGDUCHENGXU:MIEJUNGUOCHENGCAIYONGNONGDUHESHIJIANKONGZHIFANGSHI,GENJUCANSHUKAIFASUODEDEMIEJUNNONGDUHESHIJIANTIAOJIANSHEDINGCHENGXU,YIDADAOSHEDINGDEMIEJUNTIAOJIAN。
ZIJINGCHENGXU:TONGGUOGAOXIAOGUOLVQIDEGUOLVSHIXIANQIANGTINEIBUDEZIJING,YIZAIWUXUMIEJUNDETIAOJIANXIASHIXIANCHUANDI,YITIDAIZIJINGCHUANDICHUANGDEBUFENGONGNENG。
GONGYONGJIEZHIJIESHAO
YANZHENGTIXI
FUHEcGMPHEGamp5YAOQIUDEYANZHENGWENJIANTIXI,
KETIGONGCONGURS, FS, DQ, FAT, SAT, IQ, OQHEPQDEYANZHENGWENJIANHEFUWU。
BIAOZHUPEIZHI
KEXUANXIANG
1.ASME BPEGONGYIGUANLU:GONGYIGUANLUXUANYONG316LBUXIUGANGCAIZHI,TIGONGFUHEASME BPEDEHANJIERIZHIHEBAOGAO。
2.SHENJIZHUIZONG:XUANYONGXIMENZIAudit trailMOKUAIHESHOUQUAN,SHIXIANFUHEFDADESHENJIZHUIZONGYAOQIU。
3.DIANZIQIANMING:FUHE21CFR Part11DEDIANZIQIANMINGGONGNENG,YIBANZAIFDABIAOZHUNXIANGMUSHANGXUYAO。
4.SHENGWUMIFENG:FUHEBSL -3HUOBSL- 4DESHENGWUMIFENGYAOQIU,ZAISHENGWUANQUANXIANGMUSHANGXUANYONG。
5.GMPYANZHENG(FAT、SAT. DQ、I0PQ) :FUHEGMPYAOQIUDEYANZHENGWENJIANHEFUWU,KEGENJUXUQIUXUANGOU。
6.BEIJIANBAO:YONGYUSHEBEIRICHANGHUODINGQIWEIHUDEBUJIANHEHAOCAI,BAOHANCHONGQIMIFENGQUAN,GUIJIAOGUAN,VHPNONGDUTANTOUDENG。
7.ZHUANGZAICHE: 304BUXIUGANGCAIZHI,YONGYUQIANGTIZHUANGZAIZHIJIADEZHUANYUN,SHIYONGFANGBIAN。
8.VHPDINONGDUTANTOU:ANZHUANGZAIPAIFENGGUANLUSHANG,YONGYUJIANCEMIEJUNJIESHUSHIDEVHPNONGDU。
9.JIEJINGCECAOZUOPING:SHIXIANSHEBEIDESHUANGCECAOZUOHEGUANCHA,YIFANGBIANSHIYONG。
10. TCP/IPWANGKOU:YONGYUDIANZISHUJUCHUANSHUHESHEBEIYUSCADAXITONGDELIANJIE。
11.WENQIULIPENZUI:FUZHUDAQIANGTIVHPCHUANDICHUANGNEIBUDEGUOYANGHUAQINGFENBU,YIDADAOGENGHAODEFENBUXIAOGUO。