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疫苗事件后|GMP审查要点以飞检对纯化水系统更严
疫苗事件后GMP审查要点以及飞检-对纯化水的全性能检测周期进行规定

DIERJIE:CHANGFANGYUSHESHI

FEIJIANANLI:

1、CHANPINGONGYIYONGCHUNHUASHUIZHISHUISHEBEISHIFOUSHEZHIZAIJIEJINGCHEJIANNEI,ZHISHUICHEJIANDIMIANSHIFOUYOUJISHUI。

2、QIYEDEWEIXIANHUAXUEPINKUWEIYULIHUAJIANCESHINEI,WUTONGFENGHEXIAOFANGDENGCUOSHI,《HUAXUEWEIXIANPINGUANLIGUICHENG》GUIDINGDEGUANLIZHIZEBUMINGQUE;

3、换鞋间、缓冲间走廊、女一更、女二更照明灯损坏不亮,纯化水洗手器是否采用了感应水龙头;

4、WAIBAOJIANCHUANDICHUANGHEGONGYIYONGCHUNHUASHUIZHISHUIJIANDECHURUKOUSHIFOUJUNWEIYUYUANGONGJINCANXIUXISHINEI;

DISANJIE:SHEBEI

FEIJIANANLI:

1、QIYEWEIDUIKONGDIAOJINGHUAJIZUZHONGXIAOGUOLVQIJINXINGYACHAJIANKONG;

2、QIYEZIXIAOZHUNWENSHIDUJISUOCAIYONGDEFANGFAWEIFEIBIAOFANGFA,WEIJINGYANZHENG;

3、QIYETIGONGDE2~10 μlYIYEQIJIANDINGBAOGAOXIANSHIJILIANGYONGJUWEIWANFENZHIYITIANPING;2μlYIYEQISHICEZHIWEI1.8 μl ,CHAOGUOQIWUCHA2% FANWEIGUIDING,WEIDUIJIANDINGBAOGAOYOUXIAOXINGJINXINGQUEREN;

4、QIYECAIYONGZIWAIDENGDUIJIEJINGCHEJIANJINXINGXIAODU,WEIDUIXIAOAIXIAOGUOJINXINGYOUXIAOYANZHENG;

5、QIYESHENGCHANTIWAIZHENDUANSHIJICHANPINJUYOUBULIANXUXING,KONGQIJINGHUAXITONGTINGJISHIJIANJIAOZHANG,QIYESHANGWEIDUIBUTONGTINGJISHIJIANHOUZAICIKAIQIKONGQIJINGHUAXITONGSUOXUCAIQUDECUOSHIJINXINGXIANGYINGDEYANZHENGHEGUIDING;

6、KONGDIAOJINGHUAXITONGQINGJIEWEIXIUBAOYANGGUIDINGCHUXIAOMEIGEYUEQINGXIYICI,ZHONGXIAOSANGEYUEQINGXIYICI,GAOXIAOGUOLVQIMEINIANJIANCEWANZHENGXING,DANQIYESHIJIDUICHU、ZHONGXIAOMEINIANGENGHUAN,SHIJIYEWEIJIANCEGAOXIAOGUOLVQIDEWANZHENGXING;

7、KONGQIJINGHUAXITONGWEIJINXINGQUERENHEYANZHENG,WEIJINXINGCHUZHONGXIAOYACHAJIANKONG;KONGDIAOJINGHUAXITONGBULIANXUYUNXING,WEIDUIZAICIKAIQIYUNXINGTIAOJIANJINXINGQUEREN;

8、CHUNHUASHUIWEISHENGWUJIANCEBIAOZHUNGUIDINGDEJIANCELIANGWEI0.1ml ,YAODIANBIAOZHUNGUIDINGJIANCELIANGWEI1ml ;

9、WEIDUIJIEJINGCHEJIANGONGYIYONGSHUICHUSHUITONGJINXINGQINGXIXIAODUJILU;

10 、WEIDUICHUNHUASHUIDEQUANXINGNENGJIANCEZHOUQIJINXINGGUIDING。

GUANJIANDIAN:

SHEBEISHITIWAIZHENDUANSHIJISHENGCHAN,BIBEIDEYINGJIANYAOQIU,YESHIMANZUSHENGCHANZHILIANGDEJIBENTIAOJIAN。SHEBEIDETEXINGHEXUANXINGBIXUYUCHANPINTEXING,SHENGCHANGUIMOXIANGSHIYING。BIANYUQINGJIEHERICHANGWEIHU。YUANZE:SHEBEIDESHEJI、XUANXING、ANZHUANG、WEIXIUHEWEIHUBIXUFUHEYUDINGDEYONGTU,YINGJINKENENGJIANGDICHANSHENGWURAN,JIAOCHAWURAN,HUNXIAOHECHACUODEFENGXIAN,BIANYUCAOZUO,QINGJIE,WEIHU,YIJIBIYAOSHIXIAODUHUOMIEJUN。

2 、JILU

( 1)JILUKONGZHICHENGXU,BAOKUOJILUDEBIAOSHI,BAOGUAN,JIANSUO,BAOCUNQIXIANHECHUZHIDENG 4 GEFANGMIAN;

( 2)MEIPICHANPINYINGDANGYOUJILU,BAOKUOPISHENGCHANJILU,PIBAOZHUANGJILU,PIJIANYANJILUHECHANPINFANGXINGSHENHEJILUDENG。

( 3)PIJILUYINGDANGYOUZHILIANGGUANLIBUMENFUZEGUANLI,ZHISHAOBAOCUNZHICHANPINYOUXIAOQIHOUYINIAN;

( 4)ZHILIANGBIAOZHUN,GONGYIGUICHENG,CAOZUOGUICHENG,WENDINGXINGKAOCHA,QUERENHEYANZHENG,BIANGENGDENGQIYEZHONGYAOWENJIANYINGZHANGQIBAOCUN;

( 5)SOP YAOBAOZHENGCAOZUOZHEZAIYIZHAOSHISHISHIJINLIANGSHAODONGNAO, JILUYAOJINLIANGJIANSHAOXIEZINEIRONG,JINLIANGDAGOU;