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GMP药监飞检六个重点和五大特点总结

发布时间:2019-06-20 09:35来源:TMOON点击:

  

  前一阵子关于GMP飞检,无论是从国家局发布的消息还是省局发布的消息,还有很多的媒体发布的消息,都是说了很多的注意事项和迎检技巧,但是归根结底还是要认认真真做好日常GMP工作,不是为了防飞检而GMP。

 

  YIXIAZHEILIUGEZHONGDIANHEWUGETEDIAN,SHIKANLEYIPIANWEIXINJINXINGDEZHENGLI,WOJIEHEJUTIDEGONGZUOJINXINGLEWANSHAN,RUSHEJIYUANZUOZHEDENEIRONG,QINGPIPINGZHIZHENG。


  首先看看飞检有哪六个重点。

  重点一:皇冠足彩现场取证,查实物,核质量,必要时调查取证并对实物质量状况进行现场确认或送检药检部门。

  TONGCHANGFEIJIANDOUYOUHENMINGQUEDEJIANCHANEIRONG,XIANLUWANGWANGYESHIXIANQUCANGKU、CHEJIANXIANCHANGDIAOCHAQUZHENG,CHAKANCANGKUZHUYAOYAOCAI(YINPIAN)GONGYINGSHANGMINGCHENG、KUCUNSHIWUSHULIANG、PIHAO、ZHILIANGQINGKUANG(ZHONGDIANSHIZHENWEI、YOUWUCHANJIA)、RUKUYANSHOUJILUJIQIYEZHILIANGBUQUYANGZHENGMINGZILIAO、JIANYANHEGEBAOGAOJICHEJIANSHENGCHANCHANPINMINGCHENG、SUOYONGWULIAODEMINGCHENG、PIHAO,DUIYINGPIHAOWULIAOLINGYONGQINGKUANG,SHENGYUQINGKUANG。RUXIANCHANGFAXIANWULIAOYOUWENTIDEXIANJINXINGFENGCUN,XIANGGUANCHENGPINJIANGYIBINGFENGCUN,RUYOUFACHUDEHUOWU,XUYAOTIGONGCHENGPINDEXIAOSHOUJILU,RUHESHICUNZAIZHILIANGWENTIDEJIANGSHEJIJINYIBUDEZHAOHUI。

  重点二:皇冠足彩供应商审查情况,核对主要供应商的档案资料、资质,是否供应商为国家公布的飞检名单或质量公告名单或有投诉、不良反应的名单中。

  QUERENGONGYINGSHANGSHIFOUHEGE,GONGYINGFANWEIHEXIANCHANGSHIWUJILUSHIFOUYIZHI,YOUQISHIYIXIEJINKOUYAOCAIYINGYOUJINKOUPIJIANJIKOUANSUOJIANYANBAOGAOFUYINJIAN(JIAGAIGONGHUODANWEIZHILIANGZHANG)。GONGYINGSHANGYIDINGYAOSHIHEFADEQIYE,BUNENGHESIRENJINXINGCAIGOU。RUYOUZEYOUSITIAOTIAODEKENENG,BUNENGYOUXIAOZHUISUDEWULIAOJIANGCHENGWEIDINGSHIZHADAN。GONGYINGSHANGSHENJIYESHIZUIRONGYICHACHUWENTIDE,SUOYIGONGYINGSHANGXIANGGUANDEZIZHI、GOUXIAOHETONG、ZHILIANGXIEYIYIGEDOUBUNENGSHAO。

  重点三:批记录中物料平衡、收率检查,通过物料平衡和收率的复核,倒查相关的物料记录、检验记录,查物料流向。

  YIJUCAIGOURUKUYANSHOUJILU、KUCUNHUOWEIKA、JIANCHAJIEDUANXINGQIANCHULIJITIQU、ZHIJISHENGCHANJILU,HECHAZHUYAOYAOCAI(YINPIAN)RUKUYANSHOUJILUDERUKUSHIJIAN、PIHAO、SHULIANG,BINGYUSHENGCHANJILU、KUCUNSHIWU、KUCUNHUOWEIKA、FENLEIZHANGHEDUI,JINXINGTOURU、CHANCHUWULIAOPINGHENGHEDUIHEFENXI,HEDUIYAOCAI(YINPIAN)HUOWEIKAJINCHUJILUSHULIANG、SHIJIANYUQIANCHULIJITIQUJILU、CHURUKUPIAOJUDEYIZHIXING,ZHONGDIANHEDUIZHONGYAOCAI(YINPIAN)YINPIANQIANCHULIJITIQUSHENGCHANDEZHONGJIANTIJIZHIJISUOSHENGCHANDECHENGPINDEWULIAOPINGHENGSHIFOUFUHEGUIDING。

皇冠足彩  TONGSHIGENJUWULIAOPINGHENGDEQINGKUANG,CHAGONGYIGUICHENG、GONGYIYANZHENG、ZHUCEQINGKUANG,ZHEISHIRUGUOCHUXIANBUYIYANGQINGKUANG,ERQIEYOUSHIJIANCHAZHONGDIAN,NEIMEWENTIYEJIANGFEICHANGYANZHONG,RUHEZHUCEGONGYIBUYIZHI,KENENGSHEJIWEIFASHENGCHAN。

  重点四:检查批检验记录,以原料、成品、工艺中关键物料为重点对取样、留样和全检情况进行检查。

皇冠足彩  JIANYANKECHADEDONGXIJIUFEICHANGDUO,ZHIYAOSHIZUOLEDEHAIHAO,RUGUOYOUMEIZUOERJIEGUOZHONGYOUYOUDEJIANGSHEXIANZAOJIA,MUQIANSUOJIANCHACHULAIDESHUJUWANZHENGXINGWENTIJIBENSHANGSHIHUAYANSHICHACHULAIDE。

  WANGWANGHUICONGRUKUYANSHOUJILUHEHUOWEIKASHANGHUOQUDEZILIAO,JIANCHAZHILIANGBUQUYANGJILU、JIANCHAHEDUIMEIPIYAOCAI(YINPIAN)LIUYANGJILUJILIUYANGSHIWU,JIANCHAHEDUIJIANYANYUANSHIJILU、JIANYANBAOGAO,DUIGAOXIAOYEXIANG、YUANZIXISHOU、QIXIANGSEPUDENGTUPUDAKAIDIANNAOHEDUIJIAN,YOUQISHICONGRUKUYANSHOUSHIJIAN、QUYANGSHIJIAN、JIANYANSHIJIAN、CHUBAOGAOSHIJIAN、SHEBEIYIQISHIYONGJILUZHONGDUIYINGDESHIJIANLAIJINXINGZHENSHIXINGHEWANZHENGXING。TONGGUOJIANCHAQINGKUANGDUIWULIAOHEJIANYANYONGDUIZHAO、SHIJIDEPINGHENGJINXINGZHUICHA。

  重点五:皇冠足彩抽查成品留样及检查销售记录,必要时核实销售单位情况。

  XIAOSHOUJILUFANYINGZHEIGECHANPINDELIUXIANG,ZHONGDIANGUANZHUCHANPINDEZHUISUTIXI,RUCHACHUWENTIGUANJIANSHIYAOJINXINGDIAOCHAHEZHAOHUI。LIUYANGYESHIWEILEQUZHENG。WANGWANGYIJUCHENGPINKUCUNHUOWEIKAJILUJIPISHENGCHANYUANSHIJILU,SUIJICHOUCHAHEDUIZHILIANGBUCHENGPINLIUYANGQUYANGJILUHELIUYANGSHIWU,BINGYIJUSHENGCHANYUANSHIJILUZHONGCHENGPINRUKUSHULIANGHEDUIXIAOSHOUJILU、CHAKANXIAOSHOUFAPIAO。

  重点六:皇冠足彩核原辅料购进发票,并与入库验收记录、生产使用记录核对购进日期、购进数量、核查物料平衡情况。

皇冠足彩  XIANZAIJIANCHADOUHUICHADAOFAPIAO,SUOYIFAPIAOSHULIANG、CAIGOUHETONG、ZHILIANGJIANYAN、RUKUSHULIANG、GOUJINSHIJIANDOUYAODUIYINGYIZHI。RUYOUBUYIZHI,HAIKENENGHUIJINXINGZHUISUXINGDUISHANGYOUQIYEJINXINGHECHA。

  QISHISHUOZHONGDIANYEHAO,ZHISHIQIZHONGDEYIFANGMIANERYI,XIANGXINMEICIGENJUJIANCHAZHENDUIXINGDEBUTONG,KENDINGHAIYOUQITAFANGMIANDEZHONGDIANNEIRONG,XIWANGDAJIAJINXINGWANSHAN,BUCHONG。

  YOUYUFEIXINGJIANCHAYUYIWANGGMPGENZONGJIANCHACONGXINGSHISHANGDAOSHIZHISHANGDOUFASHENGLEBIANHUA,ERQIEZAIGUOJIAJUGUANYUFEIXINGJIANCHADEXIANGGUANWENJIANZHONGYEDUIFEIXINGJIANCHAJINXINGLESHUOMING,QITUCHUDETEDIANYOUWUFANGMIAN。

 

  五个特点

  特点一:行动的保密性。

  FEIXINGJIANCHAANPAIJISHIZAIZUZHISHISHIBUMENNEIBUYESHIXIANGDUIBAOMIDE,ZHIYOUGAIXIANGGONGZUODEZHUGUANLINGDAOHEJUTIFUZEDETONGZHIZHANGWOQINGKUANG。QIYESUOZAIDIYAOPINJIANDUGUANLIBUMENYESHIZAIZUIHOUSHIXIANCAIDEDAOTONGZHI,QIYEGENGBUKENENGDEDAOTONGZHI。YUANLAIYIWEIDEDANGDIBAOHU,XIANZAIKEBUNENGYOUZHEIYANGDEXIANGFALE,QIYESHIYAOPINZHILIANGDEZHUTI。

  特点二:检查的突然性。

  YOUYUFEIXINGJIANCHADEBAOMIXING,SUOYI,BEIJIANCHAQIYESHIXIANBUKENENGZUORENHEZHUNBEIGONGZUO,JIANCHAZUXIANCHANGSUOKANDAODEJIUSHIQIYERICHANGSHENGCHANGUANLIDEZHENSHIZHUANGKUANG。

  特点三:接待的绝缘性。

皇冠足彩  FEIXINGJIANCHAZUYAOZUODAOBUCHIQIYEFAN、BUZHUQIYEDIAN、BUYONGQIYECHE,FEIYONGQUANBUYOUYAOPINRENZHENGGUANLIZHONGXINZHIFU。

  特点四:现场的灵活性。

皇冠足彩  YAOPINRENZHENGGUANLIZHONGXINZHIDINGJIANCHAYUAN,ZHUYAOQUEDINGXIANCHANGJIANCHAZHONGDIAN。JIANCHAZUXIANCHANGJIANCHADEJUTISHIJIANJIBUZHOUYOUJIANCHAZUGENJUJIANCHAXUYAOQUEDING,QUEBAOJIANCHAZHILIANG。

  特点五:记录的即时性。

皇冠足彩  JIANCHAYUANYAOZAIXIANCHANGJIANCHAGUOCHENGZHONGJISHITIANXIEFEIXINGJIANCHAGONGZUOJILU。JINRUMEIYIGONGZUOXIANCHANG,JUNYAOGENJUJUTIQINGKUANGTIANXIEHAOJIANCHANEIRONG、JIECHURENYUAN、QINGKUANGJILUDENGXIANGNEIRONG。


皇冠足彩  ZONGZHI,FEIXINGJIANCHAJIUSHIDUIQIYEZHIXINGGMPDEZUIZHIJIE,YESHIZUIQINJINDEJIANCHA,ZHIYOUJIANGGMPZHIXINGZAIRICHANGGONGZUOZHONG,YEZHIYOUZHENZHENGDEANGMPGUIDINGZUOLE,SHISHILE,CAINENGJINGSHOUDEZHURENHEJIANCHA。DANGRANQIYEZUIZHONGMUBIAOSHISHENGCHANCHURENMINQUNZHONGXUYAODEANQUAN、YOUXIAO、WENDING、KEKAODEYAOPIN,ERSUOYOUDEGONGZUOYEDOUSHIWEILEBAOZHANGRENMINQUNZHONGYONGYAOANQUAN!


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