秒速赛车控制器

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新監管時代 國內首部GMP附錄《細胞治療產品》導讀
發布時間: 2019-12-05     來源: 蒲公英

 

 

2019年11月28日,國家藥品監督管理局食品藥品審核查驗中心官網重磅發布《GMP附錄-細胞治療產品》(征求意見稿),這是國內首部針對細胞治療產品的GMP附錄,彌補了我國對細胞治療產品生產質量控制法規層面和技術層面的空白,本文對《GMP附錄-細胞治療產品》中7個相關問題進行了解讀。


一、細胞治療產品為何物?

XIBAOZHILIAOTONGCHANGSHIZHIJIANGZHENGCHANGHUOSHENGWUGONGCHENGGAIZAOGUODERENTIXIBAOYIZHIHUOSHURUHUANZHETINEI,XINSHURUDEXIBAOKEYITIDAISHOUSUNXIBAO、HUOZHEJUYOUGENGQIANGDEMIANYISHASHANGGONGNENG,CONGERDADAOZHILIAOJIBINGDEMUDE。

秒速赛车控制器YIJUGUOJIASHIPINYAOPINJIANDUGUANLIZONGJU2017NIAN12YUE22RIFABUDE《XIBAOZHILIAOCHANPINYANJIUYUPINGJIAJISHUZHIDAOYUANZE(SHIXING)》XIBAOZHILIAOCHANPINSHIZHI:

YONGYUZHILIAORENDEJIBING,LAIYUAN、CAOZUOHELINCHUANGSHIYANGUOCHENGFUHELUNLIYAOQIU,ANZHAOYAOPINGUANLIXIANGGUANFAGUIJINXINGYANFAHEZHUCESHENBAODERENTILAIYUANDEHUOXIBAOCHANPIN。BUSHIYONGYUSHUXUEYONGDEXUEYECHENGFEN,YIYOUGUIDINGDE、WEIJINGTIWAICHULIDEZAOXUEGANXIBAOYIZHI,SHENGZHIXIANGGUANXIBAO,YIJIYOUXIBAOZUCHENGDEZUZHI、QIGUANLEICHANPINDENG。

秒速赛车控制器《GMPFULU-XIBAOZHILIAOCHANPIN》SUOSHUDEXIBAOZHILIAOCHANPINSHIZHI:

RENYUANDEHUOXIBAOCHANPIN,BAOKUOYOUXIBAOXI,YIJILAIYUANYUZITIHUOYITIDEMIANYIXIBAO、GANXIBAOHEZUZHIXIBAODENGSHENGCHANDECHANPIN。BUBAOKUOSHUXUEYONGDEXUEYECHENGFEN、YIYOUGUIDINGDEZAOXUEGANXIBAOYIZHI,SHENGZHIXIANGGUANXIBAO,YIJIYOUXIBAOZUCHENGDEZUZHI、QIGUANLEICHANPINDENG。

二、為什么要單獨起草《GMP附錄-細胞治療產品》

XIBAOZHILIAOZAIZHILIAOAIZHENG、XUEYEBING、XINXUEGUANBING、TANGNIAOBING、LAONIANCHIDAIZHENGDENGFANGMIANXIANSHICHUYUELAIYUEGAODEYINGYONGJIAZHI,XIBAOZHILIAOCHANPINYERIYISHOUDAOGUONEIWAIZHIYAOQIYEJIGEGUOZHENGFUBUMENDEGAODUGUANZHU。

DANXIBAOZHILIAOCHANPINDEWUZHIZUCHENGJIZUOYONGJIZHIYUXIAOFENZIYAOWU(HUAYAO)、DAFENZISHENGWUYAOWU(SHENGWUZHIPIN)BUTONG,SUOYICHUANTONGSHENGCHANHEZHILIANGKONGZHIFANGFAKENENGBUWANQUANSHIYONGYUXIBAOZHILIAOCHANPIN,GUXUGENJUXIBAOZHILIAOCHANPINDETEDIANZHIDINGXIANGGUANZHENGCEFAGUI。

秒速赛车控制器2009NIANGUOJIAWEISHENGBUSHOUCIJIANGBUFENMIANYIXIBAOZHILIAONARUDISANLEIYILIAOJISHUJINXINGZHUNRUGUANLI,SHIDUONIANLAIJINGLILECONGWUDAOYOU、CONGQIANQUEDAOBUDUANWANSHANDEFAZHANLICHENG,XIANGJIANXIABIAO。

 

三、細胞治療產品生產過程中人員有哪些特殊要求?

 

秒速赛车控制器SI、XIBAOZHILIAOCHANPINSHENGCHANGUOCHENGZHONGCHANGFANGSHESHIHESHEBEIYOUNAXIETESHUYAOQIU。

 

WU、XIBAOZHILIAOCHANPINSHENGCHANGUOCHENGZHONGWULIAOGUANLIYOUNAXIETESHUYAOQIU?

 

 

LIU、XIBAOZHILIAOCHANPINSHENGCHANGUOCHENGZHONGSHENGCHANGUANLIYOUNAXIETESHUYAOQIU? 

秒速赛车控制器QI、XIBAOZHILIAOCHANPINSHENGCHANGUOCHENGZHONGHUANJINGGUANLIYOUNAXIETESHUYAOQIU?

 

CANKAOWENXIAN

[1] www.cfdi.org.cn/resource/news/11931.html

秒速赛车控制器[2] news.yaozh.com/archive/25551.html?ga_source=mail&ga_id=55

[3] www.nmpa.gov.cn/WS04/CL2138/300457.html