{"id":122707,"date":"2020-03-23T08:58:04","date_gmt":"2020-04-21T01:03:57","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/122707\/"},"modified":"2020-04-21T09:03:59","modified_gmt":"2020-04-21T01:03:59","slug":"5aa62e916a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/122707\/","title":{"rendered":"\u75ab\u60c5\u4e0b\uff0cFDA\/EDQM\/TGA\uff0c\u6d77\u5916\u68c0\u67e5\u6309\u4e0b\u6682\u505c\u952e\uff01"},"content":{"rendered":"
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\u5bfc\u8bfb\uff1a<\/span><\/strong>
<\/section>\n
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\"\u75ab\u60c5\u4e0b\uff0cFDA\/EDQM\/TGA\uff0c\u6d77\u5916\u68c0\u67e5\u6309\u4e0b\u6682\u505c\u952e\uff01\"<\/section>\n
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EDQM\u5e0c\u671b\u544a\u77e5CEP\u6301\u6709\u8005Covid-19\u7206\u53d1\u5bf9\u4e0eCEP\u7a0b\u5e8f\u76f8\u5173\u7684\u6d3b\u52a8\u7684\u5f71\u54cd\u3002<\/span><\/section>\n
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EDQM\u610f\u8bc6\u5230\uff0c\u516c\u53f8\u53ef\u80fd\u4f1a\u9047\u5230\u4ee5\u4e0b\u95ee\u9898\uff1a\u4e0e\u88ab\u8bc4\u4f30\u7684CEP\u6863\u6848\u76f8\u5173\u7684\u4fe1\u606f\u63d0\u4ea4\uff08\u4f8b\u5982\u51c6\u5907\u548c\u53d1\u9001\u5bf9\u7f3a\u635f\u4fe1\u51fd\u7684\u7b54\u590d\uff09\uff0c\u68c0\u67e5\uff08\u4f8b\u5982\u51c6\u5907\u548c\u53d1\u9001CAPA\uff09\u4ee5\u53ca\u4e0e\u4e9a\u785d\u80fa\u6709\u5173\u7684\u98ce\u9669\u8bc4\u4f30\u3002\u4f46\u662f\uff0c\u5982\u679cCEP\u6301\u6709\u4eba\/\u539f\u6599\u836f\u5236\u9020\u5546\u4e0d\u80fd\u5728\u63d0\u4ea4\u8981\u6c42\u7684\u4fe1\u606f\u7684\u622a\u6b62\u65e5\u671f\u4e4b\u524d\u5c3d\u5feb\u5c06\u5176\u544a\u77e5EDQM\u3002<\/span><\/section>\n
\u4e3a\u4e86\u9884\u671f\u6750\u6599\u4f9b\u5e94\u7684\u4efb\u4f55\u8fdb\u4e00\u6b65\u4e2d\u65ad\uff0c\u8fd8\u5efa\u8bae\u516c\u53f8\u63d0\u524d\u5c06\u5176\u6253\u7b97\u8fdb\u884c\u7684\u4efb\u4f55\u66f4\u6539\u548c\u6253\u7b97\u63d0\u4ea4\u7684\u4efb\u4f55\u4fee\u8ba2\u544a\u77e5\u5ba2\u6237\u3002<\/span><\/section>\n
\u7531\u4e8e\u76ee\u524d\u7684\u65c5\u884c\u9650\u5236\uff0cEDQM\u8fd8\u51b3\u5b9a\u63a8\u8fdf\u5bf9API\u5236\u9020\u5546\u7684\u68c0\u67e5\uff0c\u5e76\u5c06\u5206\u522b\u901a\u77e5\u6709\u5173\u516c\u53f8\u3002<\/span><\/section>\n
EDQM\u5f53\u524d\u6b63\u5728\u5ba1\u67e5\u6b64\u95ee\u9898\u5bf9\u8bc4\u4f30\u6d3b\u52a8\u548c\u65f6\u95f4\u8868\u7684\u5f71\u54cd\uff0c\u5e76\u5c06\u5c3d\u4e00\u5207\u53ef\u80fd\u51cf\u8f7b\u5f71\u54cd\uff0c\u5e76\u5c06\u4f20\u8fbe\u5c06\u8981\u91c7\u53d6\u7684\u4efb\u4f55\u65b0\u63aa\u65bd\u3002<\/span><\/section>\n
\u53c2\u8003\u8d44\u6599<\/span><\/strong><\/span><\/section>\n
https:\/\/www.tga.gov.au\/media-release\/tga-suspends-overseas-gmp-inspections-and-qms-audits-until-further-notice<\/span><\/section>\n
https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-disease-2019-covid-19-update-foreign-inspections<\/span><\/section>\n
https:\/\/www.edqm.eu\/en\/news\/impact-covid-19-outbreak-edqm-certificate-suitability-cep-procedure<\/span><\/section>\n
\"\u75ab\u60c5\u4e0b\uff0cFDA\/EDQM\/TGA\uff0c\u6d77\u5916\u68c0\u67e5\u6309\u4e0b\u6682\u505c\u952e\uff01\"<\/section>\n
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\"\u75ab\u60c5\u4e0b\uff0cFDA\/EDQM\/TGA\uff0c\u6d77\u5916\u68c0\u67e5\u6309\u4e0b\u6682\u505c\u952e\uff01\"<\/section>\n
\u836f\u878d\u5708\u81f4\u529b\u4e8e\u6253\u9020\u533b\u836f\u884c\u4e1a\u751f\u6001\u5708\uff0c\u5171\u5efa\u3001\u5171\u521b\u3001\u5171\u8d62\u3001\u5171\u4eab\uff0c\u65e8\u5728\u89e3\u51b3\u751f\u7269\u533b\u836f\u53d1\u5c55\u8fc7\u7a0b\u4e2d\u7684\u5171\u6027\u5173\u952e\u95ee\u9898(\u9879\u76ee\u3001\u8d44\u672c\u3001\u4eba\u624d\u7b49)\uff0c\u5c06\u5e73\u53f0\u7684\u534f\u540c\u3001\u8054\u52a8\u3001\u5171\u4eab\u3001\u5171\u8d62\u4f18\u52bf\u6700\u5927\u5316\u5b9e\u73b0\u5e76\u53d1\u6325\uff0c\u60e0\u53ca\u5343\u4e07\u4f01\u4e1a\u3002\u5bf9\u5927\u4f01\u4e1a\u5b9e\u73b0\u52a0\u901f\u8d4b\u80fd\uff0c\u5bf9\u4e2d\u5c0f\u4f01\u4e1a\u5b9e\u73b0\u52a9\u529b\u5b75\u5316\uff0c\u5f62\u6210\u4f01\u4e1a\u670d\u52a1\u9886\u57df\u65b0\u751f\u6001\u3002\u836f\u878d\u5708\u56f4\u7ed5\u6211\u56fd\u751f\u7269\u533b\u836f\u4ea7\u4e1a\u94fe\uff0c\u9488\u5bf9\u751f\u7269\u533b\u836f\u5927\u6570\u636e\u3001\u6280\u672f\u548c\u8d44\u672c\u6295\u8d44\u3001\u836f\u878d\u56ed(\u4ea7\u4e1a\u56ed)\u7b49\u5f00\u5c55\u7cfb\u5217\u7cfb\u7edf\u6027\u5de5\u4f5c\uff0c\u4fc3\u8fdb\u6211\u56fd\u751f\u7269\u533b\u836f\u4ea7\u4e1a\u5065\u5eb7\u53d1\u5c55\uff0c\u5b8c\u5584\u4ea7\u4e1a\u94fe\uff0c\u5171\u540c\u9762\u5bf9\u5168\u7403\u5408\u4f5c\u548c\u7ade\u4e89\u3002<\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

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