{"id":112194,"date":"2019-05-17T00:00:50","date_gmt":"2019-05-20T01:29:52","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/112194\/"},"modified":"2019-05-20T09:29:53","modified_gmt":"2019-05-20T01:29:53","slug":"b9a8819c7a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/112194\/","title":{"rendered":"\u5728\u6700\u8fd1\u7684\u6cd5\u89c4\u76d1\u7ba1\u4e0b\u600e\u6837\u505a\u597d\u6301\u7eed\u5de5\u827a\u786e\u8ba4"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 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style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;line-height: 3em;\"><span style=\"color: rgb(217, 33, 66);font-size: 18px;\"><strong>\u4e00\u3001\u5404\u56fd\u6cd5\u89c4\u76d1\u7ba1\u7684\u8fdb\u7a0b<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">2011\u5e74\uff0c\u5f53FDA\u4fee\u8ba2\u5176\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\u65f6\uff0c \u5b83\u5f15\u5165\u4e86\u9a8c\u8bc1\u5fc5\u987b\u5728\u5236\u836f\u4ea7\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u6301\u7eed\u8fdb\u884c\u7684\u7406\u5ff5\u3002<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u5de5\u827a\u8bbe\u8ba1\uff0c\u91c7\u7528\u836f\u54c1\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\uff08QbD\uff09\u7684\u539f\u5219<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u5de5\u827a\u6027\u80fd\u786e\u8ba4\uff08PPQ\uff09<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u6301\u7eed\u5de5\u827a\u786e\u8ba4\uff08CPV\uff09<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u5236\u836f\u5382\u5546\u4e00\u76f4\u5728\u5f00\u53d1\u65b0\u7684\u65b9\u6cd5\u548c\u89e3\u51b3\u65b9\u6848\uff0c\u4ee5\u652f\u6301\u8fd9\u4e00\u5de5\u827a\u9a8c\u8bc1\u7684\u65b0\u5b9a\u4e49\uff0c FDA\u4e5f\u4e00\u76f4\u5728\u9f13\u52b1\u6240\u6709\u4e09\u4e2a\u9636\u6bb5\u7684\u57fa\u4e8e\u79d1\u5b66\u548c\u98ce\u9669\u7684\u65b9\u6cd5\u3002<\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u5176\u4ed6\u76d1\u7ba1\u673a\u6784\uff0c\u5305\u62ec\u56fd\u9645\u534f\u8c03\u59d4\u5458\u4f1a(ICH)\u5728\u5176Q8\u3001Q9\u548cQ10\u7684\u95ee\u7b54(R4)\u884c\u4e1a\u6307\u5357\u4e2d\uff0c\u4e5f\u63a5\u53d7\u4e86\u5de5\u827a\u9a8c\u8bc1\u7684\u751f\u547d\u5468\u671f\u65b9\u6cd5\u3002ICH\u5c06\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u89c6\u4e3a\uff1a\u5f00\u53d1\u3001\u6280\u672f\u8f6c\u79fb\u3001\u751f\u4ea7\u548c\u7ec8\u6b62\u3002<\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u6700\u4f73\u5b9e\u8df5\u9700\u8981\u4ee5\u4e0b\u65b9\u6cd5\uff1a<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u91c7\u7528\u5b9e\u9a8c\u8bbe\u8ba1(DOE)\u65b9\u6cd5\u8fdb\u884c\u4ea7\u54c1\u5f00\u53d1\u3001\u53d6\u6837\u548c\u6d4b\u8bd5\u8ba1\u5212\uff0c\u53ef\u53d8\u8f93\u5165\u4e0e\u7ed3\u679c\u8f93\u51fa\u4e4b\u95f4\u591a\u79cd\u56e0\u7d20\u7684\u76f8\u4e92\u4f5c\u7528\u6765\u8fdb\u884c\u3002<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u98ce\u9669\u5206\u6790\u5de5\u5177\u53ef\u7528\u4e8e\u7b5b\u9009\u7814\u7a76\u4e2d\u7684\u6f5c\u5728\u53d8\u91cf\uff0c\u5b9e\u73b0\u6700\u5c0f\u5316\u5b9e\u9a8c\u6765\u83b7\u5f97\u6700\u5927\u5316\u7684\u77e5\u8bc6\u3002DOE\u7814\u7a76\u7ed3\u679c\u53ef\u4ee5\u4f5c\u4e3a\u5efa\u7acb\u4ee5\u540e\u6210\u54c1\u8d28\u91cf\u3001\u8bbe\u5907\u53c2\u6570\u4ee5\u53ca\u4e2d\u95f4\u4f53\u8d28\u91cf\u6807\u51c6\u7684\u4f9d\u636e\u3002<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u5de5\u827a\u6027\u80fd\u786e\u8ba4\uff08PPQ\uff09\u6279\u6b21\u6570\u91cf\u7684\u786e\u5b9a\u3002<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u4f7f\u7528\u5408\u9002\u7684\u6570\u636e\u7edf\u8ba1\u5de5\u5177\u8fdb\u884c\u6301\u7eed\u5de5\u827a\u786e\u8ba4\uff08CPV\uff09<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u5de5\u827a\u8fc7\u7a0b\u5206\u6790\u6280\u672f\uff08PAT\uff09\u7684\u5e94\u7528\uff0c\u5b9e\u73b0\u8bbe\u8ba1\u3001\u5206\u6790\u3001\u548c\u63a7\u5236\u751f\u4ea7\u8fc7\u7a0b\u53ca\u65f6\u5730\u6d4b\u91cf\u3002<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40(EMA)2014\u5e74\u5de5\u827a\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219\u3001\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u76842015\u5e74\u9644\u5f557\u548c\u56fd\u9645\u836f\u54c1\u76d1\u67e5\u5408\u4f5c\u8ba1\u5212(PIC\/S)2015\u5e74\u9644\u4ef615\u5747\u53cd\u6620\u4e86\u5de5\u827a\u9a8c\u8bc1\u5e94\u5728\u6574\u4e2a\u5de5\u827a\u751f\u547d\u5468\u671f\u4e2d\u6301\u7eed\u8fdb\u884c\u7684\u9884\u671f\u3002<\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u4e2d\u56fdGMP\u9644\u5f55\u300a\u786e\u8ba4\u4e0e\u9a8c\u8bc1\u300b\u7b2c\u4e8c\u5341\u4e03\u6761\u660e\u786e\u89c4\u5b9a\uff0c\u5728\u4ea7\u54c1\u751f\u547d\u5468\u671f\u4e2d\uff0c\u5e94\u5f53\u8fdb\u884c\u6301\u7eed\u5de5\u827a\u786e\u8ba4\uff0c\u5bf9\u5546\u4e1a\u5316\u751f\u4ea7\u7684\u4ea7\u54c1\u8d28\u91cf\u8fdb\u884c\u76d1\u63a7\u548c\u8d8b\u52bf\u5206\u6790\uff0c\u4ee5\u786e\u4fdd\u5de5\u827a\u548c\u4ea7\u54c1\u8d28\u91cf\u59cb\u7ec8\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\u3002<\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u5404\u76d1\u7ba1\u673a\u6784\u90fd\u5df2\u8ba4\u53ef\u8fd9\u79cd\u5168\u751f\u547d\u5468\u671f\u7684\u5de5\u827a\u9a8c\u8bc1\u7406\u5ff5\uff0c\u5bf9\u5176\u8981\u6c42\u4e5f\u7edf\u4e00\uff0c\u5e76\u79ef\u6781\u63a8\u52a8\u5176\u53d1\u5c55\uff0c\u800c\u5236\u836f\u5382\u5546\u53ef\u4ee5\u91c7\u53d6\u4e00\u79cd\u5b8c\u6574\u7684\u751f\u547d\u5468\u671f\u65b9\u6cd5\u6765\u8fdb\u884c\u8de8\u591a\u4e2a\u6cd5\u89c4\u5e02\u573a\u7684\u5de5\u827a\u9a8c\u8bc1\u3002<\/span><br  \/><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-bottom: 10px;white-space: normal;line-height: 3em;\"><span style=\"color: rgb(217, 33, 66);font-size: 18px;\"><strong>\u4e8c\u3001FDA\u8b66\u544a\u4fe1\u4e2d\u5173\u4e8e\u5de5\u827a\u9a8c\u8bc1\u7684\u7f3a\u9677\u5206\u6790<\/strong><\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u672c\u6587\u6536\u96c6\u4e86\u4ece2017\u5e74\u81f3\u4ecaFDA\u53d1\u5e03\u7684\u8b66\u544a\u4fe1\uff0c\u901a\u8fc7\u5206\u6790FDA\u8b66\u544a\u4fe1(WLs)\uff0c\u6709\u52a9\u4e8e\u5236\u836f\u5382\u5546\u89e3\u51b3\u65b0\u7684\u5de5\u827a\u9a8c\u8bc1\u9700\u6c42\u3002\u76ee\u6807\u662f\u4e86\u89e3\u54ea\u4e9b\u73af\u8282\u53ef\u80fd\u9700\u8981\u52a0\u5f3a\uff0c\u4ee5\u63d0\u9ad8\u76d1\u7ba1\u5408\u89c4\u6027\u5e76\u4f7f\u98ce\u9669\u6700\u5c0f\u5316\u3002<\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u7531\u4e8eFDA\u5de5\u827a\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219\u9002\u7528\u4e8e\u539f\u6599\u836f\u3001\u5236\u5242\u548c\u751f\u7269\u5236\u5242\uff0c\u8b66\u544a\u4fe1\u8bc4\u4f30\u7684\u89c1\u89e3\u53ef\u4ee5\u63d0\u4f9b\u5145\u5206\u7684\u652f\u6301\u8bc1\u636e\uff0c\u4ee5\u5b9e\u73b0\u4e00\u79cd\u5b8c\u6574\u7684\u5de5\u827a\u9a8c\u8bc1\u65b9\u6cd5\u3002<\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u9488\u5bf9\u672c\u6587\u7684\u76ee\u7684\uff0c\u6211\u4eec\u5bf92017\u5e74\u548c2018\u5e74\u53d1\u5e03\u768485\u4e2aFDA \u8b66\u544a\u4fe1\u8fdb\u884c\u4e86\u5206\u6790\uff0c2017\u5e7461\u4e2a\uff0c2018\u5e7433\u4e2a\u3002\u5728\u539f\u6599\u836f\u548c\u6210\u54c1\u5236\u5242\u5de5\u5382\u4e2d\u5747\u53d1\u73b0\u4e86\u4e0d\u8db3\u4e4b\u5904\uff0c\u4f46\u4e3b\u8981\u53d1\u751f\u5728\u6210\u54c1\u5236\u5242\u5de5\u5382\u4e2d\uff0c\u5982\u8868I \u6240\u8ff0\u3002<\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"text-align: center;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u88681&nbsp; \u5de5\u827a\u9a8c\u8bc1\u7f3a\u9677\u4e00\u89c8\u8868<\/span><img class=\"\"         style=\"width: 100%;height: auto;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/5-1558315792.png\" alt=\"\u5728\u6700\u8fd1\u7684\u6cd5\u89c4\u76d1\u7ba1\u4e0b\u600e\u6837\u505a\u597d\u6301\u7eed\u5de5\u827a\u786e\u8ba4\" title=\"\u5728\u6700\u8fd1\u7684\u6cd5\u89c4\u76d1\u7ba1\u4e0b\u600e\u6837\u505a\u597d\u6301\u7eed\u5de5\u827a\u786e\u8ba4\"  \/><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u57282017\u5e74\u548c2018\u5e74\u7684FDA\u8b66\u544a\u4fe1\u4e2d\uff0c\u5de5\u827a\u9a8c\u8bc1\u95ee\u9898\u5728\u6210\u54c1\u5236\u5242\u5de5\u5382\u6bd4\u5728API\u5de5\u5382\u66f4\u5e38\u89c1\uff0c\u5728\u6240\u5206\u6790\u7684\u8b66\u544a\u4fe1\u4e2d\uff0c40%\u5305\u542b\u4e0e\u5de5\u827a\u9a8c\u8bc1\u76f8\u5173\u7684\u7f3a\u9677\u3002\u81ea2017\u5e74\u4ee5\u6765\uff0c\u5df2\u53d1\u73b031\u4e2a\u6210\u54c1\u5236\u5242\u5de5\u5382\u5728\u5de5\u827a\u9a8c\u8bc1\u65b9\u6cd5\u65b9\u9762\u4e0d\u5408\u89c4\u3002<\/span><br  \/><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">FDA\u8b66\u544a\u4fe1\u4e2d\u4e3b\u8981\u63d0\u5230\u7684\u95ee\u9898\u53ef\u5206\u4e3a\u4e24\u5927\u7c7b\uff0c\u5177\u4f53\u5982\u4e0b\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(255, 41, 65);font-size: 16px;\"><strong>1\u3001\u672a\u5f00\u5c55\u6301\u7eed\u7684\u5de5\u827a\u786e\u8ba4<\/strong><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"margin-top: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u672a\u5b9e\u65bd\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u7814\u7a76\uff0c\u7f3a\u4e4f\u76d1\u6d4b\u5de5\u827a\u63a7\u5236\u7684\u6301\u7eed\u8ba1\u5212\u6765\u786e\u4fdd\u7a33\u5b9a\u7684\u751f\u4ea7\u64cd\u4f5c\u548c\u4e00\u81f4\u7684\u836f\u54c1\u8d28\u91cf\u3002<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-top: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u5e94\u786e\u5b9a\u6bcf\u79cd\u836f\u54c1\u7684\u5de5\u827a\u6027\u80fd\u786e\u8ba4\uff08PPQ\uff09\u7684\u65f6\u95f4\u8868\uff0c\u63cf\u8ff0\u4f60\u4eec\u6301\u7eed\u76d1\u6d4b\u6279\u5185\u548c\u6279\u95f4\u5dee\u5f02\u7684\u65b9\u6cd5\uff0c\u8fd8\u7279\u6b8a\u5f3a\u8c03\u9700\u8981\u6309\u7167\u5de5\u827a\u9a8c\u8bc1\uff08PV\uff09\u6307\u5357\u7684\u89c4\u5b9a\u5236\u5b9a\u4e00\u4e2a\u7edf\u8ba1\u4e0a\u5408\u7406\u7684\u53d6\u6837\u548c\u6d4b\u8bd5\u8ba1\u5212\u3002<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-top: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u4e00\u4efd\u4ee5\u6570\u636e\u652f\u6491\u7684\u79d1\u5b66\u5408\u7406\u7684\u5de5\u827a\u9a8c\u8bc1\u8ba1\u5212\uff0c\u6070\u5f53\u5730\u8bc6\u522b\u51fa\u6ce2\u52a8\u7684\u6765\u6e90\uff0c\u786e\u4fdd\u5728\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5185\u4ee5\u6301\u7eed\u65b9\u5f0f\u5bf9\u6279\u95f4\u548c\u6279\u5185\u53d8\u5f02\u7684\u76d1\u7ba1<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><strong><span style=\"font-size: 16px;color: rgb(255, 41, 65);\"><br  \/><\/span><\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><strong><span style=\"font-size: 16px;color: rgb(255, 41, 65);\">2\u3001\u524d\u671f\u7684\u8bbe\u8ba1\u9636\u6bb5\u6216\u5de5\u827a\u9a8c\u8bc1\u9636\u6bb5\u7814\u7a76\u4e0d\u5145\u5206\uff0c\u9020\u6210\u540e\u7eed\u51fa\u73b0\u95ee\u9898<\/span><\/strong><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"margin-top: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u6ca1\u6709\u8868\u73b0\u51fa\u5145\u5206\u7684\u5de5\u827a\u7406\u89e3\uff0c\u5176\u4e2d\u5305\u62ec\u672a\u8003\u8651\u5173\u952e\u64cd\u4f5c\u7684\u64cd\u4f5c\u53c2\u6570\u3002<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-top: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u7528\u4e8e\u751f\u4ea7\u4f60\u4eec\u7684XX\u836f\u54c1\u7684\u5de5\u827a\u672a\u663e\u793a\u51fa\u5176\u4e00\u81f4\u6027\u548c\u53ef\u9760\u6027\uff0c\u4f60\u4eec\u836f\u54c1\u7684\u540e\u7eed\u6279\u6b21\u53ef\u80fd\u4f1a\u5728\u5242\u91cf\u3001\u8d28\u91cf\u548c\u7eaf\u5ea6\u65b9\u9762\u6709\u91cd\u5927\u53d8\u5f02\u3002<\/strong><\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin-top: 10px;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(2, 30, 170);font-size: 16px;\"><strong>\u7f3a\u4e4f\u5de5\u827a\u9a8c\u8bc1\u8bc1\u636e\uff0c\u56e0\u4e3a\u4f60\u4eec\u672a\u8bf4\u660e\u6240\u6709\u6f5c\u5728\u7684\u6ce2\u52a8\u6765\u6e90\uff0c\u8fd9\u4e9b\u5fc5\u987b\u53d7\u63a7\u4ee5\u6301\u7eed\u4ea7\u51fa\u5747\u4e00\u5c5e\u6027\u548c\u8d28\u91cf\u7684\u836f\u54c1\uff0c\u4e14\u672a\u8bc1\u660e\u5de5\u827a\u662f\u53ef\u91cd\u590d\u7684\u3002<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u603b\u800c\u8a00\u4e4b\uff0c\u751f\u4ea7\u5de5\u827a\u7684\u6bcf\u4e2a\u91cd\u5927\u9636\u6bb5\u90fd\u5fc5\u987b\u8bbe\u8ba1\u4ee5\u786e\u4fdd\u539f\u6599\u8f93\u5165\u3001\u4e2d\u95f4\u4f53\u548c\u5236\u5242\u6210\u54c1\u7b26\u5408\u5176\u8d28\u91cf\u5c5e\u6027\u548c\u6807\u51c6\u3002\u5de5\u827a\u9a8c\u8bc1\u8bc4\u4f30\u4e00\u4e2a\u5de5\u827a\u5728\u5176\u751f\u547d\u5468\u671f\u5185\u7684\u8bbe\u8ba1\u5408\u7406\u6027\u548c\u53d7\u63a7\u72b6\u6001\u3002\u5de5\u827a\u9a8c\u8bc1\u7814\u7a76\u80fd\u786e\u5b9a\u662f\u5426\u5df2\u5efa\u7acb\u8d77\u521d\u59cb\u7684\u53d7\u63a7\u72b6\u6001\u3002\u5728\u5546\u4e1a\u5316\u9500\u552e\u4e4b\u524d\u8981\u6c42\u6709\u6210\u529f\u7684\u5de5\u827a\u786e\u8ba4\u7814\u7a76\u3002\u4e4b\u540e\uff0c\u5bf9\u5de5\u827a\u6027\u80fd\u548c\u4ea7\u54c1\u8d28\u91cf\u8981\u6709\u6301\u7eed\u7684\u8b66\u60d5\u76d1\u7ba1\uff0c\u4ee5\u786e\u4fdd\u4f60\u4eec\u5728\u4ea7\u54c1\u751f\u547d\u5468\u671f\u4e2d\u7ef4\u6301\u7a33\u5b9a\u6027\u7684\u751f\u4ea7\u64cd\u4f5c\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(217, 33, 66);font-size: 18px;\"><strong>\u4e09\u3001\u6301\u7eed\u7684\u5de5\u827a\u786e\u8ba4\u7684\u65b9\u6cd5<\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u5728\u9884\u5148\u786e\u5b9a\u597d\u7684\u671f\u9650\uff0c\u4e00\u822c\u662f\u4e00\u4e2a\u6708\uff0c\u786e\u8ba4\u8be5\u671f\u9650\u5185\u8be5\u4ea7\u54c1CPPs\uff08\u5173\u952e\u5de5\u827a\u53c2\u6570\uff09\u3001CQAs\uff08\u4ea7\u54c1\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff09\u548cCMAs\uff08\u76f4\u63a5\u52a0\u5165\u5230\u5de5\u827a\u6d41\u4e2d\u7684\u5173\u952e\u7269\u6599\u8d28\u91cf\u5c5e\u6027\uff09\u7684\u53d7\u63a7\u60c5\u51b5\uff0c\u9664\u7b26\u5408\u5408\u683c\u6807\u51c6\u5916\uff0c\u53ef\u8981\u5bf9\u8d8b\u52bf\u8fdb\u884c\u5206\u6790\u3002\u5230\u671f\u540e\u6839\u636e\u5bf9\u5de5\u827a\u53d7\u63a7\u60c5\u51b5\u7684\u5206\u6790\uff0c\u589e\/\u51cf\u5de5\u827a\u63a7\u5236\u7b56\u7565\uff0c\u5e76\u6309\u7167\u65b0\u7684\u7b56\u7565\u5f00\u59cb\u4e0b\u4e00\u5468\u671f\u7684\u6301\u7eed\u6027\u5de5\u827a\u9a8c\u8bc1\uff0c\u4ee5\u6b64\u5faa\u73af\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u6ce8\uff1aCPPs\u3001CQAs\u548cCMAs\u4e4b\u95f4\u7684\u5173\u7cfb\u53ca\u8bc6\u522b\u7684\u65b9\u6cd5\u5728\u8fd9\u91cc\u4e0d\u518d\u9610\u8ff0\uff0c\u5df2\u6709\u5f88\u591a\u6587\u7ae0\u8fdb\u884c\u4e86\u8bb2\u89e3\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"color: rgb(217, 33, 66);font-size: 18px;\"><strong>\u56db\u3001\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u5e94\u8be5\u600e\u6837\u505a<\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u7531\u4e8e\u884c\u4e1a\u5bf9\u57fa\u4e8e\u751f\u547d\u5468\u671f\u7684\u5de5\u827a\u9a8c\u8bc1\u65b9\u6cd5\u5df2\u7ecf\u6709\u4e86\u8fdb\u6b65\uff0c\u73b0\u5728\u4e00\u4e9b\u516c\u53f8\u5c06\u9636\u6bb51\uff0c2\u548c3\u5206\u4e3a\u4ee5\u4e0b\u51e0\u4e2a\u9636\u6bb5\uff1a<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><strong><span style=\"font-size: 16px;color: rgb(2, 30, 170);\">\u9636\u6bb51A-\u4ea7\u54c1\u8bbe\u8ba1\u5f00\u53d1\uff0c\u9636\u6bb51B-\u89c4\u6a21\u653e\u5927<\/span><\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><strong><span style=\"font-size: 16px;color: rgb(2, 30, 170);\">\u9636\u6bb52A-\u8bbe\u5907\u3001\u7cfb\u7edf\u3001\u516c\u7528\u8bbe\u65bd\u3001\u8bbe\u65bd\u786e\u8ba4\uff0c\u9636\u6bb52B-\u5de5\u827a\u6027\u80fd\u786e\u8ba4<\/span><\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><strong><span style=\"font-size: 16px;color: rgb(2, 30, 170);\">\u9636\u6bb53A-\u5bf9\u65b0\u5de5\u827a\u7684\u5f3a\u5316\u786e\u8ba4\u7a0b\u5e8f\uff0c\u9636\u6bb53B-\u5e38\u89c4\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u3002<\/span><\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><strong><span style=\"font-size: 16px;color: rgb(2, 30, 170);\"><br  \/><\/span><\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u5728\u5168\u7403\u8303\u56f4\u5185\u5b9e\u65bd\u5de5\u827a\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u65b9\u6cd5\u8981\u6c42\u5236\u836f\u5382\u5546\u5728\u9009\u62e9\u6700\u6709\u6548\u7684\u7edf\u8ba1\u5de5\u5177\u548c\u9636\u6bb53\u7b56\u7565\u65f6\u8981\u7279\u522b\u6ce8\u610f\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u4e00\u4e2a\u597d\u7684\u77e5\u8bc6\u7ba1\u7406\u7b56\u7565\u662f\u81f3\u5173\u91cd\u8981\u7684\uff0c\u4ece\u5de5\u827a\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u7684\u7b2c1\u9636\u6bb5\u5f00\u59cb\u5230\u7b2c3\u9636\u6bb5\u3002\u79d1\u5b66\u5730\u786e\u5b9a\u53d8\u5f02\u6765\u6e90\u9700\u8981\u4e00\u4e2a\u5f3a\u5927\u7684\u57fa\u4e8eQbD\u7684\u4ea7\u54c1\u5f00\u53d1\u8ba1\u5212\uff0c\u4ee5\u53ca\u4e00\u4e2a\u7b2c3\u9636\u6bb5\u5141\u8bb8\u6301\u7eed\u5730\u6536\u96c6\u4ea7\u54c1\u548c\u5de5\u827a\u77e5\u8bc6\u7684CPV\u8ba1\u5212\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u4ece\u8fc7\u7a0b\u6f02\u79fb\u4e2d\u5b66\u4e60\uff0c\u8fc7\u7a0b\u6f02\u79fb\u6216\u5f53\u5de5\u827a\u672a\u80fd\u6700\u5927\u9650\u5ea6\u5730\u6267\u884c\u65f6\uff0c\u89e6\u53d1\u8bc6\u522b\u53d8\u5f02\u6765\u6e90\uff0c\u786e\u4fdd\u6539\u8fdb\u7684\u63a7\u5236\uff0c\u5e76\u5141\u8bb8\u6301\u7eed\u6539\u8fdb\u3002\u9700\u8981\u6301\u7eed\u6536\u96c6\u4ea7\u54c1\u548c\u5de5\u827a\u77e5\u8bc6\u4ee5\u6301\u7eed\u6539\u8fdb\uff0c\u5e76\u6539\u5584\u7c7b\u4f3c\u4ea7\u54c1\u7684\u5f00\u53d1\u8fc7\u7a0b\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u5408\u9002\u7684\u7edf\u8ba1\u5de5\u5177\u5e94\u80fd\u975e\u5e38\u76f4\u89c2\u5c06\u7ed3\u679c\u8868\u73b0\u51fa\u6765\u3002\u80fd\u591f\u8bc6\u53d8\u5f02\u7684\u6765\u6e90\uff0c\u786e\u5b9a\u5de5\u827a\u6539\u8fdb\u7684\u65b9\u5411\uff0c\u65e0\u8bba\u4f7f\u7528\u4f55\u79cd\u7edf\u8ba1\u5206\u6790\u5de5\u5177\uff0c\u5176\u76ee\u7684\u90fd\u662f\u5bf9\u5df2\u6709\u6570\u636e\u8fdb\u884c\u5206\u6790\uff0c\u4ee5\u786e\u8ba4\u5de5\u827a\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\u6216\u8005\u8bc6\u522b\u5de5\u827a\u6539\u8fdb\u7684\u673a\u4f1a\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 18px;\"><strong><span style=\"color: rgb(217, 33, 66);\">\u4e94\u3001\u603b\u7ed3<\/span><\/strong><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u672c\u6587\u5bf9\u8b66\u544a\u4fe1\u8d8b\u52bf\u8fdb\u884c\u4e86\u5206\u6790\uff0c\u4e3a\u751f\u4ea7\u5546\u63d0\u4f9b\u4e86\u5bf9\u76d1\u7ba1\u673a\u6784\u76ee\u6807\u7684\u4e00\u4e9b\u7406\u89e3\u3002\u5728\u6700\u8fd1\u7684\u68c0\u67e5\u4e2d\uff0c\u7531\u4e8e\u8fdd\u53cd\u4e86\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\uff0cAPI\u548c\u6210\u54c1\u5236\u5242\u751f\u4ea7\u573a\u6240\u4e00\u76f4\u88ab\u63d0\u5230\uff0c\u800c\u4e14\u56fd\u5185\u7684\u68c0\u67e5\u5458\u4e5f\u9646\u7eed\u5bf9\u5de5\u827a\u9a8c\u8bc1\u63d0\u51fa\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u7684\u8981\u6c42\u3002\u5bf9\u7f3a\u9677\u7684\u5206\u6790\u8bc1\u5b9e\u4e86\u9700\u8981\u4e00\u4e2a\u5b9a\u4e49\u660e\u786e\u7684\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u8ba1\u5212\uff0c\u6301\u7eed\u76d1\u6d4b\u53d8\u5f02\u6765\u6e90\uff0c\u5728\u9047\u5230\u8d28\u91cf\u95ee\u9898\u4e4b\u524d\uff0c\u4f7f\u7ec4\u7ec7\u80fd\u591f\u8fdb\u884c\u6301\u7eed\u6539\u8fdb\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u540c\u65f6\u6211\u4eec\u4e0d\u80fd\u4e3a\u4e86\u9a8c\u8bc1\u800c\u9a8c\u8bc1\uff0c\u8981\u5b9e\u9645\u5e94\u7528\u597d\uff0c\u505a\u597d\u77e5\u8bc6\u7ba1\u7406\uff0c\u7528\u4e8e\u5b9e\u9645\u7684\u6539\u8fdb\uff0c\u4e16\u754c\u5404\u5730\u7684\u76d1\u7ba1\u673a\u6784\u6b63\u5728\u9f13\u52b1\u4f7f\u7528\u6570\u636e\u9a71\u52a8\u7684\u3001\u4ee5\u79d1\u5b66\u4e3a\u57fa\u7840\u7684\u65b9\u6cd5\u8fdb\u884c\u5de5\u827a\u9a8c\u8bc1\u3002\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u68c0\u67e5\u5458\u5efa\u8bae\u751f\u4ea7\u5546\u5bfb\u6c42\u6709\u8d44\u8d28\u7684\u987e\u95ee\u7684\u5e2e\u52a9\uff0c\u8981\u6c42\u751f\u4ea7\u5546\u6295\u5165\u65f6\u95f4\u548c\u8d44\u6e90\u5efa\u7acb\u7b2c3\u9636\u6bb5CPV\u8ba1\u5212\u548c\u652f\u6301\u56e2\u961f\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u73b0\u5728\u66f4\u591a\u7684\u4ea7\u5546\u6b63\u5728\u52aa\u529b\u5bfb\u6c42\u6570\u636e\u7edf\u8ba1\u7684\u65b9\u6cd5\u6765\u8fdb\u884c\u7b2c3\u9636\u6bb5\u7684\u5de5\u827a\u9a8c\u8bc1\uff0c\u89e3\u51b3\u65b9\u6848\u7684\u63d0\u4f9b\u5546\u6b63\u5728\u63d0\u4f9b\u96c6\u6210\u7684\u8f6f\u4ef6\u6765\u5e2e\u52a9\u7ba1\u7406\u8fd9\u6837\u7684\u7a0b\u5e8f\u3002\u5e2e\u52a9\u6240\u6709\u7ec4\u7406\u89e3\u5b83\u4eec\u5728\u4fc3\u8fdb\u6301\u7eed\u6539\u8fdb\u4e2d\u7684\u4f5c\u7528\u3002\u8fd9\u79cd\u65b9\u6cd5\u5c06\u6709\u52a9\u4e8e\u751f\u4ea7\u5546\u9632\u6b62\u8fc7\u7a0b\u5931\u8d25\uff0c\u800c\u4e14\u8fd8\u53ef\u4ee5\u9632\u6b62\u4eba\u4eec\u5bf9\u4e2a\u522b\u4e8b\u4ef6\u53cd\u5e94\u8fc7\u5ea6\u3002\u5b83\u8fd8\u53ef\u4ee5\u786e\u4fdd\u5b83\u4eec\u6355\u6349\u5230\u5176\u4ed6\u53ef\u80fd\u672a\u88ab\u68c0\u6d4b\u5230\u7684\u53d8\u5f02\u6765\u6e90\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\"><br  \/><\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><span style=\"font-size: 16px;\">\u6539\u8fdb\u540e\u5fc5\u7136\u8981\u6d89\u53ca\u5230\u53d8\u66f4\uff0c\u505a\u597d\u540e\u7eed\u7684\u53d8\u66f4\u4e5f\u81f3\u5173\u91cd\u8981\uff0c\u505a\u597d\u5404\u79cd\u5bf9\u6bd4\u53ca\u8d28\u91cf\u7814\u7a76\uff0c\u8bc1\u660e\u6539\u8fdb\u7684\u53ef\u9760\u6027\u3002<\/span><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><strong style=\"font-size: 18px;\"><span style=\"color: rgb(217, 33, 66);\"><br  \/><\/span><\/strong><\/p>\n<p style=\"margin-top: 10px;white-space: normal;text-align: justify;line-height: 1.75em;\"><strong style=\"font-size: 18px;\"><span style=\"color: rgb(217, 33, 66);\">\u53c2\u8003\u6587\u732e<\/span><\/strong><br  \/><\/p>\n<p style=\"text-align: justify;line-height: 1.5em;\"><span style=\"font-size: 14px;\">1. FDA,&nbsp;Guidance for Industry: Process Validation-General Principles and Practices, (Silver Spring,MD, Jan 2011).<br  \/>2. ICH,&nbsp;Q10 Harmonized Tripartite Guideline, Guidance for Industry: Q8, Q9 and Q10 Questions &amp; Answers (R4) (ICH,November 2010), ich.org.<br  \/>3. ICH,&nbsp;Q10 Harmonized Tripartite Guideline, Pharmaceutical Quality Systems, (ICH, June 2008),&nbsp;ich.org.<br  \/>4. ISPE,&nbsp;Pharmaceutical Engineering, September 2017.<br  \/>5. Parenteral Drug Association (PDA), \u201cHow Global Pharma Organizations Can Achieve Process Validation Success,\u201d&nbsp;PDA Letter, February 2017.<br  \/>6. FDA,&nbsp;Title 21, Food and Drugs, 21 Code of Federal Regulations 211.100(a),&nbsp;accessdata.fda.gov.<\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.5em;\"><span style=\"font-size: 14px;\">7. Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification Pharmaceutical Technology Volume 2018 Supplement.<\/span><\/p>\n<p style=\"text-align: justify;line-height: 1.5em;\"><span style=\"font-size: 14px;\"><br  \/><\/span><\/p>\n<h2 class=\"\" style=\"margin-top: 10px;margin-bottom: 10px;font-size: 22px;white-space: normal;max-width: 100%;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);line-height: 1.4;text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"color: rgb(255, 127, 170);\"><strong><span style=\"max-width: 100%;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);font-size: 20px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzI5ODI5NDE2OA==&amp;mid=2247501032&amp;idx=2&amp;sn=0f6700af84ae8f3aa7df6da6811b0519&amp;chksm=ecaa8a1fdbdd03098fcf9b33f0777e10097ad6fad009fb8befe41da103c37668ce6e3dac0560&amp;mpshare=1&amp;scene=21&amp;srcid=&amp;pass_ticket=cLD9hndLTIy79YwTwMvVrUKoaWTLWUT4c9doEKGoSYB9fkrx3nGRx585ELIKAu6L#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5f81\u7a3f\u542f\u4e8b<\/a><\/span><\/strong><\/span><\/h2>\n<section style=\"white-space: normal;max-width: 677px;box-sizing: border-box;background-color: rgb(255, 255, 255);font-size: 16px;font-family: \u5fae\u8f6f\u96c5\u9ed1;letter-spacing: 0.54px;overflow-wrap: break-word !important;\">\n<section style=\"margin-right: 3px;margin-left: 3px;padding: 20px;max-width: 677px;box-sizing: border-box;background-color: rgb(254, 254, 254);border-color: rgb(210, 150, 20);box-shadow: rgb(210, 150, 20) 0px 0px 4px;overflow-wrap: break-word !important;\">\n<h2 class=\"\" style=\"margin-bottom: 14px;font-size: 22px;max-width: 100%;line-height: 1.4;font-variant-numeric: normal;letter-spacing: 0.544px;text-align: start;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzA5NDk0NTc4MQ==&amp;mid=2650426044&amp;idx=1&amp;sn=c87b281bb6b7baade0105eb459c19ba9&amp;scene=21#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);font-size: 14px;color: rgb(61, 167, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;\">2019\u836f\u7269\u5206\u79bb\u7eaf\u5316\u548c\u7ed3\u6784\u9274\u5b9a\u53ca\u8d4b\u503c\u6df1\u5ea6\u7814\u8ba8\u4f1a &#8211;CMC\u836f\u7269\u8d28\u91cf\u7cfb\u5217\u7814\u8ba8\u4f1a\u4e4b\u4e09<\/span><\/a><\/h2>\n<p style=\"max-width: 631px;box-sizing: border-box;min-height: 18px;color: rgb(210, 150, 20);font-weight: 700;min-width: 1px;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box;letter-spacing: 0.54px;color: rgb(51, 51, 51);overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box;color: rgb(214, 168, 65);overflow-wrap: break-word !important;\">\u540c\u5199\u610f\u8bba\u575b\uff1a<\/span><\/strong><\/p>\n<section style=\"margin-top: 10px;margin-bottom: 10px;max-width: 631px;box-sizing: border-box;border-color: rgb(210, 150, 20);overflow-wrap: break-word !important;\">\n<p style=\"margin-bottom: 5px;max-width: 100%;box-sizing: border-box;min-height: 1em;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">1.<\/span><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzA4MzgzMDM5Mg==&amp;mid=2650628137&amp;idx=1&amp;sn=31a673ec733f84c6eee6873b1fe626c8&amp;scene=21#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5199\u610f\u5de8\u732e\uff1a\u6df1\u5ea6\u89e3\u6790\u4e2d\u7f8e\u52a0\u5feb\u836f\u54c1\u7814\u53d1\u7684\u5ba1\u8bc4\u5ba1\u6279\u653f\u7b56\uff0891\u671f\u65e5\u7a0b\u66f4\u65b0\uff09<\/span><\/a><\/p>\n<p style=\"margin-bottom: 5px;max-width: 100%;box-sizing: border-box;min-height: 1em;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">2.<\/span><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzA4MzgzMDM5Mg==&amp;mid=2650627699&amp;idx=1&amp;sn=cb1df4a9fd9b4bb1582c9f94d3520f73&amp;scene=21#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7b2c93\u671f\u8bba\u575b\u4e282019\u4e2d\u7f8e\u533b\u7597\u6295\u8d44\u8bba\u575b\u548c\u8def\u6f14<\/span><\/a><\/p>\n<p style=\"margin-bottom: 5px;max-width: 100%;box-sizing: border-box;min-height: 1em;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">3.<\/span><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzA4MzgzMDM5Mg==&amp;mid=2650628250&amp;idx=2&amp;sn=bbf58c464d6eb350985cf5cf6354af1c&amp;scene=21#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u540c\u5199\u610f\u534f\u529e\u4e282019\u7ec6\u80de\u6cbb\u7597\u4ea7\u4e1a\u53d1\u5c55\u6e56\u5317\u5cf0\u4f1a\uff08free\uff09<\/span><\/a><\/p>\n<p style=\"margin-bottom: 5px;max-width: 100%;box-sizing: border-box;min-height: 1em;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">4.<\/span><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzA4MzgzMDM5Mg==&amp;mid=2650628019&amp;idx=1&amp;sn=5dae65d812e02cc8e74e2a352bbba5d6&amp;scene=21#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;letter-spacing: 0.54px;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;letter-spacing: 0.54px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7b2c94\u671f\u8bba\u575b\u4e28\u4eff\u5236\u836f\u9009\u9898\u7acb\u9879\u2014\u7b56\u7565\u4e0e\u65b9\u6cd5<\/span><\/a><\/p>\n<p style=\"margin-bottom: 5px;max-width: 100%;box-sizing: border-box;min-height: 1em;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">5.<span style=\"max-width: 100%;letter-spacing: 0.54px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzA4MzgzMDM5Mg==&amp;mid=2650628093&amp;idx=1&amp;sn=ce26e32435f63b4eb8b913c510cfb31f&amp;scene=21#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7b2c95\u671f\u8bba\u575b\u4e28BD\u4e2d\u7ea7\u73ed\uff1a\u521b\u65b0\u53d1\u9879\u76ee\u7684\u7efc\u5408\u8bc4\u4f30<\/a><\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><a href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzU2MDY5MzA0OQ==&amp;mid=2247484428&amp;idx=1&amp;sn=d7540b3b4d54422e4996085f2bbc0079&amp;chksm=fc056e5acb72e74cec1843e4eb3f9cf04dcf6ea93b9d8448da418734b13b6440111ca014de9a&amp;token=1732418045&amp;lang=zh_CN&amp;scene=21#wechat_redirect\" target=\"_blank\"  style=\"-webkit-tap-highlight-color: rgba(0, 0, 0, 0);max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"js_jump_icon h5_image_link\"  style=\"max-width: 100%;line-height: 0;top: auto;left: auto;right: auto;bottom: auto;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><img class=\"rich_pages __bg_gif\"          style=\"box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 556px !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/8-1558315793.gif\" alt=\"\u5728\u6700\u8fd1\u7684\u6cd5\u89c4\u76d1\u7ba1\u4e0b\u600e\u6837\u505a\u597d\u6301\u7eed\u5de5\u827a\u786e\u8ba4\" title=\"\u5728\u6700\u8fd1\u7684\u6cd5\u89c4\u76d1\u7ba1\u4e0b\u600e\u6837\u505a\u597d\u6301\u7eed\u5de5\u827a\u786e\u8ba4\"  \/><\/span><\/a><\/p>\n<p style=\"white-space: normal;max-width: 100%;box-sizing: border-box;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);overflow-wrap: break-word !important;\"><img class=\"\"        width=\"676.997px\"  style=\"box-sizing: border-box;font-size: 15px;letter-spacing: 0.54px;text-align: center;overflow-wrap: break-word !important;visibility: visible !important;width: 676.997px !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/7-1558315793.jpg\" alt=\"\u5728\u6700\u8fd1\u7684\u6cd5\u89c4\u76d1\u7ba1\u4e0b\u600e\u6837\u505a\u597d\u6301\u7eed\u5de5\u827a\u786e\u8ba4\" title=\"\u5728\u6700\u8fd1\u7684\u6cd5\u89c4\u76d1\u7ba1\u4e0b\u600e\u6837\u505a\u597d\u6301\u7eed\u5de5\u827a\u786e\u8ba4\"  \/><br style=\"max-width: 100%;box-sizing: border-box;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"white-space: normal;max-width: 100%;min-height: 1em;background-color: rgb(255, 255, 255);letter-spacing: 0.582857px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u662f\u4e00\u4e2a\u5f00\u653e\uff0c\u7531\u81ea\u613f\u8005\u7ec4\u6210\u7684\u56e2\u4f53\uff0c\u7531\u4ee5\u4e0b\u6210\u5458\u7ec4\u6210\uff1aVoyager88\uff0c\u96f7\u8bfa\u5c9b\uff0cHerman\uff0c\u6885\u5e0c\uff0c\u6587\u7af9\uff0cduke\uff0c\u5360\u5c0f\u5175\uff0c\u9526\u5fc3\u7ee3\u53e3\uff0c\u591a\u5df4\u80fa\uff0c\u745c\u513f\uff0c\u5b50\u708e\uff0c\u514b\u683c\u83ab\uff0cSophia \uff0c\u5076\u9635\u96e8\uff0c\u96f6\u4e0b274\u2103\uff0cHelen\uff0cZMJ\uff0c\u6da6\u513f\uff0c\u7f8a\u7f8a\u3001<span style=\"max-width: 100%;letter-spacing: 0.582857px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Admiral\u3001<\/span>\u4e8c\u53cb\u6728\u3001\u90ed\u5927\u4fa0\u3001\u8d1d\u58f3\u91cc\u7684\u4e7e\u5764\u548c\u66fe\u6587\u4eae\u3002\u6b22\u8fce\u6709\u5fd7\u4e4b\u58eb\u52a0\u5165\u6211\u4eec\u56e2\u961f\u3002\u6295\u7a3f\u3001\u5408\u4f5c\u3001\u52a0\u4e13\u4e1a\u7fa4\u8bf7\u52a0\u5fae\u4fe1437180999\uff0c\u4e8c\u5343\u4ebaQQ\u7fa422711855\u3002<\/span><\/p>\n<p style=\"white-space: normal;max-width: 100%;min-height: 1em;background-color: rgb(255, 255, 255);letter-spacing: 0.582857px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br  \/><\/p>\n<p style=\"white-space: normal;max-width: 100%;min-height: 1em;background-color: rgb(255, 255, 255);letter-spacing: 0.582857px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8d23\u4efb\u7f16\u8f91\uff1a\u96f7\u8bfa\u5c9b<\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u81ea\u4ece2011\u5e74FDA\u4fee\u8ba2\u5176\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\uff0c\u5230\u73b0\u5728\u5df2\u67098\u4e2a\u5e74\u5934\u4e86\uff0cFDA\u5df2\u7ed9\u4f01\u4e1a\u5145\u8db3\u7684\u65f6\u95f4\u5b9e\u65bd\u65b0\u6307\u5357\uff0c\u901a\u8fc7\u8fd9\u4e00\u5e74\u591a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":112195,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/112194"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=112194"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/112194\/revisions"}],"predecessor-version":[{"id":112199,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/112194\/revisions\/112199"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/112195"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=112194"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=112194"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=112194"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}