{"id":1792,"date":"2026-05-18T10:28:18","date_gmt":"2026-05-18T02:28:18","guid":{"rendered":"http:\/\/www.millibuff.com\/?p=1792"},"modified":"2026-05-18T11:26:49","modified_gmt":"2026-05-18T03:26:49","slug":"%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e7%a0%94%e7%a9%b6%e4%b8%ad%e5%bf%83%e7%a8%bd%e6%9f%a5%e5%ae%9e%e8%b7%b5%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/www.millibuff.com\/?p=1792","title":{"rendered":"\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u4e2d\u5fc3\u7a3d\u67e5\u5b9e\u8df5\u6307\u5357\u2014\u4ece\u6d41\u7a0b\u5230\u62a5\u544a\uff0c\u5168\u94fe\u6761\u5b9e\u64cd\u6307\u5f15"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">\u7a3d\u67e5\u7684\u91cd\u8981\u6027\u548c\u5206\u7c7b<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">1.1 \u4e3a\u4ec0\u4e48\u8981\u505a\u7a3d\u67e5\uff1f<\/h2>\n\n\n\n<p>\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u771f\u5b9e\u6027\u4e0e\u5b8c\u6574\u6027\u76f4\u63a5\u5f71\u54cd\u836f\u54c1\u4e0a\u5e02\u540e\u7684\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u8bc4\u4ef7\u3002\u57fa\u4e8e\u98ce\u9669\u7684\u8d28\u91cf\u7ba1\u7406\u662fICH E6(R3)\u7684\u6838\u5fc3\u7406\u5ff5\u3002\u7a3d\u67e5\u4f5c\u4e3a\u8d28\u91cf\u4fdd\u8bc1\u5de5\u5177\uff0c\u53ef\u4ee5\u8986\u76d6\u4e34\u5e8a\u8bd5\u9a8c\u6574\u4e2a\u751f\u547d\u5468\u671f\uff0c\u901a\u8fc7\u5bf9\u9ad8\u98ce\u9669\u8282\u70b9\u7684\u6df1\u5ea6\u6838\u67e5\uff0c\u4e3a\u7533\u529e\u8005\u63d0\u4f9b\u8d28\u91cf\u98ce\u9669\u7684\u72ec\u7acb\u5ba2\u89c2\u89c6\u89d2\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1.2 \u7a3d\u67e5\u4e3b\u8981\u5206\u7c7b<\/h2>\n\n\n\n<p>\u88681 \u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u4e2d\u5fc3\u7a3d\u67e5\u5206\u7c7b<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u5206\u7c7b\u7ef4\u5ea6<\/strong><\/td><td><strong>\u7a3d\u67e5\u7c7b\u578b<\/strong><\/td><td><strong>\u89e6\u53d1\u6761\u4ef6\/\u76ee\u7684<\/strong><\/td><td><strong>\u5178\u578b\u7279\u5f81<\/strong><\/td><\/tr><tr><td rowspan=\"3\">\u6309\u89e6\u53d1\u56e0\u7d20<\/td><td>\u5e38\u89c4<\/td><td>\u4f9d\u636e\u5e74\u5ea6\u7a3d\u67e5\u8ba1\u5212\uff0c\u5468\u671f\u6027\u5f00\u5c55<\/td><td>\u8ba1\u5212\u5185\uff1b\u8986\u76d6\u9762\u5e7f<\/td><\/tr><tr><td>\u89e6\u53d1\u6027<\/td><td>\u76d1\u67e5\u62a5\u544a\u5f02\u5e38\u3001\u6570\u636e\u7591\u95ee\u96c6\u4e2d\u3001\u6295\u8bc9\u4e3e\u62a5<\/td><td>\u8ba1\u5212\u5916\uff1b\u9488\u5bf9\u6027\u5f3a<\/td><\/tr><tr><td>\u76d1\u7ba1\u68c0\u67e5\u524d<\/td><td>\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u524d\u6216\u76d1\u7ba1\u673a\u6784\u516c\u544a\u68c0\u67e5\u524d<\/td><td>\u65f6\u95f4\u654f\u611f\uff1b\u7cfb\u7edf\u6027\u8bc4\u4f30<\/td><\/tr><tr><td rowspan=\"3\">\u6309\u65f6\u95f4\u8282\u70b9<\/td><td>\u542f\u52a8\u524d<\/td><td>\u8bc4\u4f30\u7814\u7a76\u4e2d\u5fc3\u8d44\u8d28\u3001\u8bbe\u65bd\u53ca\u56e2\u961f\u80fd\u529b<\/td><td>\u9884\u9632\u6027\uff1b\u51c6\u5165\u8bc4\u4f30<\/td><\/tr><tr><td>\u8fdb\u884c\u4e2d<\/td><td>\u5165\u7ec4\u53ca\u6267\u884c\u9636\u6bb5\u8d28\u91cf\u8bc4\u4f30<\/td><td>\u8fc7\u7a0b\u7ba1\u63a7<\/td><\/tr><tr><td>\u5173\u95ed\u524d<\/td><td>\u8bd5\u9a8c\u7ed3\u675f\u524d\u6700\u7ec8\u6587\u4ef6\u53ca\u6570\u636e\u5b8c\u6574\u6027\u6838\u67e5<\/td><td>\u6536\u5c3e\u5f52\u6863<\/td><\/tr><tr><td rowspan=\"2\">\u6309\u8303\u56f4<\/td><td>\u5168\u9762<\/td><td>\u8986\u76d6\u6240\u6709\u7a3d\u67e5\u8981\u7d20<\/td><td>\u8017\u65f6\u8f83\u957f\uff1b\u5168\u9762\u6df1\u5165<\/td><\/tr><tr><td>\u4e13\u9879<\/td><td>\u9488\u5bf9\u7279\u5b9a\u95ee\u9898\u6216\u9ad8\u98ce\u9669\u9886\u57df<\/td><td>\u9ad8\u6548\u805a\u7126<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u7a3d\u67e5\u6d41\u7a0b\u548c\u5e38\u7528\u5de5\u5177<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">2.1 \u4e09\u9636\u6bb5\u95ed\u73af\u6d41\u7a0b<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"678\" height=\"393\" src=\"http:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/05\/a3259327e56b2dd5eff36c19397d0541.png\" alt=\"\" class=\"wp-image-1793\" srcset=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/05\/a3259327e56b2dd5eff36c19397d0541.png 678w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/05\/a3259327e56b2dd5eff36c19397d0541-300x174.png 300w\" sizes=\"(max-width: 678px) 100vw, 678px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">2.1.1 \u7a3d\u67e5\u524d\u51c6\u5907<\/h3>\n\n\n\n<p><strong>\u5145\u5206\u7684\u51c6\u5907\u662f\u7a3d\u67e5\u8d28\u91cf\u7684\u57fa\u7840<\/strong>\u3002\u7a3d\u67e5\u524d\u5e94\u5b8c\u6210\u98ce\u9669\u8bc4\u4f30\uff0c\u8bc6\u522b\u9700\u91cd\u70b9\u5173\u6ce8\u7684\u95ee\u9898\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u98ce\u9669\u8bc4\u4f30\u4e0e\u7a3d\u67e5\u8303\u56f4\u786e\u5b9a\uff1a\u7ed3\u5408\u7814\u7a76\u4e2d\u5fc3\u65e2\u5f80\u7a3d\u67e5\/\u89c6\u5bdf\u8bb0\u5f55\u3001\u76d1\u67e5\u62a5\u544a\u4e2d\u7684\u53cd\u590d\u51fa\u73b0\u7684\u95ee\u9898\u3001\u5165\u7ec4\u901f\u5ea6\u5f02\u5e38\u3001\u65b9\u6848\u8fdd\u80cc\u53d1\u751f\u7387\u3001\u6570\u636e\u7591\u95ee\u5bc6\u5ea6\u53ca\u53d7\u8bd5\u8005\u8131\u843d\u7387\u7b49\u98ce\u9669\u4fe1\u53f7\u8fdb\u884c\u7efc\u5408\u8bc4\u4f30\u3002<ul><li>\u80cc\u666f\u8d44\u6599\u5ba1\u9605\uff1a\u7cfb\u7edf\u5ba1\u9605\u8bd5\u9a8c\u65b9\u6848\u53ca\u5386\u6b21\u4fee\u8ba2\u7248\u3001ICF\u7248\u672c\u8bb0\u5f55\u3001\u76d1\u67e5\u8bbf\u89c6\u62a5\u544a\u3001\u6570\u636e\u7591\u95ee\u5217\u8868\u3001TMF\u76ee\u5f55\u6e05\u5355\u53ca\u7814\u7a76\u4e2d\u5fc3\u76f8\u5173SOP\u3002<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>\u7a3d\u67e5\u901a\u77e5\u53d1\u9001\uff1a\u901a\u5e38\u63d0\u524d2\uff5e4\u5468\u53d1\u9001\u6b63\u5f0f\u901a\u77e5\uff1b\u89e6\u53d1\u6027\u7a3d\u67e5\u53ef\u7f29\u77ed\u81f324\uff5e48\u5c0f\u65f6\uff0c\u4ee5\u786e\u4fdd\u7a3d\u67e5\u7684\u5ba2\u89c2\u771f\u5b9e\u6027\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2.1.2 \u73b0\u573a\u7a3d\u67e5<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9996\u6b21\u4f1a\u8bae\uff1a\u53c2\u4e0e\u4eba\u5458\u901a\u5e38\u5305\u62ecPI\u3001CRC\u3001CRA\u53ca\u79d1\u5ba4\u8d1f\u8d23\u4eba\u3002\u4f1a\u8bae\u5185\u5bb9\u5305\u62ec\u7a3d\u67e5\u76ee\u7684\u3001\u65e5\u7a0b\u5b89\u6392\u3001\u6587\u4ef6\u8c03\u53d6\u65b9\u5f0f\u53ca\u4fdd\u5bc6\u534f\u8bae\u786e\u8ba4\u3002<ul><li>\u6587\u4ef6\u4e0e\u6570\u636e\u6838\u67e5\uff1a\u4f9d\u636eICH E6(R3)\uff0c\u5bf9\u5fc5\u5907\u6587\u4ef6\u8fdb\u884c\u5168\u9762\u6838\u67e5\uff0c\u91c7\u7528\u6e90\u6570\u636e\u6838\u5b9e\uff08SDV\uff09\u4e0e\u6e90\u6570\u636e\u5ba1\u67e5\uff08SDR\uff09\u65b9\u5f0f\u3002<\/li><\/ul><ul><li>\u4eba\u5458\u8bbf\u8c08\uff1a\u5bf9PI\u3001Sub-I\u3001CRC\u3001\u62a4\u7406\u4eba\u5458\u8fdb\u884c\u4e2a\u522b\u8bbf\u8c08\uff0c\u7740\u91cd\u4e86\u89e3\u5b9e\u9645\u64cd\u4f5c\u4e0eSOP\/\u65b9\u6848\u7684\u4e00\u81f4\u6027\u3002<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>\u603b\u7ed3\u4f1a\u8bae\uff1a\u53e3\u5934\u62a5\u544a\u521d\u6b65\u53d1\u73b0\uff0c\u7ed9\u4e88\u7814\u7a76\u4e2d\u5fc3\u5373\u65f6\u6f84\u6e05\u673a\u4f1a\uff0c\u786e\u8ba4\u540e\u7eedCAPA\u63d0\u4ea4\u65f6\u95f4\u8868\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2.1.3 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class=\"has-fixed-layout\"><tbody><tr><td><strong>\u5de5\u5177\u540d\u79f0<\/strong><\/td><td><strong>\u4e3b\u8981\u7528\u9014<\/strong><\/td><td><strong>\u8bf4\u660e<\/strong><\/td><\/tr><tr><td>\u7a3d\u67e5\u68c0\u67e5\u8868<\/td><td>\u7cfb\u7edf\u6027\u6838\u67e5\u5404\u5173\u6ce8\u9886\u57df\uff0c\u786e\u4fdd\u4e0d\u9057\u6f0f<\/td><td>\u6309\u77e5\u60c5\u540c\u610f\u3001\u5fc5\u5907\u6587\u4ef6\u3001\u6e90\u6570\u636e\u3001\u6837\u672c\u7b49\u6a21\u5757\u5206\u7c7b\uff1b\u53ef\u6309\u8bd5\u9a8c\u7279\u70b9\u5b9a\u5236<\/td><\/tr><tr><td>\u7a3d\u67e5\u53d1\u73b0\u8bb0\u5f55\u8868<\/td><td>\u5b9e\u65f6\u8bb0\u5f55\u73b0\u573a\u53d1\u73b0\uff0c\u4fbf\u4e8e\u540e\u7eed\u62a5\u544a\u64b0\u5199<\/td><td>\u8bb0\u5f55\u53d1\u73b0\u63cf\u8ff0\u3001\u4e25\u91cd\u7a0b\u5ea6\u3001GCP\/\u65b9\u6848\u6761\u6b3e\u4f9d\u636e<\/td><\/tr><tr><td>\u6e90\u6570\u636e\u6838\u67e5\u8ffd\u8e2a\u8868<\/td><td>\u8ffd\u8e2aCRF\u4e0e\u539f\u59cb\u8bb0\u5f55\u7684\u4e00\u81f4\u6027\u6838\u67e5\u8fdb\u5ea6<\/td><td>\u6309\u53d7\u8bd5\u8005\u7f16\u53f7\u5206\u9875\uff0c\u6807\u6ce8\u6838\u67e5\u7ed3\u679c<\/td><\/tr><tr><td>\u751f\u7269\u6837\u672c\u8ffd\u8e2a\u8bb0\u5f55\u6838\u67e5\u8868<\/td><td>\u6838\u67e5\u6837\u672c\u91c7\u96c6\u3001\u5904\u7406\u3001\u50a8\u5b58\u3001\u8f6c\u8fd0\u5168\u94fe\u6761<\/td><td>\u4e0e\u6837\u672c\u53f0\u8d26\u3001\u51b0\u7bb1\u6e29\u5ea6\u65e5\u5fd7\u53ca\u8f6c\u8fd0\u5355\u4ea4\u53c9\u6838\u5b9e<\/td><\/tr><tr><td>\u8bbe\u5907\u6821\u51c6\/\u8ba4\u8bc1\u8bb0\u5f55\u6838\u67e5\u6e05\u5355<\/td><td>\u786e\u8ba4\u5173\u952e\u8bbe\u5907\u5728\u6821\u51c6\u6709\u6548\u671f\u5185<\/td><td>\u8986\u76d6\u5206\u6790\u4eea\u5668\u3001\u8d85\u4f4e\u6e29\u51b0\u7bb1\u3001\u79bb\u5fc3\u673a\u3001\u5929\u5e73\u7b49<\/td><\/tr><tr><td>\u7535\u5b50\u6570\u636e\u7a3d\u67e5\u8f68\u8ff9\u5ba1\u67e5\u5de5\u5177<\/td><td>\u6838\u67e5EDC\u7cfb\u7edf\u64cd\u4f5c\u65e5\u5fd7\uff0c\u8bc6\u522b\u5f02\u5e38\u6570\u636e\u4fee\u6539<\/td><td>\u91cd\u70b9\u5173\u6ce8\u4fee\u6539\u65f6\u95f4\u3001\u4fee\u6539\u4eba\u3001\u4fee\u6539\u539f\u56e0\u662f\u5426\u5b8c\u6574<\/td><\/tr><tr><td>CAPA\u8ffd\u8e2a\u8868<\/td><td>\u8ffd\u8e2a\u7a3d\u67e5\u53d1\u73b0\u7684\u6574\u6539\u843d\u5b9e\u8fdb\u5ea6<\/td><td>\u542b\u8d23\u4efb\u4eba\u3001\u8ba1\u5212\u5b8c\u6210\u65e5\u671f\u3001\u5b9e\u9645\u5b8c\u6210\u65e5\u671f\u3001\u9a8c\u8bc1\u72b6\u6001<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">2.3 AI\u8f85\u52a9\u53ca\u7ebf\u4e0a\u7a3d\u67e5\u5de5\u5177<\/h2>\n\n\n\n<p>\u968f\u7740\u4e34\u5e8a\u8bd5\u9a8c\u6570\u5b57\u5316\u8fdb\u7a0b\u52a0\u901f\uff0cAI\u8f85\u52a9\u7a3d\u67e5\u5de5\u5177\u5df2\u8fdb\u5165\u5b9e\u7528\u9636\u6bb5\u3002\u4e3b\u6d41\u5546\u4e1a\u5e73\u53f0\u5305\u62ecMedidata AI\uff08\u9884\u6d4b\u6027\u98ce\u9669\u5efa\u6a21\uff09\u3001Veeva Vault CTMS\uff08\u4e91\u7aef eTMF \u6587\u6863\u5408\u89c4\u7ba1\u7406\uff09\u3001CluePoints\uff08\u7edf\u8ba1\u5206\u6790\u76d1\u6d4b\uff09\u7b49\u3002NMPA\/CDE\u8fd1\u5e74\u6765\u660e\u786e\u652f\u6301\u6570\u5b57\u5316\u624b\u6bb5\u5728\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u63a7\u5236\u4e2d\u7684\u5e94\u7528\u3002<\/p>\n\n\n\n<p>\u9700\u8981\u5f3a\u8c03\u7684\u662f\uff0cAI\u5de5\u5177\u662f\u8f85\u52a9\u5de5\u5177\uff0c\u4e0d\u80fd\u66ff\u4ee3\u7533\u529e\u8005\u7684\u7a3d\u67e5\u8d23\u4efb\u3002AI\u53ef\u9ad8\u6548\u8bc6\u522b\u6570\u636e\u5f02\u5e38\u4fe1\u53f7\uff0c\u4f46GCP\u8fdd\u80cc\u7684\u5b9a\u6027\u5224\u65ad\u4ecd\u9700\u7a3d\u67e5\u5458\u4f5c\u51fa\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u7a3d\u67e5\u62a5\u544a\u7684\u64b0\u5199<\/h2>\n\n\n\n<p>\u7a3d\u67e5\u62a5\u544a\u7684\u6838\u5fc3\u5b9a\u4f4d\u662f<strong>\u5ba2\u89c2\u9648\u8ff0\u4e8b\u5b9e<\/strong>\u2014\u2014\u7a3d\u67e5\u5458\u8d1f\u8d23\u53d1\u73b0\u548c\u8bb0\u5f55\u95ee\u9898\uff0c\u5c06\u53d1\u73b0\u5206\u7ea7\u540e\u4ea4\u7531\u7533\u529e\u8005\u7ba1\u7406\u5c42\u51b3\u7b56\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3.1 \u62a5\u544a\u7ed3\u6784<\/h2>\n\n\n\n<p>\u88683 \u7a3d\u67e5\u62a5\u544a\u7ed3\u6784<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u7ae0\u8282<\/strong><\/td><td><strong>\u5185\u5bb9\u8981\u70b9<\/strong><\/td><td><strong>\u8bf4\u660e<\/strong><\/td><\/tr><tr><td>\u57fa\u672c\u4fe1\u606f<\/td><td>\u9879\u76ee\u540d\u79f0\u3001\u65b9\u6848\u7f16\u53f7\u3001\u7814\u7a76\u4e2d\u5fc3\u540d\u79f0\/\u7f16\u53f7\u3001PI\u59d3\u540d\u3001\u7a3d\u67e5\u65e5\u671f\u3001\u7a3d\u67e5\u5458\u59d3\u540d\u3001\u62a5\u544a\u65e5\u671f<\/td><td>\u4e0eTMF\u6863\u6848\u4e00\u81f4\u7684\u57fa\u7840\u4fe1\u606f<\/td><\/tr><tr><td>\u7a3d\u67e5\u8303\u56f4\u4e0e\u65b9\u6cd5<\/td><td>\u7a3d\u67e5\u7c7b\u578b\u3001\u62bd\u6837\u6bd4\u4f8b\u3001\u6838\u67e5\u6587\u4ef6\u6e05\u5355\u3001\u65f6\u95f4\u8986\u76d6\u8303\u56f4<\/td><td>\u8bf4\u660e\u7a3d\u67e5\u7684\u8fb9\u754c\u4e0e\u5c40\u9650\u6027<\/td><\/tr><tr><td>\u603b\u4f53\u8bc4\u4f30<\/td><td>\u5bf9\u7814\u7a76\u4e2d\u5fc3\u6574\u4f53\u6267\u884c\u8d28\u91cf\u7684\u5b9a\u6027\u8bc4\u4f30\uff08\u4f18\u79c0\/\u826f\u597d\/\u4e00\u822c\/\u8f83\u5dee\uff09<\/td><td>\u4e3a\u7ba1\u7406\u5c42\u63d0\u4f9b\u5feb\u901f\u51b3\u7b56\u53c2\u8003<\/td><\/tr><tr><td>\u7a3d\u67e5\u53d1\u73b0\u8be6\u60c5<\/td><td>\u6309\u53d1\u73b0\u7f16\u53f7\u5217\u51fa\u6240\u6709\u53d1\u73b0\uff0c\u542b\u63cf\u8ff0\u3001\u4f9d\u636e\u6761\u6b3e\u7b49<\/td><td>\u62a5\u544a\u4e3b\u4f53\u5185\u5bb9<\/td><\/tr><tr><td>\u6574\u6539\u8981\u6c42<\/td><td>CAPA\u63d0\u4ea4\u65f6\u9650\uff0810\uff5e30\u4e2a\u5de5\u4f5c\u65e5\uff09\u3001\u63d0\u4ea4\u65b9\u5f0f\u3001\u540e\u7eed\u9a8c\u8bc1\u8ba1\u5212<\/td><td>\u5177\u6709\u660e\u786e\u7684\u65f6\u95f4\u8282\u70b9\u8981\u6c42<\/td><\/tr><tr><td>\u9644\u4ef6\u6e05\u5355<\/td><td>\u7a3d\u67e5\u68c0\u67e5\u8868\u3001\u7b7e\u5230\u8868\u3001\u53d1\u73b0\u7167\u7247\/\u622a\u56fe\u3001\u8bbf\u8c08\u8bb0\u5f55\u6458\u8981<\/td><td>\u652f\u6491\u62a5\u544a\u6b63\u6587<\/td><\/tr><tr><td>\u7b7e\u7f72\u9875<\/td><td>\u7a3d\u67e5\u5458\u7b7e\u540d\u3001\u7533\u529e\u8005\u8d1f\u8d23\u4eba\u7b7e\u540d<\/td><td>\u62a5\u544a\u786e\u8ba4\u4e0e\u5ba1\u6838<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">3.2\u7a3d\u67e5\u53d1\u73b0\u7684\u64b0\u5199<\/h2>\n\n\n\n<p>\u4e00\u4efd\u9ad8\u8d28\u91cf\u7684\u53d1\u73b0\u63cf\u8ff0\u5e94\u9075\u5faa\u201cC3R1\u201d\u56db\u8981\u7d20\u539f\u5219\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u60c5\u51b5\uff08Condition\uff09\uff1a\u53d1\u73b0\u7684\u7b2c\u4e00\u53e5\u8bdd\uff0c\u7b80\u5355\u63cf\u8ff0\u95ee\u9898\uff0c\u5305\u62ec\u9891\u7387\/\u6301\u7eed\u65f6\u95f4\uff0c\u4fbf\u4e8e\u4e86\u89e3\u95ee\u9898\u5168\u8c8c\u5e76\u5206\u7ea7\u3002<ul><li>\u6807\u51c6\uff08Criterion\uff09\uff1a\u4ece\u6700\u63a5\u8fd1\u5de5\u4f5c\u5185\u5bb9\u7684\u6807\u51c6\u5f00\u59cb\u5f15\u7528\uff0c\uff0c\u9700\u7cbe\u786e\u6307\u51fa GCP\/\u65b9\u6848\u6761\u6b3e\u3002<\/li><\/ul><ul><li>\u539f\u56e0\uff08Cause\uff09\uff1a\u652f\u6301\u95ee\u9898\u7684\u4f8b\u8bc1\uff0c\u6216\u5bfc\u81f4\u60c5\u51b5\u7684\u884c\u52a8\/\u884c\u4e3a\u3002<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>\u540e\u679c\uff08Result\uff09\uff1a\u95ee\u9898\u5e26\u6765\u7684\u5b9e\u9645\u635f\u5bb3\uff0c\u6216\u5982\u95ee\u9898\u6301\u7eed\u53ef\u80fd\u4ea7\u751f\u7684\u5371\u5bb3\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p><strong>\u5e38\u89c1\u64b0\u5199\u9519\u8bef\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e3b\u89c2\u5224\u65ad\u66ff\u4ee3\u5ba2\u89c2\u63cf\u8ff0\uff1a\u907f\u514d\u201c\u7814\u7a76\u8005\u4e25\u91cd\u5931\u804c\u201d\u7b49\u5b9a\u6027\u8bed\u8a00\uff0c\u6539\u4e3a\u63cf\u8ff0\u5177\u4f53\u4e8b\u5b9e\u3002<ul><li>\u63cf\u8ff0\u8fc7\u4e8e\u7b3c\u7edf\uff1a\u5982\u201c\u77e5\u60c5\u540c\u610f\u4e0d\u89c4\u8303\u201d\u5e94\u7ec6\u5316\u4e3a\u201cS001\u53d7\u8bd5\u8005\u672a\u53ca\u65f6\u7b7e\u7f72V2.0\u7248ICF\u201d<\/li><\/ul><ul><li>\u6761\u6b3e\u5f15\u7528\u9519\u8bef\uff1a\u987b\u786e\u4fdd\u5f15\u7528\u7684GCP\/ICH\u6761\u6b3e\u4e0e\u5b9e\u9645\u8fdd\u89c4\u5185\u5bb9\u7cbe\u786e\u5bf9\u5e94\u3002<\/li><\/ul>\n<ul class=\"wp-block-list\">\n<li>\u6df7\u6dc6\u53d1\u73b0\u4e0eCAPA\uff1a\u62a5\u544a\u4ec5\u9648\u8ff0\u53d1\u73b0\uff0cCAPA\u7531\u7814\u7a76\u4e2d\u5fc3\u63d0\u51fa\uff0c\u4e0d\u5e94\u9884\u5148\u8bbe\u5b9a\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">3.3 \u7a3d\u67e5\u53d1\u73b0\u5206\u7c7b<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"684\" height=\"454\" src=\"http:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/05\/b4d85233fb9803cdd76d3dcb9b4004f6.png\" alt=\"\" class=\"wp-image-1794\" srcset=\"https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/05\/b4d85233fb9803cdd76d3dcb9b4004f6.png 684w, https:\/\/www.millibuff.com\/wp-content\/uploads\/2026\/05\/b4d85233fb9803cdd76d3dcb9b4004f6-300x199.png 300w\" sizes=\"(max-width: 684px) 100vw, 684px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">3.4\u7a3d\u67e5\u53d1\u73b0\u7684\u5206\u7ea7<\/h2>\n\n\n\n<p>\u53d1\u73b0\u5206\u7ea7\u76f4\u63a5\u5f71\u54cd\u6574\u6539\u4f18\u5148\u7ea7\u4e0e\u76d1\u7ba1\u62a5\u544a\u4e49\u52a1\u3002\u4e0b\u8868\u53c2\u7167FDA Form 483\u53ca\u56fd\u5185\u884c\u4e1a\u60ef\u4f8b\uff0c\u5c06\u7a3d\u67e5\u53d1\u73b0\u5206\u4e3a\u4e09\u4e2a\u7b49\u7ea7\u3002<\/p>\n\n\n\n<p>\u88684 \u7a3d\u67e5\u53d1\u73b0\u5206\u7ea7<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u5f71\u54cd<\/strong><strong><\/strong><\/td><td><strong>\u7cfb\u7edf\u6027<\/strong><strong><\/strong><\/td><td><strong>\u65e2\u5f80\u662f\u5426\u6709\u53d1\u751f<\/strong><strong>\/<\/strong><strong>\u63aa\u65bd\u7684\u6709\u6548\u6027<\/strong><strong><\/strong><\/td><td><strong>\u5206\u7ea7<\/strong><strong><\/strong><\/td><\/tr><tr><td>\u6709\u5f71\u54cd<\/td><td>\u662f<\/td><td>\u91cd\u590d\/\u65e0\u91cd\u590d<\/td><td>\u4e25\u91cd\uff08Critical\uff09<\/td><\/tr><tr><td>\u6709\u6f5c\u5728\u5f71\u54cd<\/td><td>\u662f<\/td><td>\u91cd\u590d\/\u65e0\u91cd\u590d<\/td><td>\u4e3b\u8981\uff08Major\uff09<\/td><\/tr><tr><td>\u6f5c\u5728\u5f71\u54cd\u5c0f<\/td><td>\u5426<\/td><td>\u65e0\u91cd\u590d<\/td><td>\u4e00\u822c\uff08Minor\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">3.5 CAPA\u5ba1\u6838\u4e0e\u62a5\u544a\u5173\u95ed<\/h2>\n\n\n\n<p>\u7814\u7a76\u4e2d\u5fc3\u63d0\u4ea4CAPA\u8ba1\u5212\u540e\uff0c\u7a3d\u67e5\u5458\u548c\u7533\u529e\u8005QA\u987b\u8fdb\u884c\u53cc\u5c42\u5ba1\u6838\uff1a<\/p>\n\n\n\n<p>\u5145\u5206\u6027\u5ba1\u6838\uff1aCAPA\u662f\u5426\u9488\u5bf9\u4e86\u6839\u672c\u539f\u56e0\u800c\u975e\u4ec5\u5904\u7406\u8868\u9762\u73b0\u8c61\uff1b<\/p>\n\n\n\n<p>\u6709\u6548\u6027\u5ba1\u6838\uff1aCAPA\u5b9e\u65bd\u540e\uff0c\u901a\u8fc7\u540e\u7eed\u76d1\u67e5\u6216\u518d\u6b21\u7a3d\u67e5\u9a8c\u8bc1\u6574\u6539\u662f\u5426\u771f\u6b63\u6d88\u9664\u95ee\u9898\u7ee7\u53d1\u98ce\u9669\u3002<\/p>\n\n\n\n<p>\u62a5\u544a\u5173\u95ed\u9700\u6ee1\u8db3\uff1a\u6240\u6709\u4e25\u91cd\u53ca\u4e3b\u8981\u53d1\u73b0\u5173\u95ed\u3001QA\u786e\u8ba4CAPA \u6709\u6548\u3001TMF\u5b8c\u6574\u5f52\u6863<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u603b\u7ed3<\/h2>\n\n\n\n<p>\u968f\u7740ICH E6(R3)\u7684\u5b9e\u65bd\u63a8\u5e7f\u548c\u6df1\u5165\u6267\u884c\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u5bf9\u7a3d\u67e5\u7684\u89c4\u8303\u5316\u3001\u4e13\u4e1a\u5316\u8981\u6c42\u5c06\u6301\u7eed\u63d0\u5347\u3002\u7a3d\u67e5\u4eba\u5458\u987b\u4e0d\u65ad\u66f4\u65b0\u6cd5\u89c4\u77e5\u8bc6\u50a8\u5907\uff0c\u63d0\u5347\u7cfb\u7edf\u6027\u98ce\u9669\u8bc6\u522b\u80fd\u529b\uff0c\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u53ef\u9760\u6027\u548c\u53d7\u8bd5\u8005\u6743\u76ca\u4fdd\u969c\u63d0\u4f9b\u575a\u5b9e\u652f\u6491\u3002<\/p>\n\n\n\n<p>\u53c2\u8003\u6587\u732e<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40,\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a.\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303[S].2020.<\/li>\n\n\n\n<li>ICH. 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