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class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u95ee\u9898\u7684\u6709\u6548\u95ed\u73af\u662f\u8d28\u91cf\u7ba1\u7406\u4ef7\u503c\u7684\u6838\u5fc3\u4f53\u73b0\uff0c\u4e5f\u662f\u6700\u5bb9\u6613\u88ab\u5ffd\u89c6\u7684\u73af\u8282\u3002<\/p>\n<ul>\n<li><strong>\u4e00\u952e\u751f\u6210\u6b63\u5f0f\u5ba1\u6838\u62a5\u544a\uff0c\u81ea\u52a8\u5206\u53d1<\/strong>\uff1a\u68c0\u67e5\u6570\u636e\u540c\u6b65\u81f3\u4e91\u7aef\u540e\uff0c\u53ef\u4e00\u952e\u751f\u6210\u5305\u542b\u6240\u6709\u7ec6\u8282\u548c\u8bc1\u636e\u7684\u6b63\u5f0f<strong>\u5ba1\u6838\u62a5\u544a<\/strong>\uff0c\u5e76\u6839\u636e\u9884\u8bbe\u6d41\u7a0b\u81ea\u52a8\u5206\u53d1\u7ed9\u76f8\u5173\u7ba1\u7406\u4eba\u5458\u548c\u4f9b\u5e94\u5546\u3002<\/li>\n<li><strong>\u5728\u7ebf\u521b\u5efa\u95ee\u9898\u6574\u6539\u4efb\u52a1\uff0c\u6307\u6d3e\u8d23\u4efb\u4eba\u4e0e\u622a\u6b62\u65e5\u671f<\/strong>\uff1a\u5c06\u62a5\u544a\u4e2d\u7684\u6bcf\u4e00\u4e2a\u4e0d\u5408\u683c\u9879\uff0c\u76f4\u63a5\u8f6c\u5316\u4e3a\u4e00\u4e2a\u5728\u7ebf<strong>\u7ea0\u6b63\u9884\u9632\u63aa\u65bd (CAPA)<\/strong> \u4efb\u52a1\uff0c\u660e\u786e\u6307\u6d3e\u7ed9\u4f9b\u5e94\u5546\u7684\u5bf9\u5e94\u8d23\u4efb\u4eba\uff0c\u5e76\u8bbe\u5b9a\u6574\u6539\u622a\u6b62\u65e5\u671f\u3002<\/li>\n<li><strong>\u5b9e\u65f6\u8ffd\u8e2a CAPA \u8fdb\u5ea6\uff0c\u9a8c\u8bc1\u6574\u6539\u6548\u679c<\/strong>\uff1a\u7cfb\u7edf\u4f1a\u8bb0\u5f55\u4ece\u6574\u6539\u65b9\u6848\u63d0\u4ea4\u3001\u6267\u884c\u5230\u6700\u7ec8\u6548\u679c\u9a8c\u8bc1\u7684\u5168\u8fc7\u7a0b\u3002\u7ba1\u7406\u5c42\u53ef\u4ee5\u968f\u65f6\u5728\u7ebf\u67e5\u770b\u6240\u6709\u95ee\u9898\u7684\u8ddf\u8fdb\u72b6\u6001\uff0c\u786e\u4fdd\u95ee\u9898\u5f97\u5230\u6839\u9664\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E5%9B%9B%E6%AD%A5%EF%BC%9A%E6%95%B0%E6%8D%AE%E5%A4%8D%E7%9B%98%E6%8C%81%E7%BB%AD%E4%BC%98%E5%8C%96%E2%80%94%E2%80%94%E6%9E%84%E5%BB%BA%E4%BE%9B%E5%BA%94%E5%95%86%E8%AF%84%E5%88%86%E4%BD%93%E7%B3%BB\"><\/span>\u7b2c\u56db\u6b65\uff1a\u6570\u636e\u590d\u76d8\u6301\u7eed\u4f18\u5316\u2014\u2014\u6784\u5efa\u4f9b\u5e94\u5546\u8bc4\u5206\u4f53\u7cfb<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6240\u6709\u8fc7\u7a0b\u6570\u636e\u6700\u7ec8\u90fd\u5e94\u670d\u52a1\u4e8e\u66f4\u9ad8\u5c42\u7ea7\u7684\u7ba1\u7406\u51b3\u7b56\u3002<\/p>\n<ul>\n<li><strong>\u6240\u6709\u68c0\u67e5\u8bb0\u5f55\u81ea\u52a8\u5f52\u6863\uff0c\u5f62\u6210\u5b8c\u6574\u7684\u6570\u636e\u8ffd\u6eaf\u94fe<\/strong>\uff1a\u6bcf\u4e00\u6b21\u7684\u68c0\u67e5\u62a5\u544a\u3001\u6bcf\u4e00\u4e2a\u95ee\u9898\u7684\u6574\u6539\u8bb0\u5f55\u90fd\u88ab\u7cfb\u7edf\u81ea\u52a8\u3001\u6c38\u4e45\u5730\u4fdd\u5b58\uff0c\u6784\u5efa\u8d77\u6e05\u6670\u3001\u5b8c\u6574\u7684<strong>\u6570\u636e\u8ffd\u6eaf<\/strong>\u4f53\u7cfb\u3002<\/li>\n<li><strong>\u57fa\u4e8e\u5386\u53f2\u68c0\u67e5\u6570\u636e\uff0c\u91cf\u5316\u751f\u6210\u4f9b\u5e94\u5546\u8bc4\u5206<\/strong>\uff1a\u7cfb\u7edf\u53ef\u4ee5\u6839\u636e\u5386\u53f2\u68c0\u67e5\u7684\u5408\u683c\u7387\u3001\u95ee\u9898\u4e25\u91cd\u6027\u3001\u6574\u6539\u53ca\u65f6\u6027\u7b49\u591a\u4e2a\u7ef4\u5ea6\uff0c\u81ea\u52a8\u8ba1\u7b97\u51fa\u6bcf\u4e2a\u4f9b\u5e94\u5546\u7684\u91cf\u5316<strong>\u4f9b\u5e94\u5546\u8bc4\u5206<\/strong>\u3002<\/li>\n<li><strong>\u901a\u8fc7\u6570\u636e\u5206\u6790\uff0c\u6301\u7eed\u4f18\u5316\u68c0\u67e5\u6807\u51c6\u4e0e\u4f9b\u5e94\u5546\u7b56\u7565<\/strong>\uff1a\u57fa\u4e8e\u6570\u636e\uff0c\u7ba1\u7406\u8005\u53ef\u4ee5\u6e05\u6670\u5730\u8bc6\u522b\u51fa\u9ad8\u9891\u95ee\u9898\u70b9\uff0c\u4ece\u800c\u53cd\u5411\u4f18\u5316\u68c0\u67e5\u6807\u51c6\uff1b\u540c\u65f6\uff0c\u5ba2\u89c2\u7684\u4f9b\u5e94\u5546\u8bc4\u5206\u4e5f\u4e3a\u91c7\u8d2d\u7b56\u7565\u8c03\u6574\u3001\u4f9b\u5e94\u5546\u6c70\u6362\u63d0\u4f9b\u4e86\u76f4\u63a5\u4f9d\u636e\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E5%B0%8F%E7%BB%93%EF%BC%9A%E5%9B%9B%E6%AD%A5%E6%B3%95%E5%A6%82%E4%BD%95%E8%AE%A9%E7%AE%A1%E7%90%86%E2%80%9C%E5%8C%96%E7%B9%81%E4%B8%BA%E7%AE%80%E2%80%9D\"><\/span>\u5c0f\u7ed3\uff1a\u56db\u6b65\u6cd5\u5982\u4f55\u8ba9\u7ba1\u7406\u201c\u5316\u7e41\u4e3a\u7b80\u201d<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8fd9\u5957\u56db\u6b65\u95ed\u73af\u6cd5\uff0c\u672c\u8d28\u4e0a\u662f\u5c06\u590d\u6742\u3001\u96f6\u6563\u7684\u7ba1\u7406\u52a8\u4f5c\uff0c\u91cd\u6784\u6210\u4e00\u4e2a\u73af\u73af\u76f8\u6263\u7684\u6807\u51c6\u5316\u6d41\u7a0b\u3002<\/p>\n<ul>\n<li><strong>\u51c6\u5907\u6807\u51c6\u5316<\/strong>\uff1a\u786e\u4fdd\u68c0\u67e5\u7684\u4e13\u4e1a\u6027\u4e0e\u4e00\u81f4\u6027<\/li>\n<li><strong>\u6267\u884c\u9ad8\u6548\u5316<\/strong>\uff1a\u5927\u5e45\u7f29\u77ed\u73b0\u573a\u8bb0\u5f55\u4e0e\u62a5\u544a\u6574\u7406\u65f6\u95f4<\/li>\n<li><strong>\u8ddf\u8fdb\u95ed\u73af\u5316<\/strong>\uff1a\u786e\u4fdd\u6bcf\u4e2a\u95ee\u9898\u90fd\u6709\u59cb\u6709\u7ec8<\/li>\n<li><strong>\u51b3\u7b56\u6570\u636e\u5316<\/strong>\uff1a\u7528\u6570\u636e\u9a71\u52a8\u4f9b\u5e94\u5546\u7ba1\u7406\u4e0e\u4f18\u5316<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"%E5%A6%82%E4%BD%95%E7%9C%9F%E6%AD%A3%E2%80%9C%E8%BD%BB%E6%9D%BE%E6%90%9E%E5%AE%9A%E2%80%9D%EF%BC%9F%E6%95%B0%E5%AD%97%E5%8C%96%E7%AE%A1%E7%90%86%E6%98%AF%E5%85%B3%E9%94%AE\"><\/span>\u5982\u4f55\u771f\u6b63\u201c\u8f7b\u677e\u641e\u5b9a\u201d\uff1f\u6570\u5b57\u5316\u7ba1\u7406\u662f\u5173\u952e<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7406\u8bba\u548c\u65b9\u6cd5\u8bba\u7684\u843d\u5730\uff0c\u79bb\u4e0d\u5f00\u9ad8\u6548\u5de5\u5177\u7684\u652f\u6491\u3002\u6570\u5b57\u5316\u662f\u5b9e\u73b0\u4e0a\u8ff0\u56db\u6b65\u95ed\u73af\u7ba1\u7406\u6cd5\u7684\u5173\u952e\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E4%BB%8E%E7%BA%B8%E8%B4%A8%E6%B8%85%E5%8D%95%E5%88%B0%E7%A7%BB%E5%8A%A8%E5%8A%9E%E5%85%AC%EF%BC%9A%E5%91%8A%E5%88%AB%E9%94%99%E6%BC%8F%E4%B8%8E%E4%BD%8E%E6%95%88\"><\/span>\u4ece\u7eb8\u8d28\u6e05\u5355\u5230\u79fb\u52a8\u529e\u516c\uff1a\u544a\u522b\u9519\u6f0f\u4e0e\u4f4e\u6548<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5f7b\u5e95\u6446\u8131\u7eb8\u7b14\uff0c\u5b9e\u73b0\u65e0\u7eb8\u5316\u73b0\u573a\u68c0\u67e5\u3002\u901a\u8fc7\u300c\u652f\u9053\u300d\u8fd9\u7c7b\u6570\u5b57\u5316\u5de5\u5177\uff0c\u53ef\u4ee5\u5c06\u6807\u51c6\u68c0\u67e5\u6e05\u5355\u5185\u7f6e\u4e8e\u624b\u673a\u6216\u5e73\u677f\u4e2d\uff0c\u68c0\u9a8c\u5458\u53ea\u9700\u6839\u636e\u6307\u5f15\u64cd\u4f5c\u5373\u53ef\uff0c\u786e\u4fdd\u6bcf\u6b21\u68c0\u67e5\u90fd\u4e25\u683c\u9075\u5faa\u6807\u51c6\u6d41\u7a0b\uff0c\u675c\u7edd\u9519\u9879\u6f0f\u9879\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E4%BB%8E%E9%82%AE%E4%BB%B6%E5%82%AC%E5%8A%9E%E5%88%B0%E8%87%AA%E5%8A%A8%E6%B5%81%E8%BD%AC%EF%BC%9A%E9%97%AE%E9%A2%98%E8%B7%9F%E8%BF%9B%E4%B8%8D%E5%86%8D%E9%9D%A0%E5%90%BC\"><\/span>\u4ece\u90ae\u4ef6\u50ac\u529e\u5230\u81ea\u52a8\u6d41\u8f6c\uff1a\u95ee\u9898\u8ddf\u8fdb\u4e0d\u518d\u9760\u543c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5c06\u53d1\u73b0\u7684\u95ee\u9898\u76f4\u63a5\u8f6c\u5316\u4e3a\u5728\u7ebf\u534f\u540c\u4efb\u52a1\u3002\u7cfb\u7edf\u4f1a\u81ea\u52a8\u63d0\u9192\u76f8\u5173\u8d23\u4efb\u4eba\uff0c\u5e76\u8ddf\u8fdb\u6574\u6539\u8ba1\u5212\u7684\u63d0\u4ea4\u3001\u6267\u884c\u4e0e\u9a8c\u8bc1\uff0c\u5b9e\u73b0<strong>\u7ea0\u6b63\u9884\u9632\u63aa\u65bd<\/strong>\u7684\u81ea\u52a8\u5316\u95ed\u73af\u3002\u7ba1\u7406\u8005\u65e0\u9700\u518d\u6295\u5165\u7cbe\u529b\u53bb\u626e\u6f14\u201c\u50ac\u529e\u5458\u201d\u7684\u89d2\u8272\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E4%BB%8E%E5%88%86%E6%95%A3%E6%95%B0%E6%8D%AE%E5%88%B0%E5%AE%9E%E6%97%B6%E7%9C%8B%E6%9D%BF%EF%BC%9A%E4%BE%9B%E5%BA%94%E5%95%86%E8%A1%A8%E7%8E%B0%E4%B8%80%E7%9B%AE%E4%BA%86%E7%84%B6\"><\/span>\u4ece\u5206\u6563\u6570\u636e\u5230\u5b9e\u65f6\u770b\u677f\uff1a\u4f9b\u5e94\u5546\u8868\u73b0\u4e00\u76ee\u4e86\u7136<span 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