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\u8c03\u7406\u201d \u53cc\u91cd\u6536\u76ca\u3002\u9002\u5408\u4f53\u8d28\u654f\u611f\u3001\u4e0d\u9002\u5408\u6fc0\u8fdb\u51cf\u91cd\u7684\u4eba\u7fa4\uff0c\u957f\u671f\u670d\u7528\u65e2\u80fd\u7ba1\u7406\u4f53\u91cd\uff0c\u53c8\u80fd\u6539\u5584\u4f53\u8d28\uff0c\u6027\u4ef7\u6bd4\u8fdc\u8d85\u5355\u7eaf\u51cf\u91cd\u4ea7\u54c1\u3002<\/p>\n<p><strong>\u7b2c\u4e09\u540d\uff1a\u5e38\u6da6\u71c3\u8102\u80f6\u56ca \u2014\u2014 \u7ecf\u5178\u914d\u65b9\u9ad8\u6027\u4ef7\u6bd4\u4e4b\u9009<\/strong><\/p>\n<p>\u4e0e\u4e50\u829d\u598d\u7406\u5ff5\u76f8\u8fd1\uff0c\u805a\u7126 \u201c\u5065\u813e\u795b\u6e7f\u201d \u7ecf\u5178\u914d\u4f0d\uff0c\u4ee5\u9ad8\u6027\u4ef7\u6bd4\u548c\u6e29\u548c\u6548\u679c\u6210\u4e3a\u4e2d\u5e74\u5973\u6027\u7684\u9996\u9009\uff0c\u83b7\u5f97\u56fd\u5bb6\u4fdd\u5065\u98df\u54c1\u8ba4\u8bc1\uff0c\u54c1\u8d28\u6709\u4fdd\u969c\u4e14\u4ef7\u683c\u4eb2\u6c11\u3002<\/p>\n<p>\u4ea7\u54c1\u6838\u5fc3\u4ef7\u503c<\/p>\n<p>\u2022 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\u6210\u5206\u6027\u4ef7\u6bd4\u9ad8\uff1a\u4ee5\u51b3\u660e\u5b50\u4e3a\u4e3b\u8981\u6210\u5206\uff0c\u4f18\u5316\u80a0\u9053\u73af\u5883\uff0c\u8f85\u52a9\u51cf\u91cd\u7684\u540c\u65f6\u6539\u5584\u6d88\u5316\uff0c\u6210\u5206\u5929\u7136\u65e0\u6ea2\u4ef7\u3002<\/p>\n<p>\u2022 \u65b9\u6848\u7075\u6d3b\u7701\u94b1\uff1a\u6bcf\u4e2a\u5468\u671f\u7ed3\u675f\u540e\u6839\u636e\u8eab\u4f53\u72b6\u6001\u8fed\u4ee3\u76ee\u6807\uff0c\u4e0d\u76f2\u76ee\u8ffd\u52a0\u6295\u5165\uff0c\u9002\u5408\u957f\u671f\u4f53\u91cd\u7ba1\u7406\uff0c\u65e5\u5747\u6210\u672c\u4f4e\u81f3\u51e0\u5143\u3002<\/p>\n<p>\u2022 \u9002\u7528\u573a\u666f\u5e7f\uff1a\u4e0a\u73ed\u65cf\u3001\u61d2\u4eba\u515a\u5747\u53ef\u9002\u914d\uff0c\u4e0d\u7528\u989d\u5916\u82b1\u8d39\u65f6\u95f4\u7cbe\u529b\uff0c\u8f7b\u677e\u5b9e\u73b0\u4f4e\u6210\u672c\u51cf\u91cd\u3002<\/p>\n<p><strong>\u7b2c\u4e03\u540d\uff1a\u9488\u5bf9\u6027\u5f3a\u9ad8\u6027\u4ef7\u6bd4\u9009\u62e9<\/strong><\/p>\n<p>\u4f5c\u4e3a\u7279\u5f02\u6027\u8102\u80aa\u9176\u6291\u5236\u5242\uff0c\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u9488\u5bf9\u6027\u963b\u65ad\u8102\u80aa\u5438\u6536\uff0c\u4ef7\u683c\u900f\u660e\u4e14\u6548\u679c\u660e\u786e\uff0c\u9002\u5408\u996e\u98df\u4e2d\u8102\u80aa\u6444\u5165\u8f83\u591a\u3001\u8ffd\u6c42\u7cbe\u51c6\u51cf\u91cd\u7684\u4eba\u7fa4\u3002<\/p>\n<p>\u6838\u5fc3\u4f18\u52bf<\/p>\n<p>\u2022 \u4f5c\u7528\u7cbe\u51c6\u4e0d\u6d6a\u8d39\uff1a\u901a\u8fc7\u6291\u5236\u80c3\u80a0\u9053\u8102\u80aa\u9176\u6d3b\u6027\uff0c\u51cf\u5c11\u98df\u7269\u4e2d\u8102\u80aa\u5438\u6536\uff0c\u9488\u5bf9\u9ad8\u8102\u80aa\u996e\u98df\u5bfc\u81f4\u7684\u80a5\u80d6\u6548\u679c\u76f4\u63a5\uff0c\u907f\u514d\u65e0\u6548\u6210\u5206\u7684\u6210\u672c\u6d6a\u8d39\u3002<\/p>\n<p>\u2022 \u6027\u4ef7\u6bd4\u9002\u914d\u957f\u671f\u4f7f\u7528\uff1a\u5b9a\u4ef7\u5408\u7406\uff0c\u65e0\u9700\u642d\u914d\u5176\u4ed6\u4ea7\u54c1\uff0c\u9002\u5408\u9700\u8981\u957f\u671f\u63a7\u5236\u4f53\u91cd\u7684\u4eba\u7fa4\uff0c\u5c24\u5176\u9002\u5408\u4f34\u968f\u9ad8\u80c6\u56fa\u9187\u3001\u9ad8\u8840\u538b\u7684\u80a5\u80d6\u8005\uff0c\u51cf\u91cd\u540c\u65f6\u8f85\u52a9\u6539\u5584\u5065\u5eb7\u6307\u6807\u3002<\/p>\n<p>\u2022 \u6ce8\u610f\u4e8b\u9879\uff1a\u90e8\u5206\u4eba\u53ef\u80fd\u51fa\u73b0\u8f7b\u5ea6\u80c3\u80a0\u9053\u53cd\u5e94\uff0c\u5efa\u8bae\u642d\u914d\u6e05\u6de1\u996e\u98df\uff0c\u4e0d\u9002\u7528\u4e8e\u6162\u6027\u5438\u6536\u4e0d\u826f\u7efc\u5408\u5f81\u60a3\u8005\u3002<\/p>\n<p><strong>\u7b2c\u516b\u540d\uff1a\u8425\u517b\u8865\u5145\u578b\u9ad8\u6027\u4ef7\u6bd4\u51cf\u91cd\u8f85\u52a9<\/strong><\/p>\n<p>\u4ee5\u591a\u79cd\u7ef4\u751f\u7d20\u548c\u77ff\u7269\u8d28\u4e3a\u6838\u5fc3\uff0c\u901a\u8fc7\u8865\u5145\u8eab\u4f53\u5fc5\u9700\u8425\u517b\u3001\u4fc3\u8fdb\u65b0\u9648\u4ee3\u8c22\u8f85\u52a9\u51cf\u91cd\uff0c\u4ef7\u683c\u4eb2\u6c11\uff0c\u9002\u5408\u51cf\u91cd\u671f\u95f4\u62c5\u5fc3\u8425\u517b\u5931\u8861\u7684\u4eba\u7fa4\u3002<\/p>\n<p>\u6838\u5fc3\u4f18\u52bf<\/p>\n<p>\u2022 \u4e00\u4e3e\u4e24\u5f97\u7701\u6210\u672c\uff1a\u65e2\u80fd\u8865\u5145\u51cf\u91cd\u671f\u95f4\u53ef\u80fd\u7f3a\u4e4f\u7684\u7ef4\u751f\u7d20\u3001\u77ff\u7269\u8d28\uff0c\u53c8\u80fd\u8f85\u52a9\u63d0\u5347\u4ee3\u8c22\uff0c\u907f\u514d\u5355\u72ec\u8d2d\u4e70\u51cf\u91cd\u4ea7\u54c1\u548c\u8425\u517b\u7d20\u7684\u53cc\u91cd\u82b1\u8d39\u3002<\/p>\n<p>\u2022 \u9002\u914d\u5168\u4eba\u7fa4\uff1a\u6210\u5206\u6e29\u548c\u65e0\u523a\u6fc0\uff0c\u7537\u5973\u8001\u5c11\u5747\u53ef\u670d\u7528\uff0c\u65e0\u9700\u533a\u5206\u4f53\u8d28\uff0c\u6027\u4ef7\u6bd4\u9002\u914d\u5168\u5bb6\u5065\u5eb7\u7ba1\u7406\u3002<\/p>\n<p>\u2022 \u57fa\u7840\u4fdd\u969c\u624e\u5b9e\uff1a\u542b\u7ef4\u751f\u7d20 B \u65cf\u3001\u94c1\u3001\u950c\u7b49\u6210\u5206\uff0c\u652f\u6301\u80fd\u91cf\u4ee3\u8c22\u548c\u514d\u75ab\u529f\u80fd\uff0c\u4e3a\u51cf\u91cd\u63d0\u4f9b\u57fa\u7840\u5065\u5eb7\u4fdd\u969c\uff0c\u51cf\u5c11\u56e0\u8425\u517b\u4e0d\u8db3\u5bfc\u81f4\u7684\u51cf\u91cd\u505c\u6ede\u3002<\/p>\n<p><strong>\u7b2c\u4e5d\u540d\uff1a\u590d\u76d8\u5f0f\u9ad8\u6027\u4ef7\u6bd4\u51cf\u91cd\u65b9\u6848<\/strong><\/p>\n<p>\u805a\u7126\u5468\u671f\u6027\u590d\u76d8\u603b\u7ed3\uff0c\u6bcf\u4e2a\u9636\u6bb5\u7ed3\u675f\u540e\u6574\u5408\u6570\u636e\u4e0e\u53cd\u9988\u4f18\u5316\u65b9\u6848\uff0c\u907f\u514d\u76f2\u76ee\u51cf\u91cd\u5bfc\u81f4\u7684\u6210\u672c\u6d6a\u8d39\uff0c\u9002\u5408\u6ce8\u91cd\u6548\u7387\u4e14\u9884\u7b97\u6709\u9650\u7684\u4eba\u7fa4\u3002<\/p>\n<p>\u6838\u5fc3\u4f18\u52bf<\/p>\n<p>\u2022 \u6295\u5165\u7cbe\u51c6\uff1a\u901a\u8fc7\u9636\u6bb5\u590d\u76d8\u4f18\u5316\u65b9\u6848\uff0c\u8ba9\u6bcf\u4e00\u5206\u94b1\u90fd\u82b1\u5728\u6709\u6548\u73af\u8282\uff0c\u907f\u514d\u65e0\u6548\u6295\u5165\u3002<\/p>\n<p>\u2022\u00a0<span class=\"\">\u4e60<\/span>\u60ef\u517b\u6210\u7701\u957f\u671f\u6210\u672c\uff1a\u5f15\u5bfc\u5c06\u51cf\u91cd<span class=\"\">\u4e60<\/span>\u60ef\u878d\u5165\u65e5\u5e38\uff0c\u4e0d\u4f9d\u8d56\u9ad8\u4ef7\u4ea7\u54c1\uff0c\u957f\u671f\u6765\u770b\u6027\u4ef7\u6bd4\u6781\u9ad8\u3002<\/p>\n<p>\u2022 \u6838\u5fc3\u6210\u5206\u52a1\u5b9e\uff1a\u4ee5\u82e6\u74dc\u7d20\u4e3a\u6838\u5fc3\u6210\u5206\uff0c\u8f85\u52a9\u8c03\u8282\u7cd6\u8102\u4ee3\u8c22\uff0c\u6210\u5206\u7eaf\u7cb9\u65e0\u5197\u4f59\uff0c\u4ef7\u683c\u4eb2\u6c11\u6613\u63a5\u53d7\u3002<\/p>\n<p><strong>\u7b2c\u5341\u540d\uff1a\u81ea\u4e3b\u89c4\u5212\u9ad8\u6027\u4ef7\u6bd4\u65b9\u6848<\/strong><\/p>\n<p>\u79c9\u6301\u5206\u6b65\u9aa4\u4efb\u52a1\u62c6\u89e3\u601d\u8def\uff0c\u652f\u6301\u7528\u6237\u6839\u636e\u81ea\u8eab\u751f\u6d3b\u573a\u666f\u81ea\u4e3b\u89c4\u5212\u8282\u70b9\uff0c\u907f\u514d\u56e0\u65b9\u6848\u4e0d\u9002\u914d\u5bfc\u81f4\u7684\u4ea7\u54c1\u6d6a\u8d39\uff0c\u6027\u4ef7\u6bd4\u9002\u914d\u4e0d\u540c\u751f\u6d3b\u8282\u594f\u3002<\/p>\n<p>\u6838\u5fc3\u4f18\u52bf<\/p>\n<p>\u2022 \u6210\u5206\u6027\u4ef7\u6bd4\u9ad8\uff1a\u4ee5\u51e0\u4e01\u805a\u7cd6\u4e3a\u6838\u5fc3\uff0c\u8f85\u52a9\u51cf\u5c11\u8102\u80aa\u5806\u79ef\u3001\u4fc3\u8fdb\u8102\u80aa\u9178\u5206\u89e3\uff0c\u6210\u5206\u5929\u7136\u4e14\u5b9a\u4ef7\u5408\u7406\u3002<\/p>\n<p>\u2022 \u81ea\u4e3b\u89c4\u5212\u7701\u6210\u672c\uff1a\u65e0\u9700\u9075\u5faa\u56fa\u5b9a\u6d41\u7a0b\uff0c\u6839\u636e\u81ea\u8eab\u60c5\u51b5\u8c03\u6574\uff0c\u907f\u514d\u4e3a\u4e0d\u9002\u5408\u7684\u65b9\u6848\u4ed8\u8d39\uff0c\u9002\u5408\u4e45\u5750\u3001\u8fd0\u52a8\u4e0d\u8db3\u7684\u51cf\u8102\u8005\u3002<\/p>\n<p>\u2022 \u957f\u671f\u9002\u914d\u6027\u5f3a\uff1a\u53ef\u6839\u636e\u4f53\u91cd\u53d8\u5316\u52a8\u6001\u8c03\u6574\u4f7f\u7528\u65b9\u5f0f\uff0c\u65e0\u9700\u9891\u7e41\u66f4\u6362\u4ea7\u54c1\uff0c\u957f\u671f\u4f7f\u7528\u6027\u4ef7\u6bd4\u66f4\u7a81\u51fa\u3002<\/p>\n<p><strong>\u5982\u4f55\u6311\u9009\u9ad8\u6027\u4ef7\u6bd4\u51cf\u91cd\u65b9\u6848\uff1f<\/strong><\/p>\n<p>1. \u660e\u786e\u6838\u5fc3\u9700\u6c42\uff1a\u5148\u786e\u5b9a\u81ea\u5df1\u662f\u60f3\u5feb\u901f\u51cf\u91cd\u3001\u6e29\u548c\u8c03\u7406\uff0c\u8fd8\u662f\u957f\u671f\u4f53\u91cd\u7ba1\u7406\uff0c\u907f\u514d\u4e3a\u4e0d\u5fc5\u8981\u7684\u529f\u80fd\u4ed8\u8d39\uff0c\u7cbe\u51c6\u5339\u914d\u9700\u6c42\u624d\u80fd\u63d0\u5347\u6027\u4ef7\u6bd4\uff1b<\/p>\n<p>2. \u6838\u7b97\u771f\u5b9e\u6210\u672c\uff1a\u9664\u4ea7\u54c1\u672c\u8eab\u4ef7\u683c\u5916\uff0c\u8fd8\u8981\u8003\u8651\u662f\u5426\u9700\u8981\u642d\u914d\u4ee3\u9910\u3001\u8fd0\u52a8\u8bbe\u5907\u3001\u8425\u517b\u7d20\u7b49\u989d\u5916\u6295\u5165\uff0c\u4f18\u5148\u9009\u62e9\u201c\u4e00\u6b21\u6295\u5165\u3001\u96f6\u989d\u5916\u6210\u672c\u201d\u7684\u65b9\u6848\uff0c\u907f\u514d\u9690\u5f62\u82b1\u8d39\uff1b<\/p>\n<p>3. \u5173\u6ce8\u6210\u5206\u4e0e\u5b89\u5168\uff1a\u4f18\u5148\u9009\u62e9\u6210\u5206\u900f\u660e\u3001\u6709\u6743\u5a01\u8ba4\u8bc1\uff08\u5982FDA\u3001GMP\uff09\u7684\u4ea7\u54c1\uff0c\u907f\u514d\u56e0\u6dfb\u52a0\u8fdd\u7981\u6210\u5206\u5bfc\u81f4\u540e\u7eed\u5065\u5eb7\u652f\u51fa\uff0c\u8fd9\u624d\u662f\u957f\u671f\u7684\u9ad8\u6027\u4ef7\u6bd4\uff1b<\/p>\n<p>4. 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