{"id":60027,"date":"2018-10-15T01:00:00","date_gmt":"2018-12-07T02:52:52","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/b124626142\/"},"modified":"2018-12-07T10:53:11","modified_gmt":"2018-12-07T02:53:11","slug":"b124626142","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/60027\/","title":{"rendered":"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab"},"content":{"rendered":"
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\"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/p>\n

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FDA483\u4e0e\u8b66\u544a\u4fe1\u5173\u6ce8\u70b9<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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FDA\u73b0\u573a\u68c0\u67e5\u540e\uff0c\u4f1a\u6709\u4ee5\u4e0b\u51e0\u79cd\u7ed3\u679c\uff1a<\/span><\/p>\n

NAI\u65e0\u9700\u91c7\u53d6\u63aa\u65bd\uff08No Action Indicated\uff09\u96f6\u7f3a\u9677<\/span><\/p>\n

VAI\u81ea\u884c\u91c7\u53d6\u63aa\u65bd\uff08Voluntary Action Indicated\uff09\u5982483<\/span><\/p>\n

OAI\u91c7\u53d6\u5b98\u65b9\u884c\u52a8\uff08Official Action Indicated\uff09\u5982\u8fdb\u53e3\u4ee4\/\u8b66\u544a\u4fe1<\/span><\/p>\n

\u5b8c\u5168\u56de\u5e94\u51fdCR\uff08Complete Response\uff09\u76f4\u63a5\u62d2\u7edd\u6279\u51c6<\/span><\/p>\n

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483\u4e0d\u4ee3\u8868\u8fdd\u89c4\uff0c\u662f\u5bf9\u53ef\u80fd\u8fdd\u89c4\u7684\u89c2\u5bdf\u9879\u7684\u5ba2\u89c2\u8bb0\u5f55\uff0c\u4f46\u662f\u5982\u679c483\u6574\u6539\u548c\u56de\u590d\u4e0d\u5230\u4f4d\uff0c\u5c31\u5f88\u6709\u53ef\u80fd\u4f1a\u6536\u5230\u8b66\u544a\u4fe1\u3002\u8fd110\u5e74\u6765FDA483\u5f15\u7528\u6761\u6b3e\u6392\u540d\u524d\u4e94\uff1a<\/span><\/p>\n


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\"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/p>\n


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\u8fd15\u5e74\u6765FDA\u8b66\u544a\u4fe1\u5f15\u7528\u6761\u6b3e\u6392\u540d\u524d\u4e94\uff1a<\/span><\/p>\n


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\"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/p>\n

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\u6211\u4eec\u628a\u5173\u6ce8\u70b9\u805a\u7126\u5728\u4e24\u4e2a\u8868\u683c\u4e2d\u5747\u6392\u7b2c\u4e00\u7684\u7f3a\u9677\u2014\u2014\u8c03\u67e5\u5931\u8d25\u3002<\/span><\/p>\n


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21CFR211.192 \u4ea7\u54c1\u8bb0\u5f55\u5ba1\u6838\uff1a\u6240\u6709\u836f\u54c1\u751f\u4ea7\u548c\u63a7\u5236\u8bb0\u5f55\uff0c\u5305\u62ec\u5305\u88c5\u548c\u8d34\u6807\u7b7e\u8bb0\u5f55\u987b\u5168\u90e8\u6309\u5df2\u6279\u51c6\u7684\u7a0b\u5e8f\u8fdb\u884c\u5ba1\u6838\u548c\u6279\u51c6\u3002\u5ba1\u6838\u548c\u6279\u51c6\u5e94\u5728\u8be5\u6279\u836f\u54c1\u653e\u884c\u6216\u9500\u552e\u524d\u5b8c\u6210\u3002\u4e00\u4e9b\u975e\u89e3\u91ca\u6027\u5dee\u5f02\uff0c\u5305\u62ec\u8d85\u8fc7\u5728\u4e3b\u8981\u751f\u4ea7\u548c\u63a7\u5236\u8bb0\u5f55\u4e2d\u5236\u8ba2\u7684\u6700\u5927\u6216\u6700\u5c0f\u767e\u5206\u6570\u7684\u7406\u8bba\u4ea7\u91cf\u7684\u767e\u5206\u6570\uff0c\u6216\u4e00\u6279\u6216\u4efb\u4f55\u4e00\u4e2a\u6210\u4efd\u4e0d\u7b26\u5408\u5176\u89c4\u683c\u4e2d\u4efb\u4e00\u9879\u5219\u5e94\u4f5c\u5f7b\u5e95\u8c03\u67e5\uff0c\u4e0d\u7ba1\u8fd9\u6279\u836f\u54c1\u662f\u5426\u5df2\u9500\u552e\u3002\u8fd9\u79cd\u8c03\u67e5\u5e94\u63d0\u9ad8\u6216\u6269\u5c55\u5230\u540c\u4e00\u836f\u54c1\u7684\u5176\u4ed6\u6279\u53f7\u548c\u4e0e\u6b64\u6279\u4e0d\u5408\u683c\u6216\u5dee\u5f02\u76f8\u5173\u7684\u5176\u5b83\u836f\u54c1\u3002\u8c03\u67e5\u5e94\u6709\u4e66\u9762\u8bb0\u5f55\uff0c\u5305\u62ec\u7ed3\u8bba\u548c\u540e\u7eed\u7684\u8ddf\u8e2a\u3002<\/span><\/em><\/p>\n

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483\u4e0e\u8b66\u544a\u4fe1\u4e2d\u5e38\u89c1\u7684\u7f3a\u9677\u6c47\u603b<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

2018\u5e74FDA\u6240\u53d1\u51fa\u7684483\u548c\u8b66\u544a\u4fe1\u4e2d\u51e0\u4e4e\u6709\u4e00\u534a\u7f3a\u9677\u6d89\u53ca\u8c03\u67e5\u5931\u8d25\u3002\u6709\u4e9b\u7f3a\u9677\u7684\u5b9e\u8d28\u53ef\u80fd\u662f\u5de5\u827a\u95ee\u9898\uff0c\u4f46\u5728\u68c0\u67e5\u4e2d\u662f\u901a\u8fc7OOS\u3001\u504f\u5dee\u8bb0\u5f55\u3001\u751a\u81f3\u662f\u6295\u8bc9\u8bb0\u5f55\u66b4\u9732\u51fa\u7684\u3002\u68c0\u67e5\u65b9\u8fd8\u5c06\u8c03\u67e5\u5931\u8d25\u5ef6\u4f38\u81f3\u8d28\u91cf\u7ba1\u7406\u5931\u804c\u548c\u751f\u4ea7\u7cfb\u7edf\u7684\u7f3a\u9677\u3002\u5173\u4e8e\u8c03\u67e5\u5931\u8d25\u7ecf\u5e38\u51fa\u73b0\u7684\u95ee\u9898\u6709\u4ee5\u4e0b\u51e0\u79cd\uff1a<\/span><\/p>\n


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1. \u672a\u542f\u52a8\u8c03\u67e5\u6216\u672a\u5bf9\u8c03\u67e5\u8fdb\u884c\u5145\u5206\u8bb0\u5f55<\/span><\/p>\n

\u5de5\u827a\u9a8c\u8bc1\u4e2d\u7684\u504f\u5dee\u672a\u542f\u52a8\u8c03\u67e5\u548c\u8bb0\u5f55\u3002\u5de5\u827a\u9a8c\u8bc1\u4e2d\u6709OOS\u6216\u5173\u952e\u5de5\u827a\u53c2\u6570\u8d85\u6807\u4f46\u5e76\u672a\u542f\u52a8\u8c03\u67e5\u3002\u9a8c\u8bc1\u4e2d\u7684\u504f\u5dee\u7ba1\u7406\u4e5f\u8981\u6ce8\u610f\uff0c\u5c24\u5176\u662f\u5de5\u827a\u9a8c\u8bc1\u3002<\/span><\/p>\n


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\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u504f\u5dee\u672a\u542f\u52a8\u8c03\u67e5\u3002\u5982\uff0c\u704c\u88c5\u751f\u4ea7\u5de5\u5e8f\u76ee\u68c0\u7684\u4e2d\u63a7\u6837\u54c1\u4e0d\u5408\u683c\uff0c\u6ca1\u6709\u8fdb\u884c\u8c03\u67e5\u548c\u8bc4\u4f30\u3002\u76ee\u89c6\u68c0\u67e5\u4eba\u5458\u7531\u4e8e\u5728\u65e0\u83cc\u704c\u88c5\u4e2d\u53d1\u73b0\u5f02\u7269\u6216\u5b8c\u6574\u6027\u7f3a\u9677\u800c\u62d2\u6536\u4e86\u836f\u54c1\u7684\u4e2d\u63a7\u6837\u54c1\u3002\u4f46\u662f\uff0c\u6839\u672c\u6ca1\u6709\u8fdb\u884c\u751f\u4ea7\u548c\u5316\u9a8c\u5ba4\u8bc4\u4f30\uff0c\u751a\u81f3\u90fd\u6ca1\u6709\u754c\u5b9a\u6b64\u79cd\u60c5\u51b5\u53d1\u751f\u7684\u539f\u56e0\u3002<\/span><\/p>\n


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2. \u65e0\u6548OOS\u7387\u95ee\u9898\uff0c\u53bb\u5e74\u67d0\u836f\u4f01\u7684\u8b66\u544a\u4fe1\u4e2d\u4e5f\u6709\u76f8\u5173\u7f3a\u9677\uff1a\u8be5\u516c\u53f82016\u5e74\u7684\u65e0\u6548OOS\u7387\u8d8570% \u3002\u5e76\u4e0d\u662f\u5b9e\u9a8c\u5ba4\u539f\u56e0\u7684OOS\u5c31\u8bf4\u660e\u4ea7\u54c1\u6ca1\u6709\u95ee\u9898\uff0c\u65e0\u6548OOS\u53cd\u5e94\u7684\u8d28\u91cf\u63a7\u5236\u7684\u4e0d\u7a33\u5b9a\uff0c\u8d28\u91cf\u4f53\u7cfb\u7684\u4e0d\u53ef\u9760\u3002<\/span><\/p>\n


\u79d1\u666e\u65e0\u6548OOS\uff1a<\/span><\/p>\n

\u65e0\u6548OOS\uff1a\u5728\u6279\u6b21\u653e\u884c\u548c\u7a33\u5b9a\u6027\u68c0\u9a8c\u4e2d\u7531\u4e8e\u5b9e\u9a8c\u5ba4\u8fc7\u5931\u5bfc\u81f4\u7684\u88ab\u5224\u5b9a\u65e0\u6548\u7684 OOS \u6570\u91cf\u3002<\/span><\/p>\n

\u65e0\u6548OOS\u7387\uff1a\u6279\u6b21\u653e\u884c\u68c0\u9a8c\u548c\u957f\u671f\u7a33\u5b9a\u6027\u68c0\u9a8c\u7684OOS\u7ed3\u679c\u4e2d\uff0c\u56e0\u68c0\u9a8c\u8fc7\u7a0b\u4e2d\u7684\u8fc7\u5931\u800c\u88ab\u5224\u5b9a\u4e3a\u65e0\u6548OOS\u7ed3\u679c\uff0c\u9664\u4ee5\u6279\u6b21\u653e\u884c\u548c\u957f\u671f\u7a33\u5b9a\u6027\u68c0\u9a8c\u7684\u5168\u90e8OOS\u7ed3\u679c\u3002<\/span><\/p>\n


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3. \u65f6\u9650\u95ee\u9898\uff0c\u8c03\u67e5\u65f6\u95f4\u3001\u63aa\u65bd\u6267\u884c\u53ca\u504f\u5dee\u5173\u95ed\u7684\u65f6\u95f4\u3002<\/span><\/p>\n


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\u504f\u5dee\u8c03\u67e5\u672a\u5728\u6307\u5b9a\u65f6\u95f4\u5185\u5173\u95ed\uff08\u5ef6\u671f\u7387\u9ad8\uff09\uff0c\u91cd\u590d\u53d1\u751f\u7387\u8f83\u9ad8\u3002\u5ef6\u8fdf\u8c03\u67e5\u6ca1\u6709\u5145\u5206\u7684\u7406\u7531\u548c\u8bc4\u4f30\u3002<\/span><\/p>\n


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4. \u504f\u5dee\u7b49\u8c03\u67e5\u7684\u7ea7\u522b\u5b9a\u4e49\u4e0d\u5408\u7406\u3002\u4e3b\u8981\u4ee5\u4e0a\u7684\u504f\u5dee\u5f80\u5f80\u88ab\u4f01\u4e1a\u964d\u7ea7\u8bc4\u4ef7\u548c\u5904\u7406\u3002\u6ca1\u6709\u4e0e\u4e4b\u98ce\u9669\u76f8\u5339\u914d\u3002<\/span><\/p>\n


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5. \u6839\u672c\u539f\u56e0\u8c03\u67e5\u4e0d\u5f7b\u5e95\uff0c\u6216\u7ed9\u51fa\u4e86\u907f\u91cd\u5c31\u8f7b\u7684\u53ef\u80fd\u539f\u56e0\u3002\u4e0d\u7ba1\u95ee\u9898\u4ea7\u54c1\u662f\u8fd4\u5de5\u5904\u7406\u8fd8\u662f\u505a\u4e0d\u5408\u683c\u5904\u7406\uff0c\u90fd\u5fc5\u987b\u8fdb\u884c\u6839\u672c\u539f\u56e0\u8c03\u67e5\u3002\u5982\uff0c\u68c0\u67e5\u53d1\u73b0\u56e0\u4e2d\u95f4\u4f53OOS\u5f15\u53d1\u7684\u504f\u5dee\u5904\u7406\u63aa\u65bd\u4e3a\u8fd4\u5de5\uff0c\u4f46\u6ca1\u6709\u627e\u5230\u6839\u672c\u539f\u56e0\uff0c\u6ca1\u6709\u5145\u5206\u8c03\u67e5\u751f\u4ea7\u5de5\u827a\u548c\u6279\u8bb0\u5f55\uff0c\u672a\u5236\u8ba2\u9884\u9632\u63aa\u65bd\u8ba1\u5212\u3002<\/span><\/p>\n


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6. \u98ce\u9669\u8bc4\u4f30\u4e0d\u5f7b\u5e95\u4e0d\u5168\u9762\uff0c483\u548c\u8b66\u544a\u4fe1\u4e2d\u504f\u5dee\u548c\u53d8\u66f4\u90fd\u88ab\u63d0\u8fc7\u98ce\u9669\u8bc4\u4f30\u4e0d\u5145\u5206\u7684\u7f3a\u9677\u3002\u53d1\u751f\u4e25\u91cd\u7f3a\u9677\u6ca1\u6709\u5f62\u6210\u98ce\u9669\u8bc4\u4f30\u5c0f\u7ec4\uff0c\u6ca1\u6709\u5408\u9002\u7684\u98ce\u9669\u7ba1\u7406\u65b9\u6cd5\u548c\u5de5\u5177\uff0c\u4e5f\u6ca1\u6709\u6b63\u5f0f\u7684\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u3002<\/span><\/p>\n


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7. \u8c03\u67e5\u8303\u56f4\u4e0d\u5168\u9762\uff08\u56e0\u504f\u5dee\u6240\u5f71\u54cd\u7684\u6279\u6b21\u548c\u4ea7\u54c1\u8303\u56f4\uff09\u3002\u5982\u67d0\u836f\u4f01\u5236\u5242\u548c\u539f\u6599\u836f\u5747\u5b58\u5728\u5171\u7ebf\u751f\u4ea7\uff0c\u4f46\u662f\u504f\u5dee\u548cOOS\u8c03\u67e5\u6ca1\u6709\u5ef6\u4f38\u81f3\u76f8\u5173\u5176\u5b83\u4ea7\u54c1\u6216\u6279\u53f7\uff1a\u68c0\u67e5\u671f\u95f4\u53d1\u73b0\u4e09\u5e74\u95f4\u8fd11000\u4e2a\u504f\u5dee\u5747\u672a\u5ef6\u4f38\u8c03\u67e5\u8303\u56f4\uff0c\u800c\u76f8\u5173\u6279\u6b21\u5df2\u88ab\u653e\u884c\u3002\u6b64\u79cd\u505a\u6cd5\u663e\u793a\u51fa\u8d28\u91cf\u90e8\u95e8\u672a\u80fd\u786e\u4fdd\u8d28\u91cf\u548c\u751f\u4ea7\u4f53\u7cfb\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\u3002<\/span><\/p>\n


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8.  CAPA\u95ee\u9898\uff0c\u9996\u5148\u79d1\u666eCAPA\uff1a<\/span><\/p>\n


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CA\u7ea0\u6b63\u63aa\u65bd\uff1a\u8fdb\u884c\u6eaf\u6e90\u5206\u6790\uff0c\u4ee5\u5e2e\u52a9\u7406\u89e3\u504f\u5dee\u4ea7\u751f\u7684\u539f\u56e0\uff0c\u5e76\u9884\u9632\u7c7b\u4f3c\u95ee\u9898\u7684\u518d\u6b21\u53d1\u751f\u3002<\/span><\/p>\n

PA\u9884\u9632\u63aa\u65bd\uff1a\u6269\u5927\u6392\u9664\u53ef\u80fd\uff0c\u4ee5\u907f\u514d\u7c7b\u4f3c\u6f5c\u5728\u95ee\u9898\u7684\u53d1\u751f\u3002<\/span><\/p>\n


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    \u672a\u5236\u8ba2\u5145\u5206\u7684CAPA\u8ba1\u5212\u3002\u7ea0\u6b63\u3001\u6574\u6539\u3001\u9884\u9632\u63aa\u65bd\u4e0d\u5408\u7406\u6216\u4e0d\u5145\u5206\uff0c\u5982\u53ea\u6709\u7ea0\u6b63\u9519\u8bef\u7684\u63aa\u65bd\uff0c\u5374\u6ca1\u6709\u9488\u5bf9\u6839\u672c\u539f\u56e0\u5236\u5b9a\u6574\u6539\u63aa\u65bd\uff0c\u9632\u6b62\u518d\u6b21\u53d1\u751f\uff1b\u6839\u636e\u98ce\u9669\u7ea7\u522b\uff0c\u5e94\u8be5\u5236\u5b9a\u9884\u9632\u63aa\u65bd\u65f6\uff0c\u6ca1\u6709\u5236\u5b9a\u76f8\u5e94\u63aa\u65bd\u9632\u6b62\u53d1\u751f\u3002\u5f03\u7528\u95ee\u9898\u6279\u6b21\uff0c\u8ddf\u8e2a\u4e0b\u6279\u68c0\u67e5\u60c5\u51b5\uff0c\u8fd9\u79cdCAPA\u63aa\u65bd\u662f\u6ca1\u6709\u9488\u5bf9\u6839\u672c\u539f\u56e0\u7684\u65e0\u6548CAPA\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u63aa\u65bd\u5236\u5b9a\u548c\u5b9e\u65bd\u7684\u8303\u56f4\u8986\u76d6\u4e0d\u591f\u5168\u9762\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u8c03\u67e5\u5904\u7406\u548c\u5404\u9879\u63aa\u65bd\u5b9e\u65bd\u7684\u5b9e\u65bd\u8ddf\u8e2a\u60c5\u51b5\u548c\u6548\u679c\u8bc4\u4f30\u4e0d\u5230\u4f4d\u3002\u4f8b\u5982\uff0c\u67d0\u504f\u5dee\u5931\u8d25\u539f\u56e0\u662f\u8bbe\u5907\uff08\u706f\u68c0\u4eea\uff09\u4f7f\u7528\u4e2d\u6709\u5c40\u90e8\u96f6\u4ef6\u7834\u788e\uff0c\u4f46\u662f\u8bbe\u5907\u5728\u7ee7\u7eed\u68c0\u67e5\u6837\u54c1\u4e4b\u524d\u672a\u8fdb\u884c\u6e05\u6d01\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u5404\u8bc1\u636e\u4e0d\u5145\u5206\uff1a\u95ee\u9898\u63cf\u8ff0\u672c\u8eab\u7684\u8bc1\u636e\uff0c\u6839\u672c\u539f\u56e0\u7684\u8bc1\u636e\uff0c\u8c03\u67e5\u53ca\u98ce\u9669\u8bc4\u4f30\u7684\u8bc1\u636e\uff0c\u63aa\u65bd\u5b8c\u6210\u7684\u8bc1\u636e\u7b49\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

    \n
    \n
    \n
    \n

    <\/section>\n
    \n
    <\/section>\n
    <\/section>\n
    <\/section>\n<\/section>\n<\/section>\n
    \n
    \n
    \u603b\u7ed3<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


    <\/span><\/p>\n

    \u770b\u5230\u4e00\u4efd483\u6216\u8b66\u544a\u4fe1\uff0c\u53ef\u4ee5\u8bbe\u8eab\u5904\u5730\u7684\u8003\u8651\u4e0b\u81ea\u5df1\u6240\u5728\u7684\u5de5\u5382\u662f\u5426\u6709\u7c7b\u4f3c\u95ee\u9898\uff0c\u5982\u679c\u6709\uff0c\u8be5\u5982\u4f55\u8fdb\u884c\u6b63\u5f0f\u7684\u56de\u590d\u6574\u6539\u3002\u597d\u7684\u7f3a\u9677\u6574\u6539\u5fc5\u987b\u5305\u62ec\u4e24\u4e2a\u5fc5\u8981\u6761\u4ef6\uff1a\u8be5\u516c\u53f8\u5bf9\u7f3a\u9677\u5185\u5bb9\u8fdb\u884c\u4e86\u5145\u5206\u800c\u8db3\u591f\u6709\u6548\u7684\u8c03\u67e5\u548cCAPA\uff1b\u6574\u6539\u62a5\u544a\u63d0\u4f9b\u4e86\u8db3\u591f\u53ef\u9760\u7684\u4fe1\u606f\uff0c\u4ee5\u8bc1\u660e\u4efb\u4f55\u8fdd\u89c4\u7684\u884c\u4e3a\u90fd\u5f97\u5230\u4e86\u5145\u5206\u7684\u7ea0\u6b63\u3002\u65e0\u8bba\u662f\u4ee5\u504f\u5dee\u3001OOS\u6216\u6295\u8bc9\u3001\u9000\u8d27\u7b49\u5176\u4ed6\u8d28\u91cf\u6d3b\u52a8\u7684\u5f62\u5f0f\u5448\u73b0\uff0c\u8c03\u67e5\u53ca\u5176\u8c03\u67e5\u8bb0\u5f55\u7684\u672c\u8d28\u90fd\u662f\uff1a<\/span>
    <\/p>\n

                                <\/span>\"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/p>\n


    <\/span><\/p>\n

    \u89e3\u51b3\u65b9\u6848\u53ef\u4ee5\u53c2\u89c1\u5386\u53f2\u5fae\u4fe1\u6587\u7ae0–\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e4b\u504f\u5dee\uff0c\u4ee5\u53caOOS\u3002<\/span><\/p>\n


    <\/span><\/p>\n

    \u53c2\u8003\u8d44\u6599\uff1a<\/span><\/p>\n

    1. \u7f8e\u56fd\u8054\u90a6\u6cd5\u89c421CFR211.192<\/span><\/em><\/span><\/p>\n

    2. FDA\u76d1\u7ba1\u7a0b\u5e8f\u624b\u518c-RPM<\/span><\/em><\/span><\/p>\n

    Regulatory Procedures Manual<\/span><\/em><\/span><\/p>\n

    <\/mpcps><\/section>\n
    <\/mpcps><\/section>\n

    \u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab<\/span><\/h2>\n

    \u200d<\/span><\/span><\/span><\/strong><\/span>\u4e00\u3001<\/span>FDA<\/strong>\u68c0\u67e5<\/span><\/strong>\u7b80\u4ecb<\/span><\/strong><\/span><\/p>\n

    \u200d<\/span><\/span><\/span>1\uff09<\/span>FDA\u53ca\u4e2d\u56fd\u529e\u7b80\u4ecb<\/span><\/span><\/p>\n

    2\uff09<\/span>FDA\u68c0\u67e5\u7684\u6cd5\u89c4\u4f9d\u636e<\/span><\/span><\/p>\n

    3\uff09\u68c0\u67e5\u65f6\u95f4\u53ca\u4eba\u5458\u5b89\u6392<\/span><\/span><\/p>\n

    4\uff09\u68c0\u67e5\u7684\u76f8\u5173\u6587\u4ef6\u4ecb\u7ecd<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u4e8c\u3001<\/span>FDA<\/strong>\u68c0\u5bdf\u5b98\u7684\u7279\u70b9<\/span><\/strong><\/span><\/p>\n

    1\uff09\u68c0\u5bdf\u5b98\u7684\u4e09\u5927\u4eba\u683c\u7c7b\u578b<\/span><\/span><\/p>\n

    2\uff09\u68c0\u5bdf\u5b98\u7684\u68c0\u67e5\u601d\u8def<\/span><\/span><\/p>\n

    3\uff09\u7ebf\u7d22\u8c03\u67e5\u6cd5<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u4e09\u3001<\/span>FDA<\/strong>\u8fd1\u671f\u7f3a\u9677\u7edf\u8ba1\u53ca\u68c0\u67e5\u70ed\u70b9<\/span><\/strong><\/span><\/p>\n

    1\uff09\u8fd1\u4e94\u5e74\u836f\u4f01\u68c0\u67e5\u7684\u7f3a\u9677\u7edf\u8ba1<\/span><\/span><\/p>\n

    2\uff09\u6570\u636e\u5b8c\u6574\u6027\u70ed\u70b9\u7684\u80cc\u666f<\/span><\/span><\/p>\n

    3\uff09\u6570\u636e\u5b8c\u6574\u6027\u7684\u6cd5\u89c4\u4f9d\u636e<\/span><\/span><\/p>\n

    4\uff09\u6570\u636e\u5b8c\u6574\u6027\u7684\u5e38\u89c1\u7f3a\u9677<\/span><\/span><\/p>\n

    5\uff09\u6570\u636e\u5b8c\u6574\u6027\u7684\u6574\u6539\u601d\u8def<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u56db\u3001\u5982\u4f55\u5e94\u5bf9<\/span>FDA<\/strong>\u68c0\u67e5<\/span><\/strong><\/span><\/p>\n

    1\uff09\u786e\u5b9a\u68c0\u67e5\u7684\u8303\u56f4\u548c\u76ee\u7684<\/span><\/span><\/p>\n

    2\uff09\u8c03\u67e5\u68c0\u5bdf\u5b98\u80cc\u666f\u548c\u7279\u70b9<\/span><\/span><\/p>\n

    3\uff09\u68c0\u67e5\u524d\u7684\u51c6\u5907\u4e8b\u9879<\/span><\/span><\/p>\n

    4\uff09\u5982\u4f55\u5f00\u5c55\u6a21\u62df\u5ba1\u6838\uff08\u81ea\u67e5\uff09<\/span><\/span><\/p>\n

    5\uff09\u4e0e\u68c0\u5bdf\u5b98\u4ea4\u6d41\u7684\u6b63\u786e\u65b9\u5f0f<\/span><\/span><\/p>\n

    6\uff09\u5982\u4f55\u4e3b\u52a8\u5f15\u5bfc\u68c0\u67e5\u91cd\u5fc3<\/span><\/span><\/p>\n

    7\uff09\u5982\u4f55\u89c4\u907f\u4e25\u91cd\u7f3a\u9677<\/span><\/span><\/p>\n

    8\uff09\u63a5\u5f85\u7684\u6ce8\u610f\u4e8b\u9879<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u4e94\u3001\u7f3a\u9677\u7684\u56de\u590d\u4e0e\u6574\u6539<\/span><\/strong><\/span><\/p>\n

    1\uff09\u56de\u590d\u7684\u7d27\u8feb\u6027<\/span><\/span><\/p>\n

    2\uff09\u6210\u7acb\u6539\u5584\u5c0f\u7ec4<\/span><\/span><\/p>\n

    3\uff09\u5f7b\u5e95\u5206\u6790\u539f\u56e0<\/span><\/span><\/p>\n

    4\uff09\u63aa\u65bd\u4e00\u4e00\u5bf9\u5e94<\/span><\/span><\/p>\n

    5\uff09\u63aa\u65bd\u5fc5\u987b\u6709\u6548<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u516d\u3001\u8d28\u91cf\u5927\u52bf\u63a2\u8ba8<\/span><\/strong><\/span><\/p>\n

    1\uff09\u4e2d\u56fd\u7279\u8272\u7684\u8d28\u91cf\u6587\u5316<\/span><\/span><\/p>\n

    2\uff09\u8d28\u91cf\u6cd5\u89c4\u4eba\u624d\u7684\u56f0\u5883<\/span><\/span><\/p>\n

    3\uff09\u4f4e\u6210\u672c\u5408\u89c4\u662f\u5426\u53ef\u884c<\/span><\/span><\/p>\n

    4\uff09\u76d1\u7ba1\u98ce\u66b4\u8fd8\u80fd\u5439\u591a\u4e45<\/span> <\/span><\/p>\n

     <\/span><\/p>\n

    \n

    <\/span>
    <\/p>\n

    \u4e00\u3001<\/span>FDA<\/strong>\u68c0\u67e5\u7b80\u4ecb<\/span><\/strong><\/span><\/p>\n

    1\uff09<\/span>FDA\u53ca\u5176\u9a7b\u534e\u529e\u516c\u5ba4\u7b80\u4ecb<\/span><\/span><\/p>\n

    \u5168\u79f0\uff1a<\/span>U.S. Food and Drug Administration\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff0c\u96b6\u5c5e\u4e8e<\/span>U.S.Department of Health and Human Services (HHS)\u7f8e\u56fd\u536b\u751f\u4e0e\u4eba\u7c7b\u670d\u52a1\u90e8<\/span><\/span><\/p>\n

    \u804c\u80fd\uff1a<\/span>FDA\u4e3a\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff0c\u96b6\u5c5e\u4e8e<\/span>HHS\u7f8e\u56fd\u4eba\u7c7b\u4e0e\u5065\u5eb7\u670d\u52a1\u90e8\u3002<\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/span><\/span>\"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/p>\n

     <\/span><\/p>\n

    FDA\u7684\u5386\u53f2\u6cbf\u9769<\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
     <\/span><\/p>\n

    \u673a\u6784\u7ec4\u6210<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/p>\n

     <\/span><\/p>\n

    FDA\u9a7b\u534e\u529e\u516c\u5ba4\u4f4d\u4e8e\u5317\u4eac\uff0c\u6210\u7acb\u4e8e<\/span>2008\u5e74\uff0c\u662f<\/span>FDA\u9996\u4e2a\u6d77\u5916\u529e\u516c\u5ba4\uff0c\u4e3b\u8981\u804c\u80fd\u4e3a\u76d1\u7ba1\u5bf9\u7f8e\u51fa\u53e3\u4f01\u4e1a\u7684\u5408\u89c4\u3002\u76ee\u524d\u6709\u7ea6<\/span>18\u540d\u6b63\u5f0f\u5458\u5de5\uff08\u5305\u62ec\u51e0\u4f4d\u7f8e\u7c4d\u534e\u4eba\uff09\u3002\u53e4\u4e3dLeigh Verbois\u535a\u58eb\u4e3a\u4e3b\u4efb\uff0c\u8457\u540d\u7684\u6740\u624b\u7ea7\u68c0\u5bdf\u5b98\u5f7c\u5f97\u8d1d\u514bPeter Baker\u4e3a\u8d1f\u8d23\u836f\u54c1\u7684\u52a9\u7406\u4e3b\u4efb\uff0cNicole Smith\u4e3a\u8d1f\u8d23\u5668\u68b0\u7684\u52a9\u7406\u4e3b\u4efb\uff0cPatrick Bowen\u4e3a\u8d1f\u8d23\u98df\u54c1\u548c\u9972\u6599\u7684\u52a9\u7406\u4e3b\u4efb\u3002<\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \u5ba1\u6838\u51e0\u7387<\/span><\/span><\/p>\n

    \u636e\u7edf\u8ba1\uff0c\u76ee\u524d<\/span>FDA\u5bf9\u4e2d\u56fd\u5236\u836f\u548c\u5668\u68b0\u4f01\u4e1a\u7684\u5ba1\u6838\u6570\u91cf\u7ea6\u4e3a<\/span>130-160\u5bb6<\/span>\/\u5e74\u3002\u5bf9\u836f\u4f01\u800c\u8a00\uff0c\u6ce8\u518c\u4f01\u4e1a\u7ea6\u4e3a800\u5bb6\u3002\u800c\u5668\u68b0\u5219\u8d85\u8fc73400\u5bb6\uff0c\u5bf9\u4e8e<\/span>I\u7c7b\u4ea7\u54c1\uff0c\u6bcf\u56db\u5e74\u68c0\u67e5\u4e00\u6b21\uff0c\u5bf9\u4e8e<\/span>II\/III\u7c7b\u4ea7\u54c1\uff0c\u6bcf\u4e24\u5e74\u68c0\u67e5\u4e00\u6b21\u3002<\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"

    <\/p>\n


    <\/p>\n

    2\uff09<\/span>FDA\u68c0\u67e5\u7684\u6cd5\u89c4\u4f9d\u636e<\/span><\/span><\/p>\n

    \u5236\u836f\uff1a<\/span>21 CFR 210&211 (GMP)<\/span><\/p>\n

    \u5668\u68b0\uff1a<\/span>21 CFR 820 (QSR820), 21 CFR 803 (MDR\u533b\u7597\u5668\u68b0\u4e0d\u826f\u53cd\u5e94\u62a5\u544a<\/span>),  21CFR 801 (\u6807\u7b7e<\/span>), 21 CFR 807 (510K\u6ce8\u518c<\/span>)<\/span><\/p>\n


    <\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/span><\/p>\n


    <\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/p>\n


    <\/strong><\/span><\/p>\n

    \u533b\u7597\u5668\u68b0QSIT<\/strong>\u8d28\u91cf\u4f53\u7cfb\u68c0\u67e5\u6280\u672f<\/span><\/strong><\/span><\/p>\n

    7\u5927\u5b50\u7cfb\u7edf\u5176\u4e2d4\u4e2a\u5173\u952e\u5b50\u7cfb\u7edf<\/span><\/span><\/p>\n

    \u7ba1\u7406\u63a7\u5236\u3001\u7ea0\u6b63\u548c\u9884\u9632\u63aa\u65bd\uff08<\/span>CAPA\uff09\uff08\u5177\u6709\u8f85\u52a9\u7684\u533b\u7597\u5668\u68b0\u62a5\u544a\u7cfb\u7edf\u3001\u7ea0\u6b63\u548c\u79fb\u9664\u7cfb\u7edf\u3001\u533b\u7597\u5668\u68b0\u8bb0\u5f55\u7cfb\u7edf\uff09\u3001\u8bbe\u8ba1\u63a7\u5236\u3001\u751f\u4ea7\u548c\u8fc7\u7a0b\u63a7\u5236\uff08<\/span>P&PC\uff09\uff08\u5177\u6709\u8f85\u52a9\u7684\u706d\u83cc\u8fc7\u7a0b\u63a7\u5236\u7cfb\u7edf\uff09\u3002<\/span><\/span><\/p>\n

    \u6b64\u624b\u518c\u662f\u8c03\u67e5\u8005\u548c\u5176\u5b83<\/span>FDA\u804c\u5458\u7684\u53c2\u8003\u8d44\u6599\uff0c\u6587\u4ef6\u4e0d\u7ea6\u675f<\/span>FDA\uff0c\u4e5f\u4e0d\u5bf9\u4efb\u4f55\u4e2a\u4eba\u8fdb\u884c\u6388\u6743\u3001\u83b7\u76ca\u548c\u8c41\u514d\u3002<\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
     <\/span><\/p>\n


    <\/p>\n

    3<\/span>\uff09\u68c0\u67e5\u65f6\u95f4\u53ca\u4eba\u5458\u5b89\u6392<\/span>
    <\/p>\n

    \u5236\u836f\uff1a<\/span>2\u540d\u68c0\u5bdf\u5b98\uff08<\/span>1\u540d\u751f\u7269\u5316\u5b66\u5236\u836f\u80cc\u666f\u3001<\/span>1\u540d\u8d28\u91cf\u4f53\u7cfb\u4e13\u5bb6\uff09\uff0c<\/span>4-5\u4e2a\u5de5\u4f5c\u65e5\uff1b<\/span><\/span><\/p>\n

    \u5668\u68b0\uff1a\u4e00\u7c7b\u4e8c\u7c7b\u5668\u68b0\u5747\u4e3a<\/span>1\u540d\u68c0\u5bdf\u5b98\uff1b\u4e09\u7c7b\u5668\u68b0\u4e3a<\/span>1\u540d\u6216<\/span>2\u540d\u68c0\u5bdf\u5b98\uff0c<\/span>4-5\u4e2a\u5de5\u4f5c\u65e5<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    3\uff09\u76f8\u5173\u6587\u4ef6\u4ecb\u7ecd<\/span><\/span><\/p>\n

    FDA\u68c0\u67e5\u5e38\u89c1\u7684\u6587\u4ef6\u6709<\/span>483\u8868\uff0c<\/span>EIR\u62a5\u544a\uff0c\u8b66\u544a\u4fe1\u53ca\u8fdb\u53e3\u7981\u4ee4\u3002\u7b80\u5355\u4ecb\u7ecd\u4e0b<\/span>4\u79cd\u6587\u4ef6\u7684\u5b9a\u4e49\u53ca\u7528\u9014\u3002<\/span><\/span><\/p>\n

    1. Form 483 <\/span>\u8868\u683c<\/span><\/span><\/p>\n

    483\u8868\u683c\u7528\u4e8e\u6267\u884c\u68c0\u67e5\u7684<\/span>FDA\u68c0\u67e5\u5b98\u8bb0\u5f55\u5176\u6240\u53d1\u73b0\u7684\u7f3a\u9677\u3002\u5728\u68c0\u67e5\u7ed3\u679c\u65f6\u68c0\u67e5\u5b98\u8981\u7b7e\u53d1\u8be5\u8868\u683c\uff0c\u53d7\u68c0\u4f01\u4e1a\u5219\u9700\u8981\u5bf9\u5176\u4e2d\u7f3a\u9677\u8fdb\u884c\u6b63\u5f0f\u56de\u590d\u3002\u5bf9\u8be5\u8868\u683c\u4e2d\u7f3a\u9677\u7684\u56de\u590d\u9700\u8981\u5728\u5176\u7b7e\u7f72\u540e\u7684<\/span>15\u4e2a\u5de5\u4f5c\u65e5\u5185\u63d0\u4ea4\u3002\u53ea\u6709\u5728\u6536\u5230\u56de\u590d\u540e\uff0c<\/span>FDA\u624d\u4f1a\u53ef\u80fd\u505a\u51fa\u51b3\u5b9a\u662f\u5426\u7b7e\u53d1\u8b66\u544a\u4fe1\u3002\u68c0\u67e5\u4e2d\u82e5\u672a\u53d1\u73b0\u7f3a\u9677\uff0c\u5219\u68c0\u5bdf\u5b98\u4e0d\u4f1a\u53d1\u51fa<\/span>483\u8868\u683c\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u6ce8\uff1a\u9664\u4e86<\/span>483\u8868\uff0c\u8fd8\u6709<\/span>482\u548c<\/span>484\u8868<\/span><\/span><\/p>\n

    FDA482\uff1aNotice of Inspection\uff1a\u68c0\u67e5\u901a\u77e5\u4e66<\/span><\/p>\n

    FDA483\uff1aInspectional Observations\uff1a\u68c0\u67e5\u89c2\u5bdf\u901a\u77e5\u4e66<\/span><\/p>\n

    FDA484\uff1aReceipt for Samples\uff1a\u6837\u54c1\u6536\u636e\u8868<\/span><\/p>\n

    \n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

     \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/p>\n


    <\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/p>\n

    <\/span><\/p>\n


    <\/p>\n


    <\/p>\n


    <\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
     <\/span><\/p>\n

    3\uff09\u68c0\u67e5\u5b98\u60ef\u7528\u7684\u7ebf\u7d22\u8c03\u67e5\u6cd5<\/span><\/span><\/p>\n

    \u90a3\u4e48\u6740\u624b\u578b\u68c0\u67e5\u5b98\u5230\u5e95\u662f\u6309\u7167\u4ec0\u4e48\u601d\u8def\u8fdb\u884c\u68c0\u67e5\u7684\u5462\uff1f\u6211\u81ea\u521b\u4e86\u4e00\u4e2a\u8bcd\u53eb\u4f5c\u201c\u7ebf\u7d22\u8c03\u67e5\u6cd5\uff08<\/span>Clue investigation method\uff09\u201d\u3002<\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
     <\/span><\/p>\n

    \u7ebf\u7d22\u8c03\u67e5\u6cd5\u600e\u4e48\u7528\uff1f\u7b80\u5355\u5f52\u7ed3\u4e3a<\/span>5\u4e2a\u6b65\u9aa4\u3002<\/span><\/span><\/p>\n

    1. <\/span>\u53d1\u73b0\u6d89\u5acc\u9020\u5047\u7684\u86db\u4e1d\u9a6c\u8ff9<\/span><\/span><\/p>\n

    2. <\/span>\u67e5\u770b\u4e0e\u6b64\u8fc7\u7a0b\u76f8\u5173\u7684\u5404\u79cd\u8bb0\u5f55\u6216\u73b0\u573a\u8be2\u95ee\u76f8\u5173\u4eba\u5458<\/span><\/span><\/p>\n

    3. <\/span>\u5728\u8bb0\u5f55\u548c\u8be2\u95ee\u4e2d\u53d1\u73b0\u66f4\u591a\u7f3a\u9677<\/span><\/span><\/p>\n

    4. <\/span>\u786e\u5b9a\u6b64\u7c7b\u95ee\u9898\u7684\u8303\u56f4\uff08\u5e7f\u5ea6<\/span>\/\u6df1\u5ea6<\/span>\/\u5f71\u54cd\u9762\uff09<\/span><\/span><\/p>\n

    5. <\/span>\u5f52\u7ed3\u4e3a\u7cfb\u7edf\u6027\u7f3a\u9677\u5e76\u9020\u6210\u4ea7\u54c1\u8d28\u91cf\u7684\u5931\u63a7<\/span><\/span><\/p>\n

    6. <\/span>\u786e\u5b9a\u8be5\u4f01\u4e1a\u7684\u4ea7\u54c1\u4e25\u91cd\u5371\u5bb3\u4e86\u7f8e\u56fd\u4eba\u6c11\u7684\u5065\u5eb7<\/span><\/span><\/p>\n


    <\/p>\n

     <\/span><\/p>\n

    \u770b\u5f97\u4e0d\u662f\u5f88\u660e\u767d\uff1f\u6ca1\u5173\u7cfb\uff0c\u5c31\u4e3e\u4e00\u4e2a\u5e38\u89c1\u7684\u4f8b\u5b50\u6765\u8bf4\u660e\u3002\u4f8b\u5982\uff0c\u68c0\u67e5\u5b98\u68c0\u67e5\u4ea7\u54c1\u7684\u542b\u91cf\u68c0\u6d4b\u65f6\u53d1\u73b0\u67d0\u4e00\u9488\u7684\u6570\u636e\u88ab\u5220\u9664\u4e86\u3002\u5176\u5e76\u672a\u6d45\u5c1d\u8f84\u6b62\uff0c\u800c\u662f\u987a\u7740\u8fd9\u4e2a\u7ebf\u7d22\u4e00\u6b65\u4e00\u6b65\u67e5\u4e0b\u53bb\uff0c\u6700\u7ec8\u53d1\u73b0\u4e86\u4e25\u91cd\u7684\u7f3a\u9677\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \u201c\u7ebf\u7d22\u8c03\u67e5\u6cd5\u201d\u6709\u8fd9\u4e48\u516d\u5927\u597d\u5904<\/span><\/p>\n

    1. <\/span>\u5f88\u5bb9\u6613\u67e5\u51fa\u6570\u636e\u9020\u5047\u7684\u60c5\u51b5<\/span><\/span><\/p>\n

    2. <\/span>\u8bf4\u660e\u4ea7\u54c1\u5b58\u5728\u7cfb\u7edf\u6027\u7684\u8d28\u91cf\u98ce\u9669<\/span><\/span><\/p>\n

    3. <\/span>\u901a\u8fc7\u5404\u79cd\u8bc1\u636e\u8868\u660e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5931\u63a7<\/span><\/span><\/p>\n

    4. <\/span>\u589e\u52a0\u4f01\u4e1a\u6574\u6539\u7684\u96be\u5ea6\u5c24\u5176\u662f\u9884\u9632\u63aa\u65bd\u5de5\u4f5c\u91cf\u5927<\/span><\/span><\/p>\n

    5. <\/span>\u6709\u5229\u4e8e\u8bf4\u670d\u8bc4\u5ba1\u59d4\u5458\u4f1a\u5f00\u51fa\u8b66\u544a\u4fe1\u751a\u81f3\u8fdb\u53e3\u7981\u4ee4<\/span><\/span><\/p>\n

    6. <\/span>\u9009\u62e9\u4e00\u4e2a\u719f\u6089\u7684\u5207\u5165\u70b9\u5373\u53ef\u9493\u5230\u5927\u9c7c\uff0c\u51cf\u8f7b\u4e86\u5ba1\u8ba1\u8d1f\u8377<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u4e09\u3001<\/span>FDA<\/strong>\u8fd1\u671f\u7f3a\u9677\u7edf\u8ba1\u53ca\u68c0\u67e5\u70ed\u70b9<\/span><\/strong><\/span><\/p>\n

    1\uff09\u8fd15\u5e74\u7f3a\u9677\u7edf\u8ba1<\/span><\/span><\/p>\n

    \u7eb5\u89c2\u5404\u4e2a\u9886\u57df\u7684<\/span>483\u6570\u636e\uff0c\u98df\u54c1<\/span>483\u6bd4\u91cd\u6700\u5927\uff0c\u7ea6\u5360\u603b\u6570\u7684\u4e00\u534a\u3002\u836f\u54c1<\/span>483\u6bd4\u91cd\u4ece<\/span>2010\u81f3<\/span>2015\u8d22\u653f\u5e74\u5206\u522b\u4e3a<\/span>11.9%\u3001<\/span>10.5%\u3001<\/span>12.3%\u3001<\/span>13.2%\u3001<\/span>12.7%\u3001<\/span>14.0%\u3002<\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\" \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/span><\/p>\n

     \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
     \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
     <\/span><\/p>\n

    \n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n


    <\/p>\n

    \n


    <\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/span><\/p>\n


    <\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"
    <\/p>\n

     <\/span><\/p>\n

    3. <\/span>\u5e7f\u6cdb\u63a5\u53d7\u7684\u539f\u5219<\/span><\/span><\/p>\n

    MHRA\u7684<\/span>ALCOA+CCEA\u539f\u5219\u5df2\u88ab\u5e7f\u4e3a\u63a5\u53d7<\/span><\/span><\/p>\n

    Attributable A <\/span>\u53ef\u8ffd\u6eaf<\/span><\/strong>\u7684\u8bb0\u5f55\u53ef\u8ffd\u6eaf<\/span><\/span><\/p>\n

    Legible L <\/span>\u6e05\u6670<\/span><\/strong>\u7684\uff0c\u53ef\u89c1\u7684\u6e05\u6670\u53ef\u89c1<\/span><\/span><\/p>\n

    Contemporaneous C <\/span>\u540c\u6b65<\/span><\/strong>\u7684\u4e0e\u64cd\u4f5c\u540c\u6b65\u751f\u6210<\/span>\/\u5f55\u5165<\/span><\/span><\/p>\n

    Original O <\/span>\u539f\u59cb<\/span><\/strong>\u7684\u7b2c\u4e00\u624b\u6536\u636e\uff0c\u672a\u7ecf\u8f6c\u624b\u7684<\/span><\/span><\/p>\n

    Accurate A <\/span>\u51c6\u786e<\/span><\/strong>\u7684\u4e0e\u5b9e\u9645\u64cd\u4f5c\u76f8\u4e00\u81f4\u7684\uff0c\u65e0\u4e3b\u89c2\u9020\u5047\u6216\u5ba2\u89c2\u8f93\u5165\u9519\u8bef<\/span><\/span><\/p>\n

    Complete C <\/span>\u5b8c\u6574<\/span><\/strong>\u7684\u65e0\u9057\u6f0f<\/span><\/span><\/p>\n

    Consistent C <\/span>\u4e00\u81f4<\/span><\/strong>\u7684\u4e0e\u5b9e\u9645\u751f\u6210\u903b\u8f91\u987a\u5e8f\u4e00\u81f4\uff0c\u663e\u793a\u7684\u8bb0\u5f55\u4eba\u540c\u5b9e\u9645\u64cd\u4f5c\u8005\u4e00\u81f4<\/span><\/span><\/p>\n

    Enduring E <\/span>\u8010\u4e45<\/span><\/strong>\u7684\uff0c\u8010\u53d7\u7684\u539f\u59cb\u6570\u636e\u957f\u4e45\u4fdd\u5b58\uff0c\u4e0d\u6613\u5220\u9664\uff0c\u4e22\u5f03<\/span><\/span><\/p>\n

    Available A <\/span>\u53ef\u83b7\u5f97<\/span><\/strong>\u7684\u6570\u636e\u5728\u5ba1\u8ba1\u65f6\u53ef\u89c1\uff0c\u4e0d\u88ab\u9690\u85cf<\/span><\/span><\/p>\n


    <\/span><\/p>\n

    ALCOA+CCEA <\/span>\u539f\u5219\u4e0d\u4ec5\u662f<\/span>GMP <\/span>\u5bf9\u8bb0\u5f55\u5b8c\u6574\u6027\u7684\u8981\u6c42\uff0c\u4e5f\u662f\u6240\u6709\u7b26\u5408\u6027\u5ba1\u6838\u5bf9\u8bb0\u5f55\u5b8c\u6574\u6027\u7684\u57fa\u672c\u8981\u6c42\uff0c\u662f\u4fe1\u7528\u7684\u57fa\u77f3\u3002\u7531\u4e0a\u6587\u53ef\u5f97\uff0c<\/span>ALCOA+CCEA <\/span>\u539f\u5219\u5b9e\u9645\u4e0a\u5c31\u662f\u5bf9\u8bb0\u5f55\u751f\u6210<\/span>\/\u5f55\u5165\u3001\u4fee\u6539\u3001\u5b58\u50a8\u3001\u68c0\u7d22\u3001\u5907\u4efd\u3001\u6062\u590d\u548c\u8f93\u51fa\u7b49\u6570\u636e\u751f\u547d\u5468\u671f\u5185\u7684\u6240\u6709\u64cd\u4f5c\u7684\u8981\u6c42\u3002\u5982\u679c\u8fd9\u4e9b\u64cd\u4f5c\u6ee1\u8db3\u4e86\u4ee5\u4e0a\u539f\u5219\uff0c\u8bb0\u5f55\u7684\u5b8c\u6574\u6027\u5c31\u6ee1\u8db3\u8981\u6c42\u4e86\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

     \u6b64\u5916\uff0c<\/span>MHRA\u53d1\u5e03\u7684\u6570\u636e\u5b8c\u6574\u6027\u6307\u5357\u91cc\u660e\u786e\u6307\u51fa<\/span><\/span><\/p>\n

    1. 2017\u5e74\u5e95\u524d\u5fc5\u987b\u5b89\u88c5\u5ba1\u8ba1\u8ffd\u8e2a\u529f\u80fd<\/span><\/span><\/p>\n

    2. <\/span>\u6570\u636e\u7684\u5ba1\u6838\u5fc5\u987b\u5305\u542b\u5143\u6570\u636e\u53ca\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u5ba1\u6838<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    FDA\u53d1\u5e03\u7684\u6570\u636e\u5b8c\u6574\u6027\u548c<\/span>cGMP\u5408\u89c4\u6307\u5357\u8349\u6848\u4e2d\u6307\u51fa<\/span><\/span><\/p>\n

    1. FDA\u5efa\u8bae\uff0c\u91c7\u96c6\u5173\u952e\u6570\u636e\u53d8\u66f4\u7684\u5ba1\u8ba1\u8ffd\u8e2a\u5e94\u5728\u6bcf\u6b21\u8bb0\u5f55\u548c\u6700\u7ec8\u6279\u51c6\u8bb0\u5f55\u524d\u5ba1\u67e5\u3002<\/span><\/span><\/p>\n

    2. <\/span>\u6709\u751f\u4ea7\u548c\u63a7\u5236\u8bb0\u5f55\uff0c\u5305\u62ec\u5ba1\u8ba1\u8ffd\u8e2a\uff0c\u5fc5\u987b\u7531\u8d28\u91cf\u90e8\u95e8\u5ba1\u6838\u548c\u6279\u51c6\uff08<\/span>\u00a7 211.192\uff09\u3002\u8fd9\u4e0e<\/span>FDA\u5bf9\u4f01\u4e1a\u5728\u5ba1\u6838\u6570\u636e\u65f6\u5728\u7eb8\u4e0a\u5212\u75d5\u6807\u6ce8\u7684\u9884\u671f\u662f\u4e00\u6837\u7684\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    4\uff09\u6570\u636e\u5b8c\u6574\u6027\u7684\u5e38\u89c1\u7f3a\u9677<\/span><\/span><\/p>\n

    \u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\u5e38\u89c1\u4e8e<\/span>QC <\/span>\u5b9e\u9a8c\u5ba4<\/span>,\u4f46\u5728\u7814\u53d1\u90e8\u95e8\u3001\u751f\u4ea7\u90e8\u95e8\u3001\u5e02\u573a\u90e8\u95e8\uff0c\u751a\u81f3\u4e8e\u836f\u4e8b\u7ba1\u7406\u90e8\u95e8\uff0c\u4e5f\u540c\u6837\u5b58\u5728\u3002\u6570\u636e\u5b8c\u6574\u6027\u95ee\u9898\uff0c\u8f83\u591a\u53cd\u6620\u5728\u4ee5\u4e0b\u65b9\u9762\uff1a<\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    1. QC\u68c0\u6d4b\u95ee\u9898<\/span><\/span><\/p>\n

    \u901a\u8fc7\u6545\u610f\u4fee\u6539\u88ab\u6d4b\u6837\u54c1\u53c2\u6570\u6765\u8fbe\u5230\u5408\u683c\u6216\u8f83\u597d\u7684\u68c0\u6d4b\u7ed3\u679c\uff1b<\/span><\/p>\n

    \u65e0\u610f\u8f93\u9519\u53c2\u6570\u6765\u8fbe\u5230\u5408\u683c\u6216\u8f83\u597d\u7684\u68c0\u6d4b\u7ed3\u679c\uff1b<\/span><\/p>\n

    \u6545\u610f\u9690\u7792<\/span>OOS\uff0c\u591a\u6b21\u91cd\u590d\u68c0\u6d4b\u76f4\u81f3\u5f97\u5230\u5408\u683c\u7ed3\u679c\u8fdb\u884c\u653e\u884c\uff1b<\/span><\/span><\/p>\n

    \u539f\u59cb\u68c0\u6d4b\u7535\u5b50\u6570\u636e\u88ab\u5220\u9664\u6216\u8986\u76d6\uff1b<\/span><\/p>\n

    \u4fee\u6539\u7cfb\u7edf\u65f6\u95f4\u8fdb\u884c\u91cd\u590d\u68c0\u6d4b\uff1b<\/span><\/p>\n

    HPLC\u68c0\u6d4b\u4e2d\u5220\u9664\u4e86\u57fa\u7ebf\u4e0d\u5e73\u7684\u56fe\u8c31\uff1b<\/span><\/span><\/p>\n

    \u590d\u5370\u6216\u4fee\u6539\u4e00\u5f20\u56fe\u8c31\u7528\u4e8e\u591a\u6279\u6b21\u4ea7\u54c1\u653e\u884c\uff1b<\/span><\/p>\n

    \u8bbe\u5907\u4f7f\u7528\u8bb0\u5f55\u4e0e\u5b9e\u9645\u4e0d\u4e00\u81f4\uff1b<\/span><\/p>\n

    \u68c0\u6d4b\u8bb0\u5f55\u672a\u53ca\u65f6\u7531\u672c\u4eba\u586b\u5199\uff1b<\/span><\/p>\n

    \u68c0\u6d4b\u8bbe\u5907\u91cc\u7684\u6587\u4ef6\u5f52\u7c7b\u6df7\u4e71\uff1b<\/span><\/p>\n

    \u64cd\u4f5c\u4eba\u5458\u4e0d\u719f\u6089<\/span>SOP\u7684\u89c4\u5b9a\uff1b<\/span><\/span><\/p>\n

    \u8ba1\u7b97\u673a\u6743\u9650\u8bbe\u7f6e\u4e0d\u5408\u7406\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    2. <\/span>\u7eb8\u8d28\u8bb0\u5f55\u7684\u7ba1\u7406<\/span><\/span><\/p>\n

    \u539f\u59cb\u8bb0\u5f55\u586b\u5199\u5728\u975e\u53d7\u63a7\u6587\u4ef6\uff08\u4f8b\u5982\u4fbf\u7b3a\u3001\u5c0f\u672c\u5b50\uff09\u4e0a\uff1b<\/span><\/p>\n

    \u539f\u59cb\u8bb0\u5f55\u586b\u5199\u9519\u8bef\u540e\u91cd\u65b0\u8a8a\u6284\uff1b<\/span><\/p>\n

    \u539f\u59cb\u8bb0\u5f55\u4e0d\u5b8c\u6574\u3001\u90e8\u5206\u8bb0\u5f55\u4e22\u5931\uff1b<\/span><\/p>\n

    \u6e29\u6e7f\u5ea6\u8ba1\u8bfb\u6570\u4e0e\u5b9e\u9645\u4e0d\u4e00\u81f4\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    3. <\/span>\u539f\u6599\u7269\u6599\u8fc7\u7a0b\u4ea7\u7269\u7684\u63a7\u5236<\/span><\/span><\/p>\n

    \u4e0d\u5408\u683c\u539f\u6599\u7269\u6599\u8fc7\u7a0b\u4ea7\u7269\u672a\u6309\u8981\u6c42\u6807\u8bc6\u3001\u9694\u79bb\u3001\u5b58\u653e\uff1b<\/span><\/p>\n

    \u539f\u6599\u7269\u6599\u8fc7\u7a0b\u4ea7\u7269\u7684\u8fd0\u8f93\u6216\u4fdd\u5b58\u8fc7\u7a0b\u906d\u81f4\u6c61\u67d3\uff1b<\/span><\/p>\n

    \u7eaf\u5316\u6c34\u7684\u68c0\u6d4b\u8bb0\u5f55\u4e0d\u5b8c\u5584\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    4. <\/span>\u9a8c\u8bc1\u7ba1\u7406<\/span><\/span><\/p>\n

    \u8ba1\u7b97\u673a\u7cfb\u7edf\u9a8c\u8bc1\u3001\u5de5\u827a\u9a8c\u8bc1\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u3001\u6e05\u6d01\u9a8c\u8bc1\u7b49\u65b9\u9762\u7684\u6570\u636e\u9020\u5047\uff1b<\/span><\/p>\n

    \u9a8c\u8bc1\u53c2\u6570\u8bbe\u7f6e\u4e0d\u5408\u7406\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\"<\/span><\/p>\n

    \u57f9\u8bad\u5408\u89c4\u7684\u610f\u8bc6Training\uff1a<\/span><\/strong>QA\/QC\u5168\u5458\u8fdb\u884cGMP\u57f9\u8bad\uff0c\u5c24\u5176\u8981\u5f3a\u8c03\u4e25\u683c\u9075\u5faa\u5b9e\u9a8c\u5ba4\u63a7\u5236\u7a0b\u5e8f\u5e76\u53ca\u65f6\u3001\u771f\u5b9e\u3001\u5b8c\u6574\u3001\u51c6\u786e\u5730\u8bb0\u5f55\u6570\u636e\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \u56db\u3001\u5982\u4f55\u5e94\u5bf9<\/span>FDA<\/strong>\u68c0\u67e5<\/span><\/strong><\/span><\/p>\n

    1\uff09\u786e\u5b9a\u68c0\u67e5\u8303\u56f4\u548c\u76ee\u7684<\/span><\/span><\/p>\n

    FDA<\/span>\u4e3a\u4f55\u800c\u6765\uff1a\u4f8b\u884c\u68c0\u67e5<\/span>\/<\/span>\u8b66\u544a\u4fe1\u540e\u7684\u590d\u67e5<\/span>\/<\/span>\u6709\u4eba\u4e3e\u62a5<\/span><\/p>\n

    \u4e4b\u524d<\/span>FDA\u68c0\u67e5\u7684\u7ed3\u679c\uff1a\u6709\u65e0<\/span>483\/EIR\u62a5\u544a\u7684\u7ed3\u8bba<\/span>\/\u56de\u590d\u662f\u5426\u8ba4\u53ef<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    2\uff09\u8c03\u67e5\u68c0\u5bdf\u5b98\u7684\u80cc\u666f\uff1a\u4ece\u5404\u79cd\u6e20\u9053\u641c\u96c6\u8be5\u68c0\u5bdf\u5b98\u7684\u80cc\u666f\u4fe1\u606f\u5305\u62ec\u5b66\u5386\u3001\u7ecf\u5386\u3001\u4e2a\u6027\u3001\u5e74\u9f84\u3001\u7279\u957f\u3001\u8fd1\u671f\u884c\u7a0b\uff0c\u4ee5\u53ca<\/span>review\u5176\u5f00\u8fc7\u7684\u6240\u6709<\/span>483\u8868\u6216\u8b66\u544a\u4fe1\u627e\u51fa\u5176\u68c0\u67e5\u7684\u7279\u70b9\u3002<\/span><\/span><\/p>\n

    \"\u3010\u503c\u5f97\u6536\u85cf\u3011\u5e94\u5bf9FDA\u68c0\u67e5\u7ecf\u9a8c\u5206\u4eab\" <\/span><\/p>\n

    4\uff09\u5982\u4f55\u5f00\u5c55\u6a21\u62df\u5ba1\u6838\uff08\u81ea\u67e5\uff09<\/span><\/span><\/p>\n

    \u5148\u51c6\u5907\u597d\u5341\u5927\u6e05\u5355<\/span><\/p>\n

    1. <\/span>\u5ba2\u6237\u62b1\u6028\uff08\u7f8e\u56fd\uff09\u6e05\u5355<\/span><\/span><\/p>\n

    2. <\/span>\u5185\u90e8\u5ba1\u8ba1<\/span>\/\u7ba1\u7406\u8bc4\u5ba1\u6e05\u5355<\/span><\/span><\/p>\n

    3. <\/span>\u504f\u5dee\u8c03\u67e5\/<\/span>OOS\/CAPA\u6e05\u5355<\/span><\/span><\/p>\n

    4. <\/span>\u5de5\u827a\u9a8c\u8bc1\u548c\u8bbe\u5907\u786e\u8ba4\u6e05\u5355<\/span><\/span><\/p>\n

    5. <\/span>\u8ba1\u91cf\u548c\u7ef4\u62a4\u4fdd\u517b\u6e05\u5355<\/span><\/span><\/p>\n

    6. <\/span>\u53d1\u8d27\u8bb0\u5f55\u6e05\u5355<\/span><\/span><\/p>\n

    7. <\/span>\u7f8e\u56fd\u5ba2\u6237\u6e05\u5355<\/span><\/span><\/p>\n

    8. <\/span>\u5408\u683c\u4f9b\u65b9\u6e05\u5355<\/span><\/span><\/p>\n

    9. <\/span>\u53d8\u66f4\u6e05\u5355\uff08\u8bbe\u8ba1\u5f00\u53d1\u3001\u751f\u4ea7\u5de5\u827a\uff09<\/span><\/span><\/p>\n

    10. <\/span>\u98ce\u9669\u8bc4\u4f30\u6e05\u5355<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u81ea\u67e5\u5341\u5927\u6e05\u5355\u4e2d\u7684\u5e38\u89c1\u7f3a\u9677<\/span><\/p>\n

    1. <\/span>\u5ba2\u6237\u62b1\u6028\uff08\u7f8e\u56fd\uff09\u6e05\u5355\uff1a\u5ba2\u6237\u62b1\u6028\u662f\u5426\u5f97\u5230\u6709\u6548\u5904\u7406\u4e14\u5173\u95ed\uff0c\u662f\u5426\u6d89\u53ca<\/span>MDR<\/span><\/p>\n

    2. <\/span>\u5185\u90e8\u5ba1\u8ba1<\/span>\/\u7ba1\u7406\u8bc4\u5ba1\u6e05\u5355\uff1a\u63aa\u65bd\u662f\u5426\u6267\u884c\u5e76<\/span>review<\/span><\/p>\n

    3. <\/span>\u504f\u5dee\u8c03\u67e5<\/span>\/OOS\/CAPA\u6e05\u5355\uff1a\u539f\u56e0\u5206\u6790\u662f\u5426\u5f7b\u5e95\uff0c\u63aa\u65bd\u662f\u5426\u5b8c\u6210\u3001\u6548\u679c\u6709\u65e0\u8bc4\u4f30<\/span><\/span><\/p>\n

    4. <\/span>\u5de5\u827a\u9a8c\u8bc1\u548c\u8bbe\u5907\u786e\u8ba4\u6e05\u5355\uff1a\u9a8c\u8bc1\u65f6\u7684\u53c2\u6570\u8bbe\u5b9a\u548c\u5f53\u524d\u662f\u5426\u76f8\u7b26<\/span><\/span><\/p>\n

    5. <\/span>\u8ba1\u91cf\u548c\u7ef4\u62a4\u4fdd\u517b\u6e05\u5355\uff1a\u5bf9\u5916\u90e8\u8ba1\u91cf\u6709\u65e0\u7ed3\u679c\u8bc4\u4f30\uff0c\u7ef4\u4fdd\u8bb0\u5f55\u548c<\/span>SOP\u4e0a\u7684\u8981\u6c42\u662f\u5426\u5bf9\u5e94<\/span><\/span><\/p>\n

    6. <\/span>\u53d1\u8d27\u8bb0\u5f55\u6e05\u5355\uff1a\u6279\u653e\u884c\u7684\u6743\u9650\u662f\u5426\u5408\u7406\uff0c\u6709\u65e0\u68c0\u9a8c\u5b8c\u6210\u524d\u653e\u884c\u7684\u60c5\u51b5\uff08\u65e0\u83cc\u3001\u6b8b\u7559\uff09<\/span><\/span><\/p>\n

    7. <\/span>\u7f8e\u56fd\u5ba2\u6237\u6e05\u5355\uff1a\u81ea\u6709\u54c1\u724c\u8fd8\u662f<\/span>OEM\u9700\u8981\u5199\u6e05\u695a<\/span><\/span><\/p>\n

    8. <\/span>\u5408\u683c\u4f9b\u65b9\u6e05\u5355\uff1a\u4f9b\u5e94\u5546\u7684\u7eb3\u5165\u3001\u8003\u6838\u662f\u5426\u6709\u5ba2\u89c2\u6570\u636e<\/span><\/span><\/p>\n

    9. <\/span>\u53d8\u66f4\u6e05\u5355\uff08\u8bbe\u8ba1\u5f00\u53d1\u3001\u751f\u4ea7\u5de5\u827a\uff09\uff1a\u53d8\u66f4\u8bc4\u4f30\u9700\u8981\u505a\u7684\u68c0\u6d4b\u662f\u5426\u5b8c\u6210\uff0c\u53d8\u66f4\u662f\u5426\u6267\u884c\uff0c\u662f\u5426\u57f9\u8bad\u5230\u4f4d<\/span><\/span><\/p>\n

    10. <\/span>\u98ce\u9669\u8bc4\u4f30\u6e05\u5355\uff1a\u98ce\u9669\u56e0\u5b50\u7684\u9009\u62e9\u548c\u6253\u5206\u7684\u4f9d\u636e\u662f\u5426\u5408\u7406<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u5982\u81ea\u67e5\u53d1\u73b0\u6570\u636e\u9020\u5047\u95ee\u9898\u5982\u4f55\u5904\u7406\uff08\u6743\u5b9c\u4e4b\u8ba1\uff09<\/span><\/span><\/p>\n

    1.\u5f00<\/span>CAPA\u6216\u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u5199\u660e\u6570\u636e\u5220\u6539\u7684\u539f\u56e0\uff08\u539f\u56e0\u5f52\u7ed3\u4e3a\u566a\u58f0\u7b49\uff0c\u4e0d\u8981\u5f52\u7ed3\u4e3a\u4ea7\u54c1\u542b\u91cf\u68c0\u6d4b\u4e0d\u5408\u683c\uff09\uff0c\u4e0d\u8981\u4e3b\u52a8\u8ddf<\/span>FDA\u63d0\u53ca\u81ea\u67e5\u3002\u82e5\u88ab<\/span>FDA\u53d1\u73b0\u540c\u6837\u95ee\u9898\uff0c\u53ef\u544a\u77e5\u3002<\/span><\/span><\/p>\n

    2. <\/span>\u7edf\u8ba1\u4ee5\u4e0a\u6d89\u53ca\u53d1\u5f80\u7f8e\u56fd\u7684\u6279\u6b21\u53ca\u662f\u5426\u6d89\u53ca\u5ba2\u8bc9<\/span><\/span><\/p>\n

    3. <\/span>\u6d89\u53ca\u6570\u636e\u9020\u5047\u7684\u6279\u53f7\u82e5\u6570\u91cf\u5f88\u5c11\uff0c\u5219\u4e0d\u8981\u660e\u663e\u5730\u663e\u793a\u5728\u53d1\u8fd0\u6e05\u5355\u4e2d<\/span><\/span><\/p>\n

    4. <\/span>\u8f6f\u4ef6\u5347\u7ea7\uff08\u5b89\u88c5\u5ba1\u8ba1\u8ffd\u8e2a\u540e\uff09\u8fdb\u884c\u6570\u636e\u53ef\u9760\u6027\u57f9\u8bad\uff0c\u660e\u786e\u7981\u6b62\u8fdd\u89c4\u9020\u4f5c<\/span><\/span><\/p>\n

    5. <\/span>\u5b9e\u9a8c\u5ba4\u4eba\u5458\u5728\u56de\u7b54<\/span>FDA\u95ee\u9898\u65f6\u4e0d\u8981\u4e3b\u52a8\u63d0\u53ca\u5ba1\u8ba1\u8ffd\u8e2a\uff0c\u82e5\u88ab\u95ee\u5230\u4e0d\u8981\u544a\u77e5\u66fe\u51fa\u73b0\u8fc7\u4efb\u4f55\u6570\u636e\u5220\u6539\u884c\u4e3a<\/span><\/span><\/p>\n

    6. <\/span>\u7a0b\u5e8f\u6587\u4ef6\u4e2d\u8981\u660e\u786e\u68c0\u6d4b\u6570\u636e\u7684\u4fdd\u5b58\u8def\u5f84\u3001\u547d\u540d\u89c4\u5219\u548c\u5907\u4efd\u8981\u6c42<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    5\uff09\u4e0e\u68c0\u67e5\u5b98\u4ea4\u6d41\u7684\u6b63\u786e\u65b9\u5f0f<\/span><\/span><\/p>\n

    \u5feb\u901f\u53cd\u5e94\uff1a\u5ba1\u6838\u5f00\u59cb\u540e\u68c0\u5bdf\u5b98\u60c5\u7eea\u4e00\u822c\u8f83\u597d\uff0c\u6b64\u65f6\u4ed6\u63d0\u7684\u4efb\u4f55\u95ee\u9898\uff0c\u4e00\u5b9a\u8981\u6ce8\u610f\u503e\u542c\uff0c\u542c\u4e0d\u61c2\u4e0d\u8981\u88c5\u61c2\uff0c\u52a1\u5fc5\u542c\u61c2\u540e\u518d\u56de\u7b54\u3002\u4ed6\u8981\u7684\u6750\u6599\u5c3d\u91cf\u7b2c\u4e00\u65f6\u95f4\u9001\u5230\uff0c\u5982\u679c\u9700\u8981\u65f6\u95f4\u627e\uff0c\u5c31\u8bb0\u5f55\u5728\u672c\u5b50\u4e0a\uff0c\u5b89\u6392\u76f8\u5e94\u4eba\u5458\u53bb\u627e\u3002\u6587\u4ef6\u627e\u6765\u540e\u8bb0\u5f97\u5728\u672c\u5b50\u4e0a\u6253\u52fe\u6216\u505a\u4e00\u4e2a\u201c\u5df2\u63d0\u4f9b\u201d\u7684\u8bb0\u5f55\uff0c\u786e\u4fdd\u6ca1\u6709\u6f0f\u627e\uff0c\u4e5f\u5c55\u73b0\u4f60\u6587\u6863\u63a7\u5236\u7684\u57fa\u672c\u7d20\u517b\u3002\u6b64\u5916\uff0c\u5c3d\u53ef\u80fd\u5feb\u5730\u56de\u7b54\u68c0\u5bdf\u5b98\u63d0\u51fa\u7684\u95ee\u9898\u548c\u63d0\u4f9b\u9700\u8981\u7684\u6587\u4ef6\uff0c\u5168\u5929\u5019\u966a\u62a4\u5ba1\u67e5\u4eba\u5458\uff0c\u4f7f\u4ed6\u4eec\u5728\u6307\u5b9a\u5730\u70b9\u5185\u6d3b\u52a8\u3002\u5bf9\u68c0\u5bdf\u5b98\u9700\u8981\u7684\u6587\u4ef6\u5217\u4e00\u4e2a\u6e05\u5355\u5c3d\u91cf\u4e00\u6b21\u51c6\u5907\u591a\u4efd\u6587\u4ef6\u4f9b\u5176\u68c0\u67e5\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    \u4fdd\u6301\u5766\u8bda\u5f00\u653e\u7684\u6001\u5ea6\uff1a\u4e00\u65e6\u88ab\u53d1\u73b0\u8bc1\u636e\u786e\u51ff\u7684\u95ee\u9898\u4e0d\u8981\u518d\u8fa9\u89e3\uff0c\u4f46\u662f\u5207\u5fcc\u4e3b\u52a8\u4ea4\u5f85\u95ee\u9898\u6216\u5c55\u793a\u5185\u90e8\u81ea\u67e5\u62a5\u544a\u3002\u56e0\u4e3a\u4e00\u65e6\u544a\u77e5\u68c0\u5bdf\u5b98\u771f\u5b9e\u7684\u81ea\u67e5\u60c5\u51b5\uff0c\u5c31\u53ef\u80fd\u4f1a\u88ab\u8981\u6c42\u544a\u77e5\u53d1\u73b0\u95ee\u9898\u7684\u65b9\u6cd5\uff0c\u8fd9\u5c31\u4e3a<\/span>FDA\u67e5\u627e\u66f4\u591a\u95ee\u9898\u63d0\u4f9b\u4e86\u903b\u8f91\u548c\u7ebf\u7d22\u3002\u603b\u4e4b\uff0c\u8981\u61c2\u5f97\u4fdd\u62a4\u81ea\u5df1\u3002\u5728\u4fdd\u6301\u5bf9<\/span>FDA\u68c0\u67e5\u5b98\u7684\u8bda\u6073\u548c\u793c\u8c8c\u7684\u524d\u63d0\u4e0b\uff0c\u80fd\u5c11\u8bf4\u5c3d\u91cf\u5c11\u8bf4\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    6\uff09\u5982\u4f55\u4e3b\u52a8\u5f15\u5bfc\u68c0\u67e5\u91cd\u5fc3<\/span><\/span><\/p>\n

    \u9002\u5ea6\u5f15\u5bfc\uff1a\u4ed4\u7ec6\u89c2\u5bdf\u68c0\u5bdf\u5b98\u7684\u8868\u73b0\uff0c\u53d1\u73b0\u68c0\u5bdf\u5b98\u7684\u4f18\u52bf\u548c\u52a3\u52bf\u540e\u53ef\u9002\u5ea6\u8fdb\u884c\u5f15\u5bfc\u548c\u89c4\u907f\u3002\u53ef\u4ee5\u63d0\u4f9b\u4e00\u4efd\u4e0d\u75db\u4e0d\u75d2\u7684\u5185\u90e8\u81ea\u67e5\u62a5\u544a\u5c06\u5176\u5f15\u5411\u4e0d\u64c5\u957f\u7684\u9886\u57df\u6216\u662f\u81ea\u5df1\u505a\u5f97\u975e\u5e38\u597d\u7684\u5730\u65b9\u800c\u89c4\u907f\u68c0\u5bdf\u5b98\u64c5\u957f\u7684\u9886\u57df\u6216\u4f01\u4e1a\u6709\u660e\u663e\u7f3a\u9677\u7684\u5730\u65b9\u3002<\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \u6d88\u8017\u68c0\u5bdf\u5b98\u7684\u65f6\u95f4\uff1a<\/span>FDA\u68c0\u67e5\u5b98\u4e00\u822c\u53ea\u6709\u51e0\u5929\u65f6\u95f4\u5728\u5de5\u5382\uff0c\u6709\u4e9b\u836f\u4f01\u751a\u81f3\u5728\u516c\u53f8\u7684\u7a0b\u5e8f\u6587\u4ef6\u4e2d\u89c4\u5b9a\u53ea\u80fd\u7ed9\u4e88\u6700\u591a<\/span>3\u5929\u7684\u68c0\u67e5\u65f6\u95f4\u3002\u5728\u68c0\u67e5\u8fc7\u7a0b\u4e2d\uff0c\u53ef\u4ee5\u6709\u610f\u65e0\u610f\u5730\u8017\u8d39\u68c0\u5bdf\u5b98\u7684\u65f6\u95f4\u3002\u4f8b\u5982\u7528<\/span>PPT\u8fdb\u884c\u516c\u53f8\u8be6\u7ec6\u4ecb\u7ecd\u7136\u540e\u5e26\u9886\u68c0\u5bdf\u5b98\u8be6\u7ec6\u53c2\u89c2\u751f\u4ea7\u8fc7\u7a0b\u3002\u4e00\u822c\u6765\u8bf4\u68c0\u67e5\u5b98\u5bf9\u5177\u4f53\u836f\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e0d\u662f\u975e\u5e38\u4e86\u89e3\uff0c\u56e0\u6b64\u53ef\u8be6\u7ec6\u4ecb\u7ecd\uff0c\u4e00\u65b9\u9762\u663e\u793a\u81ea\u5df1\u4e13\u4e1a\uff0c\u53e6\u4e00\u65b9\u9762\u4e5f\u5229\u7528\u53c2\u89c2\u5382\u623f\u8017\u8d39\u4e00\u4e9b\u65f6\u95f4\u3002<\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \u51c6\u5907\u597d\u4e00\u5957\u6848\u4f8b\u4f9b\u68c0\u67e5\uff1a\u6709\u7684\u68c0\u67e5\u5b98\u4f1a\u5077\u61d2\u5730\u95ee<\/span>\u201cxxx\u65b9\u9762\u7684\u6587\u4ef6\u53ca\u6848\u4f8b\u627e\u4e00\u4efd\u7ed9\u6211\u770b\u4e00\u4e0b<\/span>\u201d\uff0c\u76f4\u63a5\u9012\u4e0a\u4e8b\u5148\u7cbe\u9009\u8fc7\u7684\u5b8c\u7f8e\u6848\u4f8b\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    7\uff09\u5982\u4f55\u89c4\u907f\u4e25\u91cd\u7f3a\u9677<\/span><\/span><\/p>\n

    \u9664\u975e\u8bc1\u636e\u786e\u51ff\u7edd\u4e0d\u8981\u627f\u8ba4\u6545\u610f\u9020\u5047\uff1a\u9664\u975e\u5728\u8bc1\u636e\u786e\u51ff\u7684\u60c5\u51b5\u4e0b\uff0c\u88ab\u53d1\u73b0\u9020\u5047\u65f6\uff0c\u53ef\u4ee5\u8fa9\u89e3\u4e3a\u5177\u4f53\u64cd\u4f5c\u4e2d\u4e00\u4e0d\u5c0f\u5fc3\u758f\u5ffd\u4e86\u3001\u8f93\u9519\u4e86\u3001\u5fd8\u8bb0\u4e86\u7b49\u7b49\u3002\u56e0\u4e3a\u4f01\u4e1a\u8bf4\u7684\u6bcf\u4e00\u53e5\u8bdd\u90fd\u6709\u53ef\u80fd\u88ab\u68c0\u5bdf\u5b98\u5199\u5165<\/span>483\u8868\u3002\u5982\u679c\u4f60\u627f\u8ba4\u4e86\uff0c<\/span>483\u8868\u91cc\u4f1a\u76f4\u63a5\u5199\u6545\u610f\u9020\u5047\u3002\u800c\u5982\u679c\u4f60\u4e0d\u627f\u8ba4\uff0c<\/span>483\u8868\u91cc\u53ea\u80fd\u5199\u6d89\u5acc\u9020\u5047\u6216\u6ca1\u6709\u8bc1\u636e\u8868\u660e\u672a\u9020\u5047\u3002<\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \u5c3d\u529b\u51cf\u5c11<\/span>483\uff1a\u68c0\u67e5\u5b98\u53d1\u73b0\u7f3a\u9677\u65f6\uff0c\u5c3d\u529b\u4e0e\u5176\u6c9f\u901a\uff0c\u63d0\u4f9b\u8db3\u591f\u7684\u8bc1\u636e\u6765\u529d\u8bf4\u68c0\u5bdf\u5b98\u653e\u5f03\u5c06\u6b64\u5217\u4e3a<\/span>observation\u3002\u672b\u6b21\u4f1a\u8bae\u4e0a\u8981\u8ba4\u771f\u9605\u8bfb<\/span>483\u8868\uff0c\u6709\u4e0d\u540c\u610f\u89c1\u65f6\u8981\u575a\u51b3\u63d0\u51fa\uff0c\u5c3d\u91cf\u6293\u4f4f\u673a\u4f1a\u5728\u68c0\u67e5\u5b98\u79bb\u5f00\u524d\uff0c\u5bf9\u7f3a\u9677\u8fdb\u884c\u89e3\u91ca\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    8\uff09\u63a5\u5f85\u7684\u6ce8\u610f\u4e8b\u9879<\/span><\/span><\/p>\n

    \u521d\u89c1\u65f6\u8981\u7ed9\u68c0\u5bdf\u5b98\u5982\u6c90\u6625\u98ce\u7684\u611f\u89c9\uff1a\u5236\u4f5c\u4e00\u5f20\u5ba1\u6838\u670d\u52a1\u5361\uff0c\u4e0a\u9762\u5199\u6e05\u695a\u8fd9\u51e0\u5929\u7684\u5de5\u4f5c\u65f6\u95f4\u5b89\u6392\u4ee5\u53ca\u7d27\u6025\u60c5\u51b5\u65f6\u7684\u8054\u7cfb\u65b9\u5f0f\u3002\u63a5\u673a\u540e\u5c31\u5c06\u6b64\u5361\u7247\u9001\u7ed9\u68c0\u5bdf\u5b98\u5e76\u544a\u77e5\u6211\u4eec<\/span>7×24<\/span>\uff0c\u968f\u65f6\u606d\u5019\u5429\u5490\uff0c\u4f46\u662f\u8981\u544a\u8bc9\u516c\u53f8\u56fa\u5b9a\u7684\u4e0a\u4e0b\u73ed\u65f6\u95f4\u3002\u6b64\u5916\uff0c\u591a\u4e0e\u68c0\u5bdf\u5b98\u804a\u5929\u95ee\u6e05\u695a\u68c0\u5bdf\u5b98\u662f\u7b2c\u51e0\u6b21\u6765\u4e2d\u56fd\uff0c\u89c2\u5bdf\u5176\u4eba\u683c\u7c7b\u578b\u3002\u68c0\u5bdf\u5b98\u5230\u8fbe\u9152\u5e97\u540e\u4e0d\u8981\u6025\u7740\u79bb\u5f00\uff0c\u800c\u5e94\u966a\u540c\u4ed6\u4eec<\/span>check in, <\/span><\/span>\u56e0\u4e3a\u6709\u65f6\u9152\u5e97\u524d\u53f0\u670d\u52a1\u5783\u573e\uff0c\u9700\u8981\u4f60\u53ca\u65f6\u534f\u8c03\u3002<\/span>Check in<\/span>\u540e\u53cc\u65b9\u786e\u5b9a\u7b2c\u4e8c\u5929\u4e00\u65e9\u7684\u63a5\u8f66\u65f6\u95f4\uff0c\u8fd9\u662f\u4f60\u5c31\u53ef\u4ee5\u63e1\u624b\u79bb\u5f00\u4e86\u3002<\/span><\/p>\n

    <\/span><\/span><\/p>\n


    <\/span><\/span><\/p>\n

    \u68c0\u67e5\u5b98\u7b2c\u4e00\u5929\u5230\u8fbe\u5de5\u5382\u65f6\u53ef\u4ee5\u6d3e\u7f8e\u5973\u6216\u5e05\u54e5\u7ed9\u5176\u9001\u4e0a\u9c9c\u82b1\uff0c\u7136\u540e\u5c06\u5176\u5e26\u5165\u4f1a\u8bae\u5ba4\u3002\u6ce1\u4e0a\u5496\u5561\u8ba9\u5176\u4f11\u606f\u4e00\u4f1a\u7ee7\u800c\u5f15\u8350\u5176\u4f1a\u89c1\u516c\u53f8\u4e0d\u540c\u5c42\u7ea7\u7684\u7ba1\u7406\u8005\uff0c\u6bcf\u4e2a\u4eba\u90fd\u4e0e\u5176\u5bd2\u6684\u51e0\u53e5\u4ee5\u83b7\u5f97\u826f\u597d\u7684\u7b2c\u4e00\u5370\u8c61\u3002\u5efa\u8bae\u6bcf\u4e00\u4f4d\u4ece\u68c0\u5bdf\u5b98\u8eab\u8fb9\u7ecf\u8fc7\u7684\u516c\u53f8\u5458\u5de5\u90fd\u5fae\u7b11\u5730\u8bf4\u4e00\u58f0\uff1a<\/span>Good morning, welcome. <\/span>\u8fd9\u53eb\u8bad\u7ec3\u6709\u7d20\u3002\u6709\u4e00\u6b21\u6211\u548c<\/span>FDA\u68c0\u67e5\u5b98\u521a\u4e0b\u8f66\u51c6\u5907\u8fdb\u5165\u516c\u53f8\u5927\u5802\uff0c\u5c31\u53d1\u73b0\u5927\u5802\u91cc\u6709\u4eba\u5728\u5927\u58f0\u55a7\u54d7\uff0c\u89c1\u5230\u8001\u5916\u540e\u53d1\u73b0\u4e0d\u59a5\uff0c\u6389\u8138\u5c31\u8dd1\uff0c\u7ed9\u68c0\u5bdf\u5b98\u7559\u4e0b\u4e0d\u4f73\u7684\u5370\u8c61\u3002<\/span><\/span><\/p>\n


    <\/p>\n

    \u9910\u996e\uff1a<\/span><\/span>\u5c3d\u91cf\u5b89\u6392\u5230\u516c\u53f8\u5916\u9762\u6c1b\u56f4\u8f83\u597d\u7684\u996d\u5e97\u7528\u9910\uff0c\u7528\u9910\u65f6\u591a\u966a\u5176\u804a\u5929\u3002\u5982\u68c0\u5bdf\u5b98\u4e0d\u80af\u5916\u51fa\u7528\u9910\u5219\u6700\u597d\u8ba2\u5fc5\u80dc\u5ba2\u7b49\u897f\u9910\u800c\u975e\u4e2d\u9910\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    \u4e94\u3001\u7f3a\u9677\u7684\u56de\u590d\u4e0e\u6574\u6539<\/span><\/strong><\/span><\/p>\n

    1\uff09\u56de\u590d\u7684\u7d27\u8feb\u6027<\/span><\/span><\/p>\n

    FDA\u5728\u53d1\u7ed9\u4f01\u4e1a<\/span>483\u8868\u540e\uff0c\u4f01\u4e1a\u6709\u4e00\u6bb5\u65f6\u95f4\uff08\u4e00\u822c\u4e3a<\/span>15\u4e2a\u5de5\u4f5c\u65e5\uff09\u901a\u8fc7\u81ea\u8eab\u7684\u6574\u6539\u6765\u5e94\u5bf9\u62a5\u544a\u7684\u56de\u590d\u3002\u5bf9<\/span>483\u8868\u7684\u7b54\u590d\u59a5\u5f53\uff0c\u4f7f<\/span>FDA\u8ba4\u5b9a\u4f01\u4e1a\u6539\u8fdb\u540e\u5df2\u57fa\u672c\u7b26\u5408<\/span>cGMP\u6807\u51c6\uff0c\u4fbf\u53ef\u907f\u514d<\/span>FDA\u8b66\u544a\u4fe1\u7684\u53d1\u51fa\u3002\u5982\u679c\u4f01\u4e1a\u5bf9<\/span>FDA483\u7684\u7b54\u590d\u8349\u7387\u4e14\u8bc1\u636e\u4e0d\u5145\u5206\uff0c\u65e0\u6cd5\u4ee4<\/span>FDA\u76f8\u4fe1\u4f01\u4e1a\u8d28\u91cf\u7cfb\u7edf\u7684\u4e25\u91cd\u7f3a\u9677\u5df2\u7ecf\u6539\u6b63\uff0c\u90a3\u4e48<\/span>FDA\u5c06\u53d1\u51fa\u8b66\u544a\u4fe1\u6566\u4fc3\u5176\u6574\u6539\u3002\u5982\u4f01\u4e1a\u7684\u6574\u6539\u4f9d\u65e7\u4e0d\u80fd\u4ee4<\/span>FDA\u6ee1\u610f\uff0c\u5176\u6700\u540e\u7684\u5927\u62db\u4fbf\u662f<\/span>import alert\u8fdb\u53e3\u7981\u4ee4\uff0c\u8fd9\u610f\u5473\u7740\u8fd9\u5bb6\u4f01\u4e1a\u7684\u4ea7\u54c1\u5c06\u65e0\u6cd5\u5728\u7f8e\u56fd\u5e02\u573a\u4e0a\u9500\u552e\u3002<\/span><\/span><\/p>\n

    \u6b64\u5916\uff0c\u52a0\u62ff\u5927\u3001\u65e5\u672c\u3001\u6fb3\u5927\u5229\u4e9a\u7b49\u836f\u76d1\u4e5f\u503e\u5411\u4e8e\u8ddf\u968f<\/span>FDA<\/span>\u8fdb\u53e3\u7981\u4ee4\u5bf9\u4f01\u4e1a\u8fdb\u884c\u8c03\u67e5\u3002<\/span><\/p>\n

    \u6211\u5efa\u8bae\u5728\u6536\u5230<\/span>483\u8868\u540e\uff0c\u4f01\u4e1a\u5e94\u7acb\u5373\u7ec4\u7ec7\u7ba1\u7406\u5c42\u5f00\u4f1a\u7814\u8ba8\uff0c\u5c3d\u65e9\u5f62\u6210\u65b9\u6848\u4ee5\u56de\u590d<\/span>FDA\u3002\u56de\u590d<\/span>FDA\u4e4b\u540e\u5982\u6709\u63aa\u65bd\u8fd8\u9700\u65f6\u65e5\u624d\u80fd\u5b8c\u6210\uff0c\u4fdd\u6301\u6bcf\u5468\u4e00\u6b21\u7684\u66f4\u65b0\uff0c\u76ee\u7684\u5c31\u662f\u544a\u8bc9<\/span>FDA\u5176<\/span>483\u8868\u5f97\u5230\u4e86\u4f01\u4e1a\u7684\u9ad8\u5ea6\u91cd\u89c6\uff0c\u4f01\u4e1a\u6b63\u5728\u6295\u5165\u8d44\u6e90\u89e3\u51b3\u95ee\u9898\u3002\u5e0c\u671b\u4ee5\u81ea\u5df1\u7684\u4e3b\u52a8\u548c\u8bda\u610f\u6253\u52a8<\/span>FDA\u4ee5\u907f\u514d\u66f4\u9ad8\u7ea7\u522b\u7684\u60e9\u7f5a\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    2\uff09\u6210\u7acb\u6539\u5584\u5c0f\u7ec4<\/span><\/span><\/p>\n

    483\u8868\u662f<\/span>FDA\u68c0\u67e5\u5b98\u4e2a\u4eba\u6839\u636e\u5176\u5bf9<\/span>cGMP\u539f\u5219\u7684\u7406\u89e3\u548c\u6838\u67e5\u7ecf\u9a8c\u5bf9\u4f01\u4e1a\u8d28\u91cf\u7cfb\u7edf\u7684\u505a\u51fa\u7684\u5224\u5b9a\uff0c\u5e76\u975e\u6240\u6709\u5224\u65ad\u90fd\u662f\u7edd\u5bf9\u7684\u7b26\u5408\u5b9e\u9645\u60c5\u51b5\u3002\u4f01\u4e1a\u6536\u5230<\/span>FDA\u68c0\u67e5\u5458\u7684<\/span>483\u8868\u540e\uff0c\u76f8\u5173\u4eba\u5458\u5e94\u6df1\u5165\u7814\u8bfb\u548c\u5224\u65ad\uff0c\u5c24\u5176\u662f\u4e00\u7ebf\u63a5\u53d7\u68c0\u67e5\u7684\u4eba\u5458\u8981\u5c06\u68c0\u67e5\u8fc7\u7a0b\u548c\u7f3a\u9677\u6e05\u695a\u5730\u8bb2\u89e3\u7ed9\u672a\u76f4\u63a5\u53c2\u4e0e\u7684\u4eba\u5458\uff0c\u76f4\u81f3\u5176\u7406\u89e3\u6240\u6709\u7684\u95ee\u9898\uff0c\u8fd9\u70b9\u5f88\u91cd\u8981\u3002\u9996\u5148\u62bd\u8c03\u76f8\u5173\u90e8\u95e8\u6210\u5458\u6210\u7acb\u4e13\u95e8\u7684\u6574\u6539\u5c0f\u7ec4\u7edf\u7b79\u6539\u8fdb\u5de5\u4f5c\u3002\u7531\u4e8e\u5236\u5b9a\u7ea0\u504f\u548c\u9884\u9632\u63aa\u65bd\u9700\u8981\u8de8\u90e8\u95e8\u7684\u534f\u8c03\uff0c\u53ef\u91c7\u7528\u9879\u76ee\u7ec4\u7684\u65b9\u6cd5\uff0c\u5c06\u4efb\u52a1\u7ec6\u5206\uff0c\u5e76\u5236\u5b9a\u4e13\u95e8\u8ba1\u5212\uff0c\u5ba2\u89c2\u7684\u8ddf\u8fdb\uff0c\u5982\u5b9e\u8bb0\u5f55\u5e76<\/span>review\u5de5\u4f5c\u8fdb\u7a0b\u548c\u7ed3\u679c\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    3\uff09\u5f7b\u5e95\u5206\u6790\u539f\u56e0<\/span><\/span><\/p>\n

    \u539f\u56e0\u5206\u6790\u7684\u5173\u952e\u662f\u5728\u76f8\u5173\u7cfb\u7edf\u4e2d\u53d1\u6398\u95ee\u9898\u6839\u6e90\u3002<\/span>483\u8868\u4e2d\u5217\u51fa\u7684\u7f3a\u9677\u5f88\u5927\u7a0b\u5ea6\u4e0a\u662f\u6df1\u5c42\u6b21\u95ee\u9898\u7684\u8868\u5f81\uff0c\u5982\u679c\u6ca1\u6709\u8ba4\u6e05\u548c\u94f2\u9664\u7f3a\u9677\u7684\u6839\u6e90\uff0c\u800c\u4ec5\u4ec5\u9488\u5bf9\u8868\u9762\u95ee\u9898\u672c\u8eab\u505a\u51fa\u6539\u6b63\uff0c\u8fd9\u5f88\u96be\u4fdd\u8bc1\u76f8\u540c\u7684\u95ee\u9898\u4e0d\u4f1a\u91cd\u73b0\u3002\u539f\u56e0\u5206\u6790\u7684\u5de5\u5177\u6709\u4f20\u7edf\u7684<\/span>5M1E\uff0c\u9c7c\u9aa8\u56fe\uff0c<\/span>5\u4e2a<\/span>Why\uff0c\u4f46\u662f\u5efa\u8bae\u4ece\u66f4\u5e7f\u66f4\u6df1\u7684\u89d2\u5ea6\u8fdb\u884c\u5206\u6790\u3002\u4f8b\u5982\u53ef\u4ee5\u4ece\u4ea7\u54c1\u8bbe\u8ba1\u3001\u5236\u9020\u5de5\u827a\u3001\u63a7\u5236\u65b9\u6cd5\u3001\u5458\u5de5\u7ba1\u7406\u7b49\u56db\u4e2a\u5c42\u9762\u5165\u624b\uff0c\u5206\u522b\u627e\u5230\u539f\u56e0\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    4\uff09\u63aa\u65bd\u4e00\u4e00\u5bf9\u5e94<\/span><\/span><\/p>\n

    \u7ea0\u6b63\u63aa\u65bd\u5fc5\u987b\u4e0e\u7f3a\u9677\u53ca\u5176\u539f\u56e0\u4e00\u4e00\u5bf9\u5e94\uff0c\u800c\u9884\u9632\u63aa\u65bd\u4e0d\u5e94\u4ec5\u9650\u4e8e<\/span>483\u8868\u4e2d\u5217\u51fa\u7684\u5177\u4f53\u7f3a\u9677\uff0c\u800c\u5e94\u8c03\u67e5\u7c7b\u4f3c\u7684\u7f3a\u9677\u662f\u5426\u4e5f\u5b58\u5728\u4e8e\u5176\u4ed6\u90e8\u95e8\u3002<\/span><\/span><\/p>\n

     <\/span><\/p>\n

    5\uff09\u63aa\u65bd\u5fc5\u987b\u6709\u6548<\/span><\/span><\/p>\n

    \u5236\u5b9a\u5e76\u5b9e\u65bd\u63aa\u65bd\u540e\u4f01\u4e1a\u8fd8\u5fc5\u987b\u63d0\u4f9b\u76f8\u5e94\u7684\u8bc1\u636e\u6765\u8bc1\u660e\u6240\u6709\u7684\u95ee\u9898\u90fd\u5f97\u5230\u5408\u7406\u89e3\u51b3\u3002\u6bd4\u5982\uff0c\u5728\u5b9e\u65bd\u6539\u8fdb\u7684\u8fc7\u7a0b\u4e2d\uff0c\u53ef\u4ee5\u5148\u5236\u5b9a\u4e00\u4e2a\u5408\u683c\u7684\u6807\u51c6\uff0c\u6700\u540e\u4ee5\u5ba2\u89c2\u7684\u6570\u636e\u8868\u660e\u6267\u884c\u7684\u63aa\u65bd\u53d6\u5f97\u4e86\u65e2\u5b9a\u7684\u6548\u679c\u3002\u6b63\u5f0f\u7684\u7b54\u590d\u4fe1\u5e94\u5148\u9648\u8ff0\u4f01\u4e1a\u9075\u5faa\u76f8\u5173\u6cd5\u89c4\u7684\u51b3\u5fc3\u548c\u627f\u8bfa\uff0c\u4ee5\u660e\u786e\u81ea\u8eab\u7684\u6cd5\u5f8b\u8d23\u4efb\uff0c\u6b64\u5904\u53ef\u9644\u4e0a\u4f01\u4e1a\u9ad8\u5c42\u7684\u627f\u8bfa\u4e66\uff0c\u4e4b\u540e\u518d\u63cf\u8ff0\u6539\u5584\u63aa\u65bd\u3002<\/span><\/p>\n

    \u56de\u590d\u4fe1\u7684\u9644\u4ef6\u5c3d\u53ef\u80fd\u8be6\u7ec6\uff0c\u81f3\u5c11\u5e94\u5305\u62ec\uff1a<\/span><\/p>\n

    \u2460\u4fee\u8ba2\u540e\u7684\u6587\u4ef6\uff08\u4e2d\u82f1\u6587\u7248\uff09<\/span><\/p>\n

    \u2461\u76f8\u5173\u4eba\u5458\u7684\u57f9\u8bad\u8bb0\u5f55<\/span><\/p>\n

    \u2462\u786c\u4ef6\u6539\u5584\u540e\u7684\u7167\u7247<\/span><\/p>\n

    \u2463\u63aa\u65bd\u5b9e\u65bd\u540e\u7684\u8fd0\u884c\u60c5\u51b5<\/span><\/p>\n

    \u2464\u6700\u65b0\u7684\u5916\u8058\u987e\u95ee\u3001\u5185\u90e8\u5ba1\u8ba1\u3001\u7ba1\u7406\u8bc4\u5ba1\u7684\u62a5\u544a\u53ca\u6539\u5584\u63aa\u65bd<\/span><\/p>\n

     <\/span><\/p>\n

    \u516d\u3001\u8d28\u91cf\u5927\u52bf\u63a2\u8ba8<\/span><\/strong><\/span><\/p>\n

    1\uff09\u4e2d\u56fd\u7279\u8272\u7684\u8d28\u91cf\u6587\u5316<\/span><\/span><\/p>\n

    \u6211\u8bbf\u95ee\u8fc7\u6570\u767e\u5bb6\u4e2d\u56fd\u516c\u53f8\uff0c\u6df1\u77e5\u5f88\u591a\u4e2d\u56fd\u4f01\u4e1a\u5bf9\u8d28\u91cf\u7684\u6001\u5ea6\uff1a\u53ea\u8981\u4ea7\u54c1\u6ca1\u95ee\u9898\u5ba2\u6237\u6ca1\u6295\u8bc9\u5c31<\/span>ok\uff0c\u81f3\u4e8e\u8d28\u91cf\u4f53\u7cfb\u3001\u786c\u4ef6\u4e0d\u8db3\u554a\uff0c\u82b1\u70b9\u5c0f\u94b1\u4fee\u4fee\u8865\u8865\u5c31\u597d\uff0c\u603b\u4e4b\u90a3\u90fd\u4e0d\u53eb\u4e8b\u513f\uff01\u5176\u5b9e\u8fd9\u79cd\u5bf9\u4ea7\u54c1\u8d28\u91cf\u91cd\u89c6\u5374\u5bf9\u8d28\u91cf\u4f53\u7cfb\u6f20\u89c6\u9020\u6210\u4e86\u4e2d\u56fd\u4f01\u4e1a\u5373\u4f7f\u80fd\u505a\u5927\u4e5f\u5f88\u96be\u505a\u5f3a\uff0c\u5373\u4f7f\u80fd\u505a\u5f3a\u4e5f\u5f88\u8106\u5f31\u3002<\/span> \u5341\u51e0\u5e74\u6765\uff0c\u4e2d\u56fd\u533b\u7597\u4ea7\u4e1a\u4ece\u65e0\u5230\u6709\uff0c\u4ece\u5c0f\u5230\u5927\uff0c\u5e74\u5747<\/span>20%\u7684\u9ad8\u901f\u589e\u957f\u80cc\u540e\u63a9\u85cf\u4e86\u5f88\u591a\u5f0a\u75c5\u3002\u8d5a\u94b1\u5bb9\u6613\u3001\u8d8a\u8d5a\u8d8a\u591a\u5bfc\u81f4\u8c01\u4e5f\u4e0d\u60f3\u53bb\u7ba1\u8fd9\u4e9b\u4e0d\u65ad\u79ef\u805a\u7684\u98ce\u9669\u54ea\u5929\u4f1a\u7206\u53d1\u3002\u6bd5\u7adf\u4e00\u4e2a\u5927\u516c\u53f8\u91cc\u7edd\u5927\u90e8\u5206\u5458\u5de5\u90fd\u662f\u6253\u5de5\u8005\uff0c\u6b64\u5904\u5e72\u4e0d\u4e0b\u53bb\uff0c\u8df3\u69fd\u4fbf\u662f\uff0c\u53ea\u8981\u4e0d\u662f\u9886\u5bfc\u6293\u73b0\u884c\u8c01\u4e5f\u4e0d\u4f1a\u628a\u9020\u5047\u5f53\u56de\u4e8b\u3002\u6bd5\u7adf\u5f53\u6574\u4e2a\u884c\u4e1a\u90fd\u9020\u5047\u6210\u98ce\u800c\u76d1\u7ba1\u4e4f\u529b\u65f6\uff0c\u4e0d\u9020\u5047\u8005\u9664\u4e86\u5403\u4e8f\u8fd8\u4f1a\u88ab\u5632\u7b11\u3002\u5e38\u5e38\u6709\u4f01\u4e1a\u8001\u677f\u5411\u6211\u5927\u5012\u82e6\u6c34\uff1a\u6211\u4eec\u4e5f\u77e5\u9053\u9020\u5047\u4e0d\u5bf9\uff0c\u4f46\u662f\u5927\u73af\u5883\u4e0b\u522b\u4eba\u90fd\u9020\u5047\u4e5f\u4e0d\u51fa\u4e8b\uff0c\u6211\u4e0d\u9020\u5047\u600e\u4e48\u751f\u5b58\u5462\uff1f\uff01\u6709\u4eba\u66fe\u8bf4\u533b\u7597\u4f01\u4e1a\u5e94\u8be5\u643a\u624b\u51c0\u5316\u5e02\u573a\u73af\u5883\uff0c\u4e0d\u9020\u5047\u4e0d\u884c\u8d3f\uff0c\u8bf4\u5f97\u5012\u662f\u5f88\u7b26\u5408\u793e\u4f1a\u4e3b\u6d41\u4ef7\u503c\u89c2\uff0c\u7136\u800c\u6211\u8ba4\u4e3a\u60f3\u6cd5\u662f\u597d\u7684\uff0c\u4f46\u662f\u73b0\u5b9e\u592a\u6b8b\u9177\u3002\u72ec\u5584\u5176\u8eab\u5e76\u4e0d\u80fd\u517c\u6d4e\u5929\u4e0b\uff0c\u56e0\u4e3a\u5728\u52a3\u5e01\u9a71\u9010\u826f\u5e01\u7684\u5927\u73af\u5883\u4e0b\uff0c\u8001\u5b9e\u4eba\u603b\u662f\u5403\u4e8f\u7684\u3002<\/span> <\/span><\/p>\n

     <\/span><\/p>\n

    2\uff09\u8d28\u91cf\u6cd5\u89c4\u4eba\u624d\u7684\u56f0\u5883<\/span><\/span><\/p>\n

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     <\/span><\/p>\n

    \u73b0\u5728\u653f\u5e9c\u529b\u63a8\u4f9b\u7ed9\u4fa7\u6539\u9769\uff0c\u9ad8\u79d1\u6280\u4f01\u4e1a\u5927\u8c08\u534e\u4e3a\u7ecf\u9a8c\u3002\u4e2a\u4eba\u8ba4\u4e3a\u8d28\u91cf\u6cd5\u89c4\u90e8\u95e8\u5728\u54cd\u5e94\u653f\u7b56\u53f7\u53ec\u548c\u5b66\u4e60\u534e\u4e3a\u7ecf\u9a8c\u65b9\u9762\u5927\u6709\u53ef\u4e3a\u3002\u505a\u5f3a\u800c\u4e0d\u4ec5\u4ec5\u662f\u505a\u5927\u66f4\u7b26\u5408\u4f01\u4e1a\u6301\u7eed\u53d1\u5c55\u7684\u8981\u6c42\uff0c\u4f01\u4e1a\u7ba1\u7406\u5c42\u8981\u8ba4\u8bc6\u5230\u533b\u836f\u884c\u4e1a\u7684\u7279\u6b8a\u6027\u3002\u8d28\u91cf\u6cd5\u89c4\u90e8\u95e8\u53ef\u5229\u7528\u81ea\u8eab\u5bf9\u6cd5\u89c4\u7684\u719f\u6089\u3001\u6d41\u7a0b\u7684\u4e86\u89e3\u4ee5\u53ca\u8f83\u5f3a\u7684\u5206\u6790\u89e3\u51b3\u95ee\u9898\u7684\u80fd\u529b\u62c5\u5f53\u5f15\u9886\u4f01\u4e1a\u53d1\u5c55\u7684\u89d2\u8272\u3002\u5982\u82e5\u4ec5\u4ec5\u4f5c\u4e3a\u7814\u53d1\u548c\u9500\u552e\u7684\u540e\u52e4\u548c\u6551\u706b\u90e8\u95e8\uff0c\u5c06\u4e0d\u5229\u4e8e\u81ea\u8eab\u4e43\u81f3\u4f01\u4e1a\u7684\u6210\u957f\u3002<\/span><\/p>\n

     <\/span><\/p>\n

    3\uff09\u4f4e\u6210\u672c\u5408\u89c4\u662f\u5426\u53ef\u884c<\/span><\/span><\/p>\n

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     <\/span><\/p>\n

    4\uff09\u76d1\u7ba1\u98ce\u66b4\u8fd8\u80fd\u5439\u591a\u4e45<\/span> <\/span><\/p>\n

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     <\/span><\/p>\n

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    <\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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