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style=\"text-indent:2em;\">\u9762\u5bf9\u8d28\u7591\uff0c\u867d\u7136\u4e0d\u662f\u6240\u6709\u7684\u76d1\u7ba1\u90e8\u95e8\u90fd\u7406\u76f4\u6c14\u58ee\uff0c\u4f46\u786e\u5b9e\u6709\u56fd\u9645\u7ecf\u9a8c\u53ef\u4ee5\u53c2\u8003\u3002\u6211\u4eec\u66fe\u5bf9193\u4e2a\u56fd\u5bb6\u7684\u836f\u76d1\u673a\u6784\u548c\u56fd\u9645\u4e0a\u6709\u5173\u836f\u54c1\u9886\u57df\u7684\u56fd\u9645\u7ec4\u7ec7\u8fdb\u884c\u4e86\u8c03\u67e5\uff0c\u53d1\u73b0\u5f3a\u5927\u7684\u5236\u836f\u4ea7\u4e1a\u9700\u8981\u5f3a\u5927\u7684\u76d1\u7ba1\u90e8\u95e8\u3002\u4ece\u5168\u7403\u6765\u770b\uff0c\u7f8e\u56fd\u3001\u6b27\u76df\u3001\u65e5\u672c\u7b49\u5236\u836f\u5f3a\u56fd\uff0c\u5176\u836f\u54c1\u76d1\u7ba1\u673a\u6784\u80fd\u529b\u4e5f\u5f88\u5f3a\u5927\u3002\u7279\u522b\u662f\u7f8e\u56fd\uff0c\u5236\u836f\u4ea7\u4e1a\u521b\u65b0\u80fd\u529b\u6700\u5f3a\u3001\u836f\u54c1\u5e02\u573a\u6700\u5927\u3001\u76d1\u7ba1\u90e8\u95e8\u6700\u5f3a\u3002\u5236\u836f\u4ea7\u4e1a\u7684\u5171\u8bc6\u662f\uff0c\u5236\u836f\u4ea7\u4e1a\u9700\u8981\u660e\u667a\u76d1\u7ba1\u624d\u80fd\u53d1\u5c55\uff0c\u4f18\u79c0\u7684\u76d1\u7ba1\u90e8\u95e8\u5851\u9020\u4f18\u79c0\u7684\u4ea7\u4e1a\u3002\u8fc7\u53bb\u76845\u301c10\u5e74\u662f\u4e3b\u8981\u53d1\u8fbe\u56fd\u5bb6\u5236\u836f\u4ea7\u4e1a\u589e\u957f\u6bd4\u8f83\u7a33\u5b9a\u7684\u65f6\u671f\uff0c\u4f46\u8fd9\u4e9b\u56fd\u5bb6\u7684\u836f\u54c1\u76d1\u7ba1\u90e8\u95e8\u5374\u4fdd\u6301\u975e\u5e38\u9ad8\u901f\u7684\u53d1\u5c55\u3002\u7f8e\u56fdFDA\u7684\u4eba\u5458\u3001\u7ecf\u8d39\u5728\u8fd9\u4e2a\u65f6\u671f\u53d1\u751f\u975e\u5e38\u5927\u5e45\u5ea6\u7684\u589e\u52a0\u3002\u8fd9\u610f\u5473\u7740\uff0c\u8fd9\u4e9b\u76d1\u7ba1\u90e8\u95e8\u6b63\u5728\u4e3a\u65b0\u4e00\u6ce2\u7684\u4ea7\u4e1a\u53d1\u5c55\u800c\u79ef\u84c4\u76d1\u7ba1\u80fd\u529b\u3002<br \/>\n\u7f8e\u56fdFDA\u521a\u521a\u5378\u4efb\u7684\u5c40\u957f\u739b\u683c\u4e3d\u7279\u2022A\u2022\u6c49\u4f2f\u683c\uff08Margaret A. Hamburg\uff09\u5c31\u575a\u5b9a\u5730\u8ba4\u4e3a\uff0c\u76d1\u7ba1\u5f97\u5f53\u65f6\uff0c\u4e0d\u662f\u4ea7\u4e1a\u53d1\u5c55\u548c\u521b\u65b0\u7684\u62e6\u8def\u864e\uff0c\u800c\u662f\u5b9e\u73b0\u6709\u610f\u4e49\u548c\u6301\u4e45\u521b\u65b0\u7684\u5207\u5b9e\u8def\u5f84\u3002\u652f\u6301\u6c49\u4f2f\u683c\u8fd9\u4e00\u89c2\u70b9\u7684\uff0c\u662fFDA\u7684\u767e\u5e74\u5386\u53f2\u3002\u4e00\u4e2a\u4e16\u7eaa\u4ee5\u524d\uff0c\u7f8e\u56fd\u897f\u5965\u591a\u00b7\u7f57\u65af\u798f\u603b\u7edf\u652f\u6301\u56fd\u4f1a\u901a\u8fc7\u300a\u7eaf\u51c0\u98df\u54c1\u4e0e\u836f\u54c1\u6cd5\u300b\uff08Pure Food and Drug Act\uff09\uff0c\u8fd9\u662f\u4e00\u90e8\u5177\u6709\u91cc\u7a0b\u7891\u610f\u4e49\u7684\u6cd5\u5f8b\uff0c\u9996\u6b21\u5168\u9762\u89c4\u5b9a\u4e86\u8054\u90a6\u653f\u5e9c\u5728\u7f8e\u56fd\u836f\u54c1\u76d1\u7ba1\u4e2d\u5e94\u5f53\u627f\u62c5\u7684\u8d23\u4efb\uff0c\u5960\u5b9a\u4e86\u7f8e\u56fd\u73b0\u4ee3\u836f\u54c1\u6cd5\u7684\u96cf\u5f62\u4e0e\u6846\u67b6\u3002\u4f9d\u7167\u8fd9\u90e8\u6cd5\u5f8b\u7684\u8981\u6c42\uff0c\u521b\u5efa\u4e86FDA\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8001\u7f57\u65af\u798f\u652f\u6301\u8fd9\u4e00\u6cd5\u5f8b\uff0c\u662f\u56e0\u4e3a\u4ed6\u8ba4\u4e3a\u8fd9\u9879\u7acb\u6cd5\u5bf9\u4f01\u4e1a\u754c\u6709\u597d\u5904\u3002\u4ed6\u76f8\u4fe1\uff0c\u901a\u8fc7\u4e3a\u6d88\u8d39\u8005\u63d0\u4f9b\u5bf9\u5176\u8d2d\u4e70\u7684\u98df\u54c1\u548c\u836f\u54c1\u5b89\u5168\u6027\u7684\u4fe1\u4efb\u548c\u4fdd\u200d\u969c\uff0c\u53ef\u4ee5\u63a8\u52a8\u5e02\u573a\u589e\u957f\uff0c\u7279\u522b\u662f\u63a8\u52a8\u4e86\u4f18\u79c0\u4f01\u4e1a\u7684\u589e\u957f\uff0c\u56e0\u6b64FDA\u7684\u5b58\u5728\uff0c\u5176\u5b9e\u662f\u4e3a\u4e86\u81ea\u7531\u5e02\u573a\u548c\u6d88\u8d39\u8005\u7684\u9700\u8981\u3002\u8fd9\u4e2a\u89c2\u70b9\u5bf9\u7f8e\u56fd\u4eba\u4e00\u76f4\u4ea7\u751f\u4e86\u975e\u5e38\u91cd\u8981\u7684\u5f71\u54cd\u529b\uff0c\u56e0\u6b64\uff0c\u65f6\u81f3\u4eca\u65e5\uff0cFDA\u8fd8\u5e38\u5e38\u6d25\u6d25\u4e50\u9053\u4e8e\u6b64\u3002<br \/>\n\u5f53\u7136\uff0cFDA\u7684\u767e\u5e74\u5386\u7a0b\u4ece\u6765\u90fd\u4e0d\u662f\u53ea\u6709\u8d5e\u7f8e\u548c\u652f\u6301\uff0c\u4e5f\u540c\u6837\u5145\u6ee1\u6307\u8d23\u548c\u6597\u4e89\u3002\u4ece19\u4e16\u7eaa30\u5e74\u4ee3\u65b0\u78fa\u80fa\u836f\u4e2d\u56e0\u4f7f\u7528\u6709\u6bd2\u6eb6\u5242\u5bfc\u81f4107\u4f8b\u6b7b\u4ea1\u4e4b\u540e\uff0c\u7f8e\u56fd\u56fd\u4f1a\u4e8e1938\u5e74\u9881\u5e03\u4e86\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u4e0e\u5316\u5986\u54c1\u6cd5\u300b\uff0c\u8981\u6c42\u5bf9\u836f\u54c1\u8fdb\u884c\u57fa\u672c\u7684\u5b89\u5168\u6027\u6d4b\u8bd5\u3002\u6cd5\u89c4\u51fa\u53f0\u65f6\uff0c\u53cd\u5bf9\u8005\u5f3a\u70c8\u8868\u793a\uff0c\u8fd9\u9879\u65b0\u7684\u6cd5\u5f8b\u5c06\u4f7f\u5de5\u5382\u5173\u95ed\uff0c\u4f7f\u591a\u5f97\u6570\u4e0d\u6e05\u7684\u4eba\u5931\u53bb\u5de5\u4f5c\uff0c\u5e76\u4f24\u5bb3\u6210\u200d\u5343\u200d\u4e0a\u200d\u4e07\u4eba\uff0c\u800c\u4e14\u5bf9\u4e8e\u836f\u54c1\u8d28\u91cf\u4e5f\u4e8e\u4e8b\u65e0\u8865\u3002\u4e0d\u8fc7\uff0cFDA\u7684\u884c\u52a8\u6700\u7ec8\u8bc1\u660e\uff0c\u8fd9\u4e9b\u53cd\u5bf9\u8005\u662f\u9519\u7684\u30021960\u5e74\u4ee3\u65e9\u671f\uff0cFDA\u7684\u5b98\u5458\u5f17\u6717\u897f\u65af\u00b7\u51ef\u65af\u52d2\u535a\u58eb\uff08\u200dFrances Kelsey\uff09\u53d1\u73b0\u53cd\u5e94\u505c\u6ca1\u6709\u5728\u598a\u5a20\u52a8\u7269\u4e0a\u505a\u8fc7\u8bd5\u9a8c\uff0c\u6ca1\u6709\u6279\u51c6\u8fd9\u79cd\u836f\u54c1\u5728\u7f8e\u56fd\u4e0a\u5e02\uff0c\u4ece\u800c\u4fdd\u62a4\u4e86\u7f8e\u56fd\u7684\u6bcd\u4eb2\u514d\u4e8e\u751f\u4e0b\u56db\u80a2\u6781\u5ea6\u7578\u5f62\u548c\u5176\u4ed6\u4e25\u91cd\u51fa\u751f\u7f3a\u9677\u7684\u513f\u7ae5\u3002\u8fd9\u4e00\u4e8b\u4f8b\uff0c\u5145\u5206\u8bf4\u660e\u4e861938\u5e74\u6cd5\u89c4\u7684\u5fc5\u8981\u6027\u3002\u7c7b\u4f3c\u7684\uff0cFDA\u5728\u201c\u4e89\u53d6\u2014\u53cd\u5bf9\u2014\u575a\u6301\u2014\u80dc\u5229\u2014\u53d6\u5f97\u793e\u4f1a\u652f\u6301\u2014\u7ee7\u7eed\u4e89\u53d6\u201d\u8fd9\u6837\u7684\u6b63\u5faa\u73af\u4e2d\u8d70\u51fa\u4e86\u4e00\u6761\u4e0d\u65ad\u6269\u5927\u76d1\u7ba1\u9762\u3001\u6269\u5927\u76d1\u7ba1\u8d44\u6e90\u3001\u6269\u5927\u76d1\u7ba1\u6743\u529b\u7684\u9053\u8def\u3002\u6709\u5b66\u8005\u4e13\u95e8\u7814\u7a76FDA\uff0c\u8ba4\u4e3a\u5176\u53d6\u5f97\u6210\u529f\u7684\u539f\u56e0\u5c31\u5728\u4e8e\u6781\u5176\u826f\u597d\u7684\u58f0\u8a89\u2014\u2014\u6240\u6709\u4eba\u90fd\u76f8\u4fe1FDA\u7684\u6240\u4f5c\u6240\u4e3a\u662f\u79d1\u5b66\u7684\u51b3\u7b56\uff0c\u662f\u4e3a\u4e86\u4fdd\u969c\u516c\u4f17\u5065\u5eb7\u3002\u56e0\u6b64\uff0c\u591a\u5e74\u6765\uff0c\u7f8e\u56fd\u56fd\u4f1a\u4e3a\u4e86\u5e94\u5bf9\u516c\u5171\u5065\u5eb7\u5371\u673a\uff0c\u603b\u662f\u8d4b\u4e88FDA\u66f4\u591a\u7684\u6743\u5229\u4ee5\u4fdd\u62a4\u548c\u4fc3\u8fdb\u516c\u4f17\u5065\u5eb7\u3002<br \/>\nFDA\u4e5f\u7528\u884c\u52a8\u547c\u5e94\u4e86\u7f8e\u56fd\u56fd\u4f1a\u7684\u652f\u6301\u3002\u867d\u7136\u8270\u96be\uff0c\u4f46\u662fFDA\u575a\u6301\u8981\u6c42\u5236\u836f\u4f01\u4e1a\u5fc5\u987b\u5f00\u5c55\u7814\u7a76\u786e\u5b9a\u836f\u7269\u7684\u5b9e\u9645\u6548\u679c\uff0c\u5fc5\u987b\u5b9e\u65bd\u5bf9\u53d7\u8bd5\u8005\u7684\u4fdd\u62a4\uff0c\u4e0d\u4ec5\u5fc5\u987b\u8bc1\u660e\u836f\u54c1\u662f\u5b89\u5168\u7684\uff0c\u800c\u4e14\u5fc5\u987b\u8bc1\u660e\u836f\u54c1\u662f\u6709\u6548\u7684\uff1b\u5fc5\u987b\u63a8\u884c\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff08Good Manufacturing Practices\uff09\uff0c\u5fc5\u987b\u5f00\u5c55\u4e0a\u5e02\u540e\u76d1\u6d4b\uff0c\u786e\u4fdd\u4ea7\u54c1\u8d28\u91cf\u59cb\u7ec8\u5982\u4e00\u3002\u51e0\u5341\u5e74\u8fc7\u53bb\u4e86\uff0c\u5728FDA\u7684\u5f15\u9886\u4e0b\uff0c\u7f8e\u56fd\uff08\u4e43\u81f3\u5168\u7403\uff09\u5236\u836f\u4ea7\u4e1a\u6446\u8131\u4e86\u6df7\u4e71\u7684\u3001\u5236\u9020\u201c\u4e07\u7075\u795e\u836f\u201d\u7684\u201c\u6c5f\u6e56\u6e38\u533b\u201d\u7684\u89d2\u8272\uff0c\u6210\u529f\u8715\u53d8\u6210\u4e3a\u4eca\u5929\u9ad8\u5ea6\u53d1\u5c55\u7684\u3001\u4ee5\u79d1\u5b66\u4e3a\u57fa\u7840\u7684\u751f\u7269\u6280\u672f\u548c\u5236\u836f\u4ea7\u4e1a\uff0c\u662f\u4e16\u4eba\u516c\u8ba4\u7684\u3001\u6700\u91cd\u8981\u7684\u9ad8\u6280\u672f\u4ea7\u4e1a\u3002\u65b0\u836f\u7814\u53d1\u5c3d\u7ba1\u4e0d\u6613\uff0c\u4f46\u662f\u91cd\u78c5\u836f\u7269\u4e0d\u65ad\u51fa\u73b0\uff0c\u786e\u5b9e\u6539\u5584\u4e86\u4eba\u7c7b\u7684\u5065\u5eb7\u548c\u751f\u5b58\u8d28\u91cf\u3002\u6240\u6709\u8fd9\u4e9b\uff0c\u5bf9\u60a3\u8005\u548c\u516c\u4f17\u5065\u5eb7\u90fd\u662f\u597d\u6d88\u606f\uff0c\u5bf9\u4f01\u4e1a\u548c\u4ea7\u4e1a\u754c\u4e5f\u662f\u5de8\u5927\u7684\u8fdb\u6b65\u3002<br 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\/>\n\u4e0d\u8fc7\uff0c\u4e5f\u8bb8\u65b0\u7684\u4e89\u8bae\u4e5f\u4f1a\u968f\u4e4b\u800c\u6765\u3002\u5f53FDA\u5f00\u59cb\u5927\u91cf\u63a5\u53d7\u4f01\u4e1a\u7684\u8d39\u7528\u6765\u8fdb\u884c\u836f\u54c1\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u8bc4\u5ba1\u65f6\uff0c\u4ed6\u4eec\u7684\u76d1\u7ba1\u51b3\u7b56\u662f\u5426\u8fd8\u80fd\u79c9\u6301\u4e2d\u7acb\uff1f\u5982\u679cFDA\u7684\u51b3\u5b9a\u603b\u662f\u5728\u4fc3\u8fdb\u4ea7\u4e1a\u7684\u5229\u76ca\uff0c\u516c\u4f17\u5065\u5eb7\u7684\u5229\u76ca\u662f\u5426\u6b63\u5728\u88ab\u6084\u6084\u5ffd\u89c6\uff1f<\/p>\n<p style=\"text-indent:2em;\">\u653f\u5e9c\u76d1\u7ba1\u7684\u8ffd\u6c42\uff1a\u5728\u516c\u4f17\u5229\u76ca\u548c\u4ea7\u4e1a\u521b\u65b0\u4e4b\u95f4\u53d6\u5f97\u7cbe\u5999\u7684\u5e73\u8861<\/p>\n<p style=\"text-indent:2em;\">\u5728FDA\u7684\u6545\u4e8b\u91cc\uff0c\u6211\u4eec\u53ef\u4ee5\u770b\u5230\uff0c\u5173\u4e8e\u5bf9\u76d1\u7ba1\u7684\u975e\u8bae\u3001\u76d1\u7ba1\u906d\u9047\u7684\u8d44\u6e90\u7ea6\u675f\u4ee5\u53ca\u76d1\u7ba1\u7684\u8270\u96be\uff0c\u4e2d\u5916\u6982\u83ab\u80fd\u5916\u3002\u4f46FDA\u7684\u7cbe\u5f69\u5728\u4e8e\uff0cFDA\u4f5c\u4e3a\u4e00\u4e2a\u76d1\u7ba1\u90e8\u95e8\u5177\u6709\u53cc\u91cd\u76ee\u6807\uff0c\u4e0d\u4ec5\u8981\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\uff0c\u4e5f\u8981\u4fc3\u8fdb\u4ea7\u4e1a\u521b\u65b0\u3002\u5386\u53f2\u663e\u793a\uff0c\u4e00\u4e2a\u5f3a\u5927\u7684FDA\u786e\u5b9e\u53ef\u4ee5\u5728\u4e8c\u8005\u4e4b\u95f4\u53d6\u5f97\u7cbe\u5999\u7684\u5e73\u8861\u548c\u517c\u987e\uff0cFDA\u6210\u957f\u4e3a\u653f\u5e9c\u76d1\u7ba1\u7ade\u76f8\u6548\u4eff\u7684\u5bf9\u8c61\u3001FDA\u7684\u76d1\u7ba1\u6807\u51c6\u6210\u4e3a\u5168\u7403\u7684\u91d1\u6807\u51c6\u3001FDA\u76d1\u7ba1\u7684\u4ea7\u54c1\u83b7\u5f97\u4e16\u4eba\u8ba4\u53ef\u3002<br \/>\n\u4ece\u4ee5FDA\u4e3a\u4ee3\u8868\u7684\u7f8e\u56fd\u76d1\u7ba1\u90e8\u95e8\u7684\u7ecf\u9a8c\u505a\u6cd5\u4e2d\uff0c\u53ef\u4ee5\u63d0\u70bc\u5e76\u503c\u5f97\u4e2d\u56fd\u5404\u4e2a\u76d1\u7ba1\u90e8\u95e8\u501f\u9274\u53c2\u8003\u7684\u5f88\u591a\uff0c\u5f52\u7eb3\u8d77\u6765\uff0c\u4e3b\u8981\u6709\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<br 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