{"id":40807,"date":"2016-12-07T15:06:50","date_gmt":"2016-12-07T15:06:50","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-issues-final-guidance-on-its-voluntary-qualified-importer-program\/"},"modified":"2020-02-07T20:54:41","modified_gmt":"2020-02-07T20:54:41","slug":"fda-issues-final-guidance-on-its-voluntary-qualified-importer-program","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-issues-final-guidance-on-its-voluntary-qualified-importer-program\/","title":{"rendered":"FDA\u53d1\u5e03\u300a\u81ea\u613f\u5408\u683c\u8fdb\u53e3\u5546\u8ba1\u5212\u300b\u6700\u7ec8\u6307\u5357"},"content":{"rendered":"<p>2016\u5e7411\u670810\u65e5\uff0c\u98df\u54c1\u53ca\u836f\u7269\u7ba1\u7406\u5c40(FDA)\u53d1\u5e03\u300a\u81ea\u613f\u5408\u683c\u8fdb\u53e3\u5546\u8ba1\u5212\u300b\u6700\u7ec8\u6307\u5357\u3002VQIP\u201c\u4ee5\u81ea\u613f\u6027\u4ed8\u8d39\u8ba1\u5212\u7684\u65b9\u5f0f\u5141\u8bb8\u5177\u6709\u53ef\u9760\u98df\u54c1\u536b\u751f\u548c\u5b89 \u5168\u8bb0\u5f55\u7684\u8fdb\u53e3\u5546\u52a0\u5feb\u5ba1\u6838\u548c\u8fdb\u53e3\u98df\u54c1\u5230\u7f8e\u56fd\u201d\uff0cFDA\u9884\u8ba1\u5c06\u4e8e2018\u5e741\u67081\u65e5\u5f00\u59cb\u63a5\u53d7VQIP\u8ba1\u5212\u7533\u8bf7\uff0c\u5e76\u4e8e2018\u5e7410\u67081\u65e5\u5f00\u59cb\u6b63\u5f0f\u5b9e\u65bd\u3002<\/p>\n<p>\u8be5\u6307\u5357\u5f88\u597d\u5730\u4ee5\u95ee\u7b54\u65b9\u5f0f\u56de\u7b54\u8fdb\u53e3\u5546\u5173\u4e8e\u8ba1\u5212\u5982\u4f55\u64cd\u4f5c\u7684\u95ee\u9898\uff0c\u5178\u578b\u95ee\u9898\u6458\u5f55\u5982\u4e0b\uff1a<\/p>\n<p><strong>Q: <\/strong><strong>\u53c2\u4e0e<\/strong><strong> VQIP<\/strong><strong>\u8ba1\u5212\u6709\u4ec0\u4e48\u4f18\u52bf\uff1f<\/strong><\/p>\n<p>A:\u53c2\u4e0eVQIP\u8ba1\u5212\u7684\u8fdb\u53e3\u5546\u6709\u591a\u65b9\u4f18\u52bf\uff0c\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u83b7\u6279\u53c2\u4e0eVQIP\u8ba1\u5212\u540e\uff0c\u53ef\u52a0\u5feb\u8fdb\u53e3\u98df\u54c1\u5230\u7f8e\u56fd<\/li>\n<li>\u5b58\u5728\u516c\u4f17\u5065\u5eb7\u98ce\u9669\u65f6\u624d\u8fdb\u884c\u68c0\u9a8c\u548c\u53d6\u6837<\/li>\n<li>\u52a0\u5feb\u6837\u54c1\u7684\u5b9e\u9a8c\u5ba4\u68c0\u9a8c<\/li>\n<li>\u6761\u4ef6\u8bb8\u53ef\u7684\u60c5\u51b5\u4e0b\uff0c\u53d6\u6837\u53ef\u5728\u8fdb\u53e3\u9996\u9009\u7684\u5730\u70b9\u8fdb\u884c<\/li>\n<li>\u53ef\u767b\u5165VQIP\u8fdb\u53e3\u5546\u5e2e\u52a9\u754c\u9762<\/li>\n<li>\u8fdb\u53e3\u5546\u53ef\u5217\u5165FDA\u7684\u516c\u5171VQIP\u5217\u8868<\/li>\n<\/ul>\n<p><strong>Q:<\/strong><strong>\u9700\u8981\u5177\u5907\u4ec0\u4e48\u7533\u8bf7\u8d44\u8d28\uff1f<\/strong><\/p>\n<p>A:\u8fdb\u53e3\u5546\u5b9a\u4e49\u4e3a\u201c\u4ece\u56fd\u5916\u5411\u7f8e\u56fd\u8f93\u9001\u548c\u5f15\u8d77\u98df\u54c1\u9500\u552e\u7684\u4e00\u65b9\u201d\uff0c\u7b26\u5408\u4ee5\u4e0b\u6807\u51c6\u7684\u8fdb\u53e3\u5546\u5373\u6ee1\u8db3\u53c2\u4e0eVQIP\u8ba1\u5212\u7684\u8d44\u8d28\uff1a<\/p>\n<ul>\n<li>\u8fdb\u53e3\u5546\u9700\u5efa\u7acb\u5e76\u6267\u884c\u300a\u8d28\u91cf\u4fdd\u8bc1\u8ba1\u5212\u300b(QAP)<\/li>\n<li>\u8fdb\u53e3\u5546\u9700\u9075\u5faa\u4f9b\u5e94\u5546\u9a8c\u8bc1\u3001\u5176\u4ed6FSVP\u548cHACCP\u6cd5\u89c4\u8981\u6c42<\/li>\n<li>VQIP\u8ba1\u5212\u4e0b\u7684\u56fd\u5916\u98df\u54c1\u4f9b\u5e94\u5546\u901a\u8fc7<a href=\"https:\/\/regstaging.wpengine.com\/2015\/11\/fda-releases-final-fsma-rule-on-accredited-third-party-certification\/\">FDA\u300a\u7b2c\u4e09\u65b9\u8ba4\u8bc1\u8ba1\u5212\u300b<\/a>\u6cd5\u89c4\u7684\u8ba4\u53ef<\/li>\n<li>\u8fdb\u53e3\u5546\u5177\u5907\u81f3\u5c11\u4e09\u5e74\u7684\u5411\u7f8e\u56fd\u8fdb\u53e3\u98df\u54c1\u7684\u7ecf\u9a8c<\/li>\n<li>\u8fdb\u53e3\u5546\u53ca\u5176\u4f9b\u5e94\u94fe\u5382\u5546\u4e0d\u5b58\u5728\u5f85\u5904\u7406\u7684FDA\u5ba1\u5224\u4e8b\u4ef6\u548c\u884c\u653f\u63aa\u65bd\uff0c\u6ca1\u6709\u5176\u4ed6\u98df\u54c1\u5b89\u5168\u6cd5\u89c4\u7684\u4e0d\u826f\u8bb0\u5f55\u3002<\/li>\n<li>\u8fdb\u53e3\u5546\u62e5\u6709\u4e00\u4e2a\u9093\u6c0f\u7f16\u7801(DUNS)<\/li>\n<\/ul>\n<p><strong>Q:<\/strong><strong>\u6211\u8be5\u5982\u4f55\u7533\u8bf7\uff1f<\/strong><\/p>\n<p>A: \u6709\u610f\u613f\u53c2\u4e0eVQIP\u8ba1\u5212\u7684\u8fdb\u53e3\u5546\u9700\u5728<a href=\"https:\/\/www.access.fda.gov\/\">FDA\u884c\u4e1a\u7cfb\u7edf\u7f51\u9875<\/a>\u83b7\u53d6\u4e00\u4e2a\u8d26\u53f7\uff0c\u83b7\u53d6\u8d26\u53f7\u540e\uff0c\u8fdb\u53e3\u5373\u53ef\u5728\u4ee5\u540e\u6bcf\u5e74\u76841\u67081\u65e5\u81f35\u670831\u65e5\u4e4b\u95f4\u5728\u7ebf\u63d0\u4ea4VQIP\u201c\u610f\u613f\u53c2\u4e0e\u901a\u77e5\u201d\u3002VQIP\u7684\u9012\u4ea4\u64cd\u4f5c\u6307\u5357\u53ef\u70b9\u51fb<a href=\"https:\/\/www.fda.gov\/downloads\/Food\/GuidanceRegulation\/GuidanceDocumentsRegulatoryInformation\/UCM525687.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery\">\u6b64\u5904<\/a>\u67e5\u770b\u3002\u7533\u8bf7\u9700\u8fdb\u884c\u5e74\u5ea6\u66f4\u65b0\u3002<\/p>\n<p><strong>Q:<\/strong><strong> VQIP<\/strong><strong>\u8ba1\u5212\u662f\u5426\u9700\u8981\u4f7f\u7528\u8005\u8d39\u7528\uff1f<\/strong><\/p>\n<p>A:\u662f\u7684\uff0c\u52a0\u5165VQIP\u7684\u8fdb\u53e3\u5546\u8981\u6c42\u652f\u4ed8\u7ba1\u7406\u9879\u76ee\u7684\u5e74\u8d39\u30022015\u5e746\u6708\uff0cFDA\u4f30\u8ba1\u8d39\u7528\u603b\u989d\u4e3a$16,400\u7f8e\u91d1\uff0cFDA\u9884\u8ba1\u5c06\u4e8e2017\u5e748\u67081\u65e5\u6572\u5b9a2018\u5e741\u6708\u7684\u8d39\u7528\u3002\u4e3a\u66f4\u597d\u5730\u8fd0\u7528\u9879\u76ee\u4f18\u52bf\uff0c\u8d39\u7528\u5e94\u4e0eVQIP\u8ba1\u5212\u5f00\u5e74\uff0810\u67081\u65e5\uff09\u652f\u4ed8\u3002<\/p>\n<p><strong>Q:<\/strong><strong>\u4ec0\u4e48\u98df\u54c1\u5728<\/strong><strong>VQIP<\/strong><strong>\u8ba1\u5212\u5141\u8bb8\u7684\u8303\u56f4\u4e4b\u5185\uff1f<\/strong><br \/>\nA:\u901a\u8fc7FDA\u300a\u7b2c\u4e09\u65b9\u8ba4\u8bc1\u8ba1\u5212\u300b\u6cd5\u89c4\uff0c\u8bc1\u660e\u5176\u98df\u54c1\u5b89\u5168\u6cd5\u89c4\u7b26\u5408VQIP\u8ba1\u5212\uff0c\u4e14\u6ca1\u6709\u6536\u5230\u8fdb\u53e3\u8b66\u62a5\u548c\u4e00\u7ea7\u53ec\u56de\u901a\u77e5\u7684\u519c\u4ea7\u54c1\u548c\u5546\u54c1\u3002<\/p>\n<p><strong>Q: FDA<\/strong><strong>\u53ef\u4ee5\u64a4\u9500\u6211\u7684<\/strong><strong>VQIP<\/strong><strong>\u8ba1\u5212\u53c2\u52a0\u8d44\u683c\u5417\uff1f\u4f1a\u901a\u8fc7\u4ec0\u4e48\u65b9\u5f0f\u901a\u77e5\u6211\u5462\uff1f<\/strong><\/p>\n<p>A:\u662f\u7684\uff0c\u5728\u8fdd\u53cd\u4e00\u6761\u6216\u4ee5\u4e0a\u9879\u76ee\u53c2\u4e0e\u6807\u51c6\u7684\u60c5\u51b5\u4e0b\uff0cFDA\u53ef\u80fd\u4f1a\u64a4\u9500VQIP\u8ba1\u5212\u53c2\u52a0\u8d44\u683c\uff0c\u3002FDA\u4f1a\u901a\u8fc7\u53d1\u9001\u201c\u64a4\u9500\u53c2\u4e0e\u8d44\u683c\u901a\u77e5\u201d\u90ae\u4ef6\u7684\u65b9\u5f0f\u544a\u77e5VQIP\u8ba1\u5212\u7684\u8054\u7cfb\u4eba\u3002<\/p>\n<p><strong>Q:<\/strong><strong>\u64a4\u9500\u540e\uff0c\u6211\u8fd8\u53ef\u4ee5\u6062\u590d<\/strong><strong>VQIP<\/strong><strong>\u8ba1\u5212\u7684\u53c2\u4e0e\u8d44\u683c\u5417\uff1f<\/strong><\/p>\n<p>A:\u53ef\u4ee5\u7684\uff0c\u60a8\u4ecd\u7136\u53ef\u4ee5\u6062\u590dVQIP\u8ba1\u5212\u7684\u53c2\u4e0e\u8d44\u683c\u3002\u53ea\u6709\u5728\u95ee\u9898\u5f97\u5230\u7ea0\u6b63\u7684\u60c5\u51b5\u4e0b\u624d\u53ef\u4ee5\u56de\u590d\u8d44\u683c\uff0c\u6062\u590d\u7533\u8bf7\u6587\u4ef6\u5e94\u8bf4\u660e\u89e3\u51b3\u95ee\u9898\u6240\u91c7\u53d6\u7684\u63aa\u65bd\u3002<\/p>\n<p>\u60f3\u4e86\u89e3\u66f4\u591a\u5173\u4e8eFDA VQIP\u8ba1\u5212\u6700\u7ec8\u6307\u5357\u7684\u4fe1\u606f\uff0c\u53ef\u6ce8\u518c\u53c2\u4e0eRegistrar Corp\u5373\u5c06\u572812\u670812\u65e5\u5468\u4e09\u4e3e\u884c\u7684\u516c\u5f00\u7f51\u7edc\u7814\u8ba8\u4f1a\u3002<\/p>\n<p>Registrar Corp\u53ef\u534f\u52a9\u7f8e\u56fd\u98df\u54c1\u8fdb\u53e3\u5546\u83b7\u53d6VQIP\u8ba1\u5212\u53c2\u52a0\u8d44\u683c\u3002Registrar Corp\u7684<a href=\"https:\/\/regstaging.wpengine.com\/monitor\/index.jsp\">FDA\u76d1\u63a7\u7cfb\u7edf<\/a>\u53ef\u5b9e\u73b0\u8fdb\u53e3\u5546\u76d1\u63a7\u5168\u7403\u98df\u54c1\u5382\u5546\u7684FDA\u8fdb\u53e3\u8b66\u62a5\u60c5\u51b5\uff0c\u6b64\u5916\uff0c\u8fd8\u53ef\u514d\u8d39\u534f\u52a9\u98df\u54c1\u4f01\u4e1a<a href=\"https:\/\/regstaging.wpengine.com\/fda-duns?lang=en\">\u83b7\u53d6\u9093\u6c0f\u7f16\u7801<\/a>\u3002\u6b22\u8fce\u81f4\u7535+1-757-224-0177\u6216\u8005\u901a\u8fc7\u767b\u5f55\u6211\u4eec\u7684\u5b98\u65b9\u7f51\u7ad9<a href=\"https:\/\/regstaging.wpengine.com\/livehelp\">regstaging.wpengine.com\/livehelp<\/a>\u5728\u7ebf\u4e0e\u6211\u4eec\u7684\u6cd5\u89c4\u987e\u95ee\u8054\u7cfb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2016\u5e7411\u670810\u65e5\uff0c\u98df\u54c1\u53ca\u836f\u7269\u7ba1\u7406\u5c40(FDA)\u53d1\u5e03\u300a\u81ea\u613f\u5408\u683c\u8fdb\u53e3\u5546\u8ba1\u5212\u300b\u6700\u7ec8\u6307\u5357\u3002VQIP\u201c\u4ee5\u81ea\u613f\u6027\u4ed8\u8d39\u8ba1\u5212\u7684\u65b9\u5f0f\u5141\u8bb8\u5177\u6709\u53ef\u9760\u98df\u54c1\u536b\u751f\u548c\u5b89 \u5168\u8bb0\u5f55\u7684\u8fdb\u53e3\u5546\u52a0\u5feb\u5ba1\u6838\u548c\u8fdb\u53e3\u98df\u54c1\u5230\u7f8e\u56fd\u201d\uff0cFDA\u9884\u8ba1\u5c06\u4e8e2018\u5e741\u67081\u65e5\u5f00\u59cb\u63a5\u53d7VQIP\u8ba1\u5212\u7533\u8bf7\uff0c\u5e76\u4e8e2018\u5e7410\u67081\u65e5\u5f00\u59cb\u6b63\u5f0f\u5b9e\u65bd\u3002 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