{"id":12132,"date":"2018-07-24T01:00:00","date_gmt":"2018-07-30T04:09:27","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/%e5%a6%82%e4%bd%95%e5%9c%a8fda%e5%ae%98%e7%bd%91%e6%9f%a5%e6%89%be%e7%8e%b0%e5%9c%ba%e6%a3%80%e6%9f%a5%e5%8e%86%e5%8f%b2%e6%b8%85%e5%8d%95\/"},"modified":"2018-07-30T12:09:29","modified_gmt":"2018-07-30T04:09:29","slug":"%e5%a6%82%e4%bd%95%e5%9c%a8fda%e5%ae%98%e7%bd%91%e6%9f%a5%e6%89%be%e7%8e%b0%e5%9c%ba%e6%a3%80%e6%9f%a5%e5%8e%86%e5%8f%b2%e6%b8%85%e5%8d%95","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/12132\/","title":{"rendered":"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355"},"content":{"rendered":"
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\u56fe\u89e3\u751f\u4ea7\u7ba1\u7406\uff1a5S\u63a8\u8fdb\u6cd5<\/h2>\n

\u4f5c\u8005\uff1a\uff08\u65e5\uff09\u8d8a\u524d\u884c\u592b<\/p>\n<\/p><\/div>\n

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<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

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\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"
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\u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1\u7406\u8d44\u6df1\u4e13\u5bb6\uff0c\u591a\u5bb6\u5236\u836f\u516c\u53f8\u987e\u95ee\uff0c\u836f\u5b66\u7855\u58eb\u3002\u56fd\u5bb6\u5de5\u827a\u6838\u5bf9\u672a\u96e8\u7ef8\u7f2a\u4e4b\u9645\uff0c\u6210\u529f\u89e3\u51b3\u4e86\u591a\u5bb6\u5728\u4ea7\u4ea7\u54c1\u5904\u65b9\u3001\u5de5\u827a\u95ee\u9898\u3002\u5904\u65b9\u5de5\u827a\u7684\u4e8c\u6b21\u5f00\u53d1\uff0c\u514d\u8d39\u54a8\u8be2\uff0c\u5168\u7a0b\u4fdd\u5bc6\u3002\u90ae\u7bb1\uff1a1193686015@qq.com\u3002<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u6700\u8fd1\u6709\u7f51\u53cb\u95ee\uff0c\u9886\u5bfc\u8981\u6211\u628a\u6700\u8fd1FDA\u68c0\u67e5\u7684\u516c\u53f8\u6e05\u5355\u6574\u7406\u4e00\u4efd\uff0c\u8fd9\u4e2a\u8981\u5230\u54ea\u91cc\u53bb\u627e\u54df\uff1f<\/p>\n

\u4e0d\u8981\u6025\uff0c\u5728FDA\u5b98\u7f51\u4e0a\u80fd\u627e\u5230\uff0c\u4e0d\u8fc7\u4f1a\u6709\u4e00\u5b9a\u7684\u6ede\u540e\u5662\uff01<\/p>\n

\u9996\u5148\uff0c\u6211\u4eec\u8fdb\u5165FDA\u5b98\u7f51\u9996\u9875\uff1ahttps:\/\/www.fda.gov\/default.htm<\/p>\n

\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n

\u5728\u9996\u9875\u6700\u4e0b\u9762\uff0c\u627e\u5230Inspection&Complaince<\/p>\n

\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n

\u70b9\u8fdb\u53bb<\/p>\n

\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n


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\u4e0b\u9762\u627e\u5230 Inspection Reference <\/span>
<\/p>\n

\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n

\u70b9\u8fdb\u53bb\uff0c\u5de6\u8fb9\u627e\u5230Inspection Classification Database
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\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n

\u70b9\u8fdb\u53bb\uff0c\u627e\u5230inspection classfication Database Search \uff08\u5982\u679c\u60f3\u8981\u4e0b\u8f7d\u6e05\u5355\uff0c\u70b9\u4e0b\u9762\u90a3\u4e2aEXCEL\u6587\u4ef6\u4e0b\u8f7d\uff09\u70b9\u8fdb\u53bb
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\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n

\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n

\u9009\u62e9\u4f60\u8981\u770b\u7684<\/p>\n

Classification: <\/span>
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NAI \u4e0d\u9700\u8981\u91c7\u53d6\u63aa\u65bd\uff08\u4e00\u822c\u662f\u96f6\u7f3a\u9677\uff09<\/p>\n

VAI \u4e3b\u52a8\u91c7\u53d6\u63aa\u65bd\uff08\u6709\u7f3a\u9677\uff09<\/p>\n

OAI \u5b98\u65b9\u91c7\u53d6\u63aa\u65bd\uff08\u4e00\u822c\u662f\u8b66\u544a\u4fe1\uff09<\/p>\n

Project Area \u4e0d\u540c\u9879\u76ee<\/p>\n

\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n


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\u7ee7\u7eed\u9009\u62e9\u516c\u53f8\u540d\u79f0\u3001\u56fd\u5bb6\u5730\u533a\u3001\u6240\u5728\u5dde\u533a\uff08\u9488\u5bf9\u7f8e\u56fd\uff09\u3001\u90ae\u7f16\u3001\u57ce\u5e02\u3001\u6392\u5e8f\u65b9\u5f0f\uff0c\u7136\u540e\u70b9search<\/p>\n

\"\u5982\u4f55\u5728FDA\u5b98\u7f51\u67e5\u627e\u73b0\u573a\u68c0\u67e5\u5386\u53f2\u6e05\u5355\"<\/p>\n

\u6bd4\u5982\u56fd\u5bb6\u5730\u533a\u9009China\uff08\u4e2d\u56fd\uff09\uff0c\u65f6\u95f4\u9009\u62e920180101-20180720\uff0c\u6309\u65f6\u95f4\u6392\u5e8f\uff0c\u641c\u7d22\u5c31\u51fa\u6765\u4e862\u9875\u8bb0\u5f55\uff0c\u6bd4\u5982\u4ee5\u4e0b\u662f\u9875\u5e95\u7684\u90e8\u5206<\/p>\n

\n

\u5927\u5bb6\u53ef\u80fd\u4f1a\u5728\u8fd9\u91cc\u770b\u5230\u81ea\u5df1\u719f\u6089\u7684\u516c\u53f8\u540d\u5b57\u54e6\uff01<\/p>\n


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\u540c\u6837\uff0c\u4e3a\u4e86\u7b80\u5355\uff0c\u5927\u5bb6\u53ef\u4ee5\u76f4\u63a5\u70b9\u51fb\u4ee5\u4e0b\u94fe\u63a5\u6216\u70b9\u51fb\u9605\u8bfb\u539f\u6587\u8fdb\u5165\u8fd9\u4e2a\u641c\u7d22\u7f51\u9875<\/p>\n

https:\/\/www.accessdata.fda.gov\/scripts\/inspsearch\/<\/p>\n


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\u662f\u4e0d\u662f\u5f88\u7b80\u5355\u5462\uff1f<\/p>\n


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\u5f53\u7136\uff0c\u4eba\u5bb6FDA\u53ef\u8bf4\u4e86<\/p>\n

** Inspection Classifications listed in this report reflect the compliance status of firms when the report was generated. These Inspection classifications may or may not represent the final Agency determination of compliance for these firms.<\/p>\n

\u5728\u672c\u62a5\u544a\u4e0a\u6240\u5217\u7684\u68c0\u67e5\u5206\u7c7b\u53cd\u6620\u7684\u662f\u62a5\u544a\u751f\u6210\u65f6\u516c\u53f8\u7684\u5408\u89c4\u72b6\u6001\u3002\u8fd9\u4e9b\u68c0\u67e5\u5206\u7c7b\u53ef\u80fd\u4ee3\u8868\u4e5f\u53ef\u80fd\u5e76\u4e0d\u4ee3\u8868FDA\u5bf9\u8fd9\u4e9b\u516c\u53f8\u5408\u89c4\u60c5\u51b5\u7684\u6700\u7ec8\u5224\u5b9a\u3002<\/p>\n

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\u7f8e\u56fdFDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e0e\u975e\u4e34\u5e8a\u7814\u7a76\u8b66\u544a\u4fe1\u6c47\u7f16\uff082008~2017\uff09<\/h2>\n

\u4f5c\u8005\uff1a\u56fd\u5bb6\u98df\u54c1 \u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\uff0c\u4e0a\u6d77\u836f\u54c1\u5ba1\u8bc4\u6838\u67e5\u4e2d\u5fc3\u7ec4\u7ec7\u7f16 \u8bd1<\/p>\n<\/p><\/div>\n

\n
<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

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\u7f8e\u56fdFDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e0e\u975e\u4e34\u5e8a\u7814\u7a76\u8b66\u544a\u4fe1\u6c47\u7f16\uff082008~2017\uff09<\/h2>\n

\u4f5c\u8005\uff1a\u56fd\u5bb6\u98df\u54c1 \u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\uff0c\u4e0a\u6d77\u836f\u54c1\u5ba1\u8bc4\u6838\u67e5\u4e2d\u5fc3\u7ec4\u7ec7\u7f16 \u8bd1<\/p>\n<\/p><\/div>\n

\n
<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u8fd9\u4e2a\u662f\u8981\u6536\u85cf\u6ef4\uff01\uff01FDA\u68c0\u67e5\u5458\u6307\u5bfc\u624b\u518cCP 7356.002:\u836f\u54c1\u751f\u4ea7\u68c0\u67e5\u7a0b\u5e8f<\/h2>\n

\u7b2c<\/span><\/strong>I<\/span><\/strong>\u90e8\u5206\u2015\u2015\u80cc\u666f<\/span><\/strong><\/span><\/p>\n

\u81f3\u516b\u5341\u5e74\u4ee3\u540e\u671f\u4ee5\u6765\uff0c\u7f8e\u56fd\u98df\u54c1\u4e0e\u836f\u54c1\u7ba1\u7406\u5c40\u4ee5\u5f3a\u5316\u4e86\u5176\u5bf9\u539f\u6599\u836f<\/span>(API)<\/span>\u751f\u4ea7\u4f01\u4e1a\u7684\u68c0\u67e5\u5185\u5bb9\u3002\u4ece\u90e8\u5206\u65b9\u9762\u6765\u8bf4\uff0c\u8fd9\u5f52\u548e\u4e8e\u5bf9\u539f\u6599\u836f\u8d28\u91cf\u5728\u5236\u5242\u7684\u8d28\u91cf\u3001\u6548\u529b\u3001\u548c\u5b89\u5168\u65b9\u9762\u6240\u8d77\u7684\u91cd\u8981\u4f5c\u7528\u8ba4\u8bc6\u7684\u63d0\u9ad8\u3002\u4f8b\u5982\uff0c\u5728\u914d\u5236\u6210\u56fa\u4f53\u53e3\u670d\u5236\u5242\uff0c\u6df7\u60ac\u5242\u548c\u5c40\u90e8\u7528\u836f\u65f6\u539f\u6599\u836f\u7684\u5316\u5b66\u7279\u6027\u4f1a\u5bf9\u5236\u5242\u7684\u6eb6\u51fa\u5ea6<\/span>\/<\/span>\u751f\u7269\u5229\u7528\u5ea6\u4ea7\u751f\u4e0d\u5229\u5f71\u54cd\u3002\u53e6\u5916\uff0c\u539f\u6599\u4e2d\u7684\u5c11\u91cf\u6ca1\u6709\u9274\u522b\u51fa\u7684\u6742\u8d28\u6216\u5176\u7279\u6027\u672a\u77e5\u7684\u6742\u8d28\u4f1a\u7ed9\u75c5\u4eba\u9020\u6210\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u3002<\/span><\/span><\/p>\n

FDA<\/span>\u957f\u671f\u4ee5\u6765\u4e00\u76f4\u8ba4\u4e3a\uff0c\u6536\u8f7d\u5728\u5236\u5242\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u89c4\u5b9a<\/span>(21 CFR 210 and211)<\/span>\u4e2d\u7684<\/span>CGMP<\/span>\u6982\u5ff5\u5bf9\u539f\u6599\u836f\u751f\u4ea7\u5de5\u827a\u540c\u6837\u6709\u6548\u3002\u8fd9\u4e9b\u6982\u5ff5\u5305\u62ec\uff0c\u4e0e\u5176\u4ed6\u4e00\u8d77\uff0c\u4ea7\u54c1\u8d28\u91cf\u662f\u751f\u4ea7\u51fa\u6765\u7684\uff0c\u96c7\u4f63\u80fd\u591f\u80dc\u4efb\u548c\u7ecf\u8fc7\u57f9\u8bad\u7684\u5458\u5de5\uff0c\u5efa\u7acb\u9002\u5b9c\u7684\u4e66\u9762\u7a0b\u5e8f\u548c\u7ba1\u7406\u89c4\u5b9a\uff0c\u5efa\u7acb\u4e00\u5957\u5728\u7ebf\u6d4b\u8bd5\u548c\u4ea7\u54c1\u6d4b\u8bd5\u7cfb\u7edf\uff0c\u5de5\u827a\u9a8c\u8bc1\uff0c\u548c\u4fdd\u8bc1\u539f\u6599\u836f\u5728\u9884\u671f\u7684\u4f7f\u7528\u671f\u5185\u8d28\u91cf\u7a33\u5b9a\u3002<\/span><\/span><\/p>\n

FDA<\/span>\u5728<\/span>1991<\/span>\u5e74\u51fa\u7248\u7684\u5316\u5b66\u539f\u6599\u836f\u68c0\u67e5\u6307\u5357\uff0c\u5728<\/span>1994<\/span>\u5e74\u7ecf\u8fc7\u5c11\u91cf\u7684\u7f16\u8f91\u53d8\u5316\uff0c\u5305\u542b\u6709\u539f\u6599\u836f\u751f\u4ea7\u7684<\/span>GMP\/<\/span>\u9a8c\u8bc1\u6982\u5ff5\u5e94\u7528\u548c\u8303\u56f4\u65b9\u9762\u7684\u57fa\u672c\u6307\u5357\uff0c\u5e76\u5305\u542b\u4e86<\/span>FDA<\/span>\u5bf9\u6742\u8d28\u548c\u6742\u8d28\u4e13\u8bba\u65b9\u9762\u7684\u8981\u6c42\u3002\u5728\u5bf9\u56fd\u5185\u548c\u56fd\u5916\u539f\u6599\u836f\u8fdb\u884c\u68c0\u67e5\u65f6\u5747\u5fc5\u987b\u4f7f\u7528\u8be5\u6307\u5357\uff0c\u4ee5\u4fc3\u8fdb\u68c0\u67e5\u7684\u4e00\u81f4\u6027\u548c\u5747\u4e00\u6027\u3002<\/span><\/span><\/p>\n

\u76ee\u524d\uff0c<\/span>FDA<\/span>\u5e0c\u671b\u751f\u4ea7\u4f01\u4e1a\u5728<\/span>API<\/span>\u751f\u4ea7\u7684\u5168\u8fc7\u7a0b\u5b9e\u65bd<\/span>CGMP<\/span>\uff0c\u5373\u4ece\u8d77\u59cb\u539f\u6599\u7684\u4f7f\u7528\u5f00\u59cb\uff0c\u5230\u5bf9\u539f\u6599\u836f\u8d28\u91cf\u548c\u7eaf\u5ea6\u4ea7\u751f\u5f71\u54cd\u7684\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u7684\u9a8c\u8bc1\u3002\u8be5\u65b9\u6cd5\u8ba4\u4e3a\u6240\u9700\u7684\u63a7\u5236\u65b9\u6cd5\u5b8c\u5168\u4f9d\u8d56\u4e8e\u5b9e\u9645\u7684\u751f\u4ea7\u5de5\u827a\u4e14\u968f\u7740\u5408\u6210\u6b65\u9aa4\u4ece\u65e9\u671f\u7684\u4e2d\u95f4\u9636\u6bb5\u5411\u6700\u7ec8\u5206\u79bb\u548c\u7eaf\u5316\u6b65\u9aa4\u7684\u5ef6\u4f38\u63a7\u5236\u6c34\u5e73\u4e5f\u5728\u4e0d\u65ad\u52a0\u5f3a\u3002\u8be5\u65b9\u6cd5\u5141\u8bb8\u4f9d\u636e\u5de5\u827a\u672c\u8eab\uff08\u5373\uff0c\u5316\u5b66\u5408\u6210\u5de5\u827a\u548c\u53d1\u9175\u5de5\u827a\uff09\u53ca\u7279\u6b8a\u5de5\u827a\u6b65\u9aa4\u7684\u98ce\u9669\u6027\u548c\u5173\u952e\u6027\u91c7\u53d6\u9002\u5b9c\u6c34\u5e73\u7684\u63a7\u5236\u65b9\u6cd5\u3002<\/span><\/span><\/p>\n

\u8be5\u201c\u63a7\u5236\u6240\u6709\u6b65\u9aa4\uff0c\u9a8c\u8bc1\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u201d\u65b9\u6cd5\u5305\u542b\u5728<\/span>FDA<\/span>\u7684\u300a\u539f\u6599\u836f\u5236\u9020\uff0c\u52a0\u5de5\u548c\u50a8\u5b58\u6307\u5357\u300b\u8349\u6848\u5185\uff0c\u5176\u5728<\/span>1996<\/span>\u5e74<\/span>9<\/span>\u6708<\/span>20<\/span>\u65e5\u516c\u5e03\u4f9b\u516c\u4f17\u8ba8\u8bba\u3002\u540e\u8005\u53ef\u4ee5\u4ece<\/span>CDER<\/span>\u7684\u7f51\u7ad9\u4e0b\u8f7d\uff1a<\/span>http:\/\/www.fda.gov\/cder\/api.htm<\/span>.<\/span>\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u7b2c<\/span><\/strong>II<\/span><\/strong>\u90e8\u5206\u5b9e\u65bd<\/span><\/strong><\/span><\/p>\n

\u76ee\u7684\uff1a\u8be5\u7b26\u5408\u6027\u7a0b\u5e8f\u7684\u4e3b\u8981\u76ee\u7684\u662f\u4e3a\u5bf9\u56fd\u5185\u548c\u56fd\u5916\u5404\u7c7b\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u7684\u68c0\u67e5\u63d0\u4f9b\u4e00\u4efd\u7efc\u5408\u6027\u7684<\/span>CGMP<\/span>\u68c0\u67e5\u6307\u5357\u3002<\/span><\/span><\/p>\n

\u7a0b\u5e8f\u7684\u7ba1\u7406\u6307\u5bfc\uff1a<\/span><\/p>\n

\u8be5\u7a0b\u5e8f\u4ec5\u9002\u7528\u4e8e\u7528\u4e8e\u5236\u5242\u7684\u539f\u6599\u836f\u3002\u539f\u6599\u7684\u5b9a\u4e49\u662f\u4efb\u4f55\u7528\u4e8e\u5236\u5242\u4e2d\u7684\u7269\u8d28\u4e14\u5f53\u7528\u4e8e\u5236\u5242\u751f\u4ea7\uff0c\u52a0\u5de5\u6216\u5305\u88c5\u65f6\uff0c<\/span>\u5b83\u6210\u4e3a\u5176\u4e2d\u7684\u4e00\u79cd\u6709\u6548\u6210\u5206\u3002\u867d\u7136\uff0c<\/span>FDA<\/span>\u4e00\u76f4\u7528\u201c<\/span>bulk pharmaceuticalchemicals<\/span>\u201d\u548c\u201c<\/span>bulk drugsubstances<\/span>\u201d\u6765\u63cf\u8ff0\u8fd9\u4e9b\u539f\u6599\uff0c<\/span>FDA<\/span>\u73b0\u5df2\u610f\u8bc6\u5230\u201c<\/span>a<\/span>ctivepharmaceutical ingredient<\/span>\u201d\u8fd9\u4e2a\u8bcd\u6c47\u5728\u56fd\u9645\u4e0a\u5f97\u5230\u8ba4\u540c\u3002\u4ece\u8fd9\u70b9\u4e0a\u6765\u770b\u4e3a\u4e86\u66f4\u6e05\u6670\uff0c<\/span>FDA<\/span>\u5728\u672c\u7b26\u5408\u6027\u7a0b\u5e8f\u4e2d\u91c7\u7528\u201c<\/span>a<\/span>ctivepharmaceutical ingredient<\/span>\u201d\u8fd9\u4e2a\u8bcd\u3002<\/span><\/span><\/p>\n

\u56fd\u5185\u6240\u6709\u836f\u54c1\u751f\u4ea7\u8bbe\u65bd\u7684\u62e5\u6709\u8005\u6216\u7ecf\u8425\u8005\uff0c\u5305\u62ec<\/span>APIs<\/span>\uff0c\u65e0\u4e00\u4f8b\u5916\u7684\u8c01\u90fd\u8981\u9075\u5b88\u8054\u90a6\u98df\u54c1\uff0c\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u6848<\/span>510(g)<\/span>\u90e8\u5206\u7684\u7ba1\u5236\uff0c\u4f5c\u4e3a\u8865\u5145\uff0c\u6216\u8005\u6309\u7167<\/span>21 CFR 207.10<\/span>\u7684\u8981\u6c42\u8fdb\u884c\u6ce8\u518c\u5e76\u5448\u62a5\u6240\u8fdb\u884c\u5546\u4e1a\u5316\u9500\u552e\u7684\u6240\u6709\u836f\u54c1\u6e05\u5355\u3002\u5bf9\u5916\u56fd\u7684\u836f\u54c1\u751f\u4ea7\u5546\u4e0d\u8981\u6c42\u8fdb\u884c\u6ce8\u518c\uff0c\u867d\u7136\u4e5f\u8981\u6c42\u4ed6\u4eec\u5217\u51fa\u6240\u8fdb\u53e3\u7684\u6216\u5411\u7f8e\u56fd\u8fdb\u53e3\u7684\u836f\u54c1\u7684\u6e05\u5355\u3002\u5728\u5bf9\u5916\u56fd\u836f\u54c1\u5236\u9020\u5546\u5217\u51fa\u836f\u54c1\u6e05\u5355\u7684\u5176\u4ed6\u4fe1\u606f\u8bf7\u53c2\u9605<\/span>21 CFR 207.40<\/span>\u3002<\/span><\/span><\/p>\n

\u867d\u7136\uff0c\u73b0\u884c\u7684\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span>(CGMP)<\/span>\u89c4\u5b9a\uff0c<\/span>21 CFR 210 <\/span>\u548c<\/span>211<\/span>\uff0c\u4e0d\u9002\u7528\u4e0e<\/span>API<\/span>\uff0c\u539f\u6599\u836f\u5fc5\u987b\u7b26\u5408\u8054\u90a6\u5927\u6cd5\u5178<\/span>501(a)(2)(B)<\/span>\u90e8\u5206\u7684\u8981\u6c42\uff0c\u5373\u6240\u6709\u7684\u836f\u54c1\u5747\u5e94\u6309\u7167\u73b0\u884c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u751f\u4ea7\u3002\u5728\u7b26\u5408\u8054\u90a6\u5927\u6cd5\u5178\u65b9\u9762\uff0c\u539f\u6599\u836f\u548c\u5236\u5242\u6ca1\u6709\u533a\u522b\uff0c\u5176\u4e2d\u4efb\u4e00\u4e2a\u4e0d\u7b26\u5408<\/span>CGMP<\/span>\u8981\u6c42\u90fd\u88ab\u89c6\u4e3a\u8fdd\u80cc\u8054\u90a6\u5927\u6cd5\u5178\u3002\u56e0\u6b64\uff0c\u5728\u672c\u6587\u4ef6\u4e2d\uff0c<\/span>CGMP<\/span>\u6307\u7684\u662f\u540e\u8005\uff0c\u800c\u4e0d\u662f<\/span>21 CFR 210 <\/span>\u548c<\/span> 211<\/span>\u3002<\/span><\/span><\/p>\n

\u4f8b\u5916\uff1a<\/span><\/p>\n

\u672c\u7a0b\u5e8f\u4e0d\u9002\u7528\u4e8e\u65e0\u83cc\u539f\u6599\u836f\u7684\u706d\u83cc\u548c\u65e0\u83cc\u52a0\u5de5\u8fc7\u7a0b\uff0c\u8fd9\u4e9b\u8fc7\u7a0b\u53d7\u7b26\u5408\u6027\u7a0b\u5e8f<\/span>7356.002A<\/span>\uff0c\u65e0\u83cc\u5de5\u827a\u68c0\u67e5\u7684\u7ba1\u7406\u3002<\/span>FDA<\/span>\u4e00\u76f4\u5c06\u65e0\u83cc\u539f\u6599\u836f\u89c6\u540c\u5236\u5242\u7ba1\u7406\uff0c\u5e76\u8981\u6c42\u5176\u9075\u5b88\u5236\u5242\u7684<\/span>CGMP<\/span>\u89c4\u5b9a<\/span>(21 CFR 210 <\/span>\u548c<\/span> 211)<\/span>\uff0c\u7406\u7531\u662f\u4ed6\u4eec\u5728\u4e0d\u9700\u8fdb\u4e00\u6b65\u7eaf\u5316\u548c\u5904\u7406\u7684\u60c5\u51b5\u4e0b\uff0c\u5728\u65e0\u83cc\u6761\u4ef6\u4e0b\u8fdb\u884c\u5206\u88c5\u4ee5\u540e\u5c31\u6210\u4e86\u5236\u5242\u3002<\/span><\/span><\/p>\n


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

\u7b2c<\/span><\/strong>III<\/span><\/strong>\u90e8\u5206\u2015\u2015\u68c0\u67e5<\/span><\/strong><\/span><\/p>\n

\u5bf9\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u7684\u68c0\u67e5\uff0c\u4e0d\u8bba\u662f\u56fd\u5185\u8fd8\u662f\u56fd\u5916\uff0c\u90fd\u5e94\u8be5\u7531\u5728\u53d1\u9175\uff0c\u5316\u5b66\u5408\u6210\uff0c<\/span>DNA<\/span>\u91cd\u7ec4\u548c\u5176\u5b83\u751f\u7269\u6280\u672f\u751f\u4ea7\u65b9\u6cd5\u53d7\u8fc7\u4e13\u95e8\u6559\u80b2\u548c<\/span>\/<\/span>\u6216\u57f9\u8bad\u7684\u6709\u7ecf\u9a8c\u7684\u68c0\u67e5\u5458\u6765\u8fdb\u884c\u3002\u5efa\u8bae\u5728<\/span>API<\/span>\u68c0\u67e5\u4e2d\u914d\u5907\u5316\u5b66\u5bb6\u6216\u5fae\u751f\u7269\u5b66\u5bb6\uff0c\u7279\u522b\u662f\u5728\u8bc4\u4f30\u5b9e\u9a8c\u5ba4\u64cd\u4f5c\uff08\u5982\uff0c\u5206\u6790\u65b9\u6cd5\u8bc4\u4f30\uff0c\u5206\u6790\u6570\u636e\uff0c\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u65b9\u6cd5\u548c\u4eea\u5668\u65b9\u9762\uff09\uff0c\u5efa\u7acb\u6742\u8d28\u4e13\u8bba\u7684\u5206\u6790\u65b9\u6cd5\u5206\u6790\uff0c\u53d1\u9175\u751f\u4ea7\u5de5\u827a\uff0c\u590d\u6742\u7684\u591a\u6b65\u9aa4\u5316\u5b66\u5408\u6210\u5de5\u827a\u3002<\/span><\/span><\/p>\n

\u4ece\u4e8b<\/span>API<\/span>\u68c0\u67e5\u7684\u68c0\u67e5\u5458\u5e94\u6307\u5bfc\u539f\u6599\u836f\u751f\u4ea7\u4e0e\u5236\u5242\u751f\u4ea7\u6709\u672c\u8d28\u7684\u533a\u522b\u3002<\/span>API<\/span>\u901a\u5e38\u901a\u8fc7\u5316\u5b66\u5408\u6210\uff0c<\/span>DNA<\/span>\u91cd\u7ec4\u6280\u672f\uff0c\u53d1\u9175\uff0c\u9176\u4fc3\u53cd\u5e94\uff0c\u7531\u5929\u7136\u6750\u6599\u4e2d\u63d0\u53d6\uff0c\u6216\u4e0a\u8ff0\u65b9\u6cd5\u7684\u7ed3\u5408\u800c\u751f\u4ea7\u51fa\u6765\u7684\u3002<\/span>API<\/span>\u7684\u751f\u4ea7\u5178\u578b\u7684\u7279\u5f81\u662f\u901a\u8fc7\u4e0d\u540c\u7684\u5316\u5b66\uff0c\u7269\u7406\u548c\u751f\u7269\u5904\u7406\u6b65\u9aa4\u4f7f\u8d77\u59cb\u539f\u6599\u548c\u4e2d\u95f4\u4f53\u53d1\u751f\u91cd\u5927\u6539\u53d8\u3002\u7eaf\u5316\u662f\u5176\u6700\u7ec8\u76ee\u7684\u3002\u4e0e\u6b64\u76f8\u53cd\uff0c\u5236\u5242\u662f\u7531\u539f\u6599\u836f\u914d\u5236\u800c\u6210\u7684\uff0c\u5176\u4e2d\u7684\u539f\u6599\u836f\u901a\u5e38\u53d7\u5230\u5236\u5242\u5382\u5bb6\u67d0\u79cd\u7a0b\u5ea6\u7684\u8d28\u91cf\u63a7\u5236\u3002\u6700\u91cd\u8981\u7684\u4e00\u70b9\u662f\uff0c\u5236\u5242\u751f\u4ea7\u5de5\u827a\u4e0d\u5305\u62ec\u5178\u578b\u7684\u7eaf\u5316\u6b65\u9aa4\u3002\u56e0\u6b64\uff0c\u539f\u6599\u751f\u4ea7\u4e2d\u6240\u7528\u5230\u7684\u751f\u4ea7\u548c\u8d28\u91cf\u63a7\u5236\u4ee5\u53ca\u4ed6\u4eec\u5728\u6574\u4e2a\u5de5\u827a\u8fc7\u7a0b\u4e2d\u7684\u5e94\u7528\uff08\u5373\uff0c\u63a7\u5236\u7684\u4e25\u683c\u7a0b\u5ea6\uff0c\u4e66\u9762\u6307\u4ee4\uff0c\u8fc7\u7a0b\u63a7\u5236\uff0c\u53d6\u6837\uff0c\u6d4b\u8bd5\uff0c\u76d1\u6d4b\u548c\u5728\u65e9\u671f\u6b65\u9aa4\u53ca\u5206\u79bb\u548c\u7eaf\u5316\u9636\u6bb5\u7528\u5230\u7684\u6587\u4ef6\uff09\u4e0e\u5728\u5236\u5242\u751f\u4ea7\u5382\u6240\u89c1\u5230\u7684\u662f\u6709\u5f88\u591a\u4e0d\u540c\u7684\u3002\u7136\u800c\uff0c\u8fd9\u79cd\u4e0d\u540c\u53ea\u662f\u4ec5\u4ec5\u53cd\u5e94\u51fa\u751f\u4ea7\u5de5\u827a\u7684\u4e0d\u540c\uff0c\u800c\u4e0d\u662f\u8bf4\u8fd9\u4e24\u7c7b\u4ea7\u54c1\u5728\u6267\u884c<\/span>GMP<\/span>\u7684\u91cd\u8981\u6027\u65b9\u9762\u7684\u56fa\u6709\u533a\u522b\u3002<\/span><\/span><\/p>\n

\u56e0\u4e3a\uff0c\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u7ecf\u5e38\u88ab\u5236\u5242\u751f\u4ea7\u8005\u5f15\u7528\uff0c\u6bcf\u4e00\u6b21\u68c0\u67e5\u90fd\u5e94\u5c3d\u53ef\u80fd\u591a\u7684\u8986\u76d6<\/span>API<\/span>\u7684\u751f\u4ea7\u5de5\u827a\u3002\u8fd9\u4e00\u7b56\u7565\u4f1a\u6700\u5927\u6548\u7387\u7684\u5229\u7528<\/span>FDA<\/span>\u7684\u8d44\u6e90\u5e76\u53ef\u907f\u514d\u5bf9\u540c\u4e00\u4e2a\u751f\u4ea7\u5382\u91cd\u590d\u68c0\u67e5\uff0c\u8fd9\u6837\u53ef\u4ee5\u8986\u76d6\u5728\u968f\u540e\u7684\u7533\u8bf7\u4e2d\u6240\u5f15\u7528\u7684\u4e0d\u540c\u7684<\/span>API<\/span>\u7c7b\u578b\u3002\u56e0\u6b21\uff0c\u968f\u7740\u672c\u7b26\u5408\u6027\u7a0b\u5e8f\u7684\u4fee\u8ba2\u7248\u7684\u751f\u6548\uff0c\u5bf9\u6240\u6709<\/span>API<\/span>\u751f\u4ea7\u4f01\u4e1a\u7684\u68c0\u67e5\uff0c\u4e0d\u8bba\u5b83\u4eec\u662f\u5982\u4f55\u751f\u4ea7\u7684\uff0c\u90fd\u5e94\u662f\u201c\u5bf9\u7b26\u5408<\/span>GMP<\/span>\u60c5\u51b5\u8fdb\u884c\u786e\u8ba4\u7684\u68c0\u67e5\u201d\u3002\u68c0\u67e5\u5e94\u8986\u76d6\u6240\u6307\u5b9a\u7684\u7279\u6b8a\u7684<\/span>API<\/span>\u68c0\u67e5\u53ca\u5728\u8fc7\u53bb\u4e24\u5e74\u6ca1\u6709\u68c0\u67e5\u5230\u7684<\/span>API<\/span>\u3002\u5bf9\u5916\u56fd<\/span>API<\/span>\u4f01\u4e1a\u6765\u8bf4\uff0c\u68c0\u67e5\u5458\u5e94\u4ec5\u68c0\u67e5\u51c6\u5907\u5728\u7f8e\u56fd\u4e0a\u5e02\u6216\u5df2\u7ecf\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684\u539f\u6599\u836f\u90e8\u5206\u3002<\/span><\/span><\/p>\n

\u6240\u9009\u62e9\u7684<\/span>API<\/span>\u8303\u56f4\u5e94\u5305\u62ec\u5728\u5236\u5242\u7533\u8bf7\u4e2d\u5f15\u7528\u7684\u90a3\u4e9b\u539f\u6599\uff0c\u4ed6\u4eec\u5e94\u662f\u6709\u91cd\u8981\u6cbb\u7597\u4ef7\u503c\u7684\uff0c\u5c06\u7528\u4e8e\u6ce8\u5c04\u5242\u4e2d\u7684\uff0c\u96be\u4ee5\u751f\u4ea7\u7684\uff0c\u6216\u90a3\u4e9b\u6709\u7b26\u5408\u6027\u65b9\u9762\u95ee\u9898\u8bb0\u5f55\u7684\u3002\u7136\u800c\uff0c\u8fd9\u5e76\u4e0d\u963b\u6b62\u9009\u62e9\u6cbb\u7597\u4ef7\u503c\u8f83\u4f4e\u7684\u539f\u6599\u836f\u6765\u8bc4\u4f30\u7279\u6b8a\u7684<\/span>API<\/span>\u5de5\u827a\uff0c\u4e5f\u4e0d\u9650\u5b9a\u5bf9\u8be5\u4f01\u4e1a\u7684\u68c0\u67e5\u6df1\u5ea6\u3002<\/span><\/span><\/p>\n

\u8fdb\u884c<\/span>API<\/span>\u68c0\u67e5\u7684\u68c0\u67e5\u5458\u5e94\u8be5\u77e5\u9053\u672c\u7a0b\u5e8f\u7b2c<\/span>II<\/span>\u90e8\u5206\u6240\u8ff0\u7684\u901a\u7528\u68c0\u67e5\u7b56\u7565\u3002\u8003\u8651\u5230<\/span>API<\/span>\u4f01\u4e1a\u7684\u5927\u5c0f\u4e0d\u540c\uff0c\u64cd\u4f5c\u7684\u591a\u6837\u6027\uff0c\u53ca\u8d28\u91cf\u4fdd\u8bc1\u7cfb\u7edf\uff0c\u68c0\u67e5\u5458\u5e94\u8be5\u4ed4\u7ec6\u7684\u8ba1\u5212\u5bf9\u6bcf\u4e2a\u4f01\u4e1a\u7684\u68c0\u67e5\u8ba1\u5212\u3002\u5e94\u7279\u522b\u5173\u6ce8\u4f4d\u4e8e\u53d1\u5c55\u4e2d\u56fd\u5bb6\u7684<\/span>API<\/span>\u751f\u4ea7\u4f01\u4e1a\u3002<\/span>API<\/span>\u751f\u4ea7\u4e2d\u5b58\u5728\u4e8e\u7ec4\u5206\uff0c\u5de5\u827a\u7528\u6c34\u548c\u6eb6\u5242\u4e2d\u7684\u6742\u8d28\u548c\u6c61\u67d3\u6216\u88ab\u5e26\u5230\u539f\u6599\u836f\u4e2d\u53bb\uff0c\u800c\u4e14\u4e0d\u8bba\u662f\u7531<\/span>API<\/span>\u751f\u4ea7\u8005\u8fd8\u662f\u5236\u5242\u751f\u4ea7\u8005\u8fdb\u884c\u7684\u6d4b\u8bd5\u5747\u4e0d\u80fd\u68c0\u6d4b\u5230\u3002\u5728\u68c0\u67e5\u4e2d\uff0c\u68c0\u67e5\u5458\u5e94\u8bc4\u4f30\u7528\u4e8e\u63d0\u53d6\u548c\u7eaf\u5316\u5de5\u5e8f\u7684\u5de5\u827a\u7528\u6c34\u548c\u6eb6\u5242\u8d28\u91cf\uff0c\u8be5\u4f01\u4e1a\u9632\u6b62<\/span>API<\/span>\u6c61\u67d3<\/span>\/<\/span>\u4ea4\u53c9\u6c61\u67d3\u7684\u65b9\u6cd5\uff0c\u63a7\u5236\u6742\u8d28\u7684\u65b9\u6cd5\uff0c\u548c\u4e3a\u6bcf\u4e00\u4e2a<\/span>API<\/span>\u5de5\u827a\u5efa\u7acb\u5b8c\u6574\u7684\u6742\u8d28\u4e13\u8bba\u7684\u7a0b\u5e8f\u548c\u6d4b\u8bd5\u65b9\u6cd5\u3002\u8fd9\u4e9b\u5185\u5bb9\u7684\u8be6\u7ec6\u90e8\u5206\u5728<\/span>FDA1991<\/span>\u5e74<\/span>9<\/span>\u6708\u51fa\u7248\u7684\u5316\u5b66\u539f\u6599\u836f\u68c0\u67e5\u6307\u5357\u53ca\u5176\u9644\u4ef6<\/span>A<\/span>\u4e2d\u3002<\/span><\/span><\/p>\n

\u5728\u68c0\u67e5\u4e2d\uff0c\u68c0\u67e5\u5458\u5e94\u5ba1\u67e5\u53bb\u5e74\u6240\u751f\u4ea7\u7684\u6279\u4ee5\u786e\u5b9a\u4e0d\u4ec5\u90a3\u4e9b\u88ab\u653e\u884c\u7684\uff0c\u8fd8\u5e94\u6709\u6240\u6709\u7684\u88ab\u62d2\u7edd\u6279\u7684\u60c5\u51b5\u3002\u8fd8\u5e94\u68c0\u67e5\u8be5\u4f01\u4e1a\u5173\u4e8e<\/span>API<\/span>\u518d\u52a0\u5de5\u548c\u91cd\u65b0\u52a0\u5de5\u7684\u653f\u7b56\u3002\u6709\u4e9b\u6279\u53f7\u4e00\u5f00\u59cb\u662f\u836f\u7528\u7ea7\uff0c\u540e\u6765\u53c8\u53d8\u6210\u6280\u672f\u7ea7\u3002\u8fd9\u53ef\u80fd\u9884\u793a\u7740\u5df2\u9a8c\u8bc1\u7684\u5de5\u827a\u5b58\u5728\u95ee\u9898\u3002\u53e6\u5916\uff0c\u4e5f\u56e0\u5bf9\u8bbe\u5907\u6e05\u6d01\u9a8c\u8bc1\u8fdb\u884c\u5ba1\u6838\u4ee5\u786e\u4fdd\u4f01\u4e1a\u80fd\u628a\u6742\u8d28\uff0c\u5fae\u751f\u7269\u6c61\u67d3\uff0c\u548c\u5185\u6bd2\u7d20\u53bb\u9664\u5230\u7528\u8be5\u539f\u6599\u6240\u505a\u7684\u5236\u5242\u662f\u6ce8\u5c04\u5242\u6216\u6db2\u4f53\u53e3\u670d\u5236\u5242\u65f6\u53ef\u4ee5\u63a5\u53d7\u7684\u6c34\u5e73\u3002<\/span><\/span><\/p>\n

\u5bf9\u6279\u51c6\u524d\u7684\u68c0\u67e5\u6765\u8bf4\uff0c\u53ef\u4ee5\u53c2\u9605<\/span>CP 7346.832<\/span>\u4e2d\u63d0\u4f9b\u7684\u6307\u5357\uff0c\u6279\u51c6\u524d\u68c0\u67e5<\/span>\/<\/span>\u8c03\u67e5\uff0c\u5e76\u8bc4\u4f30\u5236\u5242\u7533\u8bf7\u548c<\/span>DMF<\/span>\u4e2d\u6570\u636e\u7684\u771f\u5b9e\u6027\u548c\u51c6\u786e\u6027\u3002\u6309\u7167\u5f15\u7528\u4e24\u4e2a\u7b26\u5408\u6027\u7a0b\u5e8f\u4e2d\u7684\u9002\u5b9c\u7a0b\u5e8f\u5206\u914d\u4ee3\u7801<\/span>(PACs)<\/span>\u62a5\u544a\u68c0\u67e5\u65f6\u95f4\uff0c\u540c\u65f6\u5e94\u4ee5\u6bcf\u4e2a\u7a0b\u5e8f\u7684\u8986\u76d6\u8303\u56f4\u4e3a\u57fa\u7840\u3002<\/span><\/span><\/p>\n

\u56fd\u5916\u836f\u54c1\u68c0\u67e5\u7a0b\u5e8f\u4e2d\u7684\u53d8\u66f4<\/span><\/strong><\/span><\/p>\n

\u4ece<\/span>97<\/span>\u5e74\u5f00\u59cb\uff0c\u4e3a\u4f7f\u5f97\u7b26\u5408\u6027\u68c0\u67e5\u8fc7\u7a0b\u5408\u7406\u5316\uff0c<\/span>CDER<\/span>\u540c\u610f\u5bf9\u56fd\u5916\u836f\u54c1\u68c0\u67e5\u7a0b\u5e8f\u505a\u51e0\u5904\u53d8\u66f4\u3002\u7d27\u6025\u548c\u8c03\u67e5\u884c\u52a8\u5904<\/span>(ORO\/DEIO)<\/span>\u5c06\u7ee7\u7eed\u540c\u5916\u56fd\u653f\u5e9c\u4e00\u8d77\u5236\u5b9a\u56fd\u5916\u68c0\u67e5\u8ba1\u5212\uff0c\u4e3a\u68c0\u67e5\u7ec4\u505a\u65c5\u884c\u5b89\u6392\uff0c\u89e3\u51b3\u540e\u52e4\u65b9\u9762\u7684\u95ee\u9898\u3002<\/span><\/span><\/p>\n

\u7136\u800c\uff0c\u65b0\u7684\u7a0b\u5e8f\u5bf9\u5904\u7406\u5916\u56fd\u4f01\u4e1a\u5bf9<\/span>FD-483<\/span>\u7684\u56de\u590d\uff0c\u5448\u62a5\u73b0\u573a\u68c0\u67e5\u62a5\u544a\uff0c\u548c\u8bc4\u8bba\u5916\u56fd\u4f01\u4e1a\u5bf9<\/span>FD-483<\/span>\u7684\u56de\u590d\u662f\u6709\u6548\u7684\u3002<\/span><\/span><\/p>\n

\u68c0\u67e5\u5458\u5e94\u6307\u5bfc\u5916\u56fd\u4f01\u4e1a\u5c06<\/span>FD-483<\/span>\u7684\u4e66\u9762\u56de\u590d\u539f\u4ef6\u76f4\u63a5\u4ea4\u7ed9<\/span>CDER<\/span>\u7684\u7b26\u5408\u6027\u529e\u516c\u5ba4\uff0c\u540c\u65f6\u7ed9\u68c0\u67e5\u7ec4\u7ec4\u957f\u4e00\u4efd\u590d\u5370\u4ef6\u3002\u6587\u4ef6\u7684\u56de\u590d\u5e94\u4ea4\u5230\u4ee5\u4e0b\u5730\u5740\uff1a<\/span><\/span><\/p>\n

Food and Drug Administration  <\/span><\/p>\n

Foreign Inspection Team, HFD-322  <\/span><\/p>\n

Division of Manufacturing and Product Quality <\/span><\/p>\n

Center for Drug Evaluation and Research  <\/span><\/p>\n

7520 Standish Place<\/span><\/p>\n

Rockville, Maryland 20855-2737<\/span><\/p>\n


<\/p>\n

\u68c0\u67e5\u5458\u548c\u5206\u6790\u5458\u5e94\u8be5\u5c06\u5173\u4e8e\u5916\u56fd\u4f01\u4e1a\u5bf9<\/span>FD-483<\/span>\u56de\u590d\u7684\u8bc4\u8bba\u76f4\u63a5\u4ea4\u5230<\/span>CDER<\/span>\u7684\u56fd\u5916\u68c0\u67e5\u7ec4<\/span>(FIT)<\/span>\u3002\u5728\u76f8\u5173\u7684\u5730\u533a\u529e\u516c\u5ba4\u5ba1\u67e5\u5e76\u8ba4\u53ef\u540e\uff0c\u6240\u6709\u7684\u56fd\u5916\u68c0\u67e5\u73b0\u573a\u62a5\u544a<\/span>(EIRs)<\/span>\u5c06\u7acb\u5373\u9001\u81f3<\/span>FIT<\/span>\u4f9b\u8bc4\u5ba1\u548c\u6700\u540e\u5206\u7c7b\u3002<\/span>FIT<\/span>\u5c06\u7ee7\u7eed\u5411\u5916\u56fd\u4f01\u4e1a\u7b7e\u53d1\u8b66\u544a\u4fe1\uff0c\u65e0\u6807\u9898\u4fe1\u4ef6\u548c\u5176\u5b83\u4fe1\u4ef6\u3002<\/span>FIT<\/span>\u4e5f\u4f1a\u5efa\u8bae\u81ea\u52a8\u5ef6\u8fdf\u5916\u56fd\u4f01\u4e1a<\/span>\/<\/span>\u4ea7\u54c1\uff0c\u5411\u8bc4\u5ba1\u5355\u4f4d\u63d0\u4f9b\u5efa\u8bae\uff0c\u9002\u5b9c\u65f6\uff0c\u5e76\u8981\u6c42\u8ddf\u8e2a\u68c0\u67e5\u3002<\/span><\/span><\/p>\n


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


<\/p>\n

\u68c0\u67e5<\/span><\/strong><\/span><\/p>\n

\u53c2\u9605<\/span>1991<\/span>\u5e74<\/span>9<\/span>\u6708<\/span>FDA<\/span>\u7684\u5316\u5b66\u539f\u6599\u836f\u68c0\u67e5\u6307\u5357\uff0c\uff08<\/span>1994<\/span>\u5e74\u4fee\u8ba2\uff09\u4ee5\u719f\u6089\u8fdb\u884c<\/span>API<\/span>\u68c0\u67e5\u65f6\u5e94\u8003\u8651\u4e0d\u540c\u7684\u533a\u57df\u548c\u539f\u6599\u836f\u54c1\u3002\u672c\u7b26\u5408\u6027\u7a0b\u5e8f\u7684\u9644\u4ef6<\/span>A<\/span>\u662f\u5bf9<\/span>API<\/span>\u68c0\u67e5\u4e2d\u6240\u8986\u76d6\u7684\u533a\u57df\u603b\u7ed3\u3002\u8bf7\u5c06\u8be5\u9644\u4ef6\u590d\u5370\u5728\u68c0\u67e5\u4e2d\u5e26\u7740\u3002\u540c\u65f6\u83b7\u53d6\u4e00\u4efd\u8be5\u5236\u5242\u7533\u8bf7\u548c<\/span>\/<\/span>\u6216\u836f\u54c1\u4e3b\u6587\u4ef6\uff08<\/span>DMF<\/span>\uff09\u7684\u590d\u5370\u4ef6\uff0c\u5728\u53ef\u4ee5\u65f6\uff0c\u5728\u5f00\u59cb\u68c0\u67e5\u524d\u5ba1\u9605\u8fd9\u4e9b\u6587\u4ef6\u3002<\/span><\/span><\/p>\n

\u6839\u636e\u89c4\u5b9a<\/span>(<\/span>\u89c1<\/span> 21 CFR 314.440)<\/span>\uff0c\u9700\u8981\u8be5\u7533\u8bf7\u7684\u7b2c\u4e09\u4efd\u590d\u5370\u4ef6\uff0c\u589e\u8865\u6750\u6599\u548c\u5e74\u5ea6\u62a5\u544a\uff0c\u56fd\u5185\u4f01\u4e1a\u53ef\u76f4\u63a5\u5c06\u8fd9\u4e9b\u590d\u5370\u4ef6\u5448\u62a5\u7ed9\u8d77\u6240\u5c5e\u5730\u533a\u7684<\/span>FDAS<\/span>\u529e\u516c\u5ba4\u3002\u8981\u6c42\u5916\u56fd\u7533\u8bf7\u4eba\u5c06\u8fd9\u4e9b\u7533\u8bf7\u6750\u6599\u590d\u5370\u4ef6\u5448\u62a5\u7ed9\u63a5\u6536\u7b2c\u4e00\u548c\u7b2c\u4e8c\u4efd\u590d\u5370\u4ef6\u7684<\/span>FDA<\/span>\u603b\u90e8\u7684\u540c\u4e00\u4e2a\u90e8\u95e8\u3002\u8fd9\u4f7f\u5f97\u5728\u5f00\u59cb\u5bf9\u5916\u56fd\u4f01\u4e1a\u68c0\u67e5\u524d\u4ece<\/span>DEIO<\/span>\u5904\u80fd\u627e\u5230\u8fd9\u4e9b\u6587\u4ef6\u3002<\/span><\/span><\/p>\n

\u68c0\u67e5\u4eba\u5e94\u5ba1\u6838\u6240\u6709\u83b7\u5f97\u7684\u8d44\u6599\uff0c\u5305\u62ec\u524d\u6b21\u68c0\u67e5\u8d44\u6599\uff0c<\/span>FD-483<\/span>\u548c\u56de\u590d\uff0c\u6240\u6709\u7684\u8b66\u544a\u4fe1\uff0c\u8be5\u4f01\u4e1a\u7b26\u5408\u6027\u5386\u53f2\uff0c\u6837\u54c1\u5206\u6790\u7ed3\u679c\uff0c\u987e\u5ba2\u6295\u8bc9\uff0c\u4ea7\u54c1\u53ec\u56de\u7b49\uff0c\u4e3a\u68c0\u67e5\u505a\u597d\u51c6\u5907\u3002\u5bf9\u56fd\u5185\u68c0\u67e5\u800c\u8a00\uff0c\u53ef\u4ee5\u4ece\u6bcf\u4e2a\u533a\u57df\u529e\u516c\u5ba4\u7684\u6279\u51c6\u524d\u76d1\u7763\u5904<\/span>(PAMs)<\/span>\u83b7\u5f97\u8fd9\u7c7b\u4fe1\u606f\u3002\u5bf9\u56fd\u5916\u68c0\u67e5\u800c\u8a00\uff0c\u53ef\u4ee5\u4ece<\/span>DEIO<\/span>\u6216<\/span>FIT<\/span>\u5904\u83b7\u5f97\u8be5\u8d44\u6599\u3002<\/span><\/span><\/p>\n

\u68c0\u67e5\u5458\u548c\u5316\u5b66\u5bb6\u5e94\u719f\u6089\u5176\u5b83\u5efa\u8bae\u7684\u53c2\u8003\u8d44\u6599\u5305\u62ec\uff1a\u884c\u4e1a\u6307\u5357\u8349\u6848\uff0d\u539f\u6599\u836f\u7684\u751f\u4ea7\uff0c\u52a0\u5de5\u548c\u50a8\u5b58\uff1b<\/span>USP <1086><\/span>\u6cd5\u5b9a\u7269\u8d28\u4e2d\u7684\u6742\u8d28\uff1b\u5728\u6d4b\u8bd5\u5916\u6765\u7269\u8d28\u548c\u6742\u8d28\u65b9\u6cd5\u4e0a\u6700\u8fd1\u7684\u53d8\u66f4\u3002\u53e6\u5916\uff0c\u5316\u5b66\u5bb6\u8fd8\u5e94\u4e0e\u6cd5\u5f8b\u5316\u5b66\u4e2d\u5fc3<\/span>(FCC)<\/span>\u63a5\u6d3d\u4ee5\u786e\u5b9a\u5e94\u62bd\u53d6\u90a3\u79cd<\/span>API<\/span>\u6837\u54c1\uff0c\u4ee5\u907f\u514d\u5728\u4e0d\u540c\u6b21\u7684\u68c0\u67e5\u95f4\u62bd\u53d6\u91cd\u590d\u7684\u6837\u54c1\u3002<\/span><\/span><\/p>\n

\u68c0\u67e5\u5458\u8fd8\u5e94\u5411<\/span>CDER<\/span>\u7684\u6848\u4f8b\u529e\u516c\u5ba4\u54a8\u8be2\u4ee5\u6f84\u6e05\u6240\u5206\u914d\u7684\u4efb\u52a1\u4ee5\u786e\u4fdd\u4e86\u89e3\u8be5\u4f01\u4e1a\u4ee5\u524d\u7684\u4e0d\u8db3\u4e4b\u5904\u3002\u5728\u68c0\u67e5\u4e2d\uff0c\u5e94\u786e\u8ba4\u8be5\u4f01\u4e1a\u5728\u7ea0\u6b63\u95ee\u9898\u65b9\u9762\u6240\u505a\u7684\u627f\u8bfa\u548c\u6539\u8fdb\u662f\u6709\u6548\u7684\u3002\u5047\u5982\u5728\u68c0\u67e5\u4e2d\uff0c\u5df2\u786e\u5b9a\u8be5\u4f01\u4e1a\u5df2\u7ecf\u89e3\u51b3\u4e86\u6240\u6709\u4e0d\u8db3\u4e4b\u5904\uff0c\u5e94\u5c06\u8be5\u4fe1\u606f\u8f93\u8fdb<\/span>CARS<\/span>\u8ba1\u7b97\u673a\u7cfb\u7edf\u3002<\/span><\/span><\/p>\n

\u5e94\u5bf9\u6bcf\u4e2a\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u6240\u8fdb\u884c\u7684\u68c0\u67e5\u4e2d\uff0c\u8981\u8fdb\u884c\u7684\u4ea7\u54c1\u548c\u5de5\u827a\u201c\u5bf9\u7b26\u5408<\/span>GMP<\/span>\u60c5\u51b5\u8fdb\u884c\u786e\u8ba4\u7684\u68c0\u67e5\u201d\u3002<\/span>.<\/span>\u53e6\u5916\uff0c\u5e94\u5c3d\u53ef\u80fd\u7684\u5305\u62ec\u8fc7\u53bb\u4e24\u5e74\u6ca1\u6709\u68c0\u67e5\u5230\u7684<\/span>API<\/span>\u8fc7\u7a0b\u3002\u800c\u4e14\uff0c\u4e00\u65e6\u533a\u57df\u5206\u5c40\u63a5\u5230\u5173\u4e8e\u67d0\u4f01\u4e1a\u751f\u4ea7\u6709\u5173<\/span>API<\/span>\u8d28\u91cf\u7684\u8d1f\u9762\u4fe1\u606f\uff0c\u5e94\u8fdb\u884c\u6df1\u5165\u7684\u68c0\u67e5\uff0c\u5305\u62ec\u5bf9\u76f8\u5173\u7cfb\u7edf\u548c\u5de5\u827a\u7684\u68c0\u67e5\u3002<\/span><\/span><\/p>\n

\u5c06\u73b0\u5728\u7684\u8fd0\u884c\u60c5\u51b5\u4e0e\u524d\u6b21\u68c0\u67e5\u7684\u73b0\u573a\u68c0\u67e5\u62a5\u544a<\/span>(EIR)<\/span>\u76f8\u6bd4\u8f83\uff0c\u4ee5\u786e\u5b9a\u8be5\u4f01\u4e1a\u662f\u5426\u5bf9\u5de5\u827a\u8fdb\u884c\u4e86\u53d8\u66f4\u3002\u5e76\u4e14\u5c06\u73b0\u5728\u7684\u8fd0\u884c\u60c5\u51b5\u4e0e<\/span>DMF<\/span>\u4e2d\u6216\u5236\u5242\u7533\u8bf7\u4e2d\u6240\u9648\u8ff0\u7684\u76f8\u6bd4\u8f83\u4ee5\u786e\u5b9a\u8be5\u4f01\u4e1a\u662f\u5426\u9075\u5b88\u4e86\u5bf9<\/span>FDA<\/span>\u7684\u627f\u8bfa\u3002<\/span><\/span><\/p>\n

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

\u5728\u68c0\u67e5\u4e2d\uff0c\u4ee5\u4e0b\u8fd9\u4e9b\u53d1\u73b0\u662f\u6269\u5927\u68c0\u67e5\u8303\u56f4\u7684\u5145\u5206\u7406\u7531\uff1a<\/span><\/strong><\/span><\/p>\n

a.<\/span><\/strong>\u7531\u4e8e<\/span>API<\/span>\u5de5\u827a\u6216\u751f\u4ea7\u7ebf\u7684\u6539\u53d8\uff0c\u4ea7\u751f\u4e86\u8f7b\u7684\u4ea4\u53c9\u6c61\u67d3\u7684\u53ef\u80fd\u3002\u5305\u62ec\u5728\u540c\u4e00\u8bbe\u5907\u548c<\/span>\/<\/span>\u6216\u8bbe\u65bd\u5185\u52a0\u5de5\u6570\u79cd\u6cbb\u7597\u4f5c\u7528\u4e0d\u540c\u7684<\/span>API<\/span>\u3002<\/span><\/span><\/p>\n

b.<\/span>\u65b0\u6280\u672f\uff0c\u65b0\u8bbe\u5907\uff0c\u6216\u65b0\u8bbe\u65bd\u7684\u8fd0\u7528\u3002<\/span><\/span><\/p>\n

c. <\/span>\u5728<\/span>DMF<\/span>\u6216\u7533\u8bf7\u4e2d\u6ca1\u6709\u5f15\u7528\u7684\uff0c\u6700\u8fd1\u5728\u8d77\u59cb\u539f\u6599\uff0c\u4e2d\u95f4\u4f53\uff0c\u8bbe\u5907\uff0c\u8bbe\u65bd\uff0c\u652f\u6301\u7cfb\u7edf\uff0c\u52a0\u5de5\u6b65\u9aa4\uff0c\u5305\u88c5\u6750\u6599\uff0c\u548c\u8ba1\u7b97\u673a\u8f6f\u4ef6\u65b9\u9762\u7684\u53d8\u66f4\u3002<\/span><\/span><\/p>\n

2. <\/span>\u786e\u8ba4\u6700\u5927\u6279\u91cf\u6ca1\u6709\u8d85\u8fc7\u8be5\u4f01\u4e1a\u6df7\u5408\u673a\u7684\u6700\u5927\u5de5\u4f5c\u5bb9\u79ef\u3002<\/span><\/span><\/p>\n

3. <\/span>\u5ba1\u6838\u8be5\u4f01\u4e1a\u7684\u987e\u5ba2\u6295\u8bc9\u6587\u6863\u548c\u7c7b\u578b\uff1b\u4f01\u4e1a\u5185\u90e8\u62d2\u7edd\u6216\u8fd4\u5de5<\/span>\/<\/span>\u91cd\u52a0\u5de5\u7684<\/span>API<\/span>\u6279\u7684\u8bb0\u5f55\u662f\u5426\u662f\u5426\u6709\u95ee\u9898\uff1b\u67e5\u627e\u8be5\u4f01\u4e1a\u5728\u5de5\u827a\uff0c\u7cfb\u7edf\u548c\u7ba1\u7406\u65b9\u9762\u7684\u5f31\u70b9\u3002<\/span><\/span><\/p>\n

4.<\/span>\u8c03\u67e5\u5404\u79cd\u539f\u56e0\u7684<\/span>API<\/span>\u9000\u8d27\u3002\u786e\u5b9a\u8be5\u4f01\u4e1a\u662f\u5426\u5bf9\u9000\u8d27\u8fdb\u884c\u4e86\u8c03\u67e5\uff0c\u4ee5\u627e\u51fa\u8fd9\u4e9b<\/span>API<\/span>\u662f\u5426\u662f\u4e0d\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u6216\u53d7\u5230\u4e86\u6c61\u67d3\u3002\u800c\u4e14\uff0c\u786e\u5b9a\u9000\u8d27\u6700\u7ec8\u7684\u5904\u7406\u65b9\u6cd5\uff0c\u5373\uff0c\u662f\u5426\u662f\u518d\u52a0\u5de5\u4e86\u8fd8\u662f\u62a5\u5e9f\u4e86\u3002<\/span><\/span><\/p>\n

5.<\/span>\u5982\u679c\u6240\u5f00\u5c55\u7684\u68c0\u67e5\u662f\u7531\u4e8e\u8be5\u4f01\u4e1a\u88ab\u4e00\u4efd\u5236\u5242\u7533\u8bf7\uff08<\/span>NDA, ANDA, AADA<\/span>\uff09\u5f15\u7528\u4e3a<\/span>API<\/span>\u4f9b\u5e94\u5546\uff0c\u5e94\u7ed3\u5408\u7533\u8bf7\u4e2d\u7684\u548c<\/span>\/<\/span>\u6216<\/span>DMF<\/span>\u6587\u4ef6\u4e2d\u7684\u627f\u8bfa\u8bc4\u4f30\u8fd0\u884c\u60c5\u51b5\u3002\u800c\u4e14\uff0c\u8981\u786e\u8ba4\u7533\u8bf7\u4e2d\u7684\u548c<\/span>\/<\/span>\u6216<\/span>DMF<\/span>\u6587\u4ef6\u4e2d\u7684\u6570\u636e\u7684\u771f\u5b9e\u6027\u548c\u51c6\u786e\u6027\u3002<\/span><\/span><\/p>\n

6. <\/span>\u83b7\u53d6\u4e00\u4efd\u6240\u68c0\u67e5\u7684\u539f\u6599\u836f\u5de5\u827a\u7684\u6742\u8d28\u4e13\u8bba\u590d\u5370\u4ef6\uff0c\u5e76\u5c06\u5176\u4e0e<\/span>DMF<\/span>\u4e2d\u6240\u5448\u62a5\u7684\u6742\u8d28\u4e13\u8bba\u76f8\u6bd4\u8f83\u3002<\/span><\/span><\/p>\n

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

API<\/span><\/strong>\u73b0\u573a\u68c0\u67e5\u62a5\u544a\u5fc5\u987b\u5305\u62ec\uff1a<\/span><\/strong><\/span><\/p>\n

1.<\/span>\u8be5\u4f01\u4e1a\u548c\u4efb\u4f55\u9644\u5c5e\u516c\u53f8\u7684\u5386\u53f2<\/span><\/span><\/p>\n

2.<\/span>\u63a5\u6536<\/span>FDA<\/span>\u4fe1\u4ef6\u8d23\u4efb\u4eba\u7684\u540d\u5b57\uff0c\u5934\u8854\u548c\u5b8c\u6574\u7684\u90ae\u4ef6\u6295\u5bc4\u5730\u5740\u3002<\/span><\/span><\/p>\n

3. <\/span>\u6240\u751f\u4ea7\u7684<\/span>API<\/span>\u76ee\u5f55\uff0c\u5305\u62ec\u6bcf\u79cd\u539f\u6599\u7684\u751f\u4ea7\u5de5\u827a\u7c7b\u522b\uff08\u5982\uff0c\u975e\u65e0\u83cc\u5316\u5b66\u5408\u6210\uff0c\u53d1\u9175\uff0c\u81ea\u7136\u4ea7\u7269\u4e2d\u63d0\u53d6\u7b49\uff09\u3002<\/span><\/span><\/p>\n

4.<\/span>\u5bf9\u5916\u56fd<\/span>API<\/span>\u751f\u4ea7\u8005\uff0c\u8be5\u4f01\u4e1a\u7f8e\u56fd\u4ee3\u7406\u548c<\/span>\/<\/span>\u6216\u8fdb\u53e3\u5546<\/span>\/<\/span>\u7ecf\u9500\u5546\u7684\u540d\u79f0\uff0c\u5934\u8854\uff0c\u5b8c\u6574\u7684\u90ae\u4ef6\u6295\u5bc4\u5730\u5740\uff0c\u7535\u8bdd\u548c\u4f20\u771f\u53f7\u7801\u3002<\/span><\/span><\/p>\n

5.<\/span>\u5bf9\u5916\u56fd<\/span>API<\/span>\u751f\u4ea7\u8005\uff0c\u5e94\u62a5\u544a\u8fc7\u53bb\u4e09\u5e74\u8fdb\u53e3\u5230\u7f8e\u56fd\u7684\u6240\u6709\u539f\u6599\u836f\uff0c\u5b83\u4eec\u7684\u7ecf\u9500\u4eba\uff0c\u5411\u8fd9\u4e9b\u7ecf\u9500\u4eba\u8fd0\u9001\u7684\u6570\u91cf\u548c\u9891\u6b21\u7684\u4f30\u8ba1\u503c<\/span>.<\/span><\/span><\/p>\n

6.<\/span>\u5bf9\u6240\u68c0\u67e5\u7684\u533a\u57df<\/span>\/<\/span>\u5de5\u827a\u7684\u63cf\u8ff0\uff08\u5373\uff0c\u68c0\u67e5\u4e86\u90a3\u4e9b\u533a\u57df\uff0c\u7cfb\u7edf\u548c\u5de5\u827a\uff0c\u4e0e\u8c01\u89c1\u4e86\u9762\uff0c\u5728\u68c0\u67e5\u65f6\u6b63\u5728\u8fdb\u884c\u4ec0\u4e48\u751f\u4ea7\u6d3b\u52a8\uff09\u3002<\/span><\/span><\/p>\n

7.<\/span>\u5bf9\u8be5\u4f01\u4e1a\u6240\u6709\u975e\u836f\u54c1\u751f\u4ea7\u6d3b\u52a8\u7684\u63cf\u8ff0\uff0c\u5982\uff0c\u5728\u5904\u7406\u6740\u866b\u5242\u6216\u5176\u5b83\u6709\u6bd2\u7684\u5316\u5b66\u7269\u8d28\u3002\u5982\u679c\u5728\u540c\u4e00\u5382\u623f\u5185\u548c<\/span>\/<\/span>\u6216\u8bbe\u5907\u5185\u52a0\u5de5\u4e86\u975e\u836f\u54c1\uff0c\u62a5\u544a\u8be5\u4f01\u4e1a\u6240\u91c7\u53d6\u7684\u9632\u6b62\u6216\u51cf\u5c11\u4ea4\u53c9\u6c61\u67d3\u53ef\u80fd\u63aa\u65bd\u3002<\/span><\/span><\/p>\n

8.<\/span>\u5bf9\u6240\u6709<\/span>API<\/span>\u5fae\u7c89\u6216\u7c89\u788e\u64cd\u4f5c\u7684\u63cf\u8ff0\uff0c\u4e0d\u8bba\u662f\u4f01\u4e1a\u81ea\u5df1\u8fdb\u884c\u7684\u8fd8\u662f\u7531\u5408\u540c\u5fae\u7c89\u5546\u8fdb\u884c\u7684\u3002\u5168\u9762\u63cf\u8ff0\u8be5\u4f01\u4e1a\u91c7\u53d6\u7684\u9632\u6b62\u6216\u51cf\u5c11\u6f5c\u5728\u7684\u4ea4\u53c9\u6c61\u67d3\u7684\u63aa\u65bd\u3002\u5728\u5bf9\u5408\u540c\u5fae\u7c89\u5546\u68c0\u67e5\u65f6\uff0c\u8981\u83b7\u5f97\u4e00\u4efd\u5b8c\u6574\u7684\u6240\u6709\u5fae\u7c89\u5316\u539f\u6599\u836f\u7684\u6e05\u5355\u5e76\u62a5\u544a\u8fd9\u4e9b\u539f\u6599\u7684\u6765\u6e90\uff08\u62e5\u6709\u8005\uff09\u3002<\/span><\/span><\/p>\n

9. <\/span>\u8be5\u516c\u53f8\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u5de5\u827a\u9a8c\u8bc1\u65b9\u6848\u7684\u590d\u5370\u4ef6\u3002\u62a5\u544a\u6240\u6709\u9a8c\u8bc1\u52aa\u529b\u7684\u72b6\u51b5\u3002\u5982\u679c\u6ca1\u6709\u5b8c\u6210\uff0c\u5e94\u83b7\u53d6\u5e76\u4e0a\u62a5\u663e\u793a\u4f55\u65f6\u5de5\u827a\u9a8c\u8bc1\u80fd\u591f\u5b8c\u6210\u7684\u4e66\u9762\u65f6\u95f4\u8868\u3002<\/span><\/span><\/p>\n

10. <\/span>\u6309\u7167\u8c03\u67e5\u8fd0\u884c\u624b\u518c\u7684\u8981\u6c42\u62a5\u544a\u6240\u6709\u7684\u4e0d\u826f\u53d1\u73b0\u3002<\/span><\/span><\/p>\n

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

\u53d6\u6837<\/span><\/strong><\/span><\/p>\n

1.<\/span>\u5e94\u6536\u96c6\u539f\u6599\u836f\u7684\u6837\u54c1\u4f9b\u6cd5\u5f8b\u5316\u5b66\u4e2d\u5fc3<\/span>FCC (HFR-MA500)<\/span>\u548c\u4e1c\u5317\u533a\u57df\u5b9e\u9a8c\u5ba4<\/span>(NRL)<\/span>\u68c0\u9a8c\u3002\u8fd9\u4e9b\u6837\u54c1\u4e0d\u5e94\u4e0e\u5236\u5242\u6279\u51c6\u524d\u7684\u7b26\u5408\u6027\u68c0\u67e5\u7a0b\u5e8f<\/span>CP 7346.832<\/span>\u53d6\u5f97\u7684\u539f\u6599\u836f\u76f8\u6df7\u6dc6\u3002<\/span><\/span><\/p>\n

\u53d6<\/span>3<\/span>\u4e2a\u6279\u6b21\uff0c\u6bcf\u6279\u6b21\u5404\u4e24\u4efd\u3002\u6839\u636e\u6210\u672c\uff0c\u6bcf\u4efd\u5e94\u6709<\/span>25 \u2013 50g<\/span>\uff0c\u3002\u968f\u6837\u54c1\u5e94\u9644\u6709\u4e0b\u5217\u6587\u4ef6\uff1a<\/span><\/span><\/p>\n

\u2014\u2014<\/span>API<\/span>\u751f\u4ea7\u6d41\u7a0b\u56fe\u548c\u751f\u4ea7\u5de5\u827a\u7684\u7b80\u8981\u63cf\u8ff0\u3002<\/span><\/span><\/p>\n

\u2014\u2014\u8be5\u539f\u6599\u836f\u7684\u7269\u6599\u5b89\u5168\u6570\u636e\u8868<\/span><\/p>\n

\u2014\u2014\u6bcf\u6279\u5e94\u6709\u4e00\u4efd\u68c0\u9a8c\u8bc1\u4e66<\/span>(COA)<\/span>\uff0c\u53e6\u5916\uff0c\u8fd8\u8981\u5bf9\u751f\u6210\u8be5\u68c0\u9a8c\u8bc1\u4e66\u7684\u8ba1\u7b97\u673a\u7cfb\u7edf\u7684\u63cf\u8ff0\u4ee5\u53ca\u8be5\u4f01\u4e1a\u91c7\u53d6\u7684\u80fd\u907f\u514d\u5458\u5de5\u8bef\u64cd\u4f5c\u4fdd\u8bc1\u8ba1\u7b97\u673a\u6570\u636e\u5b8c\u6574\u6027\u7684\u9884\u9632\u63aa\u65bd\u3002<\/span><\/span><\/p>\n

\u2014\u2014\u4e00\u4efd\u53ef\u80fd\u7684<\/span>\/<\/span>\u5df2\u786e\u5b9a\u7684\u6742\u8d28\u4e13\u8bba\u53ca\u6240\u91c7\u7528\u7684\u65b9\u6cd5\u3002<\/span><\/span><\/p>\n

\u2014\u2014\u5206\u6790\u65b9\u6cd5\uff08\u5982\u679c\u68c0\u67e5\u7275\u6d89\u5230\u4e00\u4e2a\u65b0\u7684\u5316\u5b66\u5355\u4f53\u7684\u8bdd\uff09\u3002<\/span><\/p>\n

2. <\/span>\u5728\u8fdb\u884c\u56fd\u5916\u68c0\u67e5\u9636\u6bb5\uff0c\u5bf9\u68c0\u67e5\u5458\u6765\u8bf4\u91c7\u96c6\u6240\u9700\u7684\u6837\u54c1\u901a\u5e38\u662f\u5f88\u96be\u7684\u3002\u5982\u679c\u91c7\u96c6\u4e0d\u5230\u6837\u54c1\uff0c\u68c0\u67e5\u5458\u5e94\u6307\u5b9a\u6240\u8981\u91c7\u96c6\u7684\u6837\u54c1\u6279\u53f7\uff0c\u5e76\u8981\u6c42\u751f\u4ea7\u5546\u53d6\u6837\u540e\u5c06\u6837\u54c1\u548c\u9644\u5e26\u7684\u8bb0\u5f55\u76f4\u63a5\u5bc4\u7ed9<\/span>FCC<\/span>\u3002<\/span>FCC<\/span>\u4f1a\u51fa\u4e00\u4efd\u5e26\u6ce8\u91ca\u7684\u91c7\u96c6\u62a5\u544a\u5e76\u5c06\u526f\u672c\u548c\u8bb0\u5f55\u590d\u5370\u4ef6\u4ea4\u7ed9<\/span>NRL<\/span>\u3002\u4e5f\u4f1a\u7ed9\u68c0\u67e5\u7ec4\u7ec4\u957f\u53d1\u4e00\u4efd\u4e0a\u8bc9\u4fe1\u606f\u7684\u590d\u5370\u4ef6\u3002<\/span><\/span><\/p>\n

3.<\/span>\u5f53\u6536\u96c6\u7528\u4e8e\u5206\u6790\u7684\u6837\u54c1\u65f6\uff0c\u5e94\u4fdd\u62a4\u5176\u514d\u53d7\u5fae\u91cf\u7684\u6c61\u67d3\u3002\u5728\u6240\u6709\u60c5\u51b5\u4e0b\uff0c\u5747\u907f\u514d\u4f7f\u7528\u91d1\u5c5e\u53d6\u6837\u5319\u3002\u7528\u4e00\u4e2a\u5851\u6599\u5bb9\u5668\u548c\u5c01\u53e3\u6750\u6599\u53d6\u6837\u5e76\u63d0\u4ea4\u4e00\u4e2a\u7a7a\u7684\u5bb9\u5668\u4f5c\u4e3a\u7a7a\u767d\u6837\uff0c\u5982\u679c\u4f7f\u7528\u4e86\u5851\u6599\u53d6\u6837\u5319\uff0c\u4e5f\u4e0a\u4ea4\u4e00\u4e2a\u672a\u7528\u8fc7\u7684\u53d6\u6837\u5319\u4f5c\u4e3a\u7a7a\u767d\u6837\u3002\u7528\u6837\u54c1\u7f16\u53f7\uff0c\u4ea7\u54c1\u540d\u79f0\u548c\u6279\u53f7\uff0c\u751f\u4ea7\u8005\uff0c\u65e5\u671f\u548c\u53d6\u6837\u4eba\u6807\u8bc6\u6837\u54c1\u3002\u5728\u53d6\u6837\u8fc7\u7a0b\u4e2d\u8981\u6234\u4e00\u6b21\u6027\u7684\u6ca1\u6709\u6ed1\u77f3\u7c89\u7684\u805a\u4e59\u70ef\u624b\u5957\u3002\u6700\u4f73\u7684\u53d6\u6837\u65b9\u6cd5\u662f\u76f4\u63a5\u53d6\u6837\uff0c\u5e76\u5728\u53d6\u5b8c\u4e00\u4e2a\u6837\u54c1\u65f6\u66f4\u6362\u624b\u5957\u3002<\/span><\/span><\/p>\n

4.<\/span>\u5e94\u5efa\u7acb\u4e00\u4e2a\u8d34\u7b7e<\/span>\/<\/span>\u5bb9\u5668\u6cd5\u5f8b\u6570\u636e\u5e93\uff0c\u5728\u5bf9\u5916\u56fd\u4f01\u4e1a\u68c0\u67e5\u65f6\u5e94\u83b7\u5f97\u4e0b\u5217\u4fe1\u606f\u3002\u7528\u4f01\u4e1a\u7684\u540d\u79f0\uff0c\u4e2d\u5fc3\u6863\u6848\u53f7<\/span>(CF Number),<\/span>\u548c\u8857\u9053\u5730\u5740\u5e76\u5c06\u5176\u9001\u81f3<\/span>*FDA\/FCC, BulkDrug Group, HFR-MA500, 1141 Central Pkwy., Cincinnati, Ohio 45202.*<\/span><\/span><\/p>\n

a.<\/span>\u7535\u8bdd\u548c\u4f20\u771f\u53f7\u7801<\/span><\/span><\/p>\n

b.<\/span>\u8054\u7cfb\u4eba\u4e0e\u5934\u8854<\/span><\/span><\/p>\n

c. <\/span>\u7f16\u53f7<\/span>\/<\/span>\u6279\u53f7\u7cfb\u7edf\u7684\u89e3\u91ca<\/span><\/span><\/p>\n

d.<\/span>\u5217\u51fa\u8fc7\u53bb\u4e09\u5e74\u6240\u751f\u4ea7\u7684\u6bcf\u6279<\/span>API<\/span>\u7684\u5b9e\u9645\u6570\u91cf\u3002\u89e3\u91ca\u6279\u53f7\uff08<\/span>batch number<\/span>\uff09\u548c\u7f16\u53f7\uff08<\/span>lot number<\/span>\uff09\u4e4b\u95f4\u7684\u4efb\u4f55\u4e0d\u540c\u4e4b\u5904\u3002\u8be5\u8bb0\u5f55\u5e94\u80fd\u53cd\u5e94\u51fa\u6240\u751f\u4ea7\u7684\u603b\u4ea7\u91cf\u548c\u8fd0\u5230\u7f8e\u56fd\u7684\u6279\u91cf\u3002<\/span><\/span><\/p>\n

e.<\/span>\u63cf\u8ff0\u51c6\u5907\u9500\u5f80\u7f8e\u56fd\u7684\u539f\u6599\u836f\u7684\u5305\u88c5\u7cfb\u7edf\uff0c\u5982\u679c\u6613\u5f97\u7684\u8bdd\u5e94\u5448\u4ea4\u6837\u54c1\u3002\u56e0\u4e3a\u5404\u56fd\u95f4\u7684\u5305\u88c5\u662f\u4e0d\u540c\u7684\u3002<\/span><\/span><\/p>\n

1)<\/span>\u63cf\u8ff0\u5bb9\u5668\u7684\u5c3a\u5bf8\u6216\u7ed9\u5176\u62cd\u7167\u3002\u5982\u679c\u5bb9\u5668\u662f\u5851\u6599\u7684\uff0c\u5217\u51fa\u5176\u989c\u8272\u3002\u8be5\u5bb9\u5668\u7684\u5e95\u548c\u76d6\u662f\u4ec0\u4e48\u6210\u5206\u7684\u3002<\/span><\/span><\/p>\n

2)<\/span>\u63cf\u8ff0\u5c01\u53e3\u7cfb\u7edf\u7684\u5c3a\u5bf8\u6216\u7ed9\u5176\u62cd\u7167\u3002\u5982\u679c\u76d6\u5b50\u662f\u7528\u5c01\u6761\u5bc6\u5c01\u7684\u5417\uff1f\u5982\u679c\u662f\uff0c\u7b80\u8981\u516c\u53f8\u4ee3\u7801\u63cf\u8ff0\u7b80\u8981\u63cf\u8ff0\u76d6\u5b50\uff0c\u4e14\u5176\u662f\u5426\u7531\u72ec\u7279\u7684\u6807\u8bc6\u7b26\u53f7\u3002\u67d0\u4e9b\u516c\u53f8\u5728\u94c5\u5c01\u4e0a\u6709\u53ef\u89c1\u7684\u4ea7\u54c1\u548c<\/span>\/<\/span>\u6216\u516c\u53f8\u4ee3\u7801\u3002<\/span><\/span><\/p>\n

3)<\/span>\u7b80\u8981\u63cf\u8ff0\u5185\u5305\u6750\u6216\u7ed9\u5176\u62cd\u7167\uff08\u53cc\u5c42\u6216\u5355\u5c42\u5851\u6599\u888b\uff09\u53ca\u5185\u5c42\u888b\u7684\u5c01\u53e3\u65b9\u5f0f\u3002<\/span><\/span><\/p>\n

4)<\/span>\u5982\u679c\u5bb9\u6613\u5f97\u5230\u7684\u8bdd\uff0c\u5bf9\u6bcf\u4e00\u79cd\u51fa\u53e3\u7684<\/span>API<\/span>\u63d0\u4f9b\u4e00\u4efd\u5b9e\u9645\u6807\u7b7e\u7684\u6837\u5f20\u3002\u81ea<\/span>1991<\/span>\u5e74\u4ee5\u6765\u8be5\u6807\u7b7e\u8bbe\u8ba1\u6709\u53d8\u66f4\u5417\uff1f\u5982\u679c\u6709\u53d8\u66f4\uff0c\u7b80\u8981\u63cf\u8ff0\u3002\u8be5\u8d34\u7b7e\u6216\u5305\u88c5\u542b\u6709\u4efb\u4f55\u72ec\u7279\u7684\u6807\u8bc6\u5417\uff08\u5373\u5185\u542b\u7684\u6c34\u5370\uff09<\/span><\/span><\/p>\n

\u6ce8\uff1a\u5728\u68c0\u67e5\u65f6\u5e94\u5bf9\u6761\u6b3e<\/span>(4.) (a – d)<\/span>\u8fdb\u884c\u786e\u8ba4\u3002\u7136\u800c\uff0c\u9664\u975e\u8be5\u4f01\u4e1a\u5df2\u51c6\u5907\u4e86<\/span>(4.) (e)<\/span>\u6240\u9700\u7684\u8d44\u6599\u7684\u603b\u7ed3\u62a5\u544a\uff0c\u5426\u5219\uff0c\u5728\u68c0\u67e5\u7ed3\u675f\u524d\u662f\u4e0d\u53ef\u80fd\u83b7\u5f97\u8be5\u6570\u636e\u7684\u3002\u5bf9\u6761\u6b3e<\/span>(4.) (f)<\/span>\u548c\u5176\u4ed6\u6761\u6b3e\u53ef\u80fd\u90fd\u4e00\u6837\u3002\u5982\u679c\u662f\u8fd9\u6837\uff0c\u7ed9\u8be5\u4f01\u4e1a\u4e00\u4efd\u9644\u4ef6<\/span>B<\/span>\u7684\u590d\u5370\u4ef6\uff0c\u5e76\u8981\u6c42\u5176\u8d1f\u8d23\u4eba\u627f\u8bfa\u4ec0\u4e48\u65f6\u5019\u80fd\u5c06\u8be5\u8d44\u6599\u4ea4\u7ed9<\/span>FCC<\/span>\u3002\u5efa\u8bae\u4f7f\u7528\u7279\u5feb\u4e13\u9012\u3002<\/span><\/span><\/p>\n

5.<\/span>\u6536\u96c6\u5728\u68c0\u67e5\u4e2d\u9047\u5230\u7684\u4efb\u4f55\u53ef\u7591\u7684\u52a3\u836f\u548c\u6807\u8bc6\u8d34\u9519\u7684\u6837\u54c1\u5df2\u5bf9\u5176\u52a0\u4ee5\u8bc1\u5b9e\u3002\u6536\u96c6\u88ab\u6000\u7591\u9274\u522b\uff0c\u542b\u91cf\uff0c\u5206\u89e3\uff0c\u6c61\u67d3\u548c<\/span>\/<\/span>\u6216\u8d34\u7b7e\u65b9\u9762\u5b58\u5728\u95ee\u9898\u7684\u5b9e\u7269\u6837\u54c1\u3002<\/span><\/span><\/p>\n

6. <\/span>\u5728\u5bf9\u56fd\u5916\u4f01\u4e1a\u7684\u68c0\u67e5\u4e2d\uff0c\u6536\u96c6<\/span>API<\/span>\u751f\u4ea7\u5546\u6240\u7528\u7684\u975e\u7f8e\u56fd\u836f\u5178\u65b9\u6cd5\u7684\u68c0\u9a8c\u65b9\u6cd5\u7684\u590d\u5370\u4ef6\u3002\u6211\u4eec\u8fd8\u6ca1\u6709\u63a5\u53d7\u5176\u4ed6\u56fd\u5bb6\u7684\u836f\u5178\u6807\u51c6\u3002<\/span><\/span><\/p>\n

7. <\/span>\u5982\u679c\u6000\u7591\u53d7\u5230\u4ea4\u53c9\u6c61\u67d3\uff0c\u91c7\u96c6\u8be5<\/span>API<\/span>\u6837\u54c1\u53ca\u6000\u7591\u662f\u6c61\u67d3\u7269\u7684\u7269\u6599\u7684\u6837\u54c1\u3002\u968f\u540c\u6837\u54c1\u91c7\u96c6\u62a5\u544a<\/span>(C\/R)<\/span>\u9644\u4e0a\u5bf9\u6000\u7591\u7684\u6c61\u67d3\u9014\u5f84\u3001\u6c61\u67d3\u53ef\u80fd\u53d1\u751f\u7684\u673a\u7406\u63cf\u8ff0\u3002\u5728\u91c7\u96c6\u548c\u7ed3\u675f\u540e\u5e94\u91c7\u53d6\u63aa\u65bd\uff0c\u4fdd\u62a4\u7528\u4e8e\u652f\u6301\u4ea4\u53c9\u6c61\u67d3\u7684\u8bc1\u636e\u6837\u54c1\u514d\u53d7\u6c61\u67d3\u3002<\/span><\/span><\/p>\n


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

\u7b2c<\/span><\/strong>IV<\/span><\/strong>\u90e8\u5206\uff0d\u5206\u6790<\/span><\/strong><\/span><\/p>\n

\u5206\u6790\u5b9e\u9a8c\u5ba4<\/span><\/p>\n

1.<\/span>\u5e38\u89c4\u7684\u5316\u5b66\u5206\u6790\uff0c\uff0d\u5bf9\u5728<\/span>PACs 56002F,52R806, 56008A, <\/span>\u548c<\/span> 56008H<\/span>\u8981\u6c42\u91c7\u96c6\u7684\u6837\u54c1\uff0c\u6309\u7167\u9002\u7528\u7684\u7b26\u5408\u6027\u7a0b\u5e8f\u4e2d\u7684\u652f\u6301\u6027\u5b9e\u9a8c\u5ba4\u6307\u5357\u548c<\/span>ORA <\/span>\u5de5\u4f5c\u8ba1\u5212\u8fdb\u884c\u3002<\/span><\/span><\/p>\n

2.<\/span>\u5e38\u89c4\u7684\u5fae\u751f\u7269\u76d1\u6d4b\uff0c\uff0d\u5bf9\u5728<\/span>56002F<\/span>\u548c<\/span>56008A<\/span>\u89c4\u5b9a\u4e0b\u91c7\u96c6\u7684\u6837\u54c1\uff0c\u6309\u7167\u9002\u7528\u7684\u7b26\u5408\u6027\u7a0b\u5e8f\u4e2d\u7684\u652f\u6301\u6027\u5b9e\u9a8c\u5ba4\u6307\u5357\u548c<\/span>ORA <\/span>\u5de5\u4f5c\u8ba1\u5212\u8fdb\u884c\u3002\u76ee\u524d\u7684\u5b9e\u9a8c\u5ba4\u662f<\/span>ATL, MIN, NYK,DEN <\/span>\u548c<\/span> SAN.*<\/span><\/span><\/p>\n

3.<\/span>\u8d28\u8c31\u5316\u5b66\u4ea4\u53c9\u6c61\u67d3\u5206\u6790\uff0d<\/span>NRL, DAL, SRL,DET,DEN, <\/span>\u548c<\/span> LOS<\/span>\u3002\u65e0\u8d28\u8c31\u7684\u5b9e\u9a8c\u5ba4\u5e94\u8981\u6c42\u5176\u81ea\u5df1\u7684\u5730\u65b9\u8d28\u8c31\u5b9e\u9a8c\u5ba4\u548c<\/span>\/<\/span>\u6216\u73b0\u573a\u79d1\u5b66\u5904<\/span>(HFC-140)<\/span>\u786e\u5b9a\u7528\u4e8e\u6d4b\u5b9a\u8be5\u6c61\u67d3\u7684\u9002\u5b9c\u7684<\/span>MS<\/span>\u5b9e\u9a8c\u5ba4\u3002<\/span><\/span><\/p>\n

4. <\/span>\u6297\u751f\u7d20\u5206\u6790<\/span><\/span><\/p>\n

a.       <\/span><\/span>\u7528\u5e73\u677f\u6cd5\u6d4b\u5b9a\u9752\u9709\u7d20\uff1a\u6bb5\u843d<\/span>2<\/span>\u6240\u5217\u7684\u6240\u6709\u5b9e\u9a8c\u5ba4\uff08\u5fae\u751f\u7269\u6d4b\u8bd5\uff09<\/span><\/span><\/p>\n

b.      <\/span><\/span>\u5176\u5b83\u57fa\u4e8e\u5fae\u751f\u7269\u6cd5\u7684\u6297\u751f\u7d20\u5206\u6790<\/span><\/span><\/p>\n

c.       <\/span><\/span>\u5316\u5b66\u5206\u6790<\/span><\/span><\/p>\n

5. <\/span>\u751f\u7269\u6d4b\u5b9a\u6cd5\uff08\u5982\u80f0\u5c9b\u7d20\u548c\u809d\u78f7\u8102\u6d4b\u8bd5\uff09\uff1a\uff0d\u7814\u7a76\u548c\u6d4b\u8bd5\u5904<\/span>(HFD-470)<\/span><\/span><\/p>\n

6. API<\/span>\u4e13\u8bba\u5206\u6790\uff1a<\/span><\/span><\/p>\n

\u2014\u2014\u836f\u54c1\u7684\u8d28\u91cf\u68c0\u9a8c<\/span>(PAC 56008A)<\/span>\u548c\u5728\u56fd\u5185\u751f\u4ea7\u5546\u5904\u91c7\u96c6\u7684\u8fdb\u53e3\u539f\u6599\u6837\u54c1\u8d28\u91cf\u68c0\u9a8c<\/span>(PAC 56008H)<\/span><\/span><\/p>\n

*Northeast Regional Lab (NRL): [NMR, MS, UV, IR]*<\/span><\/p>\n

850 3rd Ave.<\/span><\/p>\n

Brooklyn, NY 11232-1593<\/span><\/p>\n

*Contact: Alfred C. King<\/span><\/p>\n

Tel: (718) 340-7000 (Extension 5067)<\/span><\/p>\n


<\/p>\n

FAX: (718) 340-7003<\/span><\/p>\n


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


<\/p>\n

\u52a3\u836f\u5206\u6790<\/span>(PAC 56008A)<\/span>\u548c\u5728\u56fd\u5185\u751f\u4ea7\u5546\u5904\u91c7\u96c6\u7684\u7528\u4e8e\u6307\u7eb9\u5206\u6790\u7684\u8fdb\u53e3\u539f\u6599\u6837\u54c1<\/span>(PAC 56008H)<\/span>\u3002<\/span><\/span><\/p>\n

Forensic Chemistry Center (FCC)<\/span><\/p>\n

1141 Central Pkwy.<\/span><\/p>\n

Cincinnati, Ohio 45202<\/span><\/p>\n

*Contact: Either Robert Sharpnack (Ext.114) or KarenWolnik (Ext.181)<\/span><\/p>\n

Tel: (513) 684-3505<\/span><\/p>\n

FAX: (513) 684-6082<\/span><\/p>\n

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

\u5206\u6790<\/span><\/p>\n

1.<\/span>\u68c0\u67e5\u6837\u54c1\u7b26\u5408\u9002\u5b9c\u6307\u6807\u7684\u60c5\u51b5\u3002\u5e94\u4f7f\u7528\u6cd5\u5b9a\u7684\u65b9\u6cd5\u8fdb\u884c\u5206\u6790\u6d4b\u8bd5\uff0c\u5f53\u6ca1\u6709\u73b0\u6709\u7684\u6cd5\u5b9a\u65b9\u6cd5\u65f6\uff0c\u4f7f\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u5206\u6790\u65b9\u6cd5\u3002\u89c1\u7b26\u5408\u6027\u653f\u7b56\u6307\u5357<\/span>(CPG) 7152.01<\/span>\u3002<\/span><\/span><\/p>\n

2.<\/span>\u91c7\u7528\u53e6\u4e00\u79cd\u65b9\u6cd5\u786e\u8ba4\u5b58\u5728\u4ea4\u53c9\u6c61\u67d3\uff0c\u5982\u8d28\u8c31\uff08<\/span>MS<\/span>\uff09<\/span>, <\/span>\u7d2b\u5916\u53ef\u89c1\uff08<\/span>Uvvisible<\/span>\uff09\uff0c\u6216\u7ea2\u5916\uff08<\/span>infrared<\/span>\uff09\u3002\u5982\u679c\u5f00\u59cb\u6240\u7528\u7684\u662f\u8272\u8c31\u6cd5\uff0c\u5018\u82e5\u5206\u79bb\u673a\u7406\u4e0d\u540c\uff0c\u4e5f\u53ef\u91c7\u7528\u53e6\u4e00\u79cd\u8272\u8c31\u65b9\u6cd5\uff08\u5982\uff0c<\/span>HPLC,GC, TLC,<\/span>\u7b49\uff09\u3002<\/span><\/span><\/p>\n

3.<\/span>\u5fae\u751f\u7269\u76d1\u6d4b\u5e94\u6309\u7167\u7f8e\u56fd\u836f\u5178<\/span>(USP 23)<\/span>\u7684\u9002\u5b9c\u7ae0\u8282\uff0c\u7b2c<\/span>7<\/span>\u7248\uff0c\u548c<\/span>A.O.A.C.<\/span>\u7b2c<\/span>17<\/span>\u7ae0\u8fdb\u884c\u3002<\/span><\/span><\/p>\n

4. USP<\/span>\u6d4b\u8bd5\u65b9\u6cd5\u5bf9\u68c0\u6d4b\u5916\u56fd\u751f\u4ea7\u7684\u539f\u6599\u5408\u6210\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u6742\u8d28\u53ef\u80fd\u4e0d\u9002\u5408\u3002\u56e0\u6b64\uff0c\u5916\u56fd\u751f\u4ea7\u7684\u539f\u6599\u4e2d\u6742\u8d28\u7684\u9650\u5ea6\u6d4b\u5b9a\u5e94\u4ee5\u5176\u81ea\u5df1\u7684\u5408\u6210\u8def\u7ebf\u4e3a\u57fa\u7840\u3002\u5982\u679c\u7f3a\u4e4f\u8fd9\u7c7b\u8d44\u6599\uff0c\u53ef\u4ee5\u548c\u73b0\u573a\u79d1\u5b66\u5904<\/span>(DFS)<\/span>\uff08<\/span>301-443-3007<\/span>\uff09\u63a5\u6d3d\u5bfb\u6c42\u5e2e\u52a9\u3002<\/span><\/span><\/p>\n

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

\u7b2c<\/span><\/strong>V<\/span><\/strong>\u90e8\u5206\uff0d\u6cd5\u89c4<\/span><\/strong>\/<\/span><\/strong>\u884c\u653f\u7b56\u7565<\/span><\/strong><\/span><\/p>\n

\u6709\u5173\u56fd\u5185\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u7684<\/span>CGMP<\/span>\u65b9\u9762\u7684\u6240\u6709\u8b66\u544a\u4fe1\u5e94\u7ecf\u8fc7<\/span>CDER<\/span>\u5ba1\u6838\u548c\u6279\u51c6\u3002\u89c1<\/span>1995<\/span>\u5e74<\/span>8<\/span>\u6708\u7684<\/span>FDA<\/span>\u6267\u6cd5\u7a0b\u5e8f\u6307\u5357<\/span> 81<\/span>\u9875\uff0c\u7b2c<\/span>4<\/span>\u7ae0\uff0c\u548c<\/span>1994<\/span>\u5e74<\/span>10<\/span>\u6708\u51fa\u7248\u7684<\/span>ORA<\/span>\u8b66\u544a\u4fe1\u53c2\u8003\u6307\u5357\u7b2c<\/span>15<\/span>\u9875\u7b2c\u4e00\u7ae0\u3002<\/span><\/span><\/p>\n

\u5c06\u5bf9\u8b66\u544a\u4fe1\u7684\u5efa\u8bae\u9001\u4ea4\u5230<\/span>CDER<\/span>\u7684\u751f\u4ea7\u548c\u4ea7\u54c1\u8d28\u91cf\u5904<\/span>(HFD-320)<\/span>\uff0c\u7b26\u5408\u6027\u529e\u516c\u5ba4\u3002\u5bf9\u5916\u56fd\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u7684\u8b66\u544a\u4fe1\u5e94\u7531<\/span>CDER<\/span>\u7684\u751f\u4ea7\u548c\u4ea7\u54c1\u8d28\u91cf\u5904<\/span>(HFD-320)<\/span>\u7b7e\u53d1\u3002<\/span><\/span><\/p>\n

\u5f53\u5efa\u8bae\u91c7\u53d6\u6cd5\u5f8b\u884c\u52a8\u65f6\uff0c\u5e94\u7262\u8bb0<\/span>CGMP<\/span>\u89c4\u5b9a<\/span>(21 CFR 210 <\/span>\u548c<\/span> 211)<\/span>\u4e0d\u9002\u7528\u4e8e\u7684\u539f\u6599\u836f\u7684\u751f\u4ea7\u3002\u4f46\u662f\uff0c\u5728\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u6848\u4e2d\u836f\u7269\uff08<\/span>drug<\/span>\uff09\u7684\u5b9a\u4e49\u5305\u542b\u539f\u6599\u836f\uff08<\/span>APIs<\/span>\uff09\u800c\u4e14\u8be5\u6cd5\u6848\u7684<\/span>501(a)(2)(B)<\/span>\u90e8\u5206\u8981\u6c42\u6240\u6709\u836f\u54c1\u5747\u5e94\u6309\u7167\u73b0\u884c\u7684\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u8fdb\u884c\u751f\u4ea7\uff0c\u52a0\u5de5\u3001\u5305\u88c5\u548c\u50a8\u5b58\u3002\u5728\u5bf9\u539f\u6599\u836f\u4e0e\u5236\u5242\u7684\u8981\u6c42\u65b9\u9762\u8be5\u6cd5\u6848\u6ca1\u6709\u533a\u522b\uff0c\u5176\u4e2d\u4efb\u4f55\u4e00\u9879\u4e0d\u80fd\u7b26\u5408<\/span>CGMP<\/span>\u90fd\u88ab\u89c6\u4e3a\u662f\u8fdd\u80cc\u8be5\u6cd5\u6848\u3002<\/span><\/span><\/p>\n

\u56e0\u4e3a\u7f3a\u5c11\u4e13\u95e8\u7528\u4e8e\u539f\u6599\u836f\u7684<\/span>GMP<\/span>\u89c4\u5219\uff0c\u4efb\u4f55\u57fa\u4e8e\u4e0d\u7b26\u5408<\/span>CGMP<\/span>\u6240\u91c7\u53d6\u7684\u6cd5\u5f8b\u884c\u52a8\u5e94\u4e0e\u4ea7\u54c1\u7684\u5b9e\u9645\u6216\u6f5c\u5728\u7684\u504f\u5dee\uff0c\u4ea7\u54c1\u6c61\u67d3\uff0c\u6216\u4ea7\u54c1\u4ea4\u53c9\u6c61\u67d3\uff0c\u6bd4\u5236\u5242\u591a\u7684\u5176\u4ed6\u7279\u6027\u7d27\u5bc6\u7ed3\u5408\u8d77\u6765\u3002\u53e6\u5916\uff0c\u5f53\u5efa\u8bae\u91c7\u53d6\u6cd5\u5f8b\u884c\u52a8\u65f6\uff0c\u5e94\u8003\u8651\u8be5\u539f\u6599\u7684\u5173\u952e\u5c5e\u6027\u3001\u5176\u6cbb\u7597\u65b9\u9762\u7684\u91cd\u8981\u6027\uff0c\u7528\u5176\u914d\u5236\u7684\u5236\u5242\u7c7b\u578b\u3002<\/span><\/span><\/p>\n

\u4e0b\u5217\u6240\u5217\u4e3a<\/span><\/strong>CDER<\/span><\/strong>\u8ba4\u4e3a\u53ef\u4ee5\u7b7e\u53d1\u8b66\u544a\u4fe1\uff0c\u64a4\u9500\u539f\u6279\u51c6\uff0c\u6216\u5176\u5b83\u9002\u5b9c\u7684\u6cd5\u5f8b\u884c\u52a8\u7684\u6709\u4ee3\u8868\u6027\u7684\u4f8b\u5b50\uff1a<\/span><\/strong><\/span><\/p>\n

1.<\/span>\u539f\u6599\u836f\u53d7\u5230\u6c61\u7269\u3001\u81f4\u75c5\u83cc\uff0c\u6bd2\u6027\u5316\u5b66\u7269\u8d28\uff0c\u5176\u4ed6\u5316\u5b66\u7269\u8d28\uff0c\u836f\u7269\u6b8b\u7559\u7269\u7684\u6c61\u67d3\uff0c\u6216\u660e\u663e\u7684\u6f5c\u5728\u6c61\u67d3\uff08\u6709\u7ecf\u8bc1\u660e\u7684\u6c61\u67d3\u9014\u5f84\uff09\u5982\u7a7a\u6c14\u4f20\u64ad\u7269\u8d28\u7684\u6c61\u67d3\u6216\u4ea7\u54c1\u63a5\u89e6\u4e86\u4e0d\u6d01\u51c0\u7684\u8bbe\u5907\u3002<\/span><\/span><\/p>\n

2.<\/span>\u4e0d\u80fd\u8868\u660e<\/span>API<\/span>\u6279\u80fd\u7b26\u5408\u65e2\u5b9a\u7684\u6307\u6807\uff0c\u5982<\/span>NDA, USP,<\/span>\u5ba2\u6237\u7684\u6307\u6807\u548c\u6807\u79f0\u503c\u3002\u89c1\u7b26\u5408\u6027\u653f\u7b56\u6307\u5357<\/span>(CPG) 7132.05<\/span>\u3002<\/span><\/span><\/p>\n

3. <\/span>\u4e0d\u7b26\u5408\u5728\u836f\u7269\u7533\u8bf7\uff0c\u5305\u62ec\u836f\u7269\u4e3b\u6587\u4ef6<\/span>(DMFs)<\/span>\u4e2d\u7684\u627f\u8bfa\u3002\u8fd9\u4e9b\u6587\u4ef6\u5e94\u8be5\u662f\u73b0\u884c\u7684\u548c\u51c6\u786e\u53cd\u5e94\u51fa\u73b0\u884c\u7684\u5408\u6210\u5de5\u827a\uff0c\u6742\u8d28\u4e13\u8bba\uff0c\u548c\u4e0e\u8be5\u539f\u6599\u836f\u751f\u4ea7\u76f8\u5173\u7684\u5176\u5b83\u6307\u6807\u548c\u7a0b\u5e8f\u3002<\/span><\/span><\/p>\n

4. <\/span>\u9500\u552e\u4e86\u4e0d\u7b26\u5408\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u7684\u539f\u6599\u836f\u3002<\/span><\/span><\/p>\n

5.<\/span>\u6ca1\u6709\u786e\u5b9a\u4ea7\u91cf\u548c\u5728\u751f\u4ea7\uff0c\u52a0\u5de5\uff0c\u5305\u88c5\u6216\u50a8\u5b58\u9636\u6bb5\u7ed3\u675f\u65f6\u7684\u6536\u7387\u3002<\/span><\/span><\/p>\n

6.<\/span>\u4e3a\u8fbe\u5230\u7a00\u91ca\u548c\u9690\u533f\u70ed\u539f\u6216\u5176\u4ed6\u6709\u6bd2\u7684\u6c61\u67d3\u76ee\u7684\u800c\u6545\u610f\u8fdb\u884c\u7684\u6df7\u5408\uff0c\u6216\u5c06\u4e0d\u7b26\u5408\u6807\u51c6\u7684\u6279\u4e0e\u4e00\u4e2a\u7b26\u5408\u6807\u51c6\u7684\u6279\u6df7\u5408\u4ee5\u5f97\u5230\u4e00\u4e2a\u7b26\u5408\u6700\u4f4e\u6307\u6807\u7684\u6279\u3002<\/span><\/span><\/p>\n

7.<\/span>\u4e0d\u80fd\u8bc1\u660e\u539f\u6599\u836f\u751f\u4ea7\u4e2d\uff0c\u6240\u7528\u7684\u5de5\u827a\u7528\u6c34\u9002\u5b9c\u4e8e\u9884\u671f\u7684\u7528\u9014\u800c\u4e14\u4e0d\u53ef\u9006\u8f6c\u7684\u5f71\u54cd\u4e86\u836f\u54c1\u8d28\u91cf\u3002<\/span><\/span><\/p>\n

8. <\/span>\u6ca1\u6709\u9a8c\u8bc1\u7528\u4e8e\u539f\u6599\u836f\u7684\u6700\u540e\u5206\u79bb\u3001\u7eaf\u5316\u7684\u5de5\u827a\u7528\u6c34\u7684\u53cd\u6e17\u900f\uff0c\u8d85\u6ee4\uff0c\u53bb\u79bb\u5b50\u6c34\u548c\u84b8\u998f\u6c34\u7cfb\u7edf\u3002<\/span><\/span><\/p>\n

9. <\/span>\u7f3a\u5c11\u6b63\u5f0f\u7684\u539f\u6599\u836f\u751f\u4ea7\u5de5\u827a\u9a8c\u8bc1\u4e66\u9762\u7a0b\u5e8f\u6216\u6ca1\u6709\u6309\u9a8c\u8bc1\u8ba1\u5212\u6267\u884c\u3002<\/span>FDA<\/span>\u5e0c\u671b<\/span>API<\/span>\u751f\u4ea7\u4f01\u4e1a\u5207\u5b9e\u6267\u884c\u6240\u6709\u539f\u6599\u836f\u7684\u9a8c\u8bc1\u8ba1\u5212\u5e76\u6309\u7167\u9a8c\u8bc1\u65b9\u6848\u4e2d\u5236\u5b9a\u7684\u65f6\u95f4\u8868\u548c\u5bf9<\/span>FDA<\/span>\u7684\u627f\u8bfa\u4ee5\u5feb\u6377\u7684\u65b9\u5f0f\u5b8c\u6210\u5de5\u827a\u9a8c\u8bc1\u3002\u56e0\u6b64\uff0c\u5728\u4f01\u4e1a\u73b0\u5df2\u6709\u4e00\u4e2a\u9002\u5b9c\u7684<\/span>API<\/span>\u9a8c\u8bc1\u8ba1\u5212\uff0c\u5305\u62ec\u5408\u7406\u7684\u65f6\u95f4\u5b89\u6392\uff0c\u5e76\u6b63\u5728\u6267\u884c\u8be5\u8ba1\u5212\u65f6\uff0c\u5c31\u4e0d\u5fc5\u91c7\u53d6\u6cd5\u5f8b\u884c\u52a8\u3002<\/span><\/span><\/p>\n

\u5f53\u51fa\u73b0\u4e0b\u5217\u60c5\u51b5\u65f6\u5e94\u91c7\u53d6\u6cd5\u5f8b\u884c\u52a8\uff1a<\/span><\/p>\n

\uff08<\/span>1<\/span>\uff09\u8be5\u4f01\u4e1a\u6ca1\u6709\u5efa\u7acb\u6216\u6ca1\u6709\u6309\u7167\u8ba1\u5212\u5bf9\u539f\u6599\u836f\u8fdb\u884c\u5de5\u827a\u9a8c\u8bc1\uff1b<\/span><\/span><\/p>\n

\uff08<\/span>2<\/span>\uff09\u6709\u8bc1\u636e\u8868\u660e<\/span>API<\/span>\u751f\u4ea7\u5de5\u827a\u4e0d\u518d\u6709\u6548\u2014\u2014\u5373\u7531\u4e8e\u751f\u4ea7\u5de5\u827a\u7684\u53ef\u53d8\u6027\uff0c\u6709\u53cd\u590d\u7684\u6279\u5931\u8d25\uff08\u4ea7\u54c1\u4e0d\u5408\u683c\uff09\uff0c\u5e76\u8bc1\u660e\u8fd9\u4e9b\u5e76\u4e0d\u662f\u7531\u4e8e\u8bbe\u5907\u6545\u969c\u6216\u64cd\u4f5c\u4eba\u5458\u5931\u8bef\u9020\u6210\u7684\u3002<\/span><\/span><\/p>\n

10.<\/span>\u5f53\u5de5\u827a\u5df2\u53d1\u751f\u91cd\u5927\u53d8\u5316\u65f6\uff1b\u5f53\u8be5\u4f01\u4e1a\u7f3a\u5c11\u6742\u8d28\u6982\u51b5\u6570\u636e\u65f6\uff1b\u6216\u6709\u8bc1\u636e\u8868\u660e\u53cd\u590d\u7684\u6279\u5931\u8d25\u662f\u7531\u5de5\u827a\u53d8\u5316\u9020\u6210\u65f6\uff1b\u5bf9\u73b0\u6709\u5de5\u827a\u8fdb\u884c\u4e86\u56de\u987e\u6027\u9a8c\u8bc1\u3002<\/span><\/span><\/p>\n

\u53ef\u63a5\u53d7\u7684\u56de\u987e\u6027\u9a8c\u8bc1\uff1a<\/span><\/p>\n

\u2014\u2014\u4ea7\u54c1\u7684\u5173\u952e\u5c5e\u6027\u548c\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u5df2\u7ecf\u5f97\u5230\u786e\u8ba4\u5e76\u6709\u4e66\u9762\u8bb0\u5f55\u3002<\/span><\/p>\n

\u2014\u2014\u5df2\u786e\u8ba4\u4e86\u5173\u952e\u5de5\u827a\u7684\u63a7\u5236\u6307\u6807\u548c\u63a7\u5236\u65b9\u6cd5\u5e76\u6709\u4e66\u9762\u8bb0\u5f55\u3002<\/span><\/p>\n

\u2014\u2014\u5f71\u54cd<\/span>API<\/span>\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u751f\u4ea7\u539f\u6599\uff0c\u8bbe\u5907\u6216\u5de5\u827a\u6ca1\u6709\u53d1\u751f\u91cd\u5927\u53d8\u66f4\uff0c\u6216\u5f71\u54cd\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\u7684\u5173\u952e\u5de5\u827a\u53c2\u6570\u6ca1\u6709\u53d1\u751f\u91cd\u5927\u53d8\u66f4\u3002<\/span><\/span><\/p>\n

\u2014\u2014\u51e0\u4e4e\u6ca1\u6709\u56e0\u5de5\u827a\u53d8\u5316\u800c\u9020\u6210\u7684\u4ea7\u54c1\u5931\u8d25\u3002<\/span><\/p>\n

\u2014\u2014\u5df2\u5bf9\u73b0\u6709\u7684<\/span>API<\/span>\u5de5\u827a\u5236\u5b9a\u4e86\u5b8c\u6574\u7684\u6742\u8d28\u4e13\u8bba\u3002<\/span><\/span><\/p>\n

\u2014\u2014\u8fc7\u7a0b\u548c\u4ea7\u54c1\u8bd5\u9a8c\u6570\u636e\u8868\u660e\u6279\u4e0e\u6279\u4e4b\u95f4\u6709\u4e00\u81f4\u6027\u3002<\/span><\/p>\n

11.<\/span>\u6ca1\u6709\u5bf9<\/span>API<\/span>\u6700\u7ec8\u6df7\u5408\u64cd\u4f5c\u8fc7\u7a0b\u8fdb\u884c\u9a8c\u8bc1\uff0c\u6765\u8bc1\u660e\u8be5\u6df7\u5408\u64cd\u4f5c\u5bf9\u4ea7\u54c1\u5747\u5300\u6027\u6ca1\u6709\u5f71\u54cd\u3002\u4ece\u800c\u4e5f\u4e0d\u80fd\u5bf9\u5236\u5242\u751f\u4ea7\u4e2d\u7684\u6df7\u5408\u63d0\u4f9b\u5747\u5300\u6027\u6307\u5bfc\u3002\u56e0\u539f\u6599\u836f\u7684\u7c92\u5ea6\u5206\u5e03\uff0c\u8868\u9762\u79ef\uff0c\u6216\u5176\u5b83\u7269\u7406\u7279\u6027\u5bf9\u5236\u5242\u7684\u6eb6\u89e3\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u662f\u975e\u5e38\u5173\u952e\u7684\u3002<\/span><\/span><\/p>\n

12.<\/span>\u6ca1\u6709\u5bf9\u6bcf\u4e00\u4e2a<\/span>API<\/span>\u5de5\u827a\u5236\u5b9a\u6742\u8d28\u4e13\u8bba\u3002<\/span>FDA<\/span>\u5e0c\u671b\u4f5c\u4e3a\u5de5\u827a\u9a8c\u8bc1\u7684\u4e00\u90e8\u5206\uff0c\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u8981\u4e3a\u6bcf\u4e00\u79cd<\/span>API<\/span>\u5efa\u7acb\u6742\u8d28\u4e13\u8bba\u3002<\/span><\/span><\/p>\n

\u8fd9\u5305\u62ec\u6536\u96c6\u4e0b\u5217\u6570\u636e<\/span><\/p>\n

\uff08<\/span>1<\/span>\uff09\u5728<\/span>API<\/span>\u7684\u5408\u6210\u3001\u7eaf\u5316\u548c\u50a8\u5b58\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u4ea7\u751f\u7684\u5b9e\u9645\u6216\u6f5c\u5728\u7684\u6709\u673a\u6742\u8d28\uff1b<\/span><\/span><\/p>\n

\uff08<\/span>2<\/span>\uff09\u5728<\/span>API<\/span>\u5de5\u827a\u4e2d\u53ef\u80fd\u4ea7\u751f\u7684\u65e0\u673a\u6742\u8d28\uff1b<\/span><\/span><\/p>\n

\uff08<\/span>3<\/span>\uff09\u5df2\u77e5\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4f1a\u5e26\u5230<\/span>API.<\/span>\u4e2d\u53bb\u7684\u6709\u673a\u548c\u65e0\u673a\u6eb6\u5242\u3002<\/span><\/span><\/p>\n

\u5728\u5bf9\u6bcf\u4e00\u6279\u6216\u4e00\u5b9a\u6570\u91cf\u6279\u540e\u8fdb\u884c\u6742\u8d28\u5206\u6790\uff0c\u53ef\u80fd\u4f1a\u68c0\u6d4b\u51fa\u56e0\u6545\u610f\u6216\u975e\u6545\u610f\u6539\u53d8<\/span>API<\/span>\u751f\u4ea7\u5de5\u827a\u800c\u51fa\u73b0\u7684\u65b0\u6742\u8d28\u3002<\/span><\/span><\/p>\n

13.<\/span>\u5982\u679c\u8fdb\u884c\u4e86\u539f\u6599\u836f\u7684\u8fd4\u5de5\uff08<\/span>reprocessing<\/span>\uff09<\/span>\uff0c\u800c\u4e14\u5236\u9020\u8005\u53c8\u7f3a\u5c11\u80fd\u8bc1\u660e\u5bf9\u539f\u6599\u836f\u8fd4\u5de5\u80fd\u4f7f\u8be5\u4ea7\u54c1\u7b26\u5408\u65e2\u5b9a\u6807\u51c6\uff0c\u6307\u6807\u548c\u7279\u6027\u7684\u6570\u636e\u3002<\/span><\/span><\/p>\n

14.<\/span>\u6ca1\u6709\u7528\u9002\u5f53\u7075\u654f\u7684\u5206\u6790\u65b9\u6cd5\u68c0\u6d4b\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u5e26\u5230\u539f\u6599\u836f\u4e2d\u53bb\u7684\u6709\u673a<\/span>\/<\/span>\u65e0\u673a\u6eb6\u5242\u6b8b\u7559\u91cf\u3002<\/span><\/span><\/p>\n

15. <\/span>\u6ca1\u6709\u6b63\u5f0f\u7684\u53d8\u66f4\u63a7\u5236\u7cfb\u7edf\uff0c\u8fdb\u884c\u8bc4\u4ef7\u53ef\u80fd\u4f1a\u5f71\u54cd<\/span>APIs<\/span>\u751f\u4ea7\u548c\u8d28\u91cf\u7684\u7ec4\u5206\u3001\u5382\u623f\u8bbe\u65bd\u3001\u652f\u6301\u7cfb\u7edf\u3001\u8bbe\u5907\u3001\u52a0\u5de5\u6b65\u9aa4\u548c\u5305\u88c5\u6750\u6599\u65b9\u9762\u7684\u53d8\u66f4\u3002<\/span><\/span><\/p>\n

16.<\/span>\u6279\u8bb0\u5f55\u6ca1\u6709\u4e0b\u5217\u5185\u5bb9\uff0c\u5305\u62ec\uff1a<\/span><\/span><\/p>\n

\u2014\u2014\u751f\u4ea7\u65e5\u671f<\/span><\/p>\n

\u2014\u2014\u4ea7\u91cf<\/span><\/p>\n

\u2014\u2014\u6279\u53f7<\/span><\/p>\n

\u2014\u2014\u6d4b\u8bd5\u7ed3\u679c\u4e0e\u65e5\u671f<\/span><\/p>\n

\u2014\u2014\u8d34\u7b7e\u8bb0\u5f55\u548c\u6240\u7528\u7684\u6807\u7b7e\u6837\u5f20<\/span><\/p>\n

\u2014\u2014\u8d1f\u8d23\u5b8c\u6210\u5173\u952e\u64cd\u4f5c\u6b65\u9aa4\u7684\u4eba\u5458\u7b7e\u540d\uff0c\u5305\u62ec\uff1a<\/span><\/p>\n

\u2014\u2014\u786e\u5b9a\u4ea7\u7387<\/span><\/p>\n

\u2014\u2014\u68c0\u67e5\u8d34\u7b7e\u5bb9\u5668\u4e0a\u6807\u7b7e\u7684\u6b63\u786e\u6027<\/span><\/p>\n

\u2014\u2014\u4e3a\u786e\u8ba4\u7b26\u5408\u6307\u6807\u800c\u8fdb\u884c\u7684\u6d4b\u8bd5<\/span><\/p>\n

\u2014\u2014\u6df7\u5408\uff0c\u5982\u9700\u8981<\/span><\/p>\n

\u2014\u2014\u786e\u4fdd\u7b26\u5408\u65e2\u5b9a\u7684\u751f\u4ea7\u7a0b\u5e8f<\/span><\/p>\n

\u2014\u2014\u8bc4\u5ba1\u751f\u4ea7\u548c\u68c0\u6d4b\u8bb0\u5f55\u5e76\u6279\u51c6\u4ea7\u54c1\u653e\u884c\u9500\u552e\u3002<\/span><\/p>\n

17.<\/span> <\/span>\u6ca1\u6709\u6309\u6279\u53f7\u8bb0\u5f55\u9500\u552e\u60c5\u51b5\uff0c\u4ee5\u4fbf\u53ef\u4ee5\u53ca\u65f6\u53ec\u56de\u3002<\/span><\/span><\/p>\n

18. <\/span>\u7a33\u5b9a\u6027\u7814\u7a76\u8d44\u6599\u4e0d\u5b8c\u5584\uff0c\u4ece\u800c\u4e0d\u80fd\u786e\u4fdd\u4ea7\u54c1\u5728\u4f7f\u7528\u671f\u9650\u5185\u8d28\u91cf\u7a33\u5b9a\u7684\u8981\u6c42\uff1b\u6216\u6ca1\u6709\u5bf9\u539f\u6599\u836f\u8fdb\u884c\u5f3a\u964d\u89e3\u8bd5\u9a8c\uff0c\u4ee5\u4fbf\u5bf9\u539f\u6599\u836f\u5728\u8d2e\u5b58\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u4ea7\u751f\u7684\u6f5c\u5728\u964d\u89e3\u7269\u8fdb\u884c\u5206\u79bb\uff0c\u9274\u522b\u3002\u9664\u6297\u751f\u7d20\uff0c\u653e\u5c04\u6027\u836f\u54c1\u548c\u6709\u6548\u671f\u4e3a\u4e8c\u5e74\u6216\u5c0f\u4e8e\u4e24\u5e74\u7684\u539f\u6599\u836f\u5916\uff0c\u662f\u4e0d\u8981\u6c42\u6709\u6548\u671f\u7684\u3002<\/span><\/span><\/p>\n

19. <\/span>\u5b9e\u9a8c\u5ba4\u4f7f\u7528\u4e86\u4e0d\u6b63\u786e\u7684\u6216\u6ca1\u6709\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u68c0\u9a8c\u65b9\u6cd5\u3002<\/span><\/span><\/p>\n

20. <\/span>\u5982\u679c\u5b58\u5728<\/span>USP<\/span>\u6807\u51c6\u54c1\uff0c\u6ca1\u6709\u5bf9\u6bcf\u4e00\u6279\u5236\u5907\u7684\u5de5\u4f5c\u54c1\uff08\u7b2c\u4e8c\u5bf9\u7167\u54c1\uff09\u5728\u4f7f\u7528\u524d\u7528<\/span>USP<\/span>\u6807\u51c6\u54c1\u6807\u5b9a\u3002<\/span><\/span><\/p>\n

21.<\/span>\u5728\u5305\u88c5\u548c\u8d34\u7b7e\u64cd\u4f5c\u4e2d\uff0c\u5b58\u5728\u4e25\u91cd\u7684\u9519\u8d34\u6807\u7b7e\u7684\u98ce\u9669\u3002<\/span><\/span><\/p>\n

22. <\/span>\u6ca1\u6709\u5411<\/span>FDA<\/span>\u5448\u62a5\u5305\u62ec\u539f\u6599\u5728\u5185\u7684\u6240\u6709\u5546\u4e1a\u9500\u552e\u7684\u836f\u54c1\u6e05\u5355\u3002\u5bf9\u5916\u56fd\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u6765\u8bf4\uff0c\u6ca1\u6709\u5217\u51fa\u51fa\u53e3\u5230\u7f8e\u56fd\u7684\u6216\u610f\u6b32\u51fa\u53e3\u5230\u7f8e\u56fd\u7684\u6240\u6709\u836f\u54c1\u6e05\u5355\u3002\u6709\u5173\u5916\u56fd\u4f01\u4e1a\u836f\u54c1\u6e05\u5355\u8981\u6c42\u7684\u9644\u52a0\u4fe1\u606f\u8bf7\u53c2\u9605<\/span>21 CFR 207.40<\/span>\u3002<\/span><\/span><\/p>\n


<\/p>\n

\u7b2c<\/span>VI<\/span><\/strong>\u90e8\u5206\uff0d\u53c2\u8003\u8d44\u6599\uff0c\u9644\u4ef6\u548c\u8054\u7cfb\u63a5\u89e6\u65b9\u5f0f<\/span><\/span><\/p>\n

\u53c2\u8003\u8d44\u6599\u6216\u6307\u5357<\/span><\/p>\n

1. FDA<\/span>\u5316\u5b66\u539f\u6599\u836f\u68c0\u67e5\u6307\u5357\uff0c<\/span>1994<\/span>\u5e74<\/span>5<\/span>\u6708\u91cd\u65b0\u7f16\u6392\u5e76\u4f5c\u4e86\u5c11\u91cf\u7684\u66f4\u6539\uff0c<\/span>1991<\/span>\u5e74<\/span>9<\/span>\u6708\u3002<\/span><\/span><\/p>\n

2. FDA<\/span>\u65e0\u83cc\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u68c0\u67e5\u6307\u5357\uff0c<\/span>1994<\/span>\u5e74<\/span>7<\/span>\u6708\u3002<\/span><\/span><\/p>\n

3. FDA<\/span>\u751f\u7269\u6280\u672f\u68c0\u67e5\u6307\u5357\uff0c<\/span>1994<\/span>\u5e74<\/span>11<\/span>\u6708\u3002<\/span><\/span><\/p>\n

4. FDA<\/span>\u5173\u4e8e\u539f\u6599\u836f\u7533\u8bf7\u5448\u62a5\u652f\u6301\u6027\u6587\u4ef6\u6307\u5357\uff0c<\/span>1987<\/span>\u5e74<\/span>2<\/span>\u6708\u3002<\/span><\/span><\/p>\n

5. FDA<\/span>\u6267\u6cd5\u7a0b\u5e8f\u6307\u5357\uff0c<\/span>8-10<\/span>\u7ae0<\/span><\/span><\/p>\n

6. FDA<\/span>\u6cd5\u5f8b\u4e8b\u52a1\u529e\u516c\u5ba4\u8b66\u544a\u4fe1\u7d22\u5f15\u6307\u5357\uff0c<\/span>1994<\/span>\u5e74<\/span>10<\/span>\u6708<\/span><\/span><\/p>\n

7. GWQAP<\/span>\u624b\u518c\uff0c\u7b2c\u5341\u4e94\u7ae0\uff0c<\/span>1991<\/span>\u5e74\u4fee\u8ba2\u3002<\/span><\/span><\/p>\n

8. <\/span>\u836f\u54c1\u751f\u4ea7\u68c0\u67e5\u7b26\u5408\u6027\u7a0b\u5e8f\uff0c<\/span>CP 7356.002<\/span><\/span><\/p>\n

9. <\/span>\u201c\u4e0a\u5e02\u6279\u51c6\u524d\u836f\u54c1\u5de5\u827a\u9a8c\u8bc1\u8981\u6c42\u201d\uff0c\u7b26\u5408\u6027\u653f\u7b56\u6307\u5357<\/span>7132c.08 <\/span>\u548c<\/span> 7125.38<\/span>\uff0c<\/span>1993<\/span>\u5e74<\/span>8<\/span>\u6708<\/span>30<\/span>\u65e5\u3002<\/span><\/span><\/p>\n

10. <\/span>\u5bf9\u836f\u5178\u6240\u5217\u4ea7\u54c1\uff0c\u836f\u5178\u8981\u6c42\u6d4b\u8bd5\u7684\u6267\u884c\uff0c\u7b26\u5408\u6027\u653f\u7b56\u6307\u5357<\/span>7132.05<\/span>\uff0c<\/span>1980<\/span>\u5e74<\/span>10<\/span>\u6708\u53d1\u5e03<\/span><\/span><\/p>\n

11.<\/span>\u7f8e\u56fd\u836f\u5178<\/span>\/<\/span>\u56fd\u5bb6\u836f\u5c40\u65b9<\/span>(USP 23\/NF 18)<\/span>\uff0c\u5305\u62ec\u589e\u8865\u672c\u3002<\/span><\/span><\/p>\n

12.<\/span>\u884c\u4e1a\u6307\u5357\u8349\u6848\uff0d\u539f\u6599\u836f\u7684\u751f\u4ea7\uff0c\u52a0\u5de5\u548c\u50a8\u5b58\uff0c<\/span>1996<\/span>\u5e74<\/span>9<\/span>\u6708<\/span>20<\/span>\u65e5\u53d1\u5e03\u4f9b\u8ba8\u8bba\u3002<\/span><\/span><\/p>\n

Office of Regional Operations (ORO)<\/span><\/strong><\/span><\/p>\n

\u5730\u65b9\u8fd0\u4f5c\u529e\u516c\u5ba4<\/span><\/strong>(ORO)<\/span><\/strong><\/span><\/p>\n

1. *Division of Emergency and Investigational Operations,Drug Group (HFC-130), ORO\/DEIO<\/span><\/p>\n

Telephone: (301) 827-5653<\/span><\/p>\n

FAX: (301) 443-6919*<\/span><\/p>\n

2. Division of Field Science (HFC-140), ORO\/DFS<\/span><\/p>\n

Telephone: (301) 443-3007<\/span><\/p>\n

\u6267\u884c\u529e\u516c\u5ba4<\/span><\/strong>(OE)<\/span><\/strong><\/span><\/p>\n

1. Medical Products Quality Assurance Staff (HFC-240),OE\/MPQAS<\/span><\/p>\n

Telephone: (301) 443-3590<\/span><\/p>\n

Center for Drug Evaluation and Research(CDER)<\/span><\/strong><\/span><\/p>\n

\u836f\u7269\u8bc4\u4ef7\u4e0e\u7814\u7a76\u4e2d\u5fc3<\/span><\/strong>(CDER)<\/span><\/strong><\/span><\/p>\n

1.<\/span>\u5bf9\u6709\u5173\u4ea7\u54c1\u8d28\u91cf\uff0c<\/span>CGMP<\/span>\u5b9e\u65bd\uff0c\u548c\u539f\u6599\u836f\u751f\u4ea7\u5de5\u827a\u9a8c\u8bc1\u7684\u4e8b\u5b9c\u63a5\u6d3d\uff1a<\/span><\/span><\/p>\n

Foreign Inspection Team, HFD-322<\/span><\/p>\n

Division of Manufacturing and Product Quality, Office ofCompliance<\/span><\/p>\n

Telephone: (301) 594-0095<\/span><\/p>\n

FAX: (301) 594-2202 or (301) 827-0145<\/span><\/p>\n

\u6cd5\u5f8b\u4e8b\u52a1\u529e\u516c\u5ba4<\/span><\/strong>(ORA)<\/span><\/strong><\/span><\/p>\n

1.<\/span>\u6709\u5173<\/span>API<\/span>\u53d6\u6837\u65b9\u9762\u7684\u95ee\u9898\uff0c\u63a5\u6d3d\uff1a<\/span><\/span><\/p>\n

Food and Drug Administration<\/span><\/p>\n

Forensic Chemistry Center (HFR-MA500)<\/span><\/p>\n

Telephone: (513) 684-3505, FAX: (513) 684-6082<\/span><\/p>\n

Contact either Robert Sharpnack (Ext.114) or Karen Wolnik(Ext.181)*<\/span><\/p>\n

\u7b2c<\/span><\/strong>VII<\/span><\/strong>\u90e8\u5206\uff0d\u4e2d\u5fc3\u7684\u804c\u8d23<\/span><\/strong><\/span><\/p>\n

\u89c1\u836f\u54c1\u5de5\u827a\u68c0\u67e5\u7b26\u5408\u6027\u7a0b\u5e8f<\/span>, 7356.002<\/span>\u3002<\/span><\/span><\/p>\n

\u9644\u4ef6<\/span><\/strong>A<\/span><\/strong><\/span><\/p>\n

\u8fd9\u4efd<\/span>1991<\/span>\u5e74<\/span>9<\/span>\u6708\u51fa\u7248\u7684\u5316\u5b66\u539f\u6599\u836f\u68c0\u67e5\u6307\u5357\u5217\u51fa\u4e86\u5728\u8fdb\u884c\u539f\u6599\u836f\u68c0\u67e5\u4e2d\u5e94\u68c0\u67e5\u7684\u5404\u79cd\u6807\u9898<\/span>\/<\/span>\u8303\u7574\uff0c\u5177\u4f53\u5305\u62ec\u4ee5\u4e0b\u5185\u5bb9\uff1a<\/span><\/span><\/p>\n

A.<\/span>\u68c0\u67e5<\/span><\/span><\/p>\n

1.<\/span>\u5efa\u7b51\u4e0e\u8bbe\u65bd<\/span><\/span><\/p>\n

–<\/span>\u6c61\u67d3\u548c\u4ea4\u53c9\u6c61\u67d3\u63a7\u5236<\/span><\/span><\/p>\n

– <\/span>\u6c34\u7cfb\u7edf\u548c\u5de5\u827a\u7528\u6c34\u5bf9\u5176\u9884\u671f\u7684\u7528\u9014\u662f\u5426\u9002\u5b9c\uff08\u5373\uff0c\u662f\u7528\u4e8e\u65e9\u671f\u6b65\u9aa4\uff0c\u8fd8\u662f\u7528\u4e8e<\/span>API<\/span>\u5de5\u827a\u540e\u671f\u7684\u7eaf\u5316\u7cbe\u5236\u6b65\u9aa4\uff09\u3002<\/span><\/span><\/p>\n

–<\/span>\u65e0\u83cc<\/span>\/<\/span>\u706d\u83cc\u5de5\u827a\uff0c\u5982\u679c\u9002\u7528<\/span>(<\/span>\u89c1<\/span> CP 7356.002A)<\/span><\/span><\/p>\n

2.<\/span>\u8bbe\u5907<\/span><\/span><\/p>\n

–<\/span>\u591a\u7528\u9014\u8bbe\u5907<\/span><\/span><\/p>\n

–<\/span>\u6e05\u6d01\u548c\u4f7f\u7528\u65e5\u5fd7<\/span><\/span><\/p>\n

–<\/span>\u4f4d\u4e8e\u5ba4\u5916\u7684\u8bbe\u5907<\/span><\/span><\/p>\n

–<\/span>\u53d7\u4fdd\u62a4\u7684\u73af\u5883<\/span><\/span><\/p>\n

–<\/span>\u63a5\u89e6\u4ea7\u54c1\u7684\u8868\u9762\u6e05\u6d01\uff0c\u5305\u62ec\u8bbe\u5907\u6e05\u6d01\u65b9\u6cd5\u9a8c\u8bc1\u3002<\/span><\/span><\/p>\n

3.<\/span>\u4eba\u5458\u57f9\u8bad\uff0c\u8d44\u683c\u548c\u7ecf\u5386<\/span><\/span><\/p>\n

4.<\/span>\u539f\u6599<\/span>\/<\/span>\u7ec4\u5206\u548c\u4e2d\u95f4\u4f53<\/span><\/span><\/p>\n

–<\/span>\u5f85\u68c0\uff0c\u5408\u683c\u548c\u4e0d\u5408\u683c\u7269\u6599\u7684\u50a8\u5b58<\/span>\/<\/span>\u5904\u7406\u548c\u63a7\u5236<\/span><\/span><\/p>\n

–<\/span>\u53d6\u6837<\/span>\/<\/span>\u6d4b\u8bd5\u7684\u9002\u5b9c\u6027\u3002<\/span><\/span><\/p>\n

5.<\/span>\u751f\u4ea7\u548c\u8fc7\u7a0b\u63a7\u5236<\/span><\/span><\/p>\n

\u2014\u2014\u6d89\u53ca\u6bcd\u6db2\u518d\u4f7f\u7528\u7684\u63a7\u5236<\/span><\/p>\n

\u2014\u2014\u5bf9<\/span>API<\/span>\u6700\u7ec8\u6df7\u5408\u64cd\u4f5c\u8fc7\u7a0b\u7684\u9a8c\u8bc1\u3002\u56e0\u539f\u6599\u836f\u7684\u7c92\u5ea6\u5206\u5e03\uff0c\u8868\u9762\u79ef\uff0c\u6216\u5176\u5b83\u7269\u7406\u7279\u6027\u5bf9\u5236\u5242\u7684\u6eb6\u89e3\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u662f\u975e\u5e38\u5173\u952e\u7684\u3002<\/span><\/span><\/p>\n

\u2014\u2014<\/span> API<\/span>\u5de5\u827a\u548c\u63a7\u5236\u7a0b\u5e8f\u7684\u9a8c\u8bc1\uff0c\u7279\u522b\u5f3a\u8c03\u7684\u662f\u5bf9<\/span>API<\/span>\u751f\u4ea7\u8fc7\u7a0b\u540e\u671f\u6216\u5c06\u6742\u8d28\u53bb\u9664\u9636\u6bb5\u7684\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u548c\u5408\u6210\u3001\u7eaf\u5316\u6b65\u9aa4\u7684\u9a8c\u8bc1\u3002<\/span><\/span><\/p>\n

\u2014\u2014<\/span> API <\/span>\u8fd4\u5de5\u7a0b\u5e8f\u548c\u6240\u8fdb\u884c\u7684\u8fd4\u5de5\u7c7b\u578b\uff08\u5373\uff0c\u91cd\u590d\u4e00\u6b21\u7ed3\u6676\u6b65\u9aa4\uff09\uff0c\u5305\u62ec\u5176\u662f\u5426\u662f\u5728\u8be5\u4f01\u4e1a\u7684\u7533\u8bf7\u4e2d\u6216<\/span>DMF<\/span>\u4e2d\u7ecf\u8fc7\u6279\u51c6\u7684\u3002<\/span><\/span><\/p>\n

\u2014\u2014\u5de5\u827a\u53d8\u66f4\u63a7\u5236\u7cfb\u7edf<\/span><\/p>\n

\u2014\u2014\u6742\u8d28\u7684\u63cf\u8ff0\u53ca\u63a7\u5236<\/span><\/p>\n

\u2014\u2014<\/span> API<\/span>\u5fae\u7c89\u5316<\/span>\/<\/span>\u7c89\u788e\u7a0b\u5e8f\uff0c\u5305\u62ec\u9632\u6b62\u6c61\u67d3\u7684\u9884\u9632\u6027\u6d4b\u8bd5\u3002<\/span><\/span><\/p>\n

6.<\/span>\u8fc7\u7a0b\u63a7\u5236<\/span><\/span><\/p>\n

\u2014\u2014\u6240\u91c7\u7528\u7684\u9002\u5f53\u7684\u6279\u53d6\u6837\u65b9\u6cd5\u548c\u8bb0\u5f55<\/span><\/p>\n

\u2014\u2014\u6240\u91c7\u7528\u7684\u3001\u8bb0\u5f55\u7684\u7279\u6b8a\u6d4b\u8bd5\u65b9\u6cd5<\/span><\/p>\n

\u2014\u2014\u4eea\u5668\u6821\u6b63\u7684\u9002\u5b9c\u6027<\/span><\/p>\n

7.<\/span>\u5305\u88c5\u4e0e\u8d34\u7b7e\u64cd\u4f5c<\/span><\/span><\/p>\n

\u2014\u2014\u8d34\u7b7e\u63a7\u5236<\/span><\/p>\n

\u2014\u2014\u6279\u53f7\u7cfb\u7edf<\/span><\/p>\n

\u2014\u2014\u786e\u8ba4\u8d34\u7b7e\u7b26\u5408<\/span>SOP<\/span>\u7684\u89c4\u5b9a<\/span><\/span><\/p>\n

8.<\/span>\u6709\u6548\u671f<\/span>\/<\/span>\u53ca\u5176\u518d\u8bc4\u4f30<\/span><\/span><\/p>\n

9.<\/span>\u5b9e\u9a8c\u5ba4\u63a7\u5236<\/span><\/span><\/p>\n

\u2014\u2014\u8fdb\u884c\u68c0\u6d4b\u7684\u80fd\u529b\uff0c\u8bb0\u5f55\u7684\u51c6\u786e\u6027<\/span><\/p>\n

\u2014\u2014\u539f\u6599\u3001\u4e2d\u95f4\u4f53\u3001\u6210\u54c1\u53d6\u6837<\/span>\/<\/span>\u6d4b\u8bd5\u7684\u9002\u5b9c\u6027\uff0c\u5305\u62ec\u5bf9<\/span>API<\/span>\u6742\u8d28\u7684\u6d4b\u8bd5\u3002\u836f\u54c1\u7684\u5bf9\u7167\u54c1\uff08\u6765\u6e90\u3001\u6d4b\u8bd5\u7ed3\u679c\u3001\u4e0e\u6cd5\u5b9a\u6807\u51c6\u54c1\u7684\u7b49\u6548\u6027\uff09<\/span><\/span><\/p>\n

\u2014\u2014\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\uff0c\u9002\u5b9c\u65f6<\/span><\/p>\n

\u2014\u2014\u5728\u53d1\u751f\u975e\u9884\u671f\u7684\u5206\u6790\u7ed3\u679c\u540e\uff0c\u4f01\u4e1a\u4e3a\u4e86\u627e\u51fa\u539f\u56e0\u9632\u6b62\u518d\u6b21\u53d1\u751f\u6240\u91c7\u53d6\u7ea0\u6b63\u63aa\u65bd\u7684\u6548\u679c\uff08\u5982\uff0c\u53e6\u5916\u7684\u8272\u8c31\u56fe\u5cf0\uff0c\u4fdd\u7559\u65f6\u95f4\u6f02\u79fb\uff0c\u5206\u5149\u5149\u5ea6\u6cd5\u6700\u5927\u5cf0\uff0c\u6216\u7194\u70b9\u8303\u56f4\u6539\u53d8\uff09<\/span><\/p>\n

\u2014\u2014\u4f01\u4e1a\u5bf9\u4eea\u5668\u548c\u5176\u5b83\u5b9e\u9a8c\u88c5\u5907\u7684\u8d28\u91cf\u4fdd\u8bc1\u7a0b\u5e8f<\/span><\/p>\n

10.<\/span>\u7a33\u5b9a\u6027\u8bd5\u9a8c\u7a0b\u5e8f<\/span>\/<\/span>\u7559\u6837<\/span><\/span><\/p>\n

11.<\/span>\u8bb0\u5f55\u548c\u62a5\u544a<\/span><\/span><\/p>\n

–<\/span>\u4e66\u9762\u7a0b\u5e8f<\/span><\/span><\/p>\n

–<\/span>\u6279\u8bb0\u5f55\u548c\u5de5\u827a\u6587\u4ef6<\/span><\/span><\/p>\n

–<\/span>\u8ba1\u7b97\u673a\u5316\u5de5\u827a\u548c\u751f\u4ea7\u8bb0\u5f55<\/span><\/span><\/p>\n


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

\u9644\u4ef6<\/span><\/strong>B<\/span><\/strong><\/span><\/p>\n

\u6cd5\u5f8b\u5316\u5b66\u4e2d\u5fc3\u9700\u8981\u5916\u56fd\u539f\u6599\u836f\u751f\u4ea7\u4f01\u4e1a\u63d0\u4f9b\u7684\u8d44\u6599<\/span><\/strong><\/span><\/p>\n

\u8bf7\u5c06\u8d44\u6599\u5bc4\u81f3\uff1a<\/span><\/p>\n

Food and Drug Administration<\/span><\/p>\n

Forensic Chemistry Center (HFR-MA500)<\/span><\/p>\n

Bulk Drug Group<\/span><\/p>\n

1141 Central Parkway<\/span><\/p>\n

Cincinnati, Ohio 45202<\/span><\/p>\n

Tel: (513) 684-3505 (Extension 184)<\/span><\/p>\n

Fax: (513) 684-6082<\/span><\/p>\n

\u5efa\u8bae\u7528\u7279\u5feb\u4e13\u9012\u3002<\/span><\/p>\n

1.<\/span>\u4f01\u4e1a\u540d\u79f0\uff0c\u4e2d\u592e\u6587\u4ef6\u7f16\u53f7\uff0c\u8857\u9053\u5730\u5740\u3002<\/span><\/span><\/p>\n

2.<\/span>\u5b8c\u6574\u7684\u7535\u8bdd\u548c\u4f20\u771f\u53f7\u7801<\/span><\/span><\/p>\n

3<\/span>\u8054\u7cfb\u4eba\u53ca\u5176\u5934\u8854<\/span><\/span><\/p>\n

4. API<\/span>\u6e05\u5355\uff0c\u5e38\u89c4\u6279\u5927\u5c0f\u548c\u6bcf\u5e74\u8fd0\u5230\u7f8e\u56fd\u7684\u6570\u91cf\u3002<\/span><\/span><\/p>\n

5. <\/span>\u6279\u53f7\u7f16\u5236\u6ce8\u91ca<\/span><\/span><\/p>\n

6.<\/span>\u63cf\u8ff0\u51c6\u5907\u9500\u5f80\u7f8e\u56fd\u7684\u539f\u6599\u836f\u7684\u5305\u88c5\u5206\u53e3\u7cfb\u7edf\uff0c\u56e0\u4e3a\u9500\u5f80\u56fd\u5185\u7684\u5305\u88c5\u662f\u4e0d\u540c\u7684\u3002<\/span><\/span><\/p>\n

a)<\/span>\u63cf\u8ff0\u5bb9\u5668\u7684\u5c3a\u5bf8\u3002\u5982\u679c\u5bb9\u5668\u662f\u5851\u6599\u7684\uff0c\u5217\u51fa\u5176\u989c\u8272\u3002\u8be5\u5bb9\u5668\u7684\u5e95\u548c\u76d6\u662f\u4ec0\u4e48\u6210\u5206\u7684\uff1f<\/span><\/span><\/p>\n

b)<\/span>\u63cf\u8ff0\u5c01\u53e3\u7cfb\u7edf\u7684\u5c3a\u5bf8\u6216\u7ed9\u5176\u62cd\u7167\uff0c\u9644\u4e0a\u6837\u54c1\uff08\u5982\u53ef\u80fd\uff09\u3002\u5982\u679c\u76d6\u5b50\u662f\u7528\u6ce2\u7eb9\u5c01\u6761\u5bc6\u5c01\u7684\u5417\uff1f\u5982\u679c\u662f\uff0c\u7b80\u8981\u516c\u53f8\u4ee3\u7801\u63cf\u8ff0\u7b80\u8981\u63cf\u8ff0\u5c01\u6761\uff0c\u4e14\u5176\u662f\u5426\u7531\u72ec\u7279\u7684\u6807\u8bc6\u7b26\u53f7\u3002\u67d0\u4e9b\u516c\u53f8\u5728\u6ce2\u7eb9\u5c01\u94c5\u5c01\u4e0a\u6709\u53ef\u89c1\u7684\u4ea7\u54c1\u548c<\/span>\/<\/span>\u6216\u516c\u53f8\u4ee3\u7801\u3002<\/span><\/span><\/p>\n

c)<\/span>\u7b80\u8981\u63cf\u8ff0\u5185\u5305\u6750\u6216\u7ed9\u5176\u62cd\u7167\uff08\u53cc\u5c42\u6216\u5355\u5c42\u5851\u6599\u888b\uff09\u53ca\u5185\u5c42\u888b\u7684\u5c01\u53e3\u65b9\u5f0f\u3002<\/span><\/span><\/p>\n

d) <\/span>\u5982\u679c\u5bb9\u6613\u5f97\u5230\u7684\u8bdd\uff0c\u5bf9\u6bcf\u4e00\u79cd\u51fa\u53e3\u7684<\/span>API<\/span>\u63d0\u4f9b\u4e00\u4efd\u5b9e\u9645\u6807\u7b7e\u7684\u6837\u5f20\u3002\u81ea<\/span>1991<\/span>\u5e74\u6765\u8be5\u6807\u7b7e\u8bbe\u8ba1\u6709\u53d8\u66f4\u5417\uff1f\u5982\u679c\u6709\u53d8\u66f4\uff0c\u7b80\u8981\u63cf\u8ff0\u3002\u8be5\u8d34\u7b7e\u6216\u5305\u88c5\u542b\u6709\u4efb\u4f55\u72ec\u7279\u7684\u6807\u8bc6\u5417\uff08\u5373\uff0c\u5185\u542b\u7684\u6c34\u5370\uff09<\/span><\/span><\/p>\n

e) <\/span>\u7ed9\u6bcf\u6279\u4ea7\u54c1\u63d0\u4f9b\u4e00\u4efd\u68c0\u9a8c\u8bc1\u4e66<\/span>(COA)<\/span>\u3002\u81ea<\/span>1991<\/span>\u5e74\u6765<\/span>COA<\/span>\u6709\u53d8\u66f4\u5417\uff1f\u5982\u679c\u6709\u53d8\u66f4\uff0c\u7b80\u8981\u63cf\u8ff0\u6216\u63d0\u4f9b\u4e00\u4efd\u6837\u5f20\u3002\u53e6\u5916\uff0c\u8fd8\u8981\u5bf9\u751f\u6210\u8be5\u68c0\u9a8c\u8bc1\u4e66\u7684\u8ba1\u7b97\u673a\u7cfb\u7edf\u7684\u63cf\u8ff0\u4ee5\u53ca\u8be5\u4f01\u4e1a\u91c7\u53d6\u7684\u80fd\u907f\u514d\u5458\u5de5\u8bef\u64cd\u4f5c\u4fdd\u8bc1\u8ba1\u7b97\u673a\u6570\u636e\u5b8c\u6574\u6027\u7684\u9884\u9632\u63aa\u65bd\u3002<\/span><\/span><\/p>\n

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<\/figure>\n
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\u7f8e\u56fdFDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e0e\u975e\u4e34\u5e8a\u7814\u7a76\u8b66\u544a\u4fe1\u6c47\u7f16\uff082008~2017\uff09<\/h2>\n

\u4f5c\u8005\uff1a\u56fd\u5bb6\u98df\u54c1 \u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\uff0c\u4e0a\u6d77\u836f\u54c1\u5ba1\u8bc4\u6838\u67e5\u4e2d\u5fc3\u7ec4\u7ec7\u7f16 \u8bd1<\/p>\n<\/p><\/div>\n

\n
<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

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\n
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<\/figure>\n
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\u7f8e\u56fdFDA\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e0e\u975e\u4e34\u5e8a\u7814\u7a76\u8b66\u544a\u4fe1\u6c47\u7f16\uff082008~2017\uff09<\/h2>\n

\u4f5c\u8005\uff1a\u56fd\u5bb6\u98df\u54c1 \u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\uff0c\u4e0a\u6d77\u836f\u54c1\u5ba1\u8bc4\u6838\u67e5\u4e2d\u5fc3\u7ec4\u7ec7\u7f16 \u8bd1<\/p>\n<\/p><\/div>\n

\n
<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5236\u836f\u5de5\u7a0b\u8bba\u575b <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u56fe\u89e3\u751f\u4ea7\u7ba1\u7406\uff1a5S\u63a8\u8fdb\u6cd5 \u4f5c\u8005\uff1a\uff08\u65e5\uff09\u8d8a\u524d\u884c\u592b \u5f53\u5f53 \u5e7f\u544a \u8d2d\u4e70 \u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1 […]<\/p>\n","protected":false},"author":1,"featured_media":12133,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12132"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=12132"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12132\/revisions"}],"predecessor-version":[{"id":12144,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/12132\/revisions\/12144"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/12133"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=12132"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=12132"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=12132"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}