{"id":5543,"date":"2018-06-15T01:00:00","date_gmt":"2018-07-27T07:07:56","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e6%94%b6%e8%97%8f%e4%b8%a8fda%e7%9a%84cgmp%e6%8c%87%e5%8d%97%e3%80%81%e8%ad%a6%e5%91%8a%e4%bf%a1%e3%80%81%e9%97%ae%e7%ad%94%e7%ad%89%e9%80%94%e5%be%84%e9%93%be%e6%8e%a5%e5%a4%a7%e9%9b%86%e5%90%88\/"},"modified":"2018-07-27T15:07:57","modified_gmt":"2018-07-27T07:07:57","slug":"%e6%94%b6%e8%97%8f%e4%b8%a8fda%e7%9a%84cgmp%e6%8c%87%e5%8d%97%e3%80%81%e8%ad%a6%e5%91%8a%e4%bf%a1%e3%80%81%e9%97%ae%e7%ad%94%e7%ad%89%e9%80%94%e5%be%84%e9%93%be%e6%8e%a5%e5%a4%a7%e9%9b%86%e5%90%88","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/5543\/","title":{"rendered":"\u6536\u85cf\u4e28FDA\u7684cGMP\u6307\u5357\u3001\u8b66\u544a\u4fe1\u3001\u95ee\u7b54\u7b49\u9014\u5f84\u94fe\u63a5\u5927\u96c6\u5408"},"content":{"rendered":"
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\"\u6536\u85cf\u4e28FDA\u7684cGMP\u6307\u5357\u3001\u8b66\u544a\u4fe1\u3001\u95ee\u7b54\u7b49\u9014\u5f84\u94fe\u63a5\u5927\u96c6\u5408\"<\/p>\n

\u258d<\/span><\/strong><\/span><\/strong><\/span>\u6765\u6e90\uff1a\u5236\u836f\u5de5\u7a0b\u8bba\u575b<\/span><\/span><\/p>\n

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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>
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FDA\u5bf9GMP\u6cd5\u89c4\u7684\u89e3\u91ca\u9014\u5f84\u7531\u4ee5\u4e0b\u51e0\u79cd\u5f62\u5f0f\u4f53\u73b0\uff0cGMP\u5bfc\u8a00(Preamble)\u3001GMP\u95ee\u7b54\uff08Questions and Answers on cGMP\uff09\u3001\u7b26\u5408\u6027\u7a0b\u5e8f(Compliance Program Manual)\u3001\u68c0\u67e5\u624b\u518c(Inspection Guide)\u3001\u6307\u5357(Guidance)\u3001483 (\u68c0\u67e5\u53d1\u73b0\u7684\u7f3a\u9677)\u3001\u8b66\u544a\u4fe1\u3001\u6cd5\u5ead\u5224\u51b3\u7b49\u3002<\/span><\/p>\n

    \u4e3e\u4f8b\u6765\u8bf4\uff0cGMP\u5bfc\u8a00\u662fFDA\u5728\u51fa\u53f0GMP\u6cd5\u89c4\u65f6\uff0c\u5bf9\u6b64\u524d\u5f81\u96c6\u7684\u4f01\u4e1a\u610f\u89c1\u548c\u95ee\u9898\u6240\u4f5c\u51fa\u7684\u6b63\u5f0f\u56de\u7b54\uff1bFDA\u51fa\u53f0\u8fc7\u56fa\u4f53\u5236\u5242\u3001\u6c34\u7cfb\u7edf\u3001\u5b9e\u9a8c\u5ba4\u7b49\u7b49\u8bf8\u591a\u68c0\u67e5\u624b\u518c\uff0c\u6307\u5bfc\u68c0\u67e5\u5458\u68c0\u67e5\u54ea\u4e9b\u5185\u5bb9\uff0c\u8fd9\u5c31\u76f8\u5f53\u4e8e\u89e3\u91ca\u4e86\u5177\u4f53\u6709\u54ea\u4e9b\u8981\u6c42\uff1bFDA\u51fa\u53f0\u8fc7\u8bf8\u591a\u6307\u5357\u6587\u4ef6\uff0c\u5185\u5bb9\u8986\u76d6GMP\u7684\u65b9\u65b9\u9762\u9762\uff0c\u4f8b\u5982\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\u3001\u5b9e\u9a8c\u5ba4\u8d85\u6807\u7ed3\u679c(OOS)\u5904\u7406\u7684\u6307\u5357\u3001\u65e0\u83cc\u64cd\u4f5c\u6307\u5357\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\u3001\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6307\u5357\u7b49\u7b49\u3002\u8fd9\u4e9b\u6210\u6587\u7684\u5bf9GMP\u7684\u89e3\u91ca\uff0c\u80fd\u591f\u5e2e\u52a9\u4f01\u4e1a\u6765\u7406\u89e3GMP\u6cd5\u89c4\u7684\u8981\u6c42\uff0c\u6309\u7167\u8981\u6c42\u6765\u6267\u884c\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\uff0c\u4ee5\u8fbe\u5230FDA\u7684\u671f\u671b\u3002\u5bf9\u4e8e\u76d1\u7ba1\u5355\u4f4d\u6765\u8bf4\uff0c\u8fd9\u4e9b\u6b63\u5f0f\u7684\u89e3\u91ca\u6709\u52a9\u4e8e\u68c0\u67e5\u5458\u638c\u63e1\u68c0\u67e5\u7684\u8981\u6c42\uff0c\u5e76\u5728\u5b9e\u9645\u68c0\u67e5\u4e2d\u5e94\u7528\u3002\u73b0\u5c06\u5176\u94fe\u63a5\u5982\u4e0b\uff1a<\/span><\/p>\n

 <\/span><\/p>\n

\u4e00\u3001GMP\u5bfc\u8a00(Preamble)<\/span><\/p>\n

1978\u5e74 Preamble\u7684\u4e0b\u8f7d\u5730\u5740\uff1a<\/span><\/p>\n

http:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/CDER\/UCM095852.txt<\/span><\/em><\/span><\/p>\n

2008\u5e74Preamble\u7684\u4e0b\u8f7d\u5730\u5740\uff1a<\/span><\/p>\n

http:\/\/frwebgate.access.gpo.gov\/cgi-bin\/getdoc.cgi?dbname=2008_register&docid=fr08se08-8<\/em><\/span><\/em><\/span><\/em><\/span><\/p>\n

 <\/span><\/p>\n

\u4e8c\u3001GMP\u95ee\u7b54\uff08Questions and Answers on cGMP\uff09<\/span><\/p>\n

http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm124740.htm<\/span><\/em><\/span><\/em><\/span><\/p>\n

 <\/span><\/p>\n

\u4e09\u3001\u7b26\u5408\u6027\u7a0b\u5e8f(Compliance Program Manual)<\/span><\/p>\n

http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm064971.htm<\/span><\/em><\/span><\/em><\/span><\/p>\n

 <\/span><\/p>\n

\u56db\u3001\u68c0\u67e5\u624b\u518c(Inspection Guide)<\/span><\/p>\n

http:\/\/www.fda.gov\/ICECI\/ComplianceManuals\/ComplianceProgramManual\/default.htm#drugs<\/span><\/em><\/span><\/p>\n

 <\/span><\/p>\n

\u4e94\u3001\u6307\u5357(Guidance)<\/span><\/p>\n

http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/default.htm<\/span><\/em><\/span><\/em><\/span><\/p>\n

 <\/span><\/p>\n

\u516d\u3001\u8b66\u544a\u4fe1<\/span><\/p>\n

http:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/default.htm<\/span><\/em><\/span>
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\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":"

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