{"id":81064,"date":"2019-03-20T00:00:50","date_gmt":"2019-04-11T06:45:28","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/81064\/"},"modified":"2019-04-11T14:45:28","modified_gmt":"2019-04-11T06:45:28","slug":"c48b504360","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/81064\/","title":{"rendered":"\u3010\u7f3a\u9677\u5206\u7c7b\u3011FDA \u53ca\u56fd\u5bb6\u5c40\u98de\u68c0\u5b9e\u9a8c\u5ba4\u63a7\u5236\u7f3a\u9677"},"content":{"rendered":"
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<\/strong><\/p>\n

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\n

\n
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\"\u3010\u7f3a\u9677\u5206\u7c7b\u3011FDA<\/p>\n

\n
<\/section>\n
\n

\u95ee\u9898\u95ee\u7b54 FAQ<\/span><\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

1.\u5728\u521d\u59cb\u8c03\u67e5\u4e2d\u65e0\u6cd5\u627e\u5230\u5b9e\u9a8c\u5ba4\u7ed3\u679c\u8d85\u6807\u4e8b\u4ef6\u7684\u6839\u672c\u539f\u56e0\uff0c\u5e0c\u671b\u80fd\u4ecb\u7ecd\u4e00\u4e9b\u5b9e\u7528\u7684\u65b9\u6cd5\u4ee5\u52a9\u4e8e\u8c03\u67e5\u3002<\/span><\/strong><\/p>\n

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<\/p>\n

2.\u5bf9\u4e8eGCHPLC\u9002\u5e94\u6027\u6d4b\u8bd5\uff0cFDA\u6709\u4ec0\u4e48\u5177\u4f53\u8981\u6c42\uff1f<\/span><\/strong><\/p>\n

\u4e0eUSP\u63cf\u8ff0\u7684\u76f8\u540c\uff0cFDA\u8981\u6c42\u6d4b\u8bd5\u62d6\u5c3e\u56e0\u5b50\u3001\u7406\u8bba\u5854\u677f\u6570\u7b49\u7b49\u3002FDA\u5bf9HPLC\u91cd\u590d\u6027\u8bd5\u9a8c\u7684\u8fdb\u6837\u8981\u6c42\u662f\u8fdb5\u9488\u6807\u51c6\u54c1\uff0c\u8ba1\u7b97RSD\uff0cRSD\u5e94\u7b26\u5408\u76f8\u5e94\u7684\u8981\u6c42\u3002<\/span><\/p>\n

3.\u5b9e\u9a8c\u5ba4\u91cc\u5e38\u7528\u4eea\u5668\u5982IR\u3001HPLC\u3001GC\u3001UV\u7b49\u7684\u6821\u6b63\u9891\u7387\uff1f<\/span><\/strong><\/p>\n

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4.\u542b\u91cf\u6d4b\u5b9a\u4e2dUSP\u8981\u6c42UV\u6d4b\u8bd5\uff0c\u4f46\u6548\u679c\u4e0d\u597d\uff0cHPLC\u80fd\u4e0d\u80fd\u66ff\u4ee3UV\uff1f<\/span><\/strong><\/p>\n

USP\u91cc\u6709\u4e00\u4e2a\u7ae0\u8282\u4ecb\u7ecd\u505a\u5206\u6790\u65b9\u6cd5\u7684\u5bf9\u7167\uff0c\u81ea\u5df1\u5236\u5b9a\u53ef\u4ee5\u8bc1\u660eHPLC\u548cUV\u7684\u7ed3\u679c\u4e00\u81f4\u7684\u65b9\u6848\uff0c\u5982\u679c\u9a8c\u8bc1\u65b9\u6848\u7ed3\u679c\u80fd\u786e\u5b9a\u8fd9\u4e00\u70b9\u4e5f\u53ef\u4ee5\u4f7f\u7528HPLC\u7684\u65b9\u6cd5\u3002\u5982\u679c\u80fd\u8bc1\u660e\u4e24\u4e2a\u65b9\u6cd5\u662f\u7b49\u540c\u7684\uff0c\u5176\u5b9e\u4f01\u4e1a\u5185\u90e8\u53ef\u4ee5\u7528HPLC\u8fdb\u884c\u5185\u90e8\u91ca\u653e\u53ca\u5185\u90e8\u63a7\u5236\u3002\u4f46\u662f\u4ea7\u54c1\u51fa\u53e3\u7684\u65f6\u5019\uff0c\u5bf9\u65b9\u6d4b\u8bd5\u65b9\u6cd5\u4e00\u5b9a\u662f\u7528USP\u4e0a\u7684\u65b9\u6cd5\u6765\u786e\u8ba4\u4ea7\u54c1\u662f\u5426\u5408\u683c\u3002<\/span>
<\/p>\n

5.\u662f\u5426\u8981\u8003\u5bdf\u5de5\u4f5c\u6807\u51c6\u54c1\u7684\u7a33\u5b9a\u6027\uff1f<\/span><\/strong><\/p>\n

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6.\u5de5\u4f5c\u6807\u51c6\u54c1\u7684\u5236\u5907\u6709\u54ea\u4e9b\u65b9\u9762\u7684\u8981\u6c42\uff1f<\/span><\/strong><\/p>\n

\u5236\u5907\u6807\u51c6\u54c1\u4e3b\u8981\u7531\u4ea7\u54c1\u672c\u8eab\u7684\u6027\u8d28\u6765\u51b3\u5b9a\uff0c\u6ca1\u6709\u4e00\u4e2a\u901a\u7528\u7684\u65b9\u6cd5\uff0c\u4f46FDA\u8981\u6c42\u5de5\u4f5c\u6807\u51c6\u54c1\u8981\u8fbe\u5230\u4e00\u5b9a\u7684\u6d53\u5ea6\u3002<\/span><\/p>\n

7.\u5b9e\u9a8c\u5ba4\u5bf9\u6837\u54c1\u7684\u6d41\u8f6c\u5982\u4f55\u8fdb\u884c\u63a7\u5236\uff1f<\/span><\/strong><\/p>\n

\u6837\u54c1\u8fdb\u5165\u5b9e\u9a8c\u5ba4\u4ee5\u540e\u901a\u5e38\u5e94\u6709\u4e00\u4e2a\u56fa\u5b9a\u7684\u5730\u65b9\u6765\u5b58\u653e\u6837\u54c1\uff0c\u7136\u540e\u5728\u6536\u6837\u767b\u8bb0\u5355\u4e0a\u8bb0\u5f55\u9001\u6837\u4eba\u53ca\u6536\u6837\u4eba\u3002\u5728\u5927\u7684\u5b9e\u9a8c\u5ba4\u901a\u5e38\u4f1a\u4f7f\u7528\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf\uff0c\u901a\u8fc7\u8fd9\u4e2a\u7cfb\u7edf\u80fd\u5f88\u6e05\u695a\u5730\u8bb0\u5f55\u6837\u54c1\u5728\u5b9e\u9a8c\u5ba4\u91cc\u6574\u4e2a\u6d41\u7a0b\u7ba1\u7406\u3002<\/span><\/p>\n

8.FDA\u68c0\u67e5\u4e2d\u53d1\u73b0\u4f01\u4e1a\u7684HPLC\u6761\u4ef6\u4e2d\uff0c\u6d41\u52a8\u76f8\u6bd4\u4f8b\u53d1\u751f\u53d8\u5316\uff0c\u662f\u5426\u5728\u53d8\u66f4\u524d\u5e94\u5148\u5907\u6848\uff1f<\/span><\/strong><\/p>\n

\u6d41\u52a8\u76f8\u7684\u53d8\u5316\u53ef\u80fd\u5f71\u54cd\u4e24\u4e2a\u65b9\u9762\uff1a\u4e00\u4e2a\u5c31\u662f\u6709\u6548\u6210\u5206\u548c\u964d\u89e3\u6210\u5206\u7684\u5206\u79bb\u5ea6\u53d1\u751f\u53d8\u5316\uff1b\u53e6\u5916\u5c31\u662f\u4fdd\u7559\u65f6\u95f4\u53d1\u751f\u53d8\u5316\uff0c\u901a\u5e38\u53ef\u80fd\u5141\u8bb8\u670910%\u7684\u53d8\u52a8\u3002\u4f46\u662f\u5982\u679c\u6d41\u52a8\u76f8\u6bd4\u4f8b\u53d8\u5316\u4f7fHPLC\u7684\u56fe\u8c31\u90fd\u53d1\u751f\u4e86\u5f88\u5927\u7684\u53d8\u5316\uff0c\u5c31\u9700\u8981\u7533\u62a5\u3002\u5982\u679c\u53d8\u5316\u4e0d\u662f\u5f88\u5927\uff0c\u80fd\u786e\u4fdd\u5206\u79bb\u5ea6\u548c\u4fdd\u7559\u65f6\u95f4\u4e0e\u539f\u6765\u57fa\u672c\u5dee\u4e0d\u591a\uff0c\u5c31\u6ca1\u95ee\u9898\u3002\u56e0\u6b64\u4f01\u4e1a\u8981\u5148\u8bc4\u4f30\u8fd9\u4e00\u70b9\u3002<\/span><\/p>\n

9.\u4ecb\u7ecd\u4e2d\u63d0\u5230\u7684\u201cOOS\u7684\u91cd\u65b0\u6d4b\u8bd5\u4e0d\u5e94\u7531\u539f\u6d4b\u8bd5\u4eba\u5458\u8fdb\u884c\u201d\u662f\u57fa\u4e8e\u4ec0\u4e48\u8003\u8651\u7684\uff1f<\/span><\/strong><\/p>\n

\u5e73\u65f6\u64cd\u4f5c\u4e2d\u8ba4\u4e3a\u8fd8\u662f\u7531\u539f\u6d4b\u8bd5\u4eba\u5458\u91cd\u6d4b\u6bd4\u8f83\u597d\uff08\u91cd\u73b0\u6027\u8f83\u597d\uff09\uff0c\u9664\u975e\u539f\u6d4b\u8bd5\u4eba\u5458\u6709\u64cd\u4f5c\u4e0d\u5f53\u6216\u5931\u8bef\u3002\u91cd\u6d4b\u7684\u76ee\u7684\u4e3b\u8981\u4e0d\u662f\u8bc1\u660e\u5b9e\u9a8c\u4eba\u5458\u4e4b\u95f4\u5dee\u5f02\u7684\u95ee\u9898\uff0c\u800c\u662f\u8bc1\u660e\u5b9e\u9a8c\u7ed3\u679c\u662f\u4e0d\u662f\u8d85\u6807\u3002\u901a\u8fc7\u53e6\u5916\u4e00\u4e2a\u4eba\u6765\u505a\u5b9e\u9a8c\u4e5f\u53ef\u4ee5\u770b\u51fa\u8fd9\u4e2a\u5b9e\u9a8c\u4eba\u5458\u7684\u57f9\u8bad\u60c5\u51b5\u548c\u64cd\u4f5c\u60c5\u51b5\u3002\u7279\u522b\u9700\u8981\u627e\u67d0\u65b9\u9762\u539f\u56e0\u7684\u65f6\u5019\u53ef\u4ee5\u7531\u540c\u4e00\u4e2a\u6d4b\u8bd5\u4eba\u5458\u6765\u505a\uff0c\u8fd9\u4e3b\u8981\u4f9d\u636e\u8c03\u67e5\u7684\u5185\u5bb9\u548c\u8c03\u67e5\u7684\u539f\u56e0\u3002<\/span><\/p>\n

10.\u5982\u679c\u5b9e\u9a8c\u5ba4OOS\u8c03\u67e5\u65e0\u7ed3\u679c\uff0c\u800c\u4e14\u751f\u4ea7\u8fc7\u7a0b\u7684\u8c03\u67e5\u4e5f\u672a\u53d1\u73b0\u5f02\u5e38\uff0c\u8fd9\u6279\u836f\u54c1\u5982\u4f55\u5904\u7406\uff1f<\/span><\/strong><\/p>\n

\u8fd9\u53ef\u80fd\u4f1a\u6709\u4e0d\u540c\u60c5\u51b5\uff0c\u5982\u679c\u4e0d\u80fd\u5f97\u51fa\u7ed3\u8bba\uff0c\u5c31\u9700\u8981\u91cd\u65b0\u6d4b\u8bd5\u3002\u5982\u679c\u91cd\u65b0\u6d4b\u8bd5\u7684\u7ed3\u679c\u8d85\u6807\uff0c\u90a3\u4e48\u8fd9\u6279\u836f\u54c1\u80af\u5b9a\u8981\u88ab\u62d2\u7edd\u3002\u5982\u679c\u5f00\u59cb\u7684\u65f6\u5019\u8d85\u6807\uff0c\u4f46\u662f\u80fd\u8bc1\u660e\u540e\u9762\u7ed3\u679c\u662f\u597d\u7684\uff0c\u8fd9\u6279\u4ea7\u54c1\u4e5f\u53ef\u4ee5\u88ab\u63a5\u53d7\u3002\u6709\u65f6\u5019\u6839\u672c\u539f\u56e0\u627e\u4e0d\u5230\uff0c\u7ed3\u679c\u4e5f\u53ef\u4ee5\u88ab\u63a5\u53d7\u3002\u4f46\u90a3\u4e9b\u60c5\u51b5\u53ef\u4ee5\u62d2\u7edd\uff1f\u4e0d\u540c\u60c5\u51b5\uff0c\u5904\u7406\u65b9\u6cd5\u90fd\u4f1a\u4e0d\u4e00\u6837\u3002<\/span><\/p>\n

\n
\n
\n
\n
\n

2018\u5e74\u56fd\u5bb6\u836f\u76d1\u5c40GMP\u98de\u884c\u68c0\u67e5\u548c\u8ddf\u8e2a\u68c0\u67e5\u516c\u5e03\u7684\u5b9e\u9a8c\u5ba4\u6570\u636e\u53ef\u9760\u6027\u7f3a\u9677\u6c47\u603b\u5982\u4e0b\uff1a<\/span><\/p>\n

\u4e00\u3001\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u4e0d\u7b26\u5408\u8981\u6c42\uff0c\u90e8\u5206\u6570\u636e\u4e0d\u771f\u5b9e<\/span><\/strong><\/span><\/p>\n

\uff08\u4e00\uff09\u897f\u54aa\u66ff\u4e01\u539f\u6599\u836f\u7ea2\u5916\u9274\u522b\u56fe\u8c31201706048\u6279\u3001201706055\u6279\u548c201704003\u6279\u96f7\u540c\uff1b201706017\u6279\u3001201706015\u6279\u96f7\u540c\uff1b201704024\u6279\u3001201704025\u6279\u548c201706037\u6279\u96f7\u540c\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u90e8\u5206\u68c0\u9a8c\u8bbe\u5907\u4e0d\u80fd\u6ee1\u8db3\u73b0\u6709\u4ea7\u54c1\u68c0\u9a8c\u9700\u8981\uff0c\u7ea2\u5916\u4e3b\u673a\u3001HPLC\u4e3b\u673a\u786c\u76d8\u635f\u574f\uff0c\u6570\u636e\u65e0\u5907\u4efd\uff1bGC\u914d\u7f6e\u504f\u4f4e\uff0c\u672a\u914d\u7f6e\u5de5\u4f5c\u7ad9\uff0c\u76f8\u5e94\u56fe\u8c31\u8bb0\u5f55\u65f6\u95f4\u4e0d\u771f\u5b9e\uff0c\u663e\u793a\u4e3a\u201c1909\u5e74\u201d\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u5b9e\u9a8c\u5ba4\u53d1\u73b0\u7a7a\u767d\u4f46\u5df2\u7b7e\u540d\u7684\u539f\u59cb\u68c0\u9a8c\u8bb0\u5f55\u3002<\/span><\/p>\n

\u4e8c\u3001\u4f01\u4e1a\u4e0a\u6b21\u8ddf\u8e2a\u68c0\u67e5\u4e25\u91cd\u7f3a\u9677\u90e8\u5206\u5185\u5bb9\u6574\u6539\u4e0d\u5230\u4f4d<\/span><\/strong><\/span><\/p>\n

1.\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\u5de5\u4f5c\u7ad9\u672a\u5b9e\u884c\u4e09\u7ea7\u6743\u9650\u7ba1\u7406\uff0c\u8bd5\u9a8c\u4eba\u5458\u5747\u4f7f\u7528\u7ba1\u7406\u5458\u8d26\u53f7\u767b\u5f55\u8fdb\u884c\u64cd\u4f5c\uff1b\u8ddf\u8e2a\u5ba1\u67e5\u65e5\u5fd7\u672a\u5f00\u542f\uff1b\u68c0\u9a8c\u6570\u636e\u672a\u8fdb\u884c\u5907\u4efd\uff1bRH-FD-15\u5e73\u65b9\u771f\u7a7a\u51b7\u51bb\u5e72\u71e5\u673a\u53c2\u6570\u63a7\u5236\u7cfb\u7edf\u672a\u8fdb\u884c\u6743\u9650\u8bbe\u7f6e\uff0c\u8fdb\u5165\u673a\u623f\u4eba\u5458\u5747\u53ef\u968f\u610f\u66f4\u6539\u7cfb\u7edf\u53c2\u6570\u3002<\/span><\/p>\n

2.\u9488\u5bf9\u201c\u6210\u54c1\u68c0\u9a8c\u548c\u7a33\u5b9a\u6027\u8003\u5bdf\u68c0\u9a8c\u7684\u7535\u8111\u7cfb\u7edf\u65f6\u95f4\u591a\u6b21\u4fee\u6539\u201d\uff0c\u4f01\u4e1a\u91c7\u53d6\u7684\u6574\u6539\u63aa\u65bd\u4e3a\u4e0d\u51c6\u4fee\u6539\u3001\u52a0\u5f3a\u57f9\u8bad\u7ba1\u7406\u3002\u4f01\u4e1a\u5bf9\u8be5\u7f3a\u9677\u53d1\u751f\u7684\u539f\u56e0\u5206\u6790\u4e0d\u5230\u4f4d\uff0c\u672a\u5bf9\u4fee\u6539\u7cfb\u7edf\u65f6\u95f4\u540e\u68c0\u67e5\u7684\u7a33\u5b9a\u6027\u8003\u5bdf\u6570\u636e\u8fdb\u884c\u5bf9\u6bd4\u5206\u6790\u98ce\u9669\u8bc4\u4f30\uff0c\u6839\u636e\u98ce\u9669\u8bc4\u4f30\u7ed3\u679c\uff0c\u91c7\u53d6\u76f8\u5e94\u7684\u7ea0\u6b63\u9884\u9632\u63aa\u65bd\u8fdb\u884c\u7ea0\u6b63\u3002<\/span><\/p>\n

\u4e09\u3001\u8ba1\u7b97\u673a\u5316\u5206\u6790\u4eea\u5668\u672a\u5efa\u7acb\u4eba\u5458\u767b\u5f55\u3001\u4f7f\u7528\u3001\u6388\u6743\u3001\u53d6\u6d88\u3001\u53d8\u66f4\u7684\u7a0b\u5e8f\u3002<\/span><\/strong><\/span><\/p>\n

\u672a\u89c4\u5b9a\u8d28\u91cf\u53d7\u6743\u4eba\uff08\u8d28\u91cf\u8d1f\u8d23\u4eba\uff09\u3001QC\u5ba4\u4e3b\u4efb\u548c\u64cd\u4f5c\u4eba\u5458\u6743\u9650\u3002\u7f3a\u5c11\u624b\u52a8\u79ef\u5206\u3001\u5220\u9664\u6570\u636e\u3001\u4fee\u6539\u65f6\u95f4\u7684\u63a7\u5236\u63aa\u65bd\u3002<\/span><\/p>\n

\u56db\u3001\u6570\u636e\u7ba1\u7406\u4e0d\u89c4\u8303\u3002<\/span><\/strong><\/span><\/p>\n

\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u4eba\u5458\u4e0d\u660e\u786e\u81ea\u5df1\u7684\u804c\u8d23\u548c\u6743\u9650\uff0c\u65e0\u76f8\u5e94\u7684\u4f7f\u7528\u548c\u7ba1\u7406\u7684\u57f9\u8bad\uff0c\u6ca1\u6709\u5efa\u7acb\u6570\u636e\u5907\u4efd\u4e0e\u6062\u590d\u7684\u64cd\u4f5c\u89c4\u7a0b\uff0c\u672a\u5b9a\u671f\u5bf9\u6570\u636e\u8fdb\u884c\u5907\u4efd\u3002\u539f\u5b50\u5438\u6536\u5149\u8c31\u4eea\u8ba1\u7b97\u673a\u7cfb\u7edf\u65e0\u5ba1\u8ba1\u8ffd\u8e2a\u529f\u80fd\uff0c\u672a\u4f7f\u7528\u5bc6\u7801\u6765\u63a7\u5236\u7cfb\u7edf\u767b\u5f55\uff1bAgilent 1200\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\uff0c\u539f\u836f\u6750\u542b\u91cf\u6d4b\u5b9a\u7684\u56fe\u8c31\u624b\u52a8\u79ef\u5206\u6216\u8005\u6570\u636e\u5e9f\u5f03\u540e\u64cd\u4f5c\u4eba\u5458\u6ca1\u6709\u8bb0\u5f55\u8fc7\u7a0b\uff0c\u672a\u7ecf\u4e3b\u7ba1\u6279\u51c6\u3002<\/span><\/p>\n

\u4e94\u3001\u4f01\u4e1a\u5b58\u5728\u8bb0\u5f55\u4e0d\u771f\u5b9e\u3001\u9009\u62e9\u6027\u4f7f\u7528\u7535\u5b50\u6570\u636e\u7b49\u6570\u636e\u53ef\u9760\u6027\u95ee\u9898\u3002<\/span>
<\/strong><\/span><\/p>\n

\uff08\u4e00\uff09\u4f01\u4e1a\u64c5\u81ea\u5c06\u67b8\u6a7c\u9178\u94c1\u94f5\u7ef4B1\u7cd6\u6d46\u2161\u4e2d\u9632\u8150\u5242\u5bf9\u7f9f\u57fa\u82ef\u7532\u9178\u4e59\u916f\u7684\u6295\u6599\u91cf\u589e\u52a0\u4e3a\u6279\u51c6\u5904\u65b9\u91cf\u76844\u500d\uff0c\u5171\u6d89\u53ca2017\u5e741\u6708\u81f32018\u5e743\u6708\u751f\u4ea7\u768424\u6279\u6b21\u4ea7\u54c1\uff0c\u76f8\u5173\u6279\u6b21\u6279\u751f\u4ea7\u8bb0\u5f55\u53ca\u7269\u6599\u53d1\u653e\u9886\u7528\u7b49\u8bb0\u5f55\u4e0d\u771f\u5b9e\u3002\u5982\uff1a\u6279\u53f7\u4e3a20170201\u7684\u5bf9\u7f9f\u57fa\u82ef\u7532\u9178\u4e59\u916f\u4e8e2017\u5e747\u67084\u65e5\u53d6\u683790\u514b\uff0c\u4f46\u5728\u8d27\u4f4d\u5361\u65e0\u76f8\u5e94\u8bb0\u5f55\uff1b\u5bf9\u7f9f\u57fa\u82ef\u7532\u9178\u4e59\u916f\u7269\u6599\u8fdb\u51fa\u53f0\u8d26\uff082017\u5e743\u670821\u65e5\u81f34\u670824\u65e5\uff09\u4e0e\u4e59\u9187\u8d27\u4f4d\u5361\uff082018\u5e743\u67084\u65e5\u81f329\u65e5\uff09\u4e2d\u4e24\u4f4d\u8bb0\u5f55\u4eba\u7684\u7b7e\u540d\u524d\u540e\u4e0d\u4e00\u81f4\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\uff08\u8bbe\u5907\u7f16\u53f7\uff1aC60015\uff09\u7cfb\u7edf\u4f7f\u7528\u65e5\u5fd7\u663e\u793a\uff0c\u8be5\u516c\u53f8\u4e8e2017\u5e747\u67089\u65e510:06:54\u300110:38:13\u300111:10:30\u300111:43:18\u300112:15:12\u300112:51:34\u300113:43:23\u8fdb\u884c\u4e86\u4e03\u6b21\u8fdb\u9488\u64cd\u4f5c\uff0c\u7528\u4e8e\u6d4b\u5b9a\u5bf9\u7f9f\u57fa\u82ef\u7532\u9178\u4e59\u916f\u7684\u6709\u5173\u7269\u8d28\u9879\u76ee\u3002\u56e010:38:13\u300111:43:18\u4e24\u9488\u7684\u7ed3\u679c\u4e0e\u9884\u671f\u4e0d\u7b26\uff0c\u68c0\u9a8c\u5458\u76f4\u63a5\u5c06\u8be5\u4e24\u6b21\u7ed3\u679c\u9057\u5f03\u800c\u672a\u8fdb\u884c\u8c03\u67e5\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u7ea2\u5916\u5206\u5149\u5149\u5ea6\u8ba1\uff08\u8bbe\u5907\u7f16\u53f7\uff1aC60055\uff09\u64cd\u4f5c\u5458\u5177\u6709\u6e05\u9664\u6570\u636e\u7684\u6743\u9650\uff1b\u539f\u5b50\u5438\u6536\u5206\u5149\u5149\u5ea6\u8ba1\uff08\u8bbe\u5907\u7f16\u53f7\uff1aC60046\uff09\u5b9e\u9a8c\u5458\u5177\u6709\u5220\u9664\u6837\u54c1\u7684\u6743\u9650\uff1bAgilent\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\uff08\u7f16\u53f7\uff1aC60064\uff09\u68c0\u9a8c\u5458\u5177\u6709\u5305\u62ec\u6570\u636e\u5220\u9664\u548c\u7cfb\u7edf\u914d\u7f6e\u7684\u4fee\u6539\u5728\u5185\u7684\u201c\u6240\u6709\u6743\u9650\u201d\u3002<\/span><\/p>\n

\u516d\u3001\u6570\u636e\u53ef\u9760\u6027\u4e0d\u7b26\u5408\u8981\u6c42\uff0c\u5173\u952e\u8bb0\u5f55\u53ca\u6570\u636e\u672a\u4fdd\u5b58\uff0c\u751f\u4ea7\u53ca\u8d28\u91cf\u63a7\u5236\u65e0\u6cd5\u6eaf\u6e90\uff0c\u6587\u4ef6\u8bb0\u5f55\u4e0d\u89c4\u8303\u3002<\/span><\/strong><\/span><\/p>\n

\uff08\u4e00\uff0920151001\u6279\u89e3\u90c1\u5b89\u795e\u9897\u7c92\u65e0\u6279\u751f\u4ea7\u8bb0\u5f55\u53ca\u68c0\u9a8c\u8bb0\u5f55\uff0c20160601\u6279\u89e3\u90c1\u5b89\u795e\u9897\u7c92\u7f3a\u5c11\u5bf9\u5e94\u6279\u6b21\u4e2d\u836f\u996e\u7247\u3001\u6d78\u818f\u3001\u4e2d\u95f4\u4f53\u53ca\u6210\u54c1\u68c0\u9a8c\u7684HPLC\u8272\u8c31\u56fe\u7535\u5b50\u6570\u636e\u3002<\/span><\/p>\n

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\uff08\u4e09\uff09\u7535\u8111\u7cfb\u7edf\u65e0QA\u4eba\u5458\u767b\u5f55\u8d26\u53f7\u3002<\/span><\/p>\n

\u5341\u4e00\u3001\u6570\u636e\u7ba1\u7406\u548c\u6587\u4ef6\u8bb0\u5f55\u3002<\/span>
<\/strong><\/span><\/p>\n

\uff08\u4e00\uff09\u6db2\u76f8\u8272\u8c31\u4eea\uff08SH-10-03\uff09\u5de5\u4f5c\u7535\u8111\u7684\u56de\u6536\u7ad9\u4e2d\u53d1\u73b0\u67092018\u5e745\u670825\u65e5\u5220\u9664\u76842014\u5e743\u6708\u7684\u6800\u5b50\u68c0\u9a8c\u7cfb\u7edf\u9002\u7528\u6027\u8bd5\u9a8c\u6570\u636e\u3002\u4f01\u4e1a\u6574\u6539\u672a\u9488\u5bf9\u9632\u6b62\u5220\u9664\u6570\u636e\u95ee\u9898\u518d\u6b21\u53d1\u751f\u91c7\u53d6\u9884\u9632\u63aa\u65bd\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09QC\u5b9e\u9a8c\u5ba4\u68c0\u9a8c\u53f0\u8d26\u3001\u53d6\u6837\u53f0\u8d26\uff0cQA\u53d8\u66f4\u53f0\u8d26\u3001\u504f\u5dee\u53f0\u8d26\u5747\u4e3aWord\u683c\u5f0f\u7684\u7535\u5b50\u7248\u672c\uff0c\u50a8\u5b58\u4e0a\u8ff0\u53f0\u8d26\u7684\u7535\u8111\u65e0\u6743\u9650\u7ba1\u7406\u8bbe\u7f6e\u3002\u7ecf\u73b0\u573a\u6838\u5bf9\uff0c\u4e2d\u836f\u6750\u68c0\u9a8c\u53f0\u8d26\u4e2d\u90e8\u5206\u6279\u6b21\u68c0\u9a8c\u7ed3\u679c\u9879\u76ee\u4e3a\u7a7a\u767d\uff0c\u68c0\u9a8c\u53f0\u8d26\u4e2d\u90e8\u5206\u4e2d\u836f\u6750\u6279\u6b21\u4fe1\u606f\u4e0e\u539f\u8f85\u6599\u53f0\u8d26\u4e2d\u7684\u76f8\u5e94\u4fe1\u606f\u4e0d\u4e00\u81f4\u3002<\/span><\/p>\n

\u5341\u4e8c\u3001QC\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u4e0d\u7b26\u5408\u8981\u6c42<\/span><\/strong><\/span><\/p>\n

1.\u67e5\u770b6\u6279\u4e94\u7ef4\u4ed6\u53e3\u670d\u6eb6\u6db2\u542b\u91cf\u6d4b\u5b9a\u9ad8\u6548\u6db2\u76f8\u56fe\u8c31\uff0c\u68c0\u6d4b\u524d\u672a\u8fdb\u884c\u8272\u8c31\u6761\u4ef6\u4e0e\u7cfb\u7edf\u9002\u7528\u6027\u5b9e\u9a8c\uff0c\u68c0\u6d4b\u65f6\u5bf9\u7167\u54c1\u548c\u6837\u54c1\u914d\u52361\u4efd\u3001\u8fdb2\u9488\u3002<\/span><\/p>\n

2.\u7269\u6599\u90e8\u5206\u68c0\u6d4b\u9879\u76ee\u59d4\u6258\u9102\u5dde\u5e02\u98df\u54c1\u836f\u54c1\u68c0\u9a8c\u68c0\u6d4b\u4e2d\u5fc3\u68c0\u9a8c\uff0c\u4f46\u73b0\u573a\u4e0d\u80fd\u63d0\u4f9b\u76f8\u5173\u68c0\u6d4b\u62a5\u544a\u3002<\/span><\/p>\n

3.\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4eea\u548c\u7ea2\u5916\u5149\u8c31\u4eea\u7535\u8111\u65f6\u95f4\u672a\u9501\u5b9a\uff0c\u9ad8\u6548\u6db2\u76f8\u4eea\u672a\u8fdb\u884c\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\uff0c\u7ea2\u5916\u5149\u8c31\u4eea\u7535\u8111\u4f7f\u7528\u65e5\u5fd7\u5b58\u5728\u4fee\u6539\u7535\u8111\u65f6\u95f4\u73b0\u8c61\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u4ee5\u4e0a\u56fe\u6587\uff0c\u5982\u6d89\u53ca\u7248\u6743\u95ee\u9898\uff0c<\/span>\u8bf7\u4e0e\u5c0f\u7f16\u8054\u7cfb\u6211\u4eec\u4f1a\u59a5\u5584\u5904\u7406<\/span><\/span><\/strong><\/strong><\/span><\/strong><\/section>\n<\/p>\n

\u65b0\u6cd5\u89c4\u4e0b\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u6587\u4ef6\u7ba1\u7406\u4e0e\u7533\u62a5<\/span>GMP\u7ba1\u7406\u4f53\u7cfb\u7814\u8ba8\u73ed<\/span><\/span><\/span><\/strong><\/p>\n<\/p>\n

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\u4e00\u3001\u836f\u54c1\u7814\u53d1\u6ce8\u518c\u7533\u62a5<\/span>GMP\u7ba1\u7406\u4f53\u7cfb\u6784\u5efa\u8981\u70b9\u89e3\u6790<\/span><\/strong><\/p>\n

\u4e8c\u3001<\/span>Q8Q11\u4e0e\u7533\u62a5CTD\u6587\u4ef6\u7f16\u5199\u8981\u7d20\u89e3\u6790<\/span><\/strong><\/p>\n

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\u56db\u3001<\/span>CTD\u6587\u4ef6\u5404\u6a21\u5757\u7684\u80cc\u666f\u7814\u53d1\u8bc1\u636e\u94fe\u8981\u6c42\u89e3\u6790<\/span><\/strong><\/p>\n

\u4e94\u3001\u836f\u54c1\u7814\u53d1\u8fc7\u7a0b\u4e2d\u7684\u98ce\u9669\u8bc4\u4f30\u4e0e\u9a8c\u8bc1\u7684\u5173\u7cfb<\/span><\/span><\/strong><\/p>\n

1\u98ce\u9669\u8bc4\u4f30\u63a7\u5236\u4f53\u7cfb\u7684\u5efa\u7acb  2\u5de5\u827a\u9a8c\u8bc1\u98ce\u9669\u63a7\u5236\u7b56\u7565<\/span><\/p>\n

3\u836f\u54c1\u7814\u53d1\u8fc7\u7a0b\u53d8\u66f4\u7684\u98ce\u9669\u63a7\u5236<\/span><\/p>\n

\u516d\u3001\u57fa\u4e8e\u751f\u547d\u5468\u671f\u7684\u836f\u54c1\u7814\u53d1\u8fc7\u7a0b\u4e2d\u504f\u5dee\u8c03\u67e5<\/span>OOSOOT\u7ba1\u7406\u8981\u7d20<\/span><\/strong><\/p>\n

1.\u836f\u54c1\u7814\u53d1\u8fc7\u7a0b\u4e2d\u600e\u6837\u505a\u504f\u5dee\u8c03\u67e5OOSOOT\u8c03\u67e5<\/span><\/p>\n

2.\u836f\u54c1\u7814\u53d1\u4e2d\u7684\u504f\u5dee\u662f\u4ec0\u4e48\uff0c\u8981\u586b\u5199\u504f\u5dee\u8c03\u67e5\u8868\u5417\uff1f<\/span><\/p>\n

3.\u504f\u5dee\u8c03\u67e5\u4e0d\u51fa\u539f\u56e0\u600e\u4e48\u529e\uff1f<\/span><\/p>\n

4.\u836f\u54c1\u7814\u53d1\u4e2d\u7684\u504f\u5dee\u5982\u4f55\u5206\u7c7b\uff0c\u600e\u6837\u7ba1\u7406\uff1f<\/span><\/p>\n

\u4e03\u3001\u7814\u53d1\u5b9e\u9a8c\u5ba4\u4f53\u7cfb\u6784\u5efa\u4e0e\u4f53\u7cfb\u8f6c\u79fb\u8981\u7d20\u89e3\u6790<\/span><\/span><\/strong><\/p>\n

1\u57fa\u4e8e\u4e0d\u540c\u4ea7\u54c1\u5206\u7c7b\u7ba1\u7406\u7684\u5b9e\u9a8c\u5ba4\u786c\u4ef6\u5efa\u8bbe\u8981\u70b9<\/span><\/p>\n

2\u57fa\u4e8e\u4e0d\u540c\u4ea7\u54c1\u5206\u7c7b\u7ba1\u7406\u7684\u5b9e\u9a8c\u5ba4\u8f6f\u4ef6\u5efa\u8bbe\u8981\u70b9<\/span><\/p>\n

3\u7814\u53d1\u5b9e\u9a8c\u5ba4\u4f53\u7cfb\u6784\u5efa\u8981\u7d20\u4e0e\u6ce8\u518c\u7533\u62a5<\/span><\/p>\n

4CROCMO\u7814\u53d1\u5b9e\u9a8c\u5ba4\u4f53\u7cfb\u4e0e\u4f53\u7cfb\u8f6c\u79fb\u8981\u7d20\u89e3\u6790<\/span><\/p>\n

\u516b\u3001\u57fa\u4e8e\u98ce\u9669\u8bc4\u4ef7\u7684\u836f\u54c1\u7814\u53d1\u8fc7\u7a0b\u7684\u8d28\u91cf\u5ba1\u8ba1\u5236\u5ea6\u7ba1\u7406\u8981\u7d20<\/span><\/span><\/strong><\/p>\n

\u5218\u8001\u5e08\uff1a<\/span> SFDA\u9ad8\u7814\u9662\u7279\u8058\u8bb2\u5e08\u4ee5\u53ca\u591a\u5bb6\u534f\u4f1a\u7279\u8058\u4e13\u5bb6   \u66fe\u5bf9\u7f57\u6c0f\u3001\u6d77\u738b\u3001\u4e1c\u5317\u5236\u836f\u3001\u4ee5\u5cad\u836f\u4e1a\u3001\u5317\u4eac\u5609\u6797\u3001\u5c71\u4e1c\u745e\u9633\u3001\u8475\u82b1\u836f\u4e1a\u8fdb\u884c\u4f53\u7cfb\u57f9\u8bad\u548c\u6784\u5efa\uff0c\u73b0\u4efb\u5eb7\u6cf0\u751f\u7269\u603b\u7ecf\u7406\u9ad8\u7ea7\u987e\u95ee\uff0c\u6784\u5efa\u751f\u7269\u7c7bGMP\u4f53\u7cfb\u3002<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/section>\n
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<\/section>\n
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\u4e00\u3001<\/span>\u836f\u54c1\u7814\u7a76\u539f\u59cb\u8d44\u6599\u89c4\u8303\u548c\u8d44\u6599\u5f52\u6863\u7ba1\u7406<\/span><\/span><\/strong><\/p>\n

1. <\/span>\u539f\u59cb\u8d44\u6599\u4e0e\u7533\u62a5\u8d44\u6599\u7684\u5173\u7cfb\u89e3\u6790<\/span><\/span><\/p>\n

2. <\/span>\u836f\u54c1\u7814\u53d1\u539f\u59cb\u6863\u6848\u8d44\u6599\u4fdd\u5b58\u5bf9\u4e8e\u836f\u54c1\u7814\u53d1\u7684\u610f\u4e49<\/span><\/span><\/p>\n

3. <\/span>\u5b9e\u9a8c\u7814\u7a76\u539f\u59cb\u6863\u6848\u7684\u7ba1\u7406\u6838\u67e5\u4e2d\u53d1\u73b0\u7684\u95ee\u9898<\/span><\/span><\/p>\n

4. <\/span>\u59d4\u6258\u8bd5\u9a8c\u7684\u6863\u6848\u7ba1\u7406\u6838\u67e5\u4e2d\u53d1\u73b0\u7684\u95ee\u9898<\/span><\/span><\/p>\n

5. <\/span>\u539f\u59cb\u8bb0\u5f55\u6863\u6848\u7ba1\u7406\u5236\u5ea6\u7684\u5efa\u7acb<\/span><\/span><\/p>\n

\u4e8c\u3001\u5982\u4f55\u505a\u597d\u6570\u636e\u5b8c\u6574\u6027<\/span><\/span><\/strong><\/p>\n

1) \u6570\u636e\u5b8c\u6574\u6027\u7684\u524d\u4e16\u4eca\u751f<\/span><\/p>\n

2) 2018\u5e74FDA\u8b66\u544a\u4fe1\u4e2d\u201c\u6570\u636e\u5b8c\u6574\u6027\u201d\u95ee\u9898\u5e26\u7ed9\u7814\u53d1\u7684\u601d\u8003<\/span><\/p>\n

3) \u5982\u4f55\u5728\u4ea7\u54c1\u7814\u53d1\u751f\u547d\u5468\u671f\u4e2d\u4fdd\u8bc1\u6570\u636e\u5b8c\u6574\u6027<\/span><\/p>\n

\u4e09\u3001\u5982\u4f55\u5b8c\u5584\u836f\u5b66\u7533\u62a5\u8d44\u6599<\/span><\/span><\/strong><\/p>\n

1\u7533\u62a5\u8d44\u6599\u57fa\u672c\u8981\u6c42\u4e0e\u5b58\u5728\u95ee\u9898<\/span><\/strong><\/p>\n

a.\u771f\u5b9e\u6027\uff08\u5982\u4f55\u5728\u7533\u62a5\u8d44\u6599\u4e0e\u539f\u59cb\u8bb0\u5f55\u4e2d\u4f53\u73b0\u8bda\u4fe1\u539f\u5219\uff09<\/span><\/p>\n

b.\u4e00\u81f4\u6027\uff08\u5904\u65b9\u548c\u5de5\u827a\u53d8\u66f4\u7684\u5904\u7406\uff09<\/span><\/p>\n

c.\u6570\u636e\u53ef\u9760\u6027<\/span><\/p>\n

d.\u5408\u89c4\u6027\uff08\u76f8\u5173\u6cd5\u89c4\u53c2\u8003\u548c\u6709\u6548\u8d28\u91cf\u4f53\u7cfb\u7684\u5efa\u7acb\uff09<\/span>   <\/span><\/strong><\/p>\n

2\u5173\u8054\u5ba1\u8bc4\u8d44\u6599\u5e38\u89c1\u95ee\u9898\u5206\u6790<\/span><\/strong>        <\/span><\/p>\n

3\u7533\u62a5\u8d44\u6599\u7684\u5185\u90e8\u5ba1\u6838<\/span><\/strong><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a\u738b\u8001\u5e08<\/span> \u7701\u98df\u54c1\u836f\u54c1\u68c0\u9a8c\u9662\u526f\u9662\u957f<\/span> \u836f\u5178\u59d4\u5458<\/span> \u65b0\u836f\u5ba1\u8bc4\u4e13\u5bb6<\/span><\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u4e00\u3001\u4f1a\u8bae\u65f6\u95f4\u5730\u70b9\uff1a<\/span><\/span><\/strong> <\/span><\/p>\n

\u65f6\u95f4\uff1a<\/span>2019\u5e7404\u670819\u65e5-21\u65e5\uff08<\/span>19<\/span>\u65e5\u5168\u5929\u62a5\u5230\uff09<\/span><\/span><\/p>\n

\u5730\u70b9<\/span>: <\/span>\u4e0a\u6d77<\/span><\/span>\u5e02<\/span> \uff08\u5730\u70b9\u786e\u5b9a\u76f4\u63a5\u901a\u77e5\u62a5\u540d\u8005\uff09<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n
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\u4e8c\u3001\u53c2\u4f1a\u5bf9\u8c61<\/span><\/strong><\/span><\/p>\n

\u3000\u5236\u836f\u4f01\u4e1a\u548c\u7814\u53d1\u673a\u6784\u4ece\u4e8b\u836f\u54c1\u7814\u53d1\u3001\u5236\u5242\u7814\u53d1\u3001\u8d28\u91cf\u7814\u7a76\u3001<\/span>QA\u3001QC\u3001\u751f\u4ea7\u4eba\u5458\u3001\u5de5\u827a\u4eba\u5458\u548c\u5de5\u7a0b\u4eba\u5458\uff0c\u9662\u6821\u3001\u79d1\u7814\u9662\u6240\u76f8\u5173\u4eba\u5458\u3002<\/span> <\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n
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\u4e09\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/strong><\/span><\/p>\n

\u4f1a\u52a1\u8d39\uff1a2200\u5143\/\u4eba<\/span><\/p>\n<\/section>\n

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\u4f1a\u8bae\u8d39\u5305\u62ec\uff1a\u4f1a\u8bae\u3001\u7814\u8ba8\u3001\u8d44\u6599\u53ca\u8bba\u6587\u96c6\u3002\u98df\u5bbf\u7edf\u4e00<\/span><\/span>\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u56db\u3001\u8054\u7cfb\u65b9\u5f0f<\/span> <\/span><\/span><\/strong><\/p>\n

\u8054<\/span> \u7cfb<\/span> \u4eba\uff1a\u6f58\u6613<\/span>      panyi2010@126.com   <\/span><\/span><\/strong><\/p>\n

  \u7535  \u8bdd\uff1a13522766753 \uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/span><\/strong><\/p>\n


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