{"id":82471,"date":"2019-04-12T00:00:50","date_gmt":"2019-04-17T02:53:42","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/82471\/"},"modified":"2019-04-17T10:53:42","modified_gmt":"2019-04-17T02:53:42","slug":"4a03e87f6b","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/82471\/","title":{"rendered":"\u5fc5\u8bfb | \u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u5982\u4f55\u505a\uff1aFDA\u65b0\u6307\u5357\u6709\u8bdd\u8bf4"},"content":{"rendered":"
\n

2017\u5e747\u6708FDA\u9881\u5e03\u4e86\u6307\u5357\u300aAnalytical Procedures and Methods Validation for Drugs and Biologics\u300b<\/strong>\u7684\u7ec8\u7a3f\u6587\u4ef6\uff0c\u8fd9\u4efd\u5173\u952e\u7684\u6307\u5357\u6587\u4ef6\uff0c\u4e3a\u5236\u836f\u884c\u4e1a\u7684\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u63d0\u4f9b\u4e86\u6280\u672f\u6307\u5bfc\u3002\u672c\u6587\u4f5c\u8005\u4e3a\u4e86\u8ba9\u5927\u5bb6\u66f4\u597d\u7684\u7406\u89e3\u548c\u638c\u63e1\u6b64\u6307\u5357\uff0c\u6839\u636e\u5de5\u4f5c\u7ecf\u9a8c\uff0c\u89e3\u8bfb\u5982\u4e0b\uff0c\u4e00\u8d77\u6765\u770b\u4e0b\u5177\u4f53\u8be6\u60c5\u3002<\/span><\/p>\n

\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u4e00\u76f4\u662f\u836f\u54c1\u7814\u53d1\u548c\u8d28\u91cf\u63a7\u5236\u7684\u5173\u952e\u95ee\u9898\uff0c\u4e5f\u662f\u91cd\u70b9\u95ee\u9898\uff0c\u4e00\u76f4\u88ab\u5236\u836f\u884c\u4e1a\u6240\u5173\u6ce8\u3002\u57282015\u5e747\u6708\u4efd\u4e4b\u524d\uff0c\u4e16\u754c\u5404\u56fd\u6cd5\u89c4\u65b9\u9881\u5e03\u4e86\u4e00\u7cfb\u5217\u7684\u76f8\u5173\u6307\u5357\u6216\u8005\u6307\u5bfc\u539f\u5219\uff1a<\/span><\/p>\n

—\u4e2d\u56fdCDE\u9881\u5e03\u7684\u300a\u5316\u5b66\u836f\u7269\u8d28\u91cf\u63a7\u5236\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b;<\/span><\/p>\n

—2015\u7248\u836f\u5178\u9644\u5f55XIX A\u300a\u836f\u54c1\u8d28\u91cf\u6807\u51c6\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219\u300b;<\/span><\/p>\n

—ICH Q2\u300aVALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY\u300b;<\/span><\/p>\n

—FDA\u6307\u5357\u300aAnalytical Procedures and Methods 17 Validation\u300b<\/span><\/p>\n

—FDA\u6307\u5357\u300aGuidelines for Submitting Samples and Analytical Data for Methods Validation\u300b<\/span><\/p>\n

\u57282015\u5e747\u6708\uff0cFDA\u9881\u5e03\u4e86\u6307\u5357\u300aAnalytical Procedures and Methods Validation for Drugs and Biologics\u300b\u7684\u7ec8\u7a3f\u6587\u4ef6\uff0c\u8fd9\u4efd\u5173\u952e\u7684\u6307\u5357\u6587\u4ef6\uff0c\u4e3a\u5236\u836f\u884c\u4e1a\u7684\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u63d0\u4f9b\u4e86\u6280\u672f\u6307\u5bfc\u3002\u4e3a\u4e86\u8ba9\u5927\u5bb6\u66f4\u597d\u7684\u7406\u89e3\u548c\u638c\u63e1\u6b64\u6307\u5357\uff0c\u7b14\u8005\u6839\u636e\u5de5\u4f5c\u7ecf\u9a8c\uff0c\u89e3\u8bfb\u5982\u4e0b\u3002<\/span><\/p>\n

\u8fd9\u90e8\u6307\u5357\u4ecb\u7ecd\u4e86\u5f88\u591a\u5185\u5bb9\uff0c\u5305\u62ec\u8d77\u8349\u80cc\u666f\u3001\u6cd5\u89c4\u8981\u6c42\u3001\u5206\u6790\u65b9\u6cd5\u7684\u7814\u53d1\u3001\u5206\u6790\u65b9\u6cd5\u7684\u5185\u5bb9\u8981\u6c42\u3001\u6807\u51c6\u54c1\u548c\u8bd5\u5242\u7684\u8981\u6c42\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u8981\u6c42\u3001\u7edf\u8ba1\u5206\u6790\u548c\u6a21\u578b\u3001\u5206\u6790\u65b9\u6cd5\u7684\u751f\u547d\u5468\u671f\u7ba1\u7406\u3001\u65b9\u6cd5\u786e\u8ba4\u7684\u5185\u5bb9\u3002\u672c\u6587\u9009\u62e9\u5173\u952e\u70b9\uff0c\u4e3a\u5404\u4f4d\u4ecb\u7ecd\u8fd9\u4efd\u6307\u5357\u7684\u6280\u672f\u8981\u6c42\u3002<\/span><\/p>\n

\u7b2c\u4e00\u90e8\u5206\uff1a\u5206\u6790\u65b9\u6cd5\u7814\u53d1\u7684\u8981\u6c42<\/span><\/p>\n

\u5728\u65b9\u6cd5\u7814\u53d1\u7684\u65e9\u671f\uff0c\u5e94\u5bf9\u65b9\u6cd5\u7684\u8010\u7528\u6027\u8fdb\u884c\u8bc4\u4f30\u548c\u7814\u7a76\uff0c\u56e0\u4e3a\u8be5\u5c5e\u6027\u53ef\u4ee5\u5e2e\u52a9\u7533\u8bf7\u8005\u51b3\u5b9a\u63d0\u4ea4\u54ea\u4e2a\u65b9\u6cd5\u53bb\u83b7\u5f97\u6279\u51c6\u3002\u7814\u53d1\u65e9\u671f\u7684\u5206\u6790\u65b9\u6cd5\u662f\u57fa\u4e8e\u5bf9\u57fa\u7840\u65b9\u6cd5\u5b66\u7684\u4e86\u89e3\u548c\u4e4b\u524d\u7684\u7ecf\u9a8c\u6765\u5efa\u7acb\u7684\u3002\u65e9\u671f\u7a0b\u5e8f\u7684\u5b9e\u9a8c\u6570\u636e\u53ef\u4ee5\u7528\u4e8e\u6307\u5bfc\u8fdb\u4e00\u6b65\u7684\u7814\u53d1\u3002\u5982\u679c\u8fd9\u4e9b\u7814\u53d1\u6570\u636e\u652f\u6301\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\u7684\u8bdd\uff0c\u7533\u8bf7\u8005\u5e94\u8be5\u5728\u65b9\u6cd5\u9a8c\u8bc1\u90e8\u5206\u63d0\u4ea4\u76f8\u5173\u7684\u7814\u53d1\u6570\u636e\u3002<\/span><\/p>\n

\u4e3a\u4e86\u5168\u9762\u4e86\u89e3\u5206\u6790\u65b9\u6cd5\u53c2\u6570\u53d8\u66f4\u7684\u5f71\u54cd\uff0c\u7533\u8bf7\u8005\u5e94\u8be5\u91c7\u7528\u4e00\u4e2a\u7cfb\u7edf\u7684\u65b9\u6cd5\u8fdb\u884c\u65b9\u6cd5\u8010\u7528\u6027\u7814\u7a76(\u4f8b\u5982\u8bbe\u8ba1\u4e00\u4e2a\u65b9\u6cd5\u53c2\u6570\u5b9e\u9a8c)\u3002\u5f00\u59cb\u7533\u8bf7\u8005\u5e94\u91c7\u7528\u98ce\u9669\u8bc4\u4f30\uff0c\u7136\u540e\u8fdb\u884c\u591a\u53d8\u91cf\u5b9e\u9a8c\u3002\u8fd9\u6837\u7684\u65b9\u6cd5\u80fd\u8ba9\u7533\u8bf7\u8005\u4e86\u89e3\u53c2\u6570\u56e0\u5b50\u5bf9\u65b9\u6cd5\u6027\u80fd\u7684\u5f71\u54cd\u3002\u5bf9\u65b9\u6cd5\u6027\u80fd\u8bc4\u4f30\u53ef\u4ee5\u5305\u62ec\u5206\u6790\u6765\u81ea\u751f\u4ea7\u5de5\u827a\u4e2d\u7684\u4e2d\u63a7\u9636\u6bb5\u5230\u6210\u54c1\u9636\u6bb5\u7684\u6837\u54c1\u3002\u4ece\u8fd9\u4e9b\u65b9\u6cd5\u53d8\u5316\u6765\u6e90\u7684\u7814\u7a76\u4e2d\u83b7\u5f97\u7684\u77e5\u8bc6\u53ef\u4ee5\u5e2e\u52a9\u7533\u8bf7\u8005\u8bc4\u4f30\u65b9\u6cd5\u7684\u6027\u80fd\u3002<\/span><\/p>\n

\u7b2c\u4e8c\u90e8\u5206\uff1a\u5206\u6790\u65b9\u6cd5\u7684\u5185\u5bb9\u8981\u6c42<\/span><\/p>\n

\u5728\u8fd9\u90e8\u5206\uff0cFDA\u6307\u5357\u5c55\u5f00\u4ecb\u7ecd\u4e86\u5f88\u591a\u5185\u5bb9\uff0c\u4f9d\u6b21\u5982\u4e0b\uff1a<\/span><\/p>\n

2.1\u539f\u7406\/\u8303\u56f4<\/span><\/strong><\/p>\n

\u9700\u8981\u63cf\u8ff0\u5206\u6790\u6d4b\u8bd5\u65b9\u6cd5\/\u6280\u672f(\u5373\u5206\u79bb\u3001\u68c0\u6d4b)\u57fa\u672c\u539f\u7406\u7684\u60c5\u51b5\u3002\u8fd8\u8981\u63cf\u8ff0\u76ee\u6807\u5206\u6790\u7269\u548c\u6837\u54c1\u7c7b\u578b(\u4f8b\u5982\u539f\u6599\u836f\u3001\u5236\u5242\u3001\u6742\u8d28\u6216\u751f\u7269\u6db2\u4f53\u4e2d\u7684\u5316\u5408\u7269)\u3002<\/span><\/p>\n

2.2\u4eea\u5668\/\u8bbe\u5907<\/span><\/strong><\/p>\n

\u5728\u8fd9\u90e8\u5206\u9700\u8981\u63cf\u8ff0\u6240\u6709\u9700\u8981\u7684\u786e\u8ba4\u8fc7\u7684\u4eea\u5668\u548c\u7ec4\u4ef6(\u4f8b\u5982\u4eea\u5668\u7c7b\u578b\u3001\u68c0\u6d4b\u5668\u3001\u67f1\u5b50\u7c7b\u578b\u3001\u5c3a\u5bf8\u548c\u53ef\u66ff\u4ee3\u7684\u67f1\u5b50\u3001\u8fc7\u6ee4\u5668\u7c7b\u578b)\u3002<\/span><\/p>\n

2.3\u8fd0\u884c\u53c2\u6570<\/span><\/strong><\/p>\n

\u9700\u8981\u63d0\u4f9b\u786e\u8ba4\u8fc7\u7684\u4f18\u5316\u7684\u53c2\u6570\u8bbe\u7f6e\u548c\u8303\u56f4(\u5305\u62ec\u6765\u81ea\u836f\u5178\u6216\u7814\u53d1\u548c\/\u6216\u9a8c\u8bc1\u7814\u7a76\u7684\u5141\u8bb8\u8c03\u6574)\uff0c\u5bf9\u4e8e\u5206\u6790\u8fc7\u7a0b\u975e\u5e38\u5173\u952e(\u4f8b\u5982\u6d41\u901f\u3001\u90e8\u4ef6\u6e29\u5ea6\u3001\u8fd0\u884c\u65f6\u95f4\u3001\u68c0\u6d4b\u5668\u8bbe\u7f6e\u3001\u68af\u5ea6\u3001\u9876\u7a7a\u8fdb\u6837\u5668)\u3002\u9002\u5f53\u65f6\uff0c\u53ef\u4ee5\u4f7f\u7528\u7ecf\u9a8c\u53c2\u6570\u8bbe\u7f6e\u548c\u79ef\u5206\u53c2\u6570\u7684\u6837\u56fe\u6765\u4f5c\u4e3a\u8865\u5145\u3002<\/span><\/p>\n

2.4\u8bd5\u5242<\/span><\/strong><\/p>\n

\u5728\u8fd9\u90e8\u5206\u9700\u8981\u63d0\u4f9b\uff1a<\/span><\/p>\n

—\u8bd5\u5242\u6216\u6807\u51c6\u7684\u63cf\u8ff0<\/span><\/p>\n

—\u5316\u5b66\u54c1\u7684\u7ea7\u522b(\u4f8b\u5982\uff0cUSP\/NF\uff0c\u7f8e\u56fd\u5316\u5b66\u534f\u4f1a\uff0cHPLC\u8272\u8c31\u7ea7\uff0c\u6216GC\u8272\u8c31\u7ea7\u6216\u65e0\u9632\u8150\u5242\u7684)<\/span><\/p>\n

—\u6765\u6e90(\u4f8b\u5982USP\u6807\u51c6\u54c1\uff0c\u5185\u90e8\u786e\u8ba4\u7684\u5bf9\u7167\u7269\u8d28\uff0cWHO\u56fd\u9645\u6807\u51c6\/\u5bf9\u7167\u7269\u8d28\uff0cCBER\u6807\u51c6)<\/span><\/p>\n

—\u7eaf\u5ea6(\u53ea\u6709\u7eaf\u7684\u5316\u5b66\u54c1\u9700\u8981)\u3001\u72b6\u6001(\u4f8b\u5982\u5e72\u54c1\uff0c\u672a\u5e72\u71e5\u54c1)\u548c\u6d53\u5ea6<\/span><\/p>\n

—\u6548\u4ef7(CFR\uff0cUSP\u6240\u8981\u6c42)<\/span><\/p>\n

—\u5b58\u8d2e\u6761\u4ef6<\/span><\/p>\n

—\u5b89\u5168\u4f7f\u7528\u6307\u793a(\u4ee5\u73b0\u884cMSDS\u4e3a\u51c6)<\/span><\/p>\n

—\u9a8c\u8bc1\u8fc7\u7684\u6216\u4e66\u9762\u786e\u8ba4\u7684\u8d27\u67b6\u50a8\u5b58\u671f<\/span><\/p>\n

—\u751f\u7269\u8bd5\u5242\u7684\u65b0\u6279\u53f7\uff0c\u4f8b\u5982\uff0c\u5355\u514b\u9686\u6297\u4f53\u3001\u591a\u514b\u9686\u6297\u539f\u3001\u6216\u7ec6\u80de\uff0c\u53ef\u80fd\u9700\u8981\u5305\u62ec\u8fdb\u4e00\u6b65\u786e\u8ba4\u7a0b\u5e8f\uff0c\u4f5c\u4e3a\u5206\u6790\u65b9\u6cd5\u7684\u4e00\u90e8\u5206\u3002<\/span><\/p>\n

2.5\u6837\u54c1\u5236\u5907<\/span><\/strong><\/p>\n

\u5404\u4f9b\u8bd5\u6837\u54c1\u7684\u5236\u5907\u7a0b\u5e8f(\u4f8b\u5982\u63d0\u53d6\u65b9\u6cd5\u3001\u7a00\u91ca\u6216\u6d53\u7f29\u3001\u9664\u76d0\u548c\u8d85\u58f0\u6df7\u5408\u3001\u9707\u6447\u6216\u8d85\u58f0\u65f6\u95f4)\u3002\u4f9b\u8bd5\u6837\u5b9a\u6027\u5355\u6837\u914d\u5236\u65b9\u6cd5\uff0c\u5b9a\u91cf\u6d4b\u8bd5\u5e73\u884c\u6837\u54c1\u914d\u5236\u65b9\u6cd5\uff0c\u5de5\u4f5c\u6eb6\u6db2\u9002\u5f53\u7684\u6d53\u5ea6\u5355\u4f4d(\u4f8b\u5982\u03bcg\/ml\u6216mg\/ml)\uff0c\u4ee5\u53ca\u6eb6\u6db2\u7684\u7a33\u5b9a\u6027\u548c\u5b58\u8d2e\u6761\u4ef6\u7684\u4fe1\u606f\u3002<\/span><\/p>\n

2.6\u6807\u51c6\u63a7\u5236\u6eb6\u6db2\u5236\u5907<\/span><\/strong><\/p>\n

\u6240\u6709\u6807\u51c6\u6eb6\u6db2\u548c\u63a7\u5236\u6eb6\u6db2\u7684\u5236\u5907\u548c\u4f7f\u7528\u7a0b\u5e8f\u3002\u9700\u8981\u6ce8\u660e\u9002\u5f53\u7684\u6d53\u5ea6\u5355\u4f4d\uff0c\u6709\u6807\u51c6\u7a33\u5b9a\u6027\u4fe1\u606f\u548c\u5b58\u8d2e\u6761\u4ef6\uff0c\u5305\u62ec\u6821\u6b63\u6807\u51c6\u3001\u5185\u90e8\u6807\u51c6\u3001\u7cfb\u7edf\u9002\u7528\u6027\u6807\u51c6\u7b49\u3002<\/span><\/p>\n

2.7\u68c0\u9a8c\u7a0b\u5e8f<\/span><\/strong><\/p>\n

\u5bf9\u65b9\u6cd5\u7684\u9010\u6b65\u63cf\u8ff0(\u4f8b\u5982\u5e73\u8861\u65f6\u95f4\uff0c\u626b\u63cf\/\u8fdb\u9488\u5e8f\u5217\uff0c\u7a7a\u767d\uff0c\u57fa\u5e95\u6837\uff0c\u6837\u54c1\uff0c\u63a7\u5236\u6837\uff0c\u654f\u611f\u6eb6\u6db2(\u6742\u8d28\u65b9\u6cd5)\u548c\u5728\u5206\u6790\u8fc7\u7a0b\u4e2d\u7ef4\u6301\u7cfb\u7edf\u9002\u7528\u6709\u6548\u6027\u7684\u6807\u51c6\u6837)\u4ee5\u53ca\u5141\u8bb8\u8fd0\u884c\u8303\u56f4\u548c\u9002\u5f53\u65f6\u7684\u8c03\u6574\u3002<\/span><\/p>\n

2.8\u7cfb\u7edf\u9002\u5e94\u6027<\/span><\/strong><\/p>\n

\u5bf9\u6d4b\u8bd5\u7a0b\u5e8f\u548c\u53c2\u6570\u8fdb\u884c\u786e\u8bc1\u4ee5\u4fdd\u8bc1\u7cfb\u7edf(\u4eea\u5668\u3001\u6570\u636e\u5de5\u4f5c\u7ad9\u548c\u5206\u6790\u64cd\u4f5c\u8981\u70b9\u548c\u5206\u6790\u7684\u63a7\u5236\u70b9)\u80fd\u5728\u4f7f\u7528\u65f6\u4f5c\u4e3a\u4e00\u4e2a\u6574\u4f53\u6b63\u786e\u8fd0\u884c\u3002\u9002\u7528\u4e8e\u5bf9\u7167\u63a7\u5236\u548c\u6837\u54c1\u7684\u7cfb\u7edf\u9002\u7528\u6027\u7684\u53ef\u63a5\u53d7\u6807\u51c6\uff0c\u5982\u62d6\u5c3e\u56e0\u5b50\u3001\u7cbe\u5bc6\u5ea6\u548c\u5206\u8fa8\u7387\u53ef\u63a5\u53d7\u6807\u51c6\uff0c\u5728\u9002\u5f53\u65f6\u53ef\u4ee5\u8fdb\u884c\u8981\u6c42\u3002\u8272\u8c31\u7cfb\u7edf\u7684\u7cfb\u7edf\u9002\u7528\u6027\uff0c\u53c2\u89c1FDA\u884c\u4e1a\u6307\u5357\u300a\u8272\u8c31\u65b9\u6cd5\u7684\u9a8c\u8bc1\u300b\u548cUSP\u901a\u8bba<621>\u8272\u8c31\u3002<\/span><\/p>\n

2.9\u8ba1\u7b97<\/span><\/strong><\/p>\n

\u6839\u636e\u6807\u8bc6\u58f0\u660e\u548c\u8d28\u91cf\u6807\u51c6(\u4f8b\u5982\u542b\u91cf\u3001\u7279\u5b9a\u548c\u975e\u7279\u5b9a\u6742\u8d28\u548c\u76f8\u5bf9\u54cd\u5e94\u56e0\u5b50)\u8fdb\u884c\u6d4b\u8bd5\u6240\u5f97\u7684\u6570\u636e\u5206\u6790(\u6807\u51c6\u3001\u63a7\u5236\u3001\u6837\u54c1)\u4e2d\u6240\u7528\u7684\u79ef\u5206\u65b9\u6cd5\u548c\u4ee3\u8868\u6027\u8ba1\u7b97\u516c\u5f0f\u3002\u5176\u4e2d\u5e94\u5305\u62ec\u6570\u636e\u5206\u6790\u4e2d\u6240\u4f7f\u7528\u7684\u6240\u6709\u6570\u5b66\u53d8\u6362\u6216\u516c\u5f0f\u7684\u63cf\u8ff0\uff0c\u4ee5\u53ca\u4f7f\u7528\u7684\u6240\u6709\u4fee\u6b63\u56e0\u5b50\u7684\u79d1\u5b66\u8bba\u8bc1\u3002<\/span><\/p>\n

2.10\u6570\u636e\u7684\u62a5\u544a<\/span><\/strong><\/p>\n

\u4e0e\u4eea\u5668\u7684\u80fd\u529b\u548c\u53ef\u63a5\u53d7\u6807\u51c6\u76f8\u4e00\u81f4\u7684\u6570\u5b57\u5f0f\u6570\u636e\u7684\u8868\u73b0\u65b9\u5f0f\u3002\u65b9\u6cd5\u4e2d\u5e94\u6307\u660e\u8981\u91c7\u7528\u4f55\u79cd\u683c\u5f0f\u6765\u62a5\u544a\u7ed3\u679c(\u4f8b\u5982\u6807\u8bc6\u58f0\u660e\u7684\u767e\u5206\u6bd4\uff0c\u91cd\u91cf\/\u91cd\u91cf\uff0c\u91cd\u91cf\/\u4f53\u79ef)\uff0c\u5e76\u6307\u5b9a\u6240\u9700\u62a5\u544a\u7684\u6709\u6548\u4f4d\u6570\u3002\u7f8e\u56fd\u6750\u6599\u8bd5\u9a8c\u534f\u4f1a(ASTM)E29\u6807\u51c6\u4e2d\u63cf\u8ff0\u4e86\u5728\u6d4b\u8bd5\u6570\u636e\u4e2d\u4f7f\u7528\u6709\u6548\u4f4d\u6570\u6765\u51b3\u5b9a\u4e0e\u8d28\u91cf\u6807\u51c6\u7b26\u5408\u6027\u7684\u6807\u51c6\u89c4\u8303\u3002\u5982\u679c\u662f\u8272\u8c31\u65b9\u6cd5\uff0c\u7533\u8bf7\u8005\u5e94\u8be5\u5305\u62ec\u4fdd\u7559\u65f6\u95f4(RT)\u7528\u4e8e\u4e0e\u6807\u51c6\u54c1\u6bd4\u8f83\uff0c\u76f8\u5bf9\u4fdd\u7559\u65f6\u95f4(RRT)(\u5df2\u77e5\u548c\u672a\u77e5\u6742\u8d28)\u53ef\u63a5\u53d7\u8303\u56f4\u548c\u6837\u54c1\u7ed3\u679c\u62a5\u544a\u6807\u51c6\u3002<\/span><\/p>\n

\u7b2c\u4e09\u90e8\u5206\uff1a\u6807\u51c6\u54c1\u548c\u8bd5\u5242\u7684\u8981\u6c42<\/span><\/p>\n

\u57fa\u51c6\u6807\u51c6\u54c1\u548c\u4e8c\u7ea7\u6807\u51c6\u54c1\u548c\u7269\u8d28\u5728ICH\u6307\u5357\u4e2d\u5df2\u6709\u5b9a\u4e49\u548c\u8ba8\u8bba\uff1aQ6B\u300a\u8d28\u91cf\u6807\u51c6\uff1a\u751f\u7269\u6280\u672f\/\u751f\u7269\u5236\u54c1\u68c0\u9a8c\u65b9\u6cd5\u548c\u53ef\u63a5\u53d7\u6807\u51c6\u300b\u548cQ7\u300a\u539f\u6599\u836fGMP\u6307\u5357\u300b\u3002\u7533\u8bf7\u8005\u8981\u786e\u4fdd\u6240\u6709\u7684\u6807\u51c6\u54c1\u5747\u9002\u5408\u4e8e\u5176\u76ee\u7684\u7528\u9014\u3002\u7533\u8bf7\u8005\u8981\u4e25\u683c\u9075\u5b88\u6807\u51c6\u54c1\u5b58\u8d2e\u548c\u4f7f\u7528\u6761\u4ef6\u53ca\u5904\u7406\u6307\u4ee4\uff0c\u907f\u514d\u6539\u52a8\u548c\u6c61\u67d3\uff0c\u8fd9\u53ef\u80fd\u4f1a\u5bfc\u81f4\u53e6\u5916\u7684\u6742\u8d28\u548c\u5206\u6790\u4e0d\u51c6\u786e\u3002\u7533\u8bf7\u8005\u5e94\u8be5\u5728\u7533\u62a5\u8d44\u6599\u4e2d\u5305\u62ec\u5404\u6807\u51c6\u54c1\u548c\u7269\u8d28\u9002\u5408\u4e8e\u5176\u7528\u9014\u7684\u652f\u6301\u4fe1\u606f\u3002\u9002\u5f53\u65f6\uff0c\u652f\u6301\u6807\u51c6\u54c1\u548c\u7269\u8d28\u7684\u4fe1\u606f\u5e94\u5305\u62ec\u786e\u8ba4\u8bd5\u9a8c\u62a5\u544a\u548c\u68c0\u9a8c\u62a5\u544a(\u5305\u62ec\u7a33\u5b9a\u6027\u8bd5\u9a8c\u65b9\u6848\u3001\u62a5\u544a\u3001\u76f8\u5173\u5df2\u77e5\u6742\u8d28\u6982\u51b5\u8d44\u6599)\u3002\u5bf9\u4e8eBLA\u4e0b\u7684\u751f\u7269\u5236\u54c1\uff0c\u8981\u5728\u5e74\u62a5\u4e2d\u5305\u62ec\u4e4b\u540e\u7684\u6807\u51c6\u54c1\u6279\u6b21\u7684\u786e\u8ba4\u3002<\/span><\/p>\n

\u6807\u51c6\u54c1\u901a\u5e38\u53ef\u4ee5\u4eceUSP\u5904\u83b7\u5f97\uff0c\u4e5f\u53ef\u4ee5\u901a\u8fc7EP\u3001JP\u3001WHO\u6216\u56fd\u9645\u6807\u51c6\u6280\u672f\u59d4\u5458\u4f1a\u83b7\u5f97\u3002\u5927\u91cf\u7684\u751f\u7269\u4ea7\u54c1\u6807\u51c6\u54c1\u4e5f\u53ef\u4ee5\u4eceCBER\u5904\u83b7\u5f97\u3002\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684\u7279\u5b9a\u751f\u7269\u5236\u54c1\uff0cCBER\u6388\u6743\u7684\u6807\u51c6\u54c1\u5fc5\u987b\u5728\u4ea7\u54c1\u653e\u884c\u4e0a\u5e02\u524d\u4f7f\u7528\u3002\u4ece\u5176\u5b83\u6765\u6e90\u83b7\u5f97\u7684\u5bf9\u7167\u7269\u8d28\u5e94\u6839\u636e\u7a0b\u5e8f\u8fdb\u884c\u786e\u8bc1\uff0c\u5305\u62ec\u5e38\u89c4\u6d4b\u8bd5\u548cICH Q6B\u91cc\u6240\u8ff0\u7684\u8d85\u51fa\u5e38\u89c4\u653e\u884c\u6d4b\u8bd5\u7684\u9879\u76ee\u3002\u7533\u8bf7\u8005\u5e94\u8003\u8651\u77e9\u9635\u65b9\u6cd5\u6765\u786e\u8bc1\u6807\u51c6\u54c1\u3002\u9644\u52a0\u6d4b\u8bd5\u53ef\u4ee5\u5305\u62ec\u786e\u5b9a\u6807\u51c6\u54c1\u7684\u9002\u7528\u6027\uff0c\u8fd9\u53ef\u80fd\u5728\u539f\u6599\u836f\u6216\u836f\u54c1\u653e\u884c\u6d4b\u8bd5\u4e2d\u53d1\u73b0\u4e0d\u4e86(\u4f8b\u5982\u66f4\u5168\u9762\u7684\u7ed3\u6784\u786e\u8bc1\u548c\u6548\u4ef7\u3001\u7eaf\u5ea6\u548c\u6742\u8d28\u77e9\u9635\u6280\u672f)\u3002<\/span><\/p>\n

\u65b0\u7684\u6807\u51c6\u54c1(\u5b98\u65b9\u7684\u6216\u81ea\u5236\u7684)\u8981\u91c7\u7528\u73b0\u884c\u7684\u6807\u51c6\u54c1\u8fdb\u884c\u786e\u8ba4\/\u6821\u6b63\u3002\u5bf9\u4e8e\u751f\u7269\u5236\u54c1\u6807\u51c6\u54c1\u548c\u7269\u8d28\uff0cFDA\u5efa\u8bae\u7533\u8bf7\u8005\u5728\u786e\u8ba4\u65b0\u7684\u6807\u51c6\u54c1\u65f6\u91c7\u7528\u53cc\u8f68\u65b9\u6cd5\uff0c\u4ee5\u9632\u6b62\u8d28\u91cf\u5c5e\u6027\u7684\u6f02\u79fb\u3002\u53cc\u8f68\u65b9\u6cd5\u662f\u5c06\u6bcf\u4e2a\u65b0\u7684\u6807\u51c6\u54c1\u4e0e\u57fa\u51c6\u6807\u51c6\u54c1\u8fdb\u884c\u6bd4\u8f83\uff0c\u8fd9\u6837\u5c06\u5176\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u7269\u8d28\u548c\u73b0\u884c\u751f\u4ea7\u5de5\u827a\u76f8\u5173\u8054\u3002<\/span><\/p>\n

\u7b2c\u56db\u90e8\u5206\uff1a\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u8981\u6c42<\/span><\/p>\n

4.1\u975e\u836f\u5178\u5206\u6790\u65b9\u6cd5<\/span><\/strong><\/p>\n

\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u662f\u8bc1\u660e\u4e00\u4e2a\u5206\u6790\u65b9\u6cd5\u9002\u5408\u4e8e\u5176\u65e2\u5b9a\u7528\u9014\u7684\u8fc7\u7a0b\u3002\u65b9\u6cd5\u5b66\u548c\u5206\u6790\u65b9\u6cd5\u7684\u76ee\u7684\u5e94\u5728\u5f00\u59cb\u9a8c\u8bc1\u7814\u7a76\u4e4b\u524d\u8fdb\u884c\u6e05\u695a\u7684\u754c\u5b9a\u548c\u4e86\u89e3\u3002\u8fd9\u79cd\u4e86\u89e3\u662f\u6765\u81ea\u4e8e\u57fa\u4e8e\u79d1\u5b66\u7684\u65b9\u6cd5\u7814\u53d1\u548c\u4f18\u5316\u7814\u7a76\u3002\u9a8c\u8bc1\u6570\u636e\u5fc5\u987b\u662f\u4ece\u7533\u8bf7\u8005\u6309GMP\u89c4\u8303\u6279\u51c6\u7684\u65b9\u6848\u4e2d\u4ea7\u751f\uff0c\u65b9\u6848\u4e2d\u8981\u6709\u6bcf\u4e2a\u9a8c\u8bc1\u9879\u76ee\u7684\u65b9\u6cd5\u5b66\u63cf\u8ff0\uff0c\u5e76\u786e\u5b9a\u548c\u8bba\u8ff0\u53ef\u63a5\u53d7\u6807\u51c6\uff0c\u91c7\u7528\u7ecf\u8fc7\u786e\u8ba4\u7684\u4eea\u5668\u5b9e\u65bd\u9a8c\u8bc1\u3002\u5e94\u8d77\u8349\u5e76\u5b9e\u65bd\u539f\u6599\u836f\u548c\u5236\u5242\u5206\u6790\u7269\u6216\u5bf9\u5e94\u57fa\u8d28\u7684\u5206\u6790\u6df7\u5408\u7269\u7684\u9a8c\u8bc1\u65b9\u6848\u3002\u7533\u8bf7\u8005\u5e94\u8be5\u5728\u7533\u62a5\u8d44\u6599\u4e2d\u5305\u62ec\u9a8c\u8bc1\u7814\u7a76\u53ca\u7ed3\u679c\u7684\u8be6\u7ec6\u5185\u5bb9\u3002<\/span><\/p>\n

4.2\u9a8c\u8bc1\u5c5e\u6027\u9879\u76ee<\/span><\/strong><\/p>\n

\u5c3d\u7ba1\u5e76\u4e0d\u662f\u6240\u6709\u7684\u9a8c\u8bc1\u5c5e\u6027\u9002\u7528\u4e8e\u6240\u6709\u7c7b\u578b\u7684\u6d4b\u8bd5\uff0c\u4f46\u4e00\u822c\u7684\u9a8c\u8bc1\u5c5e\u6027\u5305\u62ec\uff1a<\/span><\/p>\n

\u3000\u3000Specificity \u4e13\u5c5e\u6027<\/span><\/p>\n

\u3000\u3000Linearity \u7ebf\u6027<\/span><\/p>\n

\u3000\u3000Accuracy \u51c6\u786e\u5ea6<\/span><\/p>\n

\u3000\u3000Precision (repeatability, intermediate precision, and reproducibility) \u7cbe\u5bc6\u5ea6(\u91cd\u590d\u6027\u3001\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\u548c\u518d\u73b0\u6027)<\/span><\/p>\n

\u3000\u3000Range \u8303\u56f4<\/span><\/p>\n

\u3000\u3000Quantitation limit \u5b9a\u91cf\u9650<\/span><\/p>\n

\u3000\u3000Detection limit \u68c0\u51fa\u9650<\/span><\/p>\n

\u5982\u679c\u4e00\u4e2a\u65b9\u6cd5\u662f\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u5b9a\u91cf\u5206\u6790\u65b9\u6cd5\uff0c\u53ef\u4ee5\u68c0\u51fa\u539f\u6599\u836f\u548c\u5236\u5242\u5728\u5b58\u8d2e\u671f\u95f4\u7684\u8d28\u91cf\u5c5e\u6027\u7684\u53d8\u5316\uff0c\u5219\u8ba4\u4e3a\u8be5\u65b9\u6cd5\u662f\u5177\u6709\u7a33\u5b9a\u6027\u6307\u793a\u6027\u7684\u6d4b\u8bd5\u65b9\u6cd5\u3002\u4e3a\u4e86\u8bc1\u660e\u4e00\u4e2a\u7a33\u5b9a\u6027\u6307\u793a\u68c0\u9a8c\u65b9\u6cd5\u7684\u4e13\u5c5e\u6027\uff0c\u8981\u8fdb\u884c\u4e00\u7cfb\u5217\u7684\u6311\u6218\u3002\u4e00\u4e9b\u6311\u6218\u5305\u62ec\u5411\u6837\u54c1\u4e2d\u52a0\u5165\u76ee\u6807\u5206\u6790\u7269\u548c\u6240\u6709\u5df2\u77e5\u7684\u5e72\u6270\u7269\u3001\u7ecf\u8fc7\u4e0d\u540c\u5316\u9a8c\u5ba4\u5f3a\u964d\u89e3\u8bd5\u9a8c\u7684\u6837\u54c1\u3001\u5b9e\u9645\u836f\u54c1\u7684\u6837\u54c1(\u901a\u8fc7\u6700\u7ec8\u751f\u4ea7\u5de5\u827a\u751f\u4ea7\u51fa)\u7ecf\u8fc7\u957f\u671f\u653e\u7f6e\u6216\u5728\u52a0\u901f\u6e29\u6e7f\u5ea6\u6761\u4ef6\u4e0b\u5b58\u8d2e\u3002<\/span><\/p>\n

4.3\u836f\u5178\u5206\u6790\u65b9\u6cd5<\/span><\/p>\n

\u4e00\u4e2a\u5206\u6790\u65b9\u6cd5(\u4f8b\u5982USP\/NF\uff0cAOAC\u56fd\u9645\u7684\u5b98\u65b9\u5206\u6790\u65b9\u6cd5\uff0c\u6216\u5176\u5b83\u516c\u8ba4\u7684\u6807\u51c6\u5bf9\u7167)\u7684\u9002\u7528\u6027\u5e94\u5728\u5b9e\u9645\u4f7f\u7528\u6761\u4ef6\u4e0b\u7ecf\u8fc7\u786e\u8ba4\u3002\u8bc1\u660eUSP\/NF\u5206\u6790\u65b9\u6cd5\u9002\u7528\u4e8e\u539f\u6599\u836f\u6216\u5236\u5242\u7684\u8d44\u6599\u5e94\u5305\u62ec\u5728\u7533\u62a5\u8d44\u6599\u91cc\uff0c\u5e76\u4e14\u662f\u4ece\u786e\u8ba4\u65b9\u6848\u4e2d\u4ea7\u751f\u7684\u3002<\/span><\/p>\n

\u786e\u8ba4\u65b9\u6848\u5e94\u5305\u62ec\uff0c\u4f46\u4e0d\u4ec5\u9650\u4e8e(1)\u8981\u786e\u8ba4\u7684\u836f\u5178\u65b9\u6cd5\uff0c\u9884\u5b9a\u7684\u53ef\u63a5\u53d7\u6807\u51c6\uff0c(2)\u65b9\u6cd5\u5b66\u7684\u8be6\u7ec6\u8bf4\u660e(\u4f8b\u5982\u8bd5\u5242\u3001\u8bbe\u5907\u3001\u914d\u4ef6\u3001\u8272\u8c31\u6761\u4ef6\u3001\u8272\u8c31\u67f1\u3001\u68c0\u6d4b\u5668\u7c7b\u578b\u3001\u68c0\u6d4b\u5668\u4fe1\u53f7\u54cd\u5e94\u7075\u654f\u5ea6\u3001\u7cfb\u7edf\u9002\u7528\u6027\u3001\u6837\u54c1\u5236\u5907\u548c\u5176\u7a33\u5b9a\u6027)\u3002\u8be5\u65b9\u6cd5\u548c\u786e\u8ba4\u7a0b\u5ea6\u5e94\u51b3\u5b9a\u8981\u5305\u62ec\u5728\u65b9\u6848\u4e2d\u7684\u9a8c\u8bc1\u9879\u76ee\u6d4b\u8bd5(\u4f8b\u5982\u4e13\u5c5e\u6027\u3001LOD\u3001LOQ\u3001\u7cbe\u5bc6\u5ea6\u3001\u51c6\u786e\u5ea6)\u3002\u5728\u51b3\u5b9a\u65b9\u6848\u4e2d\u5e94\u5305\u62ec\u54ea\u4e9b\u9a8c\u8bc1\u9879\u76ee\u65f6\u7684\u8003\u8651\u53d6\u51b3\u4e8e\u4e00\u4e9b\u5177\u4f53\u60c5\u51b5\uff0c\u5982\u8d28\u91cf\u6807\u51c6\u9650\u5ea6\u8bbe\u5b9a\u662f\u5426\u4e25\u4e8e\u836f\u5178\u53ef\u63a5\u53d7\u6807\u51c6\uff0c\u6216RT\u6216RRT\u6982\u51b5\u7531\u4e8e\u539f\u6599\u836f\u5408\u6210\u8def\u7ebf\u3001\u751f\u4ea7\u5de5\u827a\u6216\u5236\u5242\u57fa\u5e95\u4e0d\u540c\u800c\u5728\u8272\u8c31\u65b9\u6cd5\u4e2d\u6709\u6240\u53d8\u5316\u3002\u5982\u679c\u5b8c\u5168\u6309\u7167\u836f\u5178\u65b9\u6cd5\u5b9e\u65bd\uff0c\u6ca1\u6709\u504f\u5dee\u7684\u8bdd\uff0c\u836f\u5178\u542b\u91cf\u65b9\u6cd5\u4e0d\u9700\u8981\u8fdb\u884c\u8010\u7528\u6027\u7814\u7a76\u3002<\/span><\/p>\n

\u7b2c\u4e94\u90e8\u5206\uff1a\u5206\u6790\u65b9\u6cd5\u751f\u547d\u5468\u671f\u5185\u7684\u7ba1\u7406<\/span><\/p>\n

\u5206\u6790\u65b9\u6cd5(\u5305\u62ec\u836f\u5178\u65b9\u6cd5)\u88ab\u6210\u529f\u9a8c\u8bc1(\u6216\u786e\u8ba4)\u548c\u5b9e\u65bd\u540e\uff0c\u5728\u5176\u4ea7\u54c1\u7684\u751f\u547d\u5468\u671f\u4e2d\u5e94\u9075\u5b88\u8be5\u65b9\u6cd5\uff0c\u4ee5\u6301\u7eed\u4fdd\u8bc1\u65b9\u6cd5\u4fdd\u6301\u9002\u5408\u5176\u65e2\u5b9a\u7528\u9014\u3002\u5e94\u5b9a\u671f\u5bf9\u65b9\u6cd5\u8868\u73b0\u8fdb\u884c\u8d8b\u52bf\u5206\u6790\uff0c\u8bc4\u4f30\u662f\u5426\u9700\u8981\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u4f18\u5316\uff0c\u6216\u5bf9\u5168\u9762\u6216\u90e8\u5206\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u518d\u9a8c\u8bc1\u3002\u5982\u679c\u4e00\u4e2a\u5206\u6790\u65b9\u6cd5\u53ea\u80fd\u901a\u8fc7\u4e0d\u65ad\u8c03\u6574\u5206\u6790\u65b9\u6cd5\u91cc\u8f7d\u660e\u7684\u8fd0\u884c\u53c2\u6570\u6765\u7b26\u5408\u6240\u5efa\u7acb\u7684\u7cfb\u7edf\u9002\u7528\u6027\u8981\u6c42\uff0c\u5219\u5e94\u5bf9\u8be5\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u518d\u8bc4\u4f30\u3001\u518d\u9a8c\u8bc1\uff0c\u9002\u5f53\u65f6\u8fdb\u884c\u4fee\u6b63\u3002<\/span><\/p>\n

\u5728\u4e00\u4e2a\u4ea7\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\uff0c\u65b0\u7684\u8d44\u6599\u548c\u98ce\u9669\u8bc4\u4f30(\u4f8b\u5982\u5bf9\u4ea7\u54c1CQA\u6709\u66f4\u597d\u7684\u4e86\u89e3\uff0c\u6216\u53d1\u73b0\u65b0\u7684\u6742\u8d28)\u53ef\u80fd\u4f1a\u4fdd\u8bc1\u4e00\u4e2a\u65b0\u7684\u6216\u66ff\u4ee3\u7684\u5206\u6790\u65b9\u6cd5\u7684\u7814\u53d1\u548c\u9a8c\u8bc1\u3002\u65b0\u6280\u672f\u53ef\u80fd\u4f1a\u5e26\u6765\u4ea7\u54c1\u8d28\u91cf\u4fdd\u8bc1\u65b9\u9762\u66f4\u591a\u7684\u4e86\u89e3\u548c\/\u6216\u53ef\u4fe1\u5ea6\u3002\u7533\u62a5\u8005\u5e94\u5b9a\u671f\u8bc4\u4f30\u4ea7\u54c1\u5206\u6790\u65b9\u6cd5\u7684\u9002\u5f53\u6027\uff0c\u8003\u8651\u65b0\u7684\u6216\u53ef\u66ff\u4ee3\u7684\u65b9\u6cd5\u3002<\/span><\/p>\n

\u9884\u8ba1\u5728\u751f\u547d\u5468\u671f\u4e2d\u4f1a\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u53d8\u66f4\uff0c\u56e0\u6b64\u8981\u4fdd\u7559\u9002\u5f53\u6570\u636e\u91cf\u7684\u7559\u6837\u8fdb\u884c\u5bf9\u6bd4\u7814\u7a76\u3002\u6837\u54c1\u6570\u91cf\u5e94\u57fa\u4e8e\u79d1\u5b66\u539f\u7406\u4ee5\u53ca\u98ce\u9669\u8bc4\u4f30\u3002\u5bf9\u751f\u4ea7\u5de5\u827a\u8f83\u4e3a\u654f\u611f\u7684\u590d\u6742\u4ea7\u54c1\uff0c\u5176\u7559\u6837\u53ef\u80fd\u662f\u505a\u5bf9\u6bd4\u7814\u7a76\u7684\u91cd\u8981\u5de5\u5177\u3002<\/span><\/p>\n

\u7528\u4e8e\u5bf9\u6bd4\u7814\u7a76\u7684\u7559\u6837\u5e94\u5305\u62ec\u4ee3\u8868\u4e0a\u5e02\u836f\u54c1\u7684\u6837\u54c1\uff0c\u5982\u53ef\u80fd\uff0c\u8fd8\u5e94\u5305\u62ec\u5173\u952e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7269\u6599\u3002<\/span><\/p>\n

\u5982\u679c\u57fa\u4e8e\u98ce\u9669\u7684\u8bc4\u4f30\u6216\u5176\u5b83\u539f\u56e0\u5bfc\u81f4\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u53d8\u66f4\uff0c\u6216\u91c7\u53d6\u65b0\u7684\u65b9\u6cd5\u53d6\u4ee3\u65e7\u7684\u65b9\u6cd5\uff0c\u6216\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u81f3\u4e00\u4e2a\u65b0\u7684\u68c0\u6d4b\u573a\u6240\uff0c\u5219\u8981\u8003\u8651\u8fdb\u884c\u518d\u9a8c\u8bc1\u3001\u65b0\u7684\u9a8c\u8bc1\u3001\u5206\u6790\u65b9\u6cd5\u5bf9\u6bd4\u7814\u7a76\u6216\u8054\u5408\u8fdb\u884c\u8fd9\u4e9b\u5de5\u4f5c\u3002\u5728\u6709\u4e9b\u60c5\u5f62\u4e0b\uff0c\u5bf9\u539f\u6599\u836f\u6216\u836f\u54c1\u751f\u4ea7\u5de5\u827a\u7684\u53d8\u66f4\u4e5f\u4f1a\u5bfc\u81f4\u5206\u6790\u65b9\u6cd5\u518d\u9a8c\u8bc1\u3002\u8fd9\u4e9b\u989d\u5916\u7684\u7814\u7a76\u8ba8\u8bba\u5982\u4e0b\uff1a<\/span><\/p>\n

5.1\u518d\u9a8c\u8bc1<\/span><\/strong><\/p>\n

\u5728\u524d\u9762\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u90e8\u5206\u6240\u8ff0\u539f\u5219\u9002\u7528\u4e8e\u518d\u9a8c\u8bc1\u3002\u5982\u679c\u5bf9\u4e00\u4e2a\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u4e86\u53d8\u66f4(\u4f8b\u5982\u5bf9\u8bbe\u5907\u6709\u53d8\u66f4\uff0c\u6216\u8bd5\u5242\u7684\u53d8\u66f4\uff0c\u6216\u56e0\u4e3a\u751f\u4ea7\u5de5\u827a\u6216\u914d\u65b9\u6709\u53d8\u66f4)\uff0c\u5219\u53ef\u80fd\u8981\u8003\u8651\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u5168\u90e8\u6216\u90e8\u5206\u518d\u9a8c\u8bc1\u3002\u5728\u548c\u5e73\u5de5\u827a\u53d8\u66f4\u65f6\u53ef\u80fd\u4e5f\u9700\u8981\u5bf9\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u518d\u9a8c\u8bc1\uff0c\u4f8b\u5982\u53ef\u80fd\u5f71\u54cd\u5206\u6790\u65b9\u6cd5\u6027\u80fd\u7684\u539f\u6599\u836f\u751f\u4ea7\u5de5\u827a\u53d8\u66f4(\u4f8b\u5982\u5408\u6210\u8def\u7ebf\u3001\u53d1\u9175)\u6216\u5f15\u5165\u65b0\u7684\u5236\u5242\u914d\u65b9\u3002<\/span><\/p>\n

\u7533\u8bf7\u8005\u8981\u8fdb\u884c\u518d\u9a8c\u8bc1\u4ee5\u4fdd\u8bc1\u5206\u6790\u65b9\u6cd5\u7ef4\u6301\u5176\u5173\u952e\u6027\u80fd\u6307\u6807(\u4f8b\u5982\u4e13\u5c5e\u6027\u3001\u7cbe\u5bc6\u5ea6\u3001\u51c6\u786e\u6027)\u3002\u518d\u9a8c\u8bc1\u7684\u7a0b\u5ea6\u53d6\u51b3\u4e8e\u53d8\u66f4\u7684\u6027\u8d28\u3002<\/span><\/p>\n

5.2\u5206\u6790\u65b9\u6cd5\u5bf9\u6bd4\u7814\u7a76<\/span><\/strong><\/p>\n

\u5206\u6790\u65b9\u6cd5\u5bf9\u6bd4\u7814\u7a76\u8981\u6c42\u4e00\u822c\u662f\u5728\u7533\u8bf7\u8005\u63d0\u8bae\u91c7\u7528\u4e00\u4e2a\u66ff\u4ee3\u5206\u6790\u65b9\u6cd5\u53d6\u4ee3\u4e00\u4e2aFDA\u6279\u51c6\u7684\u5206\u6790\u65b9\u6cd5\u65f6\uff0c\u6216\u5c06\u4e00\u4e2a\u5206\u6790\u65b9\u6cd5\u4ece\u4e00\u4e2a\u5b9e\u9a8c\u5ba4\u8f6c\u79fb\u81f3\u53e6\u4e00\u4e2a\u5b9e\u9a8c\u5ba4\u65f6\u4ea7\u751f\u7684\u3002\u7528\u4e8e\u51b3\u5b9a\u4e24\u4e2a\u5206\u6790\u65b9\u6cd5\u7684\u7b49\u540c\u6027\u7684\u7edf\u8ba1\u5b66\u65b9\u6cd5\u4fe1\u606f\uff0c\u9700\u8981\u5f15\u7528\u9002\u5f53\u7684\u6587\u732e\u6216\u6587\u4ef6\u3002\u8fd9\u4e9b\u60c5\u51b5\u8ba8\u8bba\u5982\u4e0b\uff1a<\/span><\/p>\n

5.2.1\u53ef\u66ff\u4ee3\u7684\u5206\u6790\u65b9\u6cd5<\/span><\/strong><\/p>\n

\u66ff\u4ee3\u6027\u5206\u6790\u65b9\u6cd5\u662f\u7533\u8bf7\u8005\u7528\u6765\u4ee3\u66ffFDA\u5df2\u7ecf\u6279\u51c6\u7684\u5206\u6790\u65b9\u6cd5\u7684\u4e00\u79cd\u5206\u6790\u65b9\u6cd5\u3002\u5bf9\u4e8e\u4e00\u4e2aNDA\u6216ANDA\uff0c\u7533\u8bf7\u8005\u8981\u5c06\u6240\u6709\u62df\u5b9a\u7684\u66ff\u4ee3\u5206\u6790\u65b9\u6cd5\u5305\u62ec\u5728\u7533\u62a5\u8d44\u6599\u4e2d\u3002\u7533\u8bf7\u8005\u5fc5\u987b\u5305\u62ec\u65b9\u6cd5\u63cf\u8ff0\u3002\u5728\u6279\u51c6\u540e\uff0c\u5bf9\u4e8e\u4e00\u4e2aNDA\u6216ANDA\uff0c\u6216\u5728BLA\u91cc\u6279\u51c6\u4f46\u672a\u5305\u62ec\u5728FDA\u6cd5\u89c4\u91cc\u7684\u5206\u6790\u65b9\u6cd5\uff0c\u51e1\u589e\u52a0\u3001\u4fee\u6539\u6216\u5220\u9664\u66ff\u4ee3\u5206\u6790\u65b9\u6cd5\u5747\u8981\u5728\u4e0b\u4e00\u6b21\u5e74\u62a5\u4e2d\u8bb0\u8f7d\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u751f\u7269\u5236\u54c1\uff0cFDA\u6cd5\u89c4\u91cc\u53ef\u80fd\u5f88\u5c11\u5305\u62ec\u5206\u6790\u65b9\u6cd5\u3002\u5982\u679c\u6240\u9700\u7684\u5206\u6790\u65b9\u6cd5\u5728\u6cd5\u89c4\u91cc\u8fdb\u884c\u4e86\u63cf\u8ff0\uff0c\u4f46\u7533\u8bf7\u8005\u60f3\u4f7f\u7528\u4e00\u4e2a\u65b9\u6cd5\u6765\u66ff\u4ee3\uff0c\u7533\u8bf7\u8005\u5fc5\u987b\u6839\u636e21 CFR 610.9(a)\u63d0\u4ea4\u66ff\u4ee3\u65b9\u6cd5\u4f9b\u5ba1\u6838\u548c\u6279\u51c6\u3002\u7533\u8bf7\u8005\u5fc5\u987b\u63d0\u4ea4\u8bc1\u636e”\u2026\u2026\u8bc1\u660e\u65b9\u6cd5\u4fee\u8ba2\u80fd\u786e\u4fdd\u751f\u7269\u5236\u54c1\u7684\u5b89\u5168\u3001\u7eaf\u5ea6\u3001\u6548\u4ef7\u548c\u6709\u6548\u6027\u7b49\u540c\u6216\u4f18\u4e8e\u751f\u7269\u5236\u54c1\u901a\u7528\u6807\u51c6\u6216\u9644\u52a0\u6807\u51c6\u4e2d\u7ed9\u51fa\u7684\u65b9\u6cd5\u6216\u7a0b\u5e8f”\u3002\u5bf9\u8fd9\u6837\u7a0b\u5e8f\u7684\u4fee\u8ba2\u9700\u8981\u5728\u7533\u62a5\u8d44\u6599\u8bc4\u4f30\u8fc7\u7a0b\u4e2d\u6216\u5728\u6279\u51c6\u540e\u589e\u8865\u4e2d\u83b7\u5f97FDA\u6279\u51c6\u3002<\/span><\/p>\n

\u7533\u8bf7\u8005\u8981\u5206\u8fa8\u53ef\u66ff\u4ee3\u6027\u5206\u6790\u65b9\u6cd5\u7684\u4f7f\u7528(\u4f8b\u5982\u653e\u884c\u68c0\u6d4b\u3001\u7a33\u5b9a\u6027\u6d4b\u8bd5)\uff0c\u63d0\u4f9b\u5176\u5185\u5bb9\u7684\u5408\u7406\u6027\u8bba\u8bc1\u3001\u9a8c\u8bc1\u6570\u636e\u548c\u4e0eFDA\u6279\u51c6\u7684\u5206\u6790\u65b9\u6cd5\u7684\u5bf9\u6bd4\u6570\u636e\u3002\u7533\u8bf7\u8005\u8981\u8fdb\u884c\u5206\u6790\u65b9\u6cd5\u5bf9\u6bd4\u7814\u7a76\uff0c\u81f3\u5c11\u8bc1\u660e\uff1a<\/span><\/p>\n

—\u65b0\u7684\u65b9\u6cd5\u914d\u5907\u4e86\u53e6\u5916\u7684\u63a7\u5236\u624b\u6bb5\uff0c\u5728\u5176\u65e2\u5b9a\u7528\u9014\u4e0a\u7b49\u540c\u6216\u8d85\u8fc7\u539f\u59cb\u65b9\u6cd5<\/span><\/p>\n

—\u65b0\u7684\u5206\u6790\u65b9\u6cd5\u6bd4\u539f\u59cb\u65b9\u6cd5\u66f4\u4e0d\u6613\u53d7\u5230\u57fa\u8d28\u7684\u5f71\u54cd<\/span><\/p>\n

\u5982\u679c\u91c7\u7528\u65b0\u7684\u68c0\u9a8c\u65b9\u6cd5\u80fd\u53d1\u540c\u65b0\u7684\u4e0e\u5de5\u827a\u6742\u8d28\u6216\u4ea7\u54c1\u53d8\u5316\u4ea7\u751f\u7684\u6742\u8d28\u6216\u6240\u6709\u65b0\u7684\u6742\u8d28\uff0c\u5219\u5e94\u5bf9\u5386\u53f2\u6279\u51c6\u7684\u7559\u6837\u8fdb\u884c\u68c0\u67e5\uff0c\u8bc1\u5b9e\u65b0\u65b9\u6cd5\u68c0\u51fa\u7684\u53d8\u5316\/\u6742\u8d28\u662f\u56e0\u4e3a\u65b0\u7684\u65b9\u6cd5\u7075\u654f\u5ea6\u6216\u9009\u62e9\u6027\u589e\u52a0\u7684\u7ed3\u679c\uff0c\u800c\u4e0d\u662f\u5de5\u827a\u6742\u8d28\u53d8\u5316\u7684\u7ed3\u679c\u3002<\/span><\/p>\n

\u5982\u679c\u5206\u6790\u65b9\u6cd5\u5177\u6709\u7a33\u5b9a\u6027\u6307\u793a\u7279\u6027\uff1a<\/span><\/p>\n

—\u5e94\u5305\u62ec\u9002\u5f53\u7684\u6837\u54c1\uff0c\u6bd4\u8f83\u65b0\u7684\u65b9\u6cd5\u548c\u539f\u59cb\u65b9\u6cd5\u68c0\u51fa\u76f8\u5173\u4ea7\u54c1\u53d8\u5316\u548c\u964d\u89e3\u7269\u7684\u80fd\u529b;<\/span><\/p>\n

—\u5bf9\u6bd4\u65f6\u6240\u5206\u6790\u7684\u6279\u6b21\u6570\u5e94\u80fd\u63d0\u4f9b\u8db3\u591f\u7684\u7edf\u8ba1\u6027\u80fd;<\/span><\/p>\n

—\u8981\u91c7\u7528\u9002\u5f53\u7684\u7edf\u8ba1\u5b66\u65b9\u6cd5\u6765\u5b9e\u65bd\u7b49\u540c\u6027\u3001\u4e0d\u4f4e\u4e8e\u6216\u4f18\u8d8a\u6027\u7814\u7a76\uff0c\u6765\u8bc1\u660e\u65b0\u65b9\u6cd5\u6216\u4fee\u8ba2\u8fc7\u7684\u65b9\u6cd5\u7684\u6027\u80fd\u7b49\u540c\u6216\u4f18\u4e8e\u539f\u59cb\u65b9\u6cd5;<\/span><\/p>\n

—\u8981\u8bc6\u522b\u51fa\u7528\u4e8e\u6bd4\u8f83\u4ea7\u54c1\u68c0\u6d4b\u7ed3\u679c\u7684\u7edf\u8ba1\u5b66\u5206\u6790\u65b9\u6cd5;<\/span><\/p>\n

—\u9002\u5f53\u65f6\uff0c\u5206\u6790\u65b9\u6cd5\u95f4\u6240\u6709\u89c2\u5bdf\u5230\u7684\u504f\u5dee\u6216\u5dee\u5f02\u4ee5\u53ca\u5bf9\u6bd4\u7ed3\u679c\u5747\u5e94\u8fdb\u884c\u8ba8\u8bba\uff0c\u5e76\u63d0\u51fa\u89e3\u91ca\u3002<\/span><\/p>\n

5.2.2\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7814\u7a76<\/span><\/strong><\/p>\n

\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u4e00\u822c\u8981\u4f7f\u7528\u8f6c\u79fb\u65b9\u6848\u8fdb\u884c\u7ba1\u7406\uff0c\u5728\u65b9\u6848\u4e2d\u8be6\u7ec6\u5199\u660e\u8981\u8bc4\u4f30\u7684\u53c2\u6570\uff0c\u4ee5\u53ca\u9002\u7528\u4e8e\u7ed3\u679c\u7684\u9884\u5b9a\u53ef\u63a5\u53d7\u6807\u51c6\u3002\u8f6c\u79fb\u7814\u7a76\u901a\u5e38\u5305\u62ec\u4e24\u4e2a\u6216\u66f4\u591a\u5316\u9a8c\u5ba4\u6216\u573a\u6240(\u8f6c\u51fa\u5316\u9a8c\u5ba4\u548c\u63a5\u6536\u5316\u9a8c\u5ba4)\uff0c\u7531\u5176\u5b9e\u65bd\u9884\u5148\u6279\u51c6\u7684\u8f6c\u79fb\u65b9\u6848\u3002\u8f6c\u51fa\u5316\u9a8c\u5ba4\u548c\u63a5\u6536\u5316\u9a8c\u5ba4\u4f7f\u7528\u5177\u6709\u4ee3\u8868\u6027\u7684\u8db3\u591f\u6570\u91cf\u7684\u6d4b\u8bd5\u7269(\u4f8b\u5982\u76f8\u540c\u6279\u53f7\u7684\u539f\u6599\u836f\u6216\u5236\u5242)\u3002\u5b9e\u65bd\u5bf9\u6bd4\u7814\u7a76\u662f\u4e3a\u4e86\u8bc4\u4f30\u51c6\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6\uff0c\u7279\u522b\u662f\u5b9e\u9a8c\u5ba4\u4e4b\u95f4\u7684\u5dee\u5f02\u3002\u5982\u679c\u6240\u8f6c\u79fb\u7684\u5206\u6790\u65b9\u6cd5\u4e5f\u662f\u7a33\u5b9a\u6027\u6307\u793a\u6027\u65b9\u6cd5\uff0c\u5219\u5e94\u5728\u4e24\u4e2a\u5316\u9a8c\u5ba4\u5747\u5bf9\u5f3a\u964d\u89e3\u6837\u54c1\u6216\u542b\u6709\u6240\u8981\u68c0\u6d4b\u7684\u76f8\u5173\u6742\u8d28\u7684\u6837\u54c1\u8fdb\u884c\u68c0\u6d4b\u3002USP\u901a\u8bba<1224>”\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb”\u63d0\u4f9b\u4e86\u5173\u4e8e\u6b64\u95ee\u9898\u7684\u66f4\u591a\u6307\u5357\u3002<\/span><\/p>\n


<\/p>\n

\u7efc\u8ff0\uff1a<\/span><\/p>\n

\n

\u4ece\u4e0a\u9762\u7684\u4ecb\u7ecd\u6765\u770b\uff0cFDA\u6700\u65b0\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5357\u5177\u6709\u5982\u4e0b\u7279\u70b9\uff1a<\/span><\/p>\n

\u7b2c\u4e00\u3001 \u66f4\u91cd\u89c6\u65b9\u6cd5\u5f00\u53d1\u7684\u4f5c\u7528\u3002\u6839\u636eQBD\u7684\u7406\u5ff5\uff0c\u597d\u7684\u5206\u6790\u65b9\u6cd5\u4e00\u5b9a\u662f\u5f00\u53d1\u51fa\u6765\u7684\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u9a8c\u8bc1\u7684\u7ed3\u679c\u3002<\/span><\/p>\n

\u7b2c\u4e8c\u3001 \u5206\u6790\u65b9\u6cd5\u7684\u63cf\u8ff0\u5fc5\u987b\u5168\u9762\uff0c\u5728\u6307\u5357\u7684\u5206\u6790\u65b9\u6cd5\u5185\u5bb9\u8981\u6c42\u90e8\u5206\uff0c\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u5206\u6790\u65b9\u6cd5\u5e94\u8be5\u542b\u6709\u7684\u6280\u672f\u5185\u5bb9\u3002\u8fd9\u548c\u56fd\u5185\u5f88\u591a\u4f01\u4e1a\u5206\u6790\u89c4\u7a0b\u53ea\u5305\u62ec\u9879\u76ee\u548c\u9650\u5ea6\u7684\u505a\u6cd5\uff0c\u662f\u660e\u663e\u4e0d\u540c\u7684\u3002\u4e00\u4e2a\u53ea\u5305\u62ec\u9879\u76ee\u548c\u9650\u5ea6\u7684\u5206\u6790\u89c4\u7a0b\uff0c\u662f\u4e0d\u5b8c\u6574\u7684\uff0c\u4e0d\u80fd\u4f53\u73b0\u5206\u6790\u65b9\u6cd5\u7684\u5168\u8c8c\u3002<\/span><\/p>\n

\u7b2c\u4e09\u3001 \u5206\u6790\u65b9\u6cd5\u5fc5\u987b\u5b9e\u65bd\u751f\u547d\u5468\u671f\u5185\u7684\u7ba1\u7406\uff0c\u5982\u679c\u51fa\u73b0\u5404\u7c7b\u53d8\u66f4\uff0c\u5e94\u8be5\u53ca\u65f6\u8fdb\u884c\u518d\u9a8c\u8bc1\u3002<\/span><\/p>\n

\u7b2c\u56db\u3001 FDA\u4ecb\u7ecd\u4e86\u5206\u6790\u65b9\u6cd5\u5bf9\u6bd4\u7684\u8981\u6c42\u7684\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u7684\u8981\u6c42\uff0c\u8fd9\u90fd\u662f\u56fd\u5185\u6307\u5bfc\u539f\u5219\u7684\u4e0d\u8db3\u4e4b\u5904\uff0c\u53ef\u4ee5\u8d77\u5230\u8865\u5145\u4f5c\u7528\u3002<\/span><\/p>\n<\/p>\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

<\/span><\/span><\/span><\/strong>\u4e2d\u7f8e\u836f\u5178\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u3001\u8f6c\u79fb\u4e0e\u786e\u8ba4\u7814\u8ba8\u4f1a<\/span><\/strong><\/p>\n<\/p>\n

\n
\n
\n
\n
\n
\n
\n
\n
\n

2020\u5e74\u7248\u4e2d\u56fd\u836f\u5178\u5173\u4e8e\u65b9\u6cd5\u5b66\u7684\u5f81\u6c42\u610f\u89c1\u7a3f\u7684\u89e3\u8bfb\u4e0e\u8ba8\u8bba<\/strong>
<\/p>\n

\n
\n
\n
\n
\n
\n

\u4e00\u3001\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u7684\u4fee\u8ba2\u5185\u5bb9\u89e3\u8bfb\u53ca\u95ee\u9898<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

1. \u9898\u76ee\u7684\u4fee\u8ba2\uff08\u6269\u5927\u4e86\u8303\u56f4\u3001\u8f6c\u53d8\u4e86\u89c2\u5ff5\uff09<\/span><\/span><\/strong><\/p>\n

2.\u6821\u6b63\u56e0\u5b50\u90e8\u5206\u7684\u5220\u9664\uff08\u5220\u9664\u4e86\u4ec0\u4e48\uff0c\u4e3a\u4ec0\u4e48\u5220\u9664\uff09<\/span><\/span><\/strong><\/p>\n

3.\u51c6\u786e\u5ea6\u90e8\u5206\u7684\u4fee\u8ba2\uff08\u51c6\u786e\u5ea6\u53ef\u63a5\u53d7\u7684\u6807\u51c6\uff09<\/span>  <\/span><\/strong><\/p>\n

4.\u540d\u8bcd\u672f\u8bed\u7684\u4fee\u8ba2<\/span><\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

\u4e8c\u3001\u65b9\u6cd5\u5b66\u786e\u8ba4\u6307\u5bfc\u539f\u5219\u7684\u89e3\u8bfb<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

1. \u76ee\u7684<\/span>           <\/span><\/strong><\/p>\n

2.\u6db5\u76d6\u8303\u56f4<\/span>    <\/span><\/strong><\/p>\n

3.\u4eba\u5458\u8d44\u8d28<\/span>          <\/span><\/strong><\/p>\n

4.\u786e\u8ba4\u7684\u7ed3\u8bba\uff08\u540e\u7eed\u5e94\u6ce8\u610f\u7684\u95ee\u9898\uff09<\/span><\/span><\/strong><\/p>\n

5.\u786e\u8ba4\u539f\u5219\u3001\u8003\u5bdf\u6307\u6807\u3001\u786e\u8ba4\u8c41\u514d<\/span><\/span><\/strong><\/p>\n

6.\u5bf9\u7f8e\u56fd\u836f\u5178\u7684\u501f\u9274\uff08\u836f\u5178\u591a\u79cd\u65b9\u6cd5\u7684\u53ef\u80fd\u6027\uff09<\/span><\/span><\/strong> <\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

\u4e09\u3001\u65b9\u6cd5\u5b66\u8f6c\u79fb\u6307\u5bfc\u539f\u5219\u7684\u89e3\u8bfb<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

1.\u76ee\u7684<\/span>            <\/span><\/strong><\/p>\n

2.\u6db5\u76d6\u8303\u56f4<\/span>     <\/span><\/strong><\/p>\n

3.\u8f6c\u79fb\u7c7b\u578b\uff08\u5982\u4f55\u9009\u62e9\uff09<\/span><\/span><\/strong><\/p>\n

4.\u8f6c\u79fb\u7684\u5173\u952e\u70b9<\/span>    <\/span><\/strong><\/p>\n

5.\u8f6c\u79fb\u65b9\u6848\uff08\u5e94\u5305\u62ec\u7684\u5185\u5bb9\uff09<\/span><\/span><\/strong><\/p>\n

6.\u8f6c\u79fb\u65b9\u6cd5<\/span>        <\/span><\/strong><\/p>\n

7.\u8f6c\u79fb\u62a5\u544a<\/span><\/span><\/strong><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a<\/span><\/strong>\u5468<\/span><\/strong>\u7acb\u6625<\/span>  <\/span><\/strong>\u5317\u4eac\u5e02\u836f\u68c0\u6240<\/span><\/strong> <\/span><\/strong>\u6240\u957f\u52a9\u7406<\/span><\/strong><\/p>\n

\u836f\u54c1\u68c0\u9a8c\u4e00\u7ebf\u5de5\u4f5c\u4e09\u5341\u4f59\u5e74\uff0c\u66fe\u4efb\u5317\u4eac\u5e02\u836f\u54c1\u68c0\u9a8c\u6240\u5316\u5b66\u5ba4\u4e3b\u4efb\u3001\u6297\u751f\u7d20\u5ba4\u4e3b\u4efb\u3001\u751f\u5316\u751f\u68c0\u5ba4\u4e3b\u4efb\u53ca\u6240\u957f\u52a9\u7406\u3002\u7b2c\u4e5d\u3001\u5341\u5c4a\u836f\u5178\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u56fd\u5bb6\u5c40<\/span>CDE\u4eff\u5236\u836f\u7acb\u5377\u5ba1\u67e5\u7ec4\u6210\u5458\uff0c\u5317\u4eac\u5e02\u4e0a\u5e02\u540e\u836f\u54c1\u5b89\u5168\u6027\u76d1\u6d4b\u4e0e\u518d\u8bc4\u4ef7\u4e13\u5bb6\u5e93\u4e13\u5bb6\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7b49\u591a\u4e2a\u673a\u6784\u5ba1\u8bc4\u4e13\u5bb6\u5e93\u4e13\u5bb6\u3002<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

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

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

\n
\n
\n
\n
\n
\n
\n
\n
\n

\u4e00\u3001\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\u3001\u8f6c\u79fb\u548c\u786e\u8ba4\u5b9a\u4e49<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

\u4e2d\u56fd\u836f\u5178\u4e0e\u56fd\u51c6<\/span>GB\/T\u300a\u5408\u683c\u8bc4\u5b9a \u5316\u5b66\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u548c\u9a8c\u8bc1\u6307\u5357\u300b\u7684\u533a\u522b<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

\u4e8c\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u4e3b\u8981\u5185\u5bb9\u3001\u5173\u952e\u56e0\u7d20\u548c\u96be\u70b9\u63a7\u5236<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

1\u4e0d\u540c\u542b\u91cf\u6d4b\u5b9a\u6cd5\u51c6\u786e\u5ea6\u63a5\u53d7\u6807\u51c6  2\u7cbe\u5bc6\u5ea6\u7684\u505a\u6cd5\u548c\u8bc4\u4f30<\/span><\/strong><\/p>\n

3\u4e13\u5c5e\u6027\u4e0e\u964d\u89e3\u8bd5\u9a8c\u7684\u5e38\u89c1\u95ee\u9898   4 \u591a\u79cd\u65b9\u6cd5\u8054\u7528\u9a8c\u8bc1\u65b9\u6cd5\u4e13\u5c5e\u6027<\/span><\/strong><\/p>\n

5\u68c0\u6d4b\u9650\u548c\u5b9a\u91cf\u9650\u7684\u505a\u6cd5\u548c\u8bc4\u4f30   6 \u7ebf\u6027\u4e0e\u8303\u56f4\u8bd5\u9a8c\u7684\u5e38\u89c1\u95ee\u9898 <\/span><\/strong><\/p>\n

7\u65b9\u6cd5\u8010\u7528\u6027\u7684\u505a\u6cd5\u548c\u8bc4\u4f30     8\u7cfb\u7edf\u9002\u7528\u6027\u7684\u505a\u6cd5\u548c\u8bc4\u4f30<\/span><\/strong><\/p>\n

9\u5206\u79bb\u5ea6\u4e0e\u5cf0\u7eaf\u5ea6\u8003\u5bdf       10\u5236\u5242\u8f85\u6599\u5cf0\u7684\u6263\u9664\u4e0e\u5904\u7406<\/span><\/strong><\/p>\n

11\u56de\u6536\u7387\u7684\u505a\u6cd5\u548c\u8bc4\u4f30      12HPLC\u68c0\u6d4b\u6ce2\u957f\u7684\u9009\u62e9\u4e0e\u95ee\u9898\u89e3\u51b3\u65b9\u6848<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

\u4e09\u3001\u8ba8\u8bba\u65b9\u6cd5\u8f6c\u79fb\u7684\u4e0d\u540c\u65b9\u5f0f\u548c\u514d\u9664\u8f6c\u79fb <\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n
\n
\n
\n

\u56db\u3001\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u8be5\u600e\u4e48\u505a\uff0c\u6709\u6ca1\u6709\u7edf\u4e00\u7684\u89c4\u5b9a<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

\u4e94\u3001\u4e09\u4e2a\u901a\u5219\u4e4b\u95f4\u7684\u76f8\u4e92\u5173\u7cfb<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n

1 \u54ea\u4e9b\u65b9\u6cd5\u505a\u9a8c\u8bc1\uff0c\u54ea\u4e9b\u65b9\u6cd5\u505a\u786e\u8ba4\uff1f<\/span><\/strong><\/p>\n

2\u836f\u5178\u6807\u51c6\u65b9\u6cd5\u662f\u5426\u6bcf\u4e2a\u7269\u6599\u7684\u68c0\u9a8c\u9879\u76ee\u90fd\u8981\u9a8c\u8bc1\u6216\u786e\u8ba4\uff1f<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\n
\n

\u516d\u3001\u4ea4\u6d41<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

2020\u836f\u5178\u65b9\u6cd5\u5b66\u9a8c\u8bc1\/\u8f6c\u79fb\/\u786e\u8ba4\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u7684\u53d8\u5316\u4e0e\u6ce8\u610f\u4e8b\u9879<\/strong><\/p>\n<\/section>\n

\u4e3b\u8bb2\u4eba\uff1a\u738b\u8001\u5e08  \u4e2d\u56fd\u836f\u5178\u5206\u6790\u68c0\u6d4b\u6280\u672f\u6307\u5357\u526f\u4e3b\u7f16 \u4e2d\u56fd\u836f\u5178\u7406\u5316\u4e13\u4e1a\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u4e2d\u56fd\u836f\u5927\u517c\u804c\u6559\u6388\uff0c\u535a\u5bfc\u3002\u4e3b\u6301\u5b8c\u6210\u591a\u9879\u56fd\u5bb6\u79d1\u6280\u652f\u6491\u8ba1\u5212\u548c\u81ea\u7136\u79d1\u5b66\u57fa\u91d1\u7b49\u8bfe\u9898\uff0c\u53d1\u8868\u8bba\u6587\u4e00\u767e\u4f59\u7bc7\uff1b\u4e3b\u7f16\u4e13\u8457\u300a\u836f\u54c1\u68c0\u9a8c\u300b\u4e00\u90e8\uff0c\u53c2\u7f16\u4e13\u8457\u6570\u90e8\u3002<\/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<\/section>\n
\n
\n
\n

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

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

\u676d\u5dde\u5e02\uff1a2019\u5e745\u670810\u65e5-5\u670812\u65e5\uff0810\u65e5\u5168\u5929\u62a5\u5230\uff09<\/strong>
<\/p>\n

\u5317\u4eac\u5e02\uff1a2019\u5e745\u670824\u65e5-5\u670826\u65e5 (24\u65e5\u5168\u5929\u62a5\u5230)<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

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

\u3000<\/span><\/span> \u4e0e\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u3001\u786e\u8ba4\u548c\u8f6c\u79fb\u5de5\u4f5c\u76f8\u5173\u7684QA\/QC\u90e8\u95e8\u3001\u7814\u53d1\u90e8\u95e8\u3001\u9879\u76ee\u7ba1\u7406\u90e8\u95e8\u3001\u751f\u4ea7\u90e8\u95e8\u3001\u5408\u540c\u7814\u7a76\u673a\u6784\u7684\u5b9e\u9a8c\u5ba4\u7ecf\u7406\u3001\u5206\u6790\u5316\u5b66\u5e08\u3001\u7814\u7a76\u5458\u548c\u6cd5\u89c4\u7b26\u5408\u4eba\u5458<\/span><\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

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

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

\n

\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

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

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

\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<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

2017\u5e747\u6708FDA\u9881\u5e03\u4e86\u6307\u5357\u300aAnalytical Procedures and Methods Valid […]<\/p>\n","protected":false},"author":1,"featured_media":82472,"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\/82471"}],"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=82471"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82471\/revisions"}],"predecessor-version":[{"id":82473,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82471\/revisions\/82473"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/82472"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=82471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=82471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=82471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}