{"id":96573,"date":"2019-03-06T00:00:50","date_gmt":"2019-05-17T08:02:07","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/96573\/"},"modified":"2019-05-17T16:02:08","modified_gmt":"2019-05-17T08:02:08","slug":"a5294076f4","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/96573\/","title":{"rendered":"\u4e34\u5e8a\u7814\u7a76\u8d28\u91cf\u98ce\u9669\u70b9\uff01\u77e5\u60c5\u540c\u610f\u4e66\u4e94\u5927\u5e38\u89c1\u95ee\u9898"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"white-space: normal;text-align: center;\"><img class=\"__bg_gif\"         width=\"auto\" style=\"letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-family: \u5fae\u8f6f\u96c5\u9ed1;z-index: -1;cursor: pointer;font-size: 14px;line-height: 22.4px;width: 558px;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;\" 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normal;\">\u3000\u3000\u53d7\u8bd5\u8005\u6743\u76ca\u7684\u4fdd\u62a4\u548c\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\u7684\u53ef\u9760\u6027\uff0c\u662f\u4e34\u5e8a\u7814\u7a76\u8d28\u91cf\u7ba1\u7406\u6700\u91cd\u8981\u7684\u73af\u8282\u3002\u800c\u77e5\u60c5\u540c\u610f\u4e66\u5219\u662f\u4e0e\u53d7\u8bd5\u8005\u6743\u76ca\u4fdd\u62a4\u76f8\u5173\u7684\u6700\u91cd\u8981\u6587\u4ef6\u3002\u4efb\u4f55\u4e0e\u77e5\u60c5\u540c\u610f\u4e66\u76f8\u5173\u7684\u95ee\u9898\uff0c\u90fd\u53ef\u80fd\u6210\u4e3a\u4e34\u5e8a\u7814\u7a76\u4e2d\u5173\u952e\u7684\u8d28\u91cf\u95ee\u9898\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<section class=\"_135editor\"   style=\"white-space: normal;border-width: 0px;border-style: none;border-color: initial;\">\n<section style=\"padding: 12px;text-align: center;\">\n<section style=\"padding-right: 12px;padding-bottom: 4px;padding-left: 12px;display: inline-block;border-bottom: 2px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px;border-width: 2px;border-style: solid;border-color: rgb(239, 112, 96);border-radius: 6px;background: rgb(249, 227, 224);box-sizing: border-box;\">\n<section class=\"135brush\"  style=\"padding: 5px 1em;box-sizing: border-box;border-radius: 6px;border-width: 2px;border-style: dashed;border-color: rgb(247, 161, 150);background: rgb(254, 254, 254);font-size: 16px;letter-spacing: 1.5px;line-height: 1.75em;\"><span style=\"color: rgb(63, 63, 63);font-size: 20px;\"><strong><span style=\"color: rgb(89, 89, 89);\">\u56fd\u5185\u73b0\u72b6<\/span><\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"white-space: normal;\">\u3000\u3000\u3000\u3000<\/p>\n<section class=\"_135editor\"     style=\"white-space: normal;border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section class=\"135brush\" style=\"margin-top: 10px;margin-bottom: 10px;padding: 5px 10px;border-left: 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normal;\">\u3000\u3000\u4e8c\u662f\u7531\u4e8e\u7533\u529e\u65b9\u63d0\u4f9b\u7ed9\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u6a21\u677f\u5f80\u5f80\u6765\u81ea\u5728\u7f8e\u56fd\u6216\u6b27\u6d32\u56fd\u5bb6\u8fdb\u884c\u7684\u4e34\u5e8a\u7814\u7a76\uff0c\u4e0d\u4e00\u5b9a\u90fd\u9002\u5408\u4e2d\u56fd\u7684\u60c5\u51b5\uff0c\u4e2d\u56fd\u548c\u5404\u533b\u9662\u7684\u7279\u6b8a\u6027\u4e5f\u4e0d\u4e00\u5b9a\u5728\u77e5\u60c5\u540c\u610f\u4e66\u4e2d\u5f97\u5230\u4f53\u73b0\u3002\u6b64\u5916\uff0c\u4e00\u4e9b\u7ffb\u8bd1\u8fc7\u6765\u7684\u77e5\u60c5\u540c\u610f\u4e66\u6a21\u677f\uff0c\u4f7f\u7528\u7684\u662f\u7ffb\u8bd1\u8bed\u8a00\uff0c\u4e0d\u7b26\u5408\u4e2d\u6587\u7684\u884c\u6587\u4e60\u60ef\uff0c\u4e5f\u5c31\u4e0d\u7b26\u5408\u77e5\u60c5\u540c\u610f\u4e66\u901a\u4fd7\u6613\u61c2\u7684\u8981\u6c42\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u4e0b\u9762\u5c31\u51e0\u4e2a\u5e38\u89c1\u7684\u95ee\u9898\u8fdb\u884c\u8ba8\u8bba\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<section class=\"_135editor\"   style=\"white-space: normal;border-width: 0px;border-style: none;border-color: initial;\">\n<section style=\"padding: 12px;text-align: center;\">\n<section style=\"padding-right: 12px;padding-bottom: 4px;padding-left: 12px;display: inline-block;border-bottom: 2px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px;border-width: 2px;border-style: solid;border-color: rgb(239, 112, 96);border-radius: 6px;background: rgb(249, 227, 224);box-sizing: border-box;\">\n<section class=\"135brush\"  style=\"padding: 5px 1em;box-sizing: border-box;border-radius: 6px;border-width: 2px;border-style: dashed;border-color: rgb(247, 161, 150);background: rgb(254, 254, 254);font-size: 16px;letter-spacing: 1.5px;line-height: 1.75em;\"><span style=\"color: rgb(63, 63, 63);font-size: 20px;\"><strong><span style=\"color: rgb(89, 89, 89);\">\u5e38\u89c1\u95ee\u9898<\/span><\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<section class=\"_135editor\"    style=\"white-space: normal;border-width: 0px;border-style: none;border-color: initial;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;padding-right: 3px;padding-left: 3px;\">\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<section class=\"135brush\" ><span style=\"line-height: 32px;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);font-size: 20px;\"><strong>&nbsp;1&nbsp;<\/strong><\/span><span style=\"font-size: 20px;line-height: 32px;color: rgb(255, 255, 255);\"><strong><span style=\"line-height: 32px;\">&nbsp;<\/span><\/strong><\/span><span style=\"color: rgb(239, 112, 96);line-height: 32px;font-size: 20px;\"><strong>\u4fdd\u9669\u95ee\u9898<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<section  style=\"border-top: 1px solid rgb(239, 112, 96);width: 550px;float: left;\"><\/section>\n<section style=\"margin-top: -4px;width: 6px;height: 6px;border-radius: 100%;float: right;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section class=\"135brush\" style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<p><span style=\"color: rgb(79, 129, 189);font-size: 18px;\">\u25ce\u662f\u5426\u9700\u8981\u63d0\u5230\u4fdd\u9669\u4e8b\u5b9c\uff0c\u503c\u5f97\u5546\u69b7\uff01<\/span><\/p>\n<\/section>\n<\/section>\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<\/section>\n<section style=\"width: 0px;height: 0px;clear: both;\"><\/section>\n<\/section>\n<p style=\"white-space: normal;\">\u3000\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u5728\u4fdd\u9669\u95ee\u9898\u4e0a\uff0c\u4e2d\u56fdGCP\u6709\u4e00\u5b9a\u7684\u8d85\u524d\u610f\u8bc6\u3002\u73b0\u884c2003\u7248GCP\u7b2c\u5341\u4e8c\u6761\u7b2c4\u9879\u89c4\u5b9a\uff0c\u5728\u9012\u4ea4\u4f26\u7406\u59d4\u5458\u4f1a\u5ba1\u67e5\u7684\u8d44\u6599\u4e2d\u5e94\u8be5\u6709\u201c\u53d7\u8bd5\u8005\u56e0\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u800c\u53d7\u5230\u635f\u5bb3\u751a\u81f3\u53d1\u751f\u6b7b\u4ea1\u65f6\uff0c\u7ed9\u4e88\u7684\u6cbb\u7597\u548c\/\u6216\u4fdd\u9669\u63aa\u65bd\u201d\uff1b\u5728\u7b2c\u56db\u5341\u4e09\u6761\u4e5f\u660e\u786e\u89c4\u5b9a\u201c\u7533\u529e\u8005\u5e94\u5bf9\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u8bd5\u8005\u63d0\u4f9b\u4fdd\u9669\u201d\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u4f46\u662f\uff0c\u57282003\u5e74\u7684\u65f6\u5019\uff0c\u4e2d\u56fd\u6ca1\u6709\u54ea\u5bb6\u4fdd\u9669\u516c\u53f8\u6709\u8fd9\u4e2a\u9669\u79cd\u3002\u771f\u6b63\u5728\u4e2d\u56fd\u51fa\u73b0\u8fd9\u4e2a\u9669\u79cd\uff0c\u662f\u5728\u5927\u7ea610\u5e74\u4ee5\u540e\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u800c\u4e0d\u8bba\u662fICH E6 R2\u8fd8\u662f\u7f8e\u56fd\u768421CFR50.25\uff0c\u90fd\u6ca1\u6709\u8981\u6c42\u4f26\u7406\u7684\u9012\u4ea4\u8d44\u6599\u4e2d\u5305\u542b\u4fdd\u9669\u8bc1\u4e66\uff0c\u4e5f\u6ca1\u6709\u8981\u6c42\u7533\u529e\u65b9\u4e00\u5b9a\u8981\u8d2d\u4e70\u4fdd\u9669\u3002\u77e5\u60c5\u540c\u610f\u4e66\u4e2d\u4e5f\u6ca1\u6709\u8981\u6c42\u5fc5\u987b\u63d0\u5230\u6709\u5173\u4fdd\u9669\u7684\u5185\u5bb9\u3002\u56e0\u6b64\uff0c\u4e2d\u56fd\u7684GCP\u5728\u4fdd\u9669\u4e0a\u7684\u8981\u6c42\u662f\u9ad8\u4e8eICH GCP\u548c\u7f8e\u56fd\u7684\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u4e2d\u56fdGCP\u8fd9\u4e00\u5bf9\u4fdd\u9669\u7684\u8d85\u524d\u8981\u6c42\uff0c\u66fe\u7ecf\u7ed9\u90a3\u4e9b\u5728\u4e2d\u56fd\u8fdb\u884c\u6b63\u89c4\u64cd\u4f5c\u7684\u4e34\u5e8a\u7814\u7a76\u5e26\u6765\u5de8\u5927\u56f0\u96be\u3002\u597d\u5728\u540e\u6765\u4e00\u4e9b\u4fdd\u9669\u884c\u4e1a\u4eba\u5458\u53d1\u73b0\u4e86\u8fd9\u4e00\u5de8\u5927\u5546\u673a\uff0c\u8bd5\u63a2\u7740\u8fdb\u5165\u4e86\u8fd9\u4e2a\u5bf9\u4e8e\u4ed6\u4eec\u6765\u8bb2\u975e\u5e38\u964c\u751f\u7684\u9886\u57df\uff0c\u4e34\u5e8a\u7814\u7a76\u7684\u4fdd\u9669\u95ee\u9898\u624d\u5f97\u4ee5\u89e3\u51b3\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u867d\u7136ICH E6 R2\u548c\u7f8e\u56fd\u768421CFR50.25\u90fd\u6ca1\u6709\u5728\u77e5\u60c5\u540c\u610f\u4e66\u4e2d\u8981\u6c42\u4fdd\u9669\u7684\u5185\u5bb9\uff0c\u4f46\u662f\uff0c\u4e2d\u56fd\u7684\u7814\u7a76\u4e2d\u5fc3\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u4eba\u5458\u4f9d\u636e\u4e2d\u56fd\u7684GCP\uff0c\u5f80\u5f80\u8981\u6c42\u5728\u77e5\u60c5\u540c\u610f\u4e66\u4e0a\u5199\u4e0a\uff1a\u201c\u7533\u529e\u8005\u5df2\u7ecf\u4e3a\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u8bd5\u8005\u63d0\u4f9b\u4fdd\u9669\u201d\u3002\u56e0\u4e3a\u7533\u529e\u65b9\u8d2d\u4e70\u7684\u4fdd\u9669\u6db5\u76d6\u4e86\u53c2\u52a0\u4e34\u5e8a\u7814\u7a76\u7684\u6bcf\u4f4d\u53d7\u8bd5\u8005\uff0c\u6240\u4ee5\uff0c\u4ece\u7406\u8bba\u4e0a\u6765\u8bb2\uff0c\u8fd9\u79cd\u8bf4\u6cd5\u662f\u6ca1\u6709\u95ee\u9898\u7684\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u4f46\u662f\uff0c\u8fd9\u79cd\u7528\u4e2d\u56fd\u7684GCP\u539f\u8bdd\u7167\u642c\u8fc7\u6765\u7684\u8bf4\u6cd5\uff0c\u867d\u7136\u66f4\u5bb9\u6613\u4e0eGCP\u7684\u8981\u6c42\u76f8\u7b26\uff0c\u4f46\u5bb9\u6613\u4ea7\u751f\u6b67\u4e49\u3002\u65e2\u7136\u7533\u529e\u8005\u5df2\u7ecf\u4e3a\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u8bd5\u8005\u63d0\u4f9b\u4fdd\u9669\uff0c\u53d7\u8bd5\u8005\u53ef\u4ee5\u7406\u89e3\u4e3a\u8fd9\u4e2a\u4fdd\u9669\u662f\u4e3a\u53d7\u8bd5\u8005\u672c\u4eba\u8d2d\u4e70\u7684\u4fdd\u9669\u3002\u5982\u679c\u4fdd\u9669\u7684\u53d7\u76ca\u4eba\u662f\u53d7\u8bd5\u8005\u672c\u4eba\uff0c\u90a3\u4e48\u4fdd\u5355\u4e0a\u5e94\u8be5\u662f\u53d7\u8bd5\u8005\u672c\u4eba\u7684\u540d\u5b57\u3002\u4f46\u4e34\u5e8a\u7814\u7a76\u4fdd\u5355\u4e0a\u7684\u53d7\u76ca\u4eba\u662f\u7533\u529e\u65b9\uff0c\u6ca1\u6709\u53d7\u8bd5\u8005\u7684\u540d\u5b57\u3002\u5982\u679c\u53d7\u8bd5\u8005\u4e00\u5b9a\u8981\u8fdb\u884c\u8ffd\u7a76\uff0c\u5bb9\u6613\u4ea7\u751f\u4e00\u4e9b\u95ee\u9898\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u6240\u4ee5\uff0c\u5728\u4e34\u5e8a\u7814\u7a76\u4fdd\u9669\u7684\u95ee\u9898\u4e0a\uff0c\u6700\u597d\u91c7\u7528\u8fd9\u79cd\u65b9\u5f0f\u63cf\u8ff0\uff1a\u201c\u7533\u529e\u65b9\u5df2\u7ecf\u4e3a\u4e34\u5e8a\u7814\u7a76\u8d2d\u4e70\u4e86\u4fdd\u9669\uff0c\u8fd9\u4e2a\u4fdd\u9669\u6db5\u76d6\u4e86\u53c2\u52a0\u4e34\u5e8a\u7814\u7a76\u7684\u6bcf\u4f4d\u53d7\u8bd5\u8005\u3002\u201d<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u7b14\u8005\u8ba4\u4e3a\uff0c\u77e5\u60c5\u540c\u610f\u4e66\u4e0a\u5176\u5b9e\u6ca1\u6709\u5fc5\u8981\u63d0\u5230\u4fdd\u9669\u7684\u4e8b\u5b9c\u3002\u7533\u529e\u65b9\u662f\u5426\u8d2d\u4e70\u4fdd\u9669\uff0c\u4e0e\u53d7\u8bd5\u8005\u6743\u76ca\u7684\u4fdd\u62a4\u6ca1\u6709\u76f4\u63a5\u5173\u7cfb\u3002ICH GCP\u5173\u5fc3\u7684\u662f\u7533\u529e\u65b9\u5bf9\u53d7\u8bd5\u8005\u7684\u8d54\u4ed8\uff0c\u8fd9\u4e2a\u8d54\u4ed8\u662f\u7531\u7533\u529e\u65b9\u627f\u62c5\uff0c\u8fd8\u662f\u7531\u4fdd\u9669\u516c\u53f8\u627f\u62c5\uff0c\u5e76\u4e0d\u662f\u6700\u5173\u952e\u7684\u95ee\u9898\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<section class=\"_135editor\"    style=\"white-space: normal;border-width: 0px;border-style: none;border-color: initial;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;padding-right: 3px;padding-left: 3px;\">\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<section class=\"135brush\" ><span style=\"line-height: 32px;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);font-size: 20px;\"><strong>&nbsp;2&nbsp;<\/strong><\/span><span style=\"font-size: 20px;line-height: 32px;color: rgb(255, 255, 255);\"><strong><span style=\"line-height: 32px;\">&nbsp;<\/span><\/strong><\/span><span style=\"color: rgb(239, 112, 96);line-height: 32px;font-size: 20px;\"><strong>\u53d7\u8bd5\u8005\u4ea4\u901a\u8d39\u548c\u8425\u517b\u8d39\u95ee\u9898<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<section  style=\"border-top: 1px solid rgb(239, 112, 96);width: 550px;float: left;\"><\/section>\n<section style=\"margin-top: -4px;width: 6px;height: 6px;border-radius: 100%;float: right;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section class=\"135brush\" style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<p><span style=\"color: rgb(79, 129, 189);font-size: 18px;\">\u25ce\u8d39\u7528\u4e0d\u80fd\u592a\u591a\uff0c\u907f\u514d\u8bf1\u5bfc\u53d7\u8bd5\u8005\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76<\/span><\/p>\n<p><span style=\"color: rgb(79, 129, 189);font-size: 18px;\">\u25ce\u9700\u9610\u660e\u4ed8\u8d39\u65b9\u6cd5\u3001\u6570\u91cf\u548c\u4ed8\u8d39\u65f6\u95f4<\/span><\/p>\n<\/section>\n<\/section>\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<\/section>\n<section style=\"width: 0px;height: 0px;clear: both;\"><\/section>\n<\/section>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u77e5\u60c5\u540c\u610f\u4e66\u4e0a\u4e00\u822c\u90fd\u8bf4\u660e\u4e86\u53d7\u8bd5\u8005\u4ea4\u901a\u8d39\u548c\u8425\u517b\u8d39\u7684\u95ee\u9898\uff0c\u7ed9\u53d7\u8bd5\u8005\u8865\u507f\u8fd9\u4e9b\u8d39\u7528\u662f\u7b26\u5408\u4f26\u7406\u7684\u3002\u4f46\u662f\uff0c\u8fd9\u79cd\u8d39\u7528\u4e0d\u5e94\u8be5\u5927\u5230\u8db3\u4ee5\u8bf1\u5bfc\u53d7\u8bd5\u8005\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76\u3002\u4e5f\u5c31\u662f\u8bf4\uff0c\u8fd9\u79cd\u8d39\u7528\u53ea\u662f\u4e00\u79cd\u8865\u507f\uff0c\u800c\u975e\u4e00\u79cd\u53d7\u76ca\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u73b0\u5728\u6709\u7684\u533b\u9662\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u89c4\u5b9a\u53d7\u8bd5\u8005\u7684\u4ea4\u901a\u8d39\u8865\u52a9\u4e0d\u5f97\u4f4e\u4e8e\u591a\u5c11\u8d39\u7528\u3002\u8fd9\u5c31\u9700\u8981\u8003\u8651\u8fc7\u9ad8\u7684\u8d39\u7528\u6709\u6ca1\u6709\u8bf1\u5bfc\u53d7\u8bd5\u8005\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76\u7684\u98ce\u9669\uff0c\u56e0\u4e3a\u8d85\u51fa\u5b9e\u9645\u9700\u8981\u7684\u8865\u52a9\u4e5f\u662f\u4e0d\u5408\u7406\u7684\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000ICH E6 R2\u76843.1.9\u4e2d\u89c4\u5b9a\uff1a\u77e5\u60c5\u540c\u610f\u4e66\u4e2d\u9700\u8981\u9610\u660e\u7ed9\u53d7\u8bd5\u8005\u4ed8\u8d39\u7684\u65b9\u6cd5\u3001\u6570\u91cf\u548c\u4ed8\u8d39\u65f6\u95f4\u3002\u8fd9\u4e00\u70b9\u5f80\u5f80\u5728\u56fd\u5185\u77e5\u60c5\u540c\u610f\u4e66\u4e2d\u6ca1\u6709\u8bb2\u6e05\u695a\u3002\u73b0\u5728\u5927\u591a\u6570\u77e5\u60c5\u540c\u610f\u4e66\u4e0a\u53ea\u662f\u63d0\u5230\u4e86\u8865\u507f\u8d39\u7528\u7684\u91d1\u989d\uff0c\u4f46\u6ca1\u6709\u63d0\u5230\u4ec0\u4e48\u65f6\u5019\u7528\u4ec0\u4e48\u65b9\u6cd5\u652f\u4ed8\u8d39\u7528\u3002\u7533\u529e\u65b9\u63d0\u4f9b\u7684\u77e5\u60c5\u540c\u610f\u4e66\u6a21\u677f\u4e2d\uff0c\u5f80\u5f80\u4e5f\u4e0d\u4f1a\u6709\u5bf9\u652f\u4ed8\u65b9\u6cd5\u7684\u63cf\u8ff0\uff0c\u56e0\u4e3a\u6bcf\u5bb6\u533b\u9662\u7684\u652f\u4ed8\u65b9\u6cd5\u662f\u4e0d\u4e00\u6837\u7684\uff0c\u9700\u8981\u6839\u636e\u6bcf\u5bb6\u533b\u9662\u7684\u8d22\u52a1\u6d41\u7a0b\u6765\u786e\u5b9a\u3002\u6240\u4ee5\uff0c\u5728\u652f\u4ed8\u65b9\u6cd5\u4e0a\uff0c\u7531\u4e8e\u77e5\u60c5\u540c\u610f\u4e66\u7684\u6a21\u677f\u6ca1\u6709\u63d0\u4f9b\uff0c\u5404\u533b\u9662\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u4e5f\u5c31\u5ffd\u7565\u4e86\u8fd9\u4e00\u70b9\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<section class=\"_135editor\"    style=\"white-space: normal;border-width: 0px;border-style: none;border-color: initial;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;padding-right: 3px;padding-left: 3px;\">\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<section class=\"135brush\" ><span style=\"line-height: 32px;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);font-size: 20px;\"><strong>&nbsp;3&nbsp;<\/strong><\/span><span style=\"font-size: 20px;line-height: 32px;color: rgb(255, 255, 255);\"><strong><span style=\"line-height: 32px;\">&nbsp;<\/span><\/strong><\/span><span style=\"color: rgb(239, 112, 96);line-height: 32px;font-size: 20px;\"><strong>\u8bd5\u9a8c\u76f8\u5173\u7684\u68c0\u67e5\u8d39\u7528\u548c\u4f4f\u9662\u8d39\u7528\u7b49<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<section  style=\"border-top: 1px solid rgb(239, 112, 96);width: 550px;float: left;\"><\/section>\n<section style=\"margin-top: -4px;width: 6px;height: 6px;border-radius: 100%;float: right;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section class=\"135brush\" style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<p><span style=\"color: rgb(79, 129, 189);font-size: 18px;\">\u25ce\u8fd9\u4e9b\u7ec6\u8282\u4e0d\u5e94\u6784\u6210\u8bf1\u5bfc\u53d7\u8bd5\u8005\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76\uff0c\u56e0\u6b64\u4e00\u5b9a\u8981\u5199\uff01<\/span><\/p>\n<\/section>\n<\/section>\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<\/section>\n<section style=\"width: 0px;height: 0px;clear: both;\"><\/section>\n<\/section>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u5728\u4e00\u4e9b\u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u4e0e\u4e34\u5e8a\u7814\u7a76\u76f8\u5173\u7684\u68c0\u67e5\u8d39\u7528\u3001\u4f4f\u9662\u8d39\u7528\u751a\u81f3\u5bf9\u7167\u836f\u7269\u7684\u8d39\u7528\uff0c\u90fd\u4f1a\u7531\u7533\u529e\u65b9\u6765\u627f\u62c5\u3002\u5982\u679c\u7533\u529e\u65b9\u63d0\u4f9b\u4e86\u8fd9\u4e9b\u8d39\u7528\uff0c\u5e94\u8be5\u5728\u77e5\u60c5\u540c\u610f\u4e66\u4e2d\u8bf4\u660e\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u6709\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u8ba4\u4e3a\uff0c\u5728\u77e5\u60c5\u540c\u610f\u4e66\u4e2d\u63d0\u5230\u8fd9\u4e9b\u8d39\u7528\u7531\u7533\u529e\u65b9\u627f\u62c5\uff0c\u4f1a\u8d77\u5230\u8bf1\u5bfc\u53d7\u8bd5\u8005\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76\u7684\u4f5c\u7528\uff0c\u6240\u4ee5\u4e0d\u540c\u610f\u5c06\u8fd9\u4e9b\u7ec6\u8282\u5199\u5728\u77e5\u60c5\u540c\u610f\u4e66\u4e0a\u3002\u4f46\u662f\uff0c\u7531\u4e8e\u8fd9\u4e9b\u8d39\u7528\u662f\u4e34\u5e8a\u7814\u7a76\u76f8\u5173\u7684\u8d39\u7528\uff0c\u53d7\u8bd5\u8005\u4e0d\u4e00\u5b9a\u80fd\u591f\u4ece\u8fd9\u4e9b\u68c0\u67e5\u6216\u5904\u7406\u4e2d\u83b7\u76ca\uff0c\u6240\u4ee5\u4e0d\u5e94\u8be5\u6784\u6210\u5bf9\u53d7\u8bd5\u8005\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76\u7684\u8bf1\u5bfc\u3002\u540c\u65f6\uff0c\u5373\u4f7f\u77e5\u60c5\u540c\u610f\u4e66\u91cc\u9762\u6ca1\u6709\u5199\uff0c\u53e3\u5934\u7684\u77e5\u60c5\u8fc7\u7a0b\u4e2d\uff0c\u4e5f\u662f\u9700\u8981\u5bf9\u53d7\u8bd5\u8005\u8bf4\u6e05\u695a\u7684\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u6709\u65f6\uff0c\u4e00\u4e9b\u53d7\u8bd5\u8005\u4f1a\u5728\u7814\u7a76\u4e2d\u5fc3\u4ee5\u5916\u7684\u533b\u9662\u4ea7\u751f\u4e00\u4e9b\u8d39\u7528\u3002\u5982\u679c\u8fd9\u4e9b\u8d39\u7528\u4e0e\u4e34\u5e8a\u7814\u7a76\u6709\u5173\uff0c\u4e14\u7533\u529e\u65b9\u613f\u610f\u5bf9\u8fd9\u4e9b\u8d39\u7528\u63d0\u4f9b\u8865\u507f\uff0c\u4e5f\u5e94\u8be5\u5728\u77e5\u60c5\u540c\u610f\u4e66\u91cc\u8bb2\u6e05\u695a\u3002\u5982\u679c\u6ca1\u6709\u8bb2\u6e05\u695a\uff0c\u53d7\u8bd5\u8005\u5c31\u53ef\u80fd\u4f1a\u5fd8\u8bb0\u62a5\u9500\u5728\u5916\u9662\u53d1\u751f\u7684\u8fd9\u4e9b\u8d39\u7528\u3002<\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u3000\u3000&nbsp;<\/p>\n<section class=\"_135editor\"    style=\"white-space: normal;border-width: 0px;border-style: none;border-color: initial;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;padding-right: 3px;padding-left: 3px;\">\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<section class=\"135brush\" ><span style=\"line-height: 32px;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);font-size: 20px;\"><strong>&nbsp;4&nbsp;<\/strong><\/span><span style=\"font-size: 20px;line-height: 32px;color: rgb(255, 255, 255);\"><strong><span style=\"line-height: 32px;\">&nbsp;<\/span><\/strong><\/span><span style=\"color: rgb(239, 112, 96);line-height: 32px;font-size: 20px;\"><strong>\u827e\u6ecb\u75c5\u68c0\u67e5\u95ee\u9898<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<section  style=\"border-top: 1px solid rgb(239, 112, 96);width: 550px;float: left;\"><\/section>\n<section style=\"margin-top: -4px;width: 6px;height: 6px;border-radius: 100%;float: right;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<section class=\"135brush\" style=\"border-left: 1px solid rgb(239, 112, 96);\">\n<section style=\"padding: 3px 10px;\">\n<p><span style=\"color: rgb(79, 129, 189);font-size: 18px;\">\u25ce\u4e2d\u56fd\u827e\u6ecb\u75c5\u68c0\u67e5\u6709\u7279\u6b8a\u7a0b\u5e8f\uff0c\u5fc5\u987b\u5199\u6e05\u695a\uff0c\u4e0d\u80fd\u7167\u642c\u56fd\u5916\u6a21\u677f\uff01<\/span><\/p>\n<\/section>\n<\/section>\n<section style=\"margin-left: -3px;width: 6px;height: 6px;border-radius: 100%;color: rgb(255, 255, 255);background-color: rgb(239, 112, 96);\"><\/section>\n<\/section>\n<section style=\"width: 0px;height: 0px;clear: both;\"><\/section>\n<\/section>\n<p style=\"white-space: normal;\">\u3000\u3000\u3000<\/p>\n<p style=\"white-space: 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normal;font-size: 16px;border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;font-family: \u5fae\u8f6f\u96c5\u9ed1;transform: none;\">\n<section  style=\"width: 556px;box-sizing: border-box;color: inherit;\">\n<section style=\"border-width: 0px;border-style: initial;border-color: initial;box-sizing: border-box;clear: both;overflow: hidden;color: inherit;\">\n<section style=\"box-sizing: border-box;display: inline-block;color: inherit;\">\n<section style=\"color: inherit;box-sizing: border-box;\">\n<p style=\"padding-right: 10px;display: inline-block;color: inherit;background-color: rgb(254, 254, 254);\"><span style=\"color: rgb(79, 129, 189);font-size: 20px;\"><strong>\u7ed3\u8bed&gt;&gt;<\/strong><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin-top: -14px;height: 2px;color: rgb(255, 255, 255);border-color: rgb(241, 201, 196);box-sizing: border-box;background-color: rgb(239, 112, 96);\"><\/section>\n<\/section>\n<section style=\"width: 0px;height: 0px;clear: both;box-sizing: border-box;\"><\/section>\n<\/section>\n<p style=\"white-space: normal;\"><br  \/><\/p>\n<p style=\"white-space: normal;\">\u3000\u3000<br  \/><\/p>\n<p style=\"white-space: normal;\">\u3000\u3000\u9879\u76ee\u7ba1\u7406\u4eba\u5458\u5e94\u9886\u4f1aGCP\u4e2d\u5bf9\u53d7\u8bd5\u8005\u4fdd\u62a4\u7684\u7cbe\u795e\uff0c\u7ed3\u5408\u5404\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u7279\u6b8a\u8981\u6c42\u4ee5\u53ca\u4e2d\u56fd\u56fd\u60c5\u7684\u8981\u6c42\uff0c\u8ba9\u77e5\u60c5\u540c\u610f\u4e66\u66f4\u52a0\u5168\u9762\u548c\u89c4\u8303\u3002<\/p>\n<p style=\"white-space: normal;text-align: left;\"><br  \/><\/p>\n<p style=\"white-space: normal;text-align: left;\"><br  \/><\/p>\n<p style=\"white-space: normal;\"><strong style=\"color: rgb(62, 62, 62);font-size: 16px;max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(79, 129, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"color: rgb(62, 62, 62);max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(79, 129, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"color: rgb(62, 62, 62);max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(79, 129, 189);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u25a0\u7f16\u8f91 \u4f59\u5982\u747e<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/p>\n<p style=\"white-space: normal;\"><br  \/><\/p>\n<p style=\"white-space: normal;text-align: center;\"><img class=\"\"       src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/0-1558080128.jpeg\" 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