{"id":3787,"date":"2023-03-20T10:15:30","date_gmt":"2023-03-20T02:15:30","guid":{"rendered":"https:\/\/www.ncgt.org.cn\/ncgt\/?p=3787"},"modified":"2023-03-20T10:15:31","modified_gmt":"2023-03-20T02:15:31","slug":"%e8%a7%a3%e8%af%bb-fda%e8%8d%af%e5%93%81%e5%ae%a1%e8%af%84%e5%92%8c%e7%a0%94%e7%a9%b6%e4%b8%ad%e5%bf%83%e5%8f%91%e5%b8%83%e3%80%8a%e8%8d%af%e5%93%81%e7%94%9f%e4%ba%a7%e4%b8%ad%e7%9a%84%e4%ba%ba","status":"publish","type":"post","link":"https:\/\/www.ncgt.org.cn\/ncgt\/2023\/03\/20\/%e8%a7%a3%e8%af%bb-fda%e8%8d%af%e5%93%81%e5%ae%a1%e8%af%84%e5%92%8c%e7%a0%94%e7%a9%b6%e4%b8%ad%e5%bf%83%e5%8f%91%e5%b8%83%e3%80%8a%e8%8d%af%e5%93%81%e7%94%9f%e4%ba%a7%e4%b8%ad%e7%9a%84%e4%ba%ba\/","title":{"rendered":"\u89e3\u8bfb | FDA\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3\u53d1\u5e03\u300a\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u4eba\u5de5\u667a\u80fd\u300b\u8ba8\u8bba\u7a3f"},"content":{"rendered":"\n<p class=\"has-small-font-size\">\u6765\u6e90\uff1a\u5148\u8fdb\u7ec6\u80de\u667a\u9020\u7cfb\u7edf\u7814\u53d1\u5e73\u53f0<\/p>\n\n\n\n<p class=\"has-small-font-size\">\u627f\u8f7d\u5355\u4f4d\uff1a\u6df1\u5733\u8d5b\u52a8\u667a\u9020\u79d1\u6280\u6709\u9650\u516c\u53f8<\/p>\n\n\n\n<p class=\"has-small-font-size\">\u65f6\u95f4\uff1a2023-03-20<\/p>\n\n\n\n<p style=\"margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-size: 17px;     letter-spacing: 0.544px;        text-decoration-thickness: initial;   visibility: visible;text-align:justify;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\" align=\"justify\">\n\t<span style=\"caret-color: red; letter-spacing: 0.544px;font-family: Optima-Regular, PingFangTC-light;\"><br\/><\/span>\n<\/p>\n<p style=\"margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-size: 17px;     letter-spacing: 0.544px;        text-decoration-thickness: initial;   visibility: visible;text-align:justify;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\" align=\"justify\">\n\t<span style=\"caret-color: red; letter-spacing: 0.544px;font-family: Optima-Regular, PingFangTC-light;\">2023\u5e743\u67082\u65e5\uff0cFDA\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3\u53d1\u5e03\u4e86\u300aArtificial Intelligence in Drug Manufacturing\u300b\u8ba8\u8bba\u6587\u4ef6\uff0c\u4f9b\u516c\u4f17\u57282023\u5e745\u67081\u65e5\u524d\u63d0\u51fa\u610f\u89c1\u3002<\/span>\n<\/p>\n<section data-role=\"outer\" label=\"edit by 135editor\" style=\"margin: 0px 0px 24px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 17px;     letter-spacing: 0.544px;  text-align: justify;       background-color: rgb(255, 255, 255); text-decoration-thickness: initial;   visibility: visible;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\" class=\"\">\n\t<section style=\"margin: 25px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); text-align: center; line-height: 0; visibility: visible;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; vertical-align: middle; display: inline-block; line-height: 0; visibility: visible;\" class=\"\">\n\t\t\t<img decoding=\"async\" class=\"rich_pages wxw-img\" width=\"100%\" data-index=\"2\" src=\"https:\/\/www.ncgt.org.cn\/ncgt\/wp-content\/uploads\/2023\/03\/1-4.png\" _width=\"100%\" alt=\"\u56fe\u7247\" data-fail=\"0\" style=\"margin: 0px; padding: 0px; outline: 0px; vertical-align: middle; width: 100%; overflow-wrap: break-word !important; height: auto !important; visibility: visible !important;;;margin:0px;width:100% !important;box-sizing:border-box;max-width: 100% !important;\" height=\"auto\" border=\"0\" mapurl=\"\" title=\"\u56fe\u7247\" data-ratio=\"1.2918454935622317\" data-w=\"932\"\/>\n\t\t<\/section>\n\t<\/section>\n\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; color: rgb(136, 136, 136); font-size: 11px; letter-spacing: 0.544px;text-align:justify;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\" align=\"justify\">\n\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\">\u8ba8\u8bba\u7a3f\u539f\u6587\uff0c\u8bf7\u70b9\u51fb\uff1a<a href=\"https:\/\/www.fda.gov\/media\/165743\/download\">Artificial Intelligence Discussion Paper (fda.gov)<\/a><\/span><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 15px; letter-spacing: 0.544px;\"><\/span>\n\t<\/p>\n\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; color: rgb(136, 136, 136); font-size: 11px; letter-spacing: 0.544px;text-align:justify;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\"  align=\"justify\">\n\t\t<br\/>\n\t<\/p>\n\t<section data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"124411\" style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"_135editor\">\n\t\t<section style=\"margin: 10px auto; padding: 4px; outline: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word !important; border-width: 1px; border-style: solid; border-color: #eabb8a;\" class=\"\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; display: flex; justify-content: space-between; align-items: flex-start;\">\n\t\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; width: 0px; height: 1px; border-top: 8px solid #f8cc6e; border-right: 8px solid transparent; overflow: hidden;box-sizing:border-box;\">\n\t\t\t\t\t<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t\t<\/section>\n\t\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; width: 0px; height: 1px; border-top: 8px solid #f8cc6e; border-left: 8px solid transparent; overflow: hidden;box-sizing:border-box;\">\n\t\t\t\t\t<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t\t<section data-autoskip=\"1\" style=\"margin: -5px 10px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; line-height: 1.75em; letter-spacing: 1.5px; font-size: 14px; color: #706155;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;text-align:center;\" align=\"center\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\">FRAME\u4f18\u5148\u8003\u8651\u7684\u56db\u79cd\u6280\u672f<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\">\u5148\u8fdb\u7684\u751f\u4ea7\u6280\u672f\u6709\u53ef\u80fd\u63d0\u9ad8\u751f\u4ea7\u8fc7\u7a0b\u548c\u4f9b\u5e94\u94fe\u7684\u53ef\u9760\u6027\u548c\u7a33\u5065\u6027\uff0c\u5e76\u589e\u52a0\u7f8e\u56fd\u516c\u4f17\u53ca\u65f6\u83b7\u5f97\u4f18\u8d28\u836f\u54c1\u7684\u673a\u4f1a\u3002\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3 (CDER) \u5efa\u7acb\u4e86\u5148\u8fdb\u751f\u4ea7\u8bc4\u4f30\u76d1\u7ba1\u6846\u67b6 (Regulatory Advanced Manufacturing Evaluation\uff0cFRAME) \u8ba1\u5212\uff0c\u4ee5\u652f\u6301\u91c7\u7528\u53ef\u4ee5\u4e3a\u60a3\u8005\u5e26\u6765\u76ca\u5904\u7684\u5148\u8fdb\u751f\u4ea7\u6280\u672f\u3002<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\">\u7f8e\u56fd\u56fd\u5bb6\u79d1\u5b66\u9662\u3001\u5de5\u7a0b\u9662\u548c\u533b\u5b66\u9662 (NASEM) \u53d1\u5e03\u4e86\u4e00\u4efd\u62a5\u544a\uff0c\u786e\u5b9aCDER\u53ef\u80fd\u9047\u5230\u7684\u5177\u6709\u63a8\u8fdb\u5236\u836f\u751f\u4ea7\u6f5c\u529b\u7684\u521b\u65b0\u3002\u6839\u636e\u8fd9\u4efd\u62a5\u544a\u4ee5\u53ca\u901a\u8fc7\u65b0\u5174\u6280\u672f\u8ba1\u5212\u4e0e\u5229\u76ca\u76f8\u5173\u8005\u7684\u63a5\u89e6\uff0cFRAME\u8ba1\u5212\u4f18\u5148\u8003\u8651\u56db\u79cd\u6280\u672f\uff1a<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u7aef\u5230\u7aef\u8fde\u7eed\u751f\u4ea7<\/strong>(End-to-End Continuous Manufacturing, E2E CM)\uff1a\u4e00\u4e2a\u5b8c\u5168\u96c6\u6210\u7684\u8fc7\u7a0b\uff0c\u539f\u6750\u6599\u4e0d\u65ad\u88ab\u8f93\u5165\u548c\u8f6c\u5316\uff0c\u836f\u54c1\u6210\u54c1\u4e0d\u65ad\u88ab\u751f\u4ea7\u51fa\u6765\u3002<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; line-height: 2em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; text-shadow: none;  color: #00b050;font-family: &quot;microsoft yahei&quot;, Verdana, \u534e\u6587\u7ec6\u9ed1, \u9ed1\u4f53, arial;\">\u6df1\u5733\u8d5b\u52a8\u667a\u9020\u79d1\u6280\u6709\u9650\u516c\u53f8\uff08\u540e\u7b80\u79f0\u8d5b\u52a8\u667a\u9020\uff09\u81ea\u4e3b\u7814\u53d1\u7684CELLAUTO Matrix Platform\u8d5b\u52a8\u5168\u81ea\u52a8\u7ec6\u80de\u667a\u9020\u7cfb\u7edf\uff0c\u4ee5\u751f\u4ea7\u7269\u6599\u81ea\u52a8\u5206\u914d\u3001\u4f20\u8f93\u4e3a\u5165\u53e3\uff0c\u5168\u6d41\u7a0b\u5c01\u95ed\u751f\u4ea7\uff0c\u4ee5\u6210\u54c1\u7ec6\u80de\u5236\u5242\u5206\u88c5\u4e3a\u51fa\u53e3\uff0c\u5b9e\u73b0\u4e86\u7aef\u5230\u7aef\u7684\u8fde\u7eed\u751f\u4ea7\u3002<\/span><\/strong><\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u5206\u5e03\u5f0f\u751f\u4ea7<\/strong>&nbsp;(Distributed Manufacturing\uff0cDM)\uff1a\u4e00\u4e2a\u5206\u6563\u7684\u751f\u4ea7\u5e73\u53f0\uff0c\u5176\u751f\u4ea7\u5355\u5143\u53ef\u4ee5\u90e8\u7f72\u5230\u591a\u4e2a\u4f4d\u7f6e\u3002<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #00b050; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">CELLAUTO Matrix Platform\u8d5b\u52a8\u5168\u81ea\u52a8\u7ec6\u80de\u667a\u9020\u7cfb\u7edf\u901a\u8fc7\u53ef\u652f\u6491\u7684\u529f\u80fd\u6027\u5e73\u53f0\uff0c\u5b9e\u73b0\u5206\u5e03\u5f0f\u751f\u4ea7\u3002\u5168\u6d41\u7a0b\u81ea\u52a8\u5b8c\u6210\u7ec6\u80de\u6d17\u6da4\u3001\u7ec6\u80de\u914d\u5236\u3001 \u57f9\u517b\u6269\u589e\u3001\u7ec6\u80de\u6536\u83b7\u3001\u7ec6\u80de\u6d53\u7f29\u3001\u5236\u5242\u5206\u88c5\u3002<\/strong><\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u5373\u65f6\u62a4\u7406\u751f\u4ea7<\/strong>(Point-of-Care Manufacturing, POC)\uff1a\u4e00\u4e2aDM\u5e73\u53f0\uff0c\u5176\u751f\u4ea7\u5355\u5143\u9760\u8fd1\u60a3\u8005\u62a4\u7406\uff0c\u4f8b\u5982\uff0c\u5728\u533b\u7597\u673a\u6784\u3002<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #00b050; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u8d5b\u52a8\u667a\u9020\u7075\u6d3b\u7684\u7ec6\u80de\u751f\u4ea7\u5e73\u53f0\uff0c\u65e2\u6709\u652f\u6301I\/II\/III\u4e34\u5e8a\u8bd5\u9a8c\u3001\u4ea7\u54c1\u4e0a\u5e02\u540e\u5927\u89c4\u6a21\u751f\u4ea7\u7684\u5f02\u4f53\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u7684\u5927\u6279\u91cf\u751f\u4ea7\u5e73\u53f0\u53ca\u901a\u7528\u578b\u514d\u75ab\u7ec6\u80de\u7684\u5927\u6279\u91cf\u751f\u4ea7\u5e73\u53f0\uff0c\u53c8\u6709\u9002\u7528\u573a\u666f\u4e3a\u7ec6\u80de\u50a8\u5b58\u3001\u533b\u9662\u201c\u5e8a\u8fb9\u5f0f\u201d\u751f\u4ea7\u3001\u5b9e\u9a8c\u5ba4\u3001I\u4e34\u5e8a\u8bd5\u9a8c\u3001CAR-T\u3001IPS\u751f\u4ea7\u7684\u81ea\u4f53\u53ca\u5c0f\u6279\u91cf\u751f\u4ea7\u5e73\u53f0\u3002<\/strong><\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u4eba\u5de5\u667a\u80fd\uff1a<\/strong>\u53ef\u4ee5\u611f\u77e5\u73af\u5883\u3001\u89e3\u91ca\u6570\u636e\u548c\u51b3\u5b9a\u884c\u52a8\u7684\u8f6f\u4ef6\u548c\u786c\u4ef6\u7cfb\u7edf\u3002<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #00b050; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u8d5b\u52a8\u667a\u9020\u975e\u4fb5\u5165\u6027\u7ec6\u80de\u8d28\u91cf\u5728\u7ebf\u76d1\u6d4b\u548c\u5206\u6790\u5e73\u53f0\uff0c\u901a\u8fc7\u6d77\u91cf\u7ec6\u80de\u7279\u5f81\u3001\u7ec6\u80de\u529f\u80fd\u548c\u4e34\u5e8a\u6cbb\u7597\u6548\u679c\u6570\u636e\uff0c\u8fdb\u884c\u7ec6\u80de\u8d28\u91cf\u56de\u6eaf\u5206\u6790\uff0c\u9a71\u52a8\u4e34\u5e8a\u65b9\u6848\u4f18\u5316\u3001\u751f\u4ea7\u5de5\u827a\u4f18\u5316\u3002<\/strong><\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<br\/>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #00b050; font-size: 17px;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">GMP\u751f\u4ea7\u81ea\u52a8\u5316\u8f6f\u4ef6\uff0c\u901a\u8fc7\u4eba\u673a\u6599\u6cd5\u73af\u7684\u6570\u5b57\u5316\u7ba1\u7406\uff0c\u5b9e\u73b0\u7269\u6599\u8017\u6750\u7528\u91cf\u9884\u6d4b\u53ca\u89c4\u5212\uff0c\u751f\u4ea7\u667a\u80fd\u5907\u6599\uff0c\u5de5\u4e1a\u5927\u8111\u6307\u6325\u81ea\u52a8\u5316\u5236\u5907\u4e0e\u8d28\u68c0\uff0c\u5de5\u4e1a\u5927\u8111\u8f85\u52a9\u8d28\u91cf\u4e8b\u4ef6\u9884\u8b66\u8bca\u65ad\uff0c\u667a\u80fd\u4eea\u5668\u8bbe\u5907\u4e92\u8054\u4e92\u901a\u7b49\u3002<\/strong><\/span>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; display: flex; justify-content: space-between; align-items: flex-end;\">\n\t\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; width: 0px; height: 1px; border-bottom: 8px solid #f8cc6e; border-right: 8px solid transparent; overflow: hidden;box-sizing:border-box;\">\n\t\t\t\t\t<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t\t<\/section>\n\t\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; width: 0px; height: 1px; border-bottom: 8px solid #f8cc6e; border-left: 8px solid transparent; overflow: hidden;box-sizing:border-box;\">\n\t\t\t\t\t<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 35px 0px 25px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\" class=\"\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\n\t\t\t<section data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"89101\" style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 15px;\" class=\"_135editor\">\n\t\t\t\t<section style=\"margin: 10px auto; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\n\t\t\t\t\t<section data-role=\"splitline\" data-tools=\"135\u7f16\u8f91\u5668\" data-id=\"16401\" style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"_135editor\">\n\t\t\t\t\t\t<section style=\"margin: 10px auto; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; text-align: center;\">\n\t\t\t\t\t\t\t<section style=\"margin: 0px 0px 6px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; display: flex; justify-content: center; align-items: center;\">\n\t\t\t\t\t\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; flex: 1 1 0%; background-image: linear-gradient(to right, rgba(211, 19, 20, 0) 0%, rgb(0, 0, 0) 100%); height: 1px; overflow: hidden;\">\n\t\t\t\t\t\t\t\t\t<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t\t\t\t\t\t<\/section>\n\t\t\t\t\t\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; flex: 1 1 0%; background-image: linear-gradient(to left, rgba(211, 19, 20, 0) 0%, rgb(0, 0, 0) 100%); height: 1px; overflow: hidden;\">\n\t\t\t\t\t\t\t\t\t<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t\t\t\t\t\t<\/section>\n\t\t\t\t\t\t\t<\/section>\n\t\t\t\t\t\t<\/section>\n\t\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; font-size: 15px;\">\n\t\t\t<br\/>\n\t\t<\/p>\n\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; font-size: 15px;\">\n\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 17px; letter-spacing: 0px;font-family: Optima-Regular, PingFangTC-light;\">\u4ee5\u4e0b\u662f\u8ba8\u8bba\u7a3f\u5168\u6587\u5185\u5bb9\uff0c\u6765\u6e90\uff1a\u5236\u836f\u5de5\u827a\u4e0e\u88c5\u5907<\/span>\n\t\t<\/p>\n\t<\/section>\n\t<section style=\"margin: 10px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); display: flex; flex-flow: row nowrap; text-align: left; justify-content: flex-start;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; display: inline-block; width: auto; vertical-align: top; background-color: rgb(245, 245, 245); flex: 100 100 0%; height: auto;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 8px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\n\t\t\t\t<section style=\"margin: 0px; padding: 0px 10px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 16px; color: rgb(0, 86, 167); line-height: 1.6; letter-spacing: 1px; text-align: center;\" class=\"\">\n\t\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;font-family: Optima-Regular, PingFangTC-light;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">Discussion Paper:<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/><\/strong><\/span>\n\t\t\t\t\t<\/p>\n\t\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;font-family: Optima-Regular, PingFangTC-light;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">Artificial Intelligence in Drug Manufacturing<\/strong><\/span>\n\t\t\t\t\t<\/p>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 20px 0px 25px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 13px; color: #a0a0a0;\" class=\"\">\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;font-family: Optima-Regular, PingFangTC-light;\">\u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u4ec5\u7528\u4e8e\u8ba8\u8bba\uff0c\u4e0d\u662f\u8349\u6848\u6216\u6700\u7ec8\u6307\u5357\u3002\u5b83\u7684\u76ee\u7684\u662f\u4fc3\u8fdb\u672c\u673a\u6784\u4ee5\u5916\u7684\u5229\u76ca\u76f8\u5173\u8005\u7684\u65e9\u671f\u6295\u5165\u3002\u8be5\u673a\u6784\u6253\u7b97\u5728\u5236\u5b9a\u672a\u6765\u7684\u76d1\u7ba1\u6846\u67b6\u65f6\u8003\u8651\u8fd9\u4e9b\u610f\u89c1\u3002\u56e0\u6b64\uff0c\u672c\u6587\u4ef6\u65e0\u610f\u4f20\u8fbe\u4efb\u4f55\u4e0e\u4eba\u5de5\u667a\u80fd\u751f\u4ea7\u6280\u672f\u6709\u5173\u7684\u73b0\u884c\u6cd5\u89c4\u6216\u653f\u7b56\u3002<\/span>\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 30px 0px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); display: flex; flex-flow: row nowrap; text-align: left; justify-content: flex-start;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; display: inline-block; vertical-align: top; width: auto; background-color: rgb(0, 92, 175); flex: 0 0 auto; align-self: flex-start; min-width: 10%; height: auto; border-width: 0px;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;transform:       translate3d(-1px, 0px, 0px);-webkit-transform:       translate3d(-1px, 0px, 0px);-moz-transform:       translate3d(-1px, 0px, 0px);-o-transform:       translate3d(-1px, 0px, 0px);\">\n\t\t\t\t<section style=\"margin: 0px; padding: 0px 10px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 16px; color: rgb(255, 255, 255); line-height: 2.2; letter-spacing: 1px; text-align: justify;\">\n\t\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t\t<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;font-family: Optima-Regular, PingFangTC-light;\"><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">01<\/strong><\/span><strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><\/strong><br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t\t\t<\/p>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; display: inline-block; vertical-align: top; width: auto; background-color: rgb(245, 245, 245); flex: 100 100 0%; height: auto;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px 10px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 16px; color: rgb(0, 86, 167); line-height: 2.2; letter-spacing: 1px; text-align: justify;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u7b80\u4ecb<\/strong>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3\uff08CDER\uff09\u7684\u4f7f\u547d\u662f\u786e\u4fdd\u4eba\u7c7b\u836f\u7269\u7684\u5b89\u5168\u548c\u6709\u6548\uff0c\u7b26\u5408\u65e2\u5b9a\u7684\u8d28\u91cf\u6807\u51c6\uff0c\u5e76\u63d0\u4f9b\u7ed9\u60a3\u8005\u3002\u4e3a\u4e86\u63a8\u8fdb\u8fd9\u4e00\u4f7f\u547d\uff0cFDA\u7684&quot;Pharmaceutical Quality for the 21st Century\uff0821\u4e16\u7eaa\u836f\u54c1\u8d28\u91cf\u8ba1\u5212\uff09&quot;\u4fc3\u8fdb\u4e86\u4e00\u4e2a\u9ad8\u6548\u3001\u654f\u6377\u548c\u7075\u6d3b\u7684\u836f\u54c1\u751f\u4ea7\u90e8\u95e8\uff0c\u5728\u6ca1\u6709\u8fc7\u5ea6\u76d1\u7ba1\u7684\u60c5\u51b5\u4e0b\u53ef\u9760\u5730\u751f\u4ea7\u4f18\u8d28\u836f\u54c1\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; 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padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\tFDA\u5df2\u7ecf\u8ba4\u8bc6\u5230\u5e76\u63a5\u53d7\u4e86\u5148\u8fdb\u751f\u4ea7\u7684\u6f5c\u529b\u30022014\u5e74\uff0cCDER\u5efa\u7acb\u4e86\u65b0\u5174\u6280\u672f\u9879\u76ee\uff08Emerging Technology Program\uff0cETP\uff09\uff0c\u4e0e\u4f01\u4e1a\u5408\u4f5c\uff0c\u652f\u6301\u5148\u8fdb\u751f\u4ea7\u7684\u4f7f\u7528\u3002CDER\u901a\u8fc7ETP\u89c2\u5bdf\u5230\u5148\u8fdb\u751f\u4ea7\u6280\u672f\u7684\u5feb\u901f\u51fa\u73b0\uff0c\u5e76\u8ba4\u8bc6\u5230\u76d1\u7ba1\u653f\u7b56\u548c\u8ba1\u5212\u53ef\u80fd\u9700\u8981\u6f14\u53d8\uff0c\u8ba9\u6280\u672f\u5f97\u5230\u53ca\u65f6\u91c7\u7528\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u7f8e\u56fd\u56fd\u5bb6\u79d1\u5b66\u3001\u5de5\u7a0b\u548c\u533b\u5b66\u7814\u7a76\u9662\u57282021\u5e74\u53d1\u5e03\u4e86\u4e00\u4efd\u62a5\u544a\uff0c\u9898\u76ee\u662fInnovation in Pharmaceutical Manufacturing on the Horizon: Technical Challenge, Regulatory Issues, and Recommendations (\u5730\u5e73\u7ebf\u4e0a\u7684\u836f\u54c1\u751f\u4ea7\u521b\u65b0: \u6280\u672f\u6311\u6218\u3001\u76d1\u7ba1\u95ee\u9898\u548c\u5efa\u8bae) ,\u5f3a\u8c03\u4e86\u7efc\u5408\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u521b\u65b0\u3002\u8fd9\u4e9b\u521b\u65b0\u53ef\u80fd\u4f1a\u5bf9\u5236\u836f\u751f\u4ea7\u4e2d\u4f7f\u7528\u7684\u6d4b\u91cf\u3001\u5efa\u6a21\u548c\u63a7\u5236\u6280\u672f\u4ea7\u751f\u5f71\u54cd\u3002\u4eba\u5de5\u667a\u80fd\uff08AI\uff09\u53ef\u80fd\u5728\u76d1\u6d4b\u548c\u63a7\u5236\u5148\u8fdb\u7684\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u53d1\u6325\u91cd\u8981\u4f5c\u7528\u3002\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 35px 0px 10px; 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padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #576b95;\">1. \u4e91\u5e94\u7528\u53ef\u80fd\u4f1a\u5f71\u54cd\u5bf9\u836f\u54c1\u751f\u4ea7\u6570\u636e\u548c\u8bb0\u5f55\u7684\u76d1\u7763<\/span><\/strong>\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u968f\u7740\u4e91\u8ba1\u7b97\u548c\u8fb9\u7f18\u8ba1\u7b97\u7684\u4e0d\u65ad\u53d1\u5c55\uff0c\u6d89\u53ca\u836f\u54c1\u751f\u4ea7\u7684\u8f6f\u4ef6\u7684\u90e8\u7f72\u4f4d\u7f6e\u53ef\u80fd\u53d1\u751f\u53d8\u5316\u3002\u4f8b\u5982\uff0c\u63a7\u5236\u6267\u884c\u7684\u8f6f\u4ef6\u53ef\u80fd\u4ecd\u7136\u5728\u9760\u8fd1\u751f\u4ea7\u8bbe\u5907\u7684\u5730\u65b9\u90e8\u7f72\uff0c\u4ee5\u786e\u4fdd\u4e0d\u5f71\u54cd\u6027\u80fd\u6216\u5b89\u5168\uff0c\u800c\u5176\u4ed6\u4e0d\u662f\u65f6\u95f4\u5173\u952e\u7684\u8f6f\u4ef6\u529f\u80fd\u53ef\u4ee5\u5728\u4e91\u4e2d\u8fdb\u884c\uff08\u4f8b\u5982\uff0c\u6a21\u578b\u66f4\u65b0\u3001\u63a7\u5236\u8bca\u65ad\u548c\u8fc7\u7a0b\u76d1\u63a7\u5206\u6790\uff09\u3002\u7b2c\u4e09\u65b9\u6570\u636e\u7ba1\u7406\u7cfb\u7edf\u53ef\u7528\u4e8e\u6570\u636e\u5b58\u50a8\u4e4b\u5916\u7684\u529f\u80fd\u3002\u4f8b\u5982\uff0c\u5b58\u50a8\u5728\u8fd9\u4e9b\u7cfb\u7edf\u4e2d\u7684\u6570\u636e\u53ef\u4ee5\u7531\u4eba\u5de5\u667a\u80fd\u8fdb\u884c\u5206\u6790\uff0c\u4ee5\u652f\u6301\u8fc7\u7a0b\u76d1\u6d4b\u548cAPC\u7684\u6a21\u578b\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u5728\u8fd9\u4e9b\u73af\u5883\u4e2d\u5fc5\u987b\u786e\u4fdd\u6570\u636e\u7684\u5b8c\u6574\u6027\u548c\u6570\u636e\u8d28\u91cf\u3002\u867d\u7136FDA\u5141\u8bb8\u5728\u751f\u4ea7\u5546\u7684\u9002\u5f53\u76d1\u7763\u4e0b\u4f7f\u7528\u7b2c\u4e09\u65b9\u7684CGMP\u529f\u80fd\uff0c\u4f46\u751f\u4ea7\u5546\u548c\u7b2c\u4e09\u65b9\u4e4b\u95f4\u73b0\u6709\u7684\u8d28\u91cf\u534f\u8bae\uff08\u4f8b\u5982\uff0c\u4e91\u6570\u636e\u7ba1\u7406\uff09\u5728\u7ba1\u7406\u751f\u4ea7\u76d1\u6d4b\u548c\u63a7\u5236\u65b9\u9762\u7684\u4eba\u5de5\u667a\u80fd\u98ce\u9669\u65b9\u9762\u53ef\u80fd\u5b58\u5728\u5dee\u8ddd\u3002\u5728\u68c0\u67e5\u8fc7\u7a0b\u4e2d\uff0c\u8fd9\u53ef\u80fd\u5bfc\u81f4\u5728\u786e\u4fdd\u7b2c\u4e09\u65b9\u521b\u5efa\u548c\u66f4\u65b0\u4eba\u5de5\u667a\u80fd\u8f6f\u4ef6\u65f6\u6709\u9002\u5f53\u7684\u6570\u636e\u5b89\u5168\u548c\u4fdd\u969c\u63aa\u65bd\u65b9\u9762\u7684\u6311\u6218\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u6b64\u5916\uff0c\u7531\u4e8e\u7ba1\u7406\u7b2c\u4e09\u65b9\u4e91\u6570\u636e\u548c\u6a21\u578b\u7684\u590d\u6742\u6027\uff0cFDA\u5bf9\u8bb0\u5f55\u7ba1\u7406\u7684\u8bc1\u636e\u6536\u96c6\u7684\u68c0\u67e5\u65b9\u6cd5\u53ef\u80fd\u9700\u8981\u6269\u5927\u3002\u4f8b\u5982\uff0c\u4e91\u5e94\u7528\u7a0b\u5e8f\u548c\u6d41\u7a0b\u63a7\u5236\u4e4b\u95f4\u7684\u6301\u7eed\u4e92\u52a8\u53ef\u80fd\u4f1a\u4f7f\u5efa\u7acb\u6570\u636e\u53ef\u8ffd\u6eaf\u6027\u7684\u80fd\u529b\u590d\u6742\u5316\uff0c\u4ea7\u751f\u6f5c\u5728\u7684\u7f51\u7edc\u5b89\u5168\u6f0f\u6d1e\uff0c\u5e76\u9700\u8981\u5728\u68c0\u67e5\u671f\u95f4\u8bc4\u4f30\u76d1\u6d4b\u6570\u636e\u5b8c\u6574\u6027\u6f0f\u6d1e\u7684\u73b0\u6709\u7a0b\u5e8f\u3002\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 15px 10px; outline: 0px; max-width: 100%; display: inline-block; width: 100%; border-width: 1px; border-style: solid; border-color: rgb(221, 222, 226); background-color: rgb(247, 247, 249); overflow-wrap: break-word !important;box-sizing:border-box;\" class=\"\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; line-height: 1.6;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;text-align:center;\" align=\"center\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">\u4e00\u4e9b\u6f5c\u5728\u7684\u76f8\u5173\u8981\u6c42\u548c\u653f\u7b56<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Regulations:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t21 CFR 11, 211.180, 211.184, 211.194, 600.12\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Draft Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tData Integrity and Compliance with CGMP (April 2016)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tContract Manufacturing Arrangements for Drugs: Quality Agreements (November 2016)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016)\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0px;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #576b95;\">2. \u7269\u8054\u7f51\u53ef\u80fd\u4f1a\u589e\u52a0\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4ea7\u751f\u7684\u6570\u636e\u91cf\uff0c\u5f71\u54cd\u73b0\u6709\u7684\u6570\u636e\u7ba1\u7406\u5b9e\u8df5<\/span><\/strong>\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u751f\u4ea7\u63a7\u5236\u7684\u6570\u5b57\u5316\u53ef\u80fd\u4f1a\u4ea7\u751f\u66f4\u591a\u5173\u4e8e\u5de5\u827a\u548c\u4ea7\u54c1\u7684\u4fe1\u606f\u3002\u6570\u636e\u7684\u589e\u52a0\u53ef\u80fd\u4f53\u73b0\u5728\u8bb0\u5f55\u6570\u636e\u7684\u9891\u7387\u548c\u7c7b\u578b\u4e24\u65b9\u9762\u3002\u6709\u6cd5\u89c4\u548c\u6307\u5357\u6d89\u53ca\u6bcf\u6279\u836f\u54c1\u751f\u4ea7\u7684\u6570\u636e\u548c\u5143\u6570\u636e\u7684\u5b58\u50a8\u91cf\uff1b\u4f46\u662f\uff0c\u5982\u679c\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u6536\u96c6\u7684\u539f\u59cb\u6570\u636e\u663e\u8457\u589e\u52a0\uff0c\u53ef\u80fd\u9700\u8981\u7ed3\u5408\u6570\u636e\u7ba1\u7406\u7ec4\u7ec7\u5de5\u4f5c\uff0c\u5e73\u8861\u6570\u636e\u7684\u5b8c\u6574\u6027\u548c\u4fdd\u7559\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u7533\u8bf7\u4eba\u53ef\u80fd\u9700\u8981\u660e\u786e\u751f\u6210\u6570\u636e\u7684\u76d1\u7ba1\u5408\u89c4\u6027\uff08\u4f8b\u5982\uff0c\u54ea\u4e9b\u6570\u636e\u9700\u8981\u5b58\u50a8\u548c\/\u6216\u5ba1\u67e5\uff0c\u4ee5\u53ca\u8fd9\u4e9b\u6570\u636e\u7684\u4e22\u5931\u5c06\u5982\u4f55\u5f71\u54cd\u672a\u6765\u7684\u8d28\u91cf\u51b3\u7b56\uff0c\u5982\u4ea7\u54c1\u53ec\u56de\uff09\u3002\u6b64\u5916\uff0c\u7533\u8bf7\u4eba\u53ef\u80fd\u9700\u8981\u8fdb\u4e00\u6b65\u660e\u786e\u6570\u636e\u91c7\u6837\u7387\u3001\u6570\u636e\u538b\u7f29\u6216\u5176\u4ed6\u6570\u636e\u7ba1\u7406\u65b9\u6cd5\uff0c\u4ee5\u786e\u4fdd\u4fdd\u6301\u836f\u54c1\u751f\u4ea7\u8fc7\u7a0b\u7684\u51c6\u786e\u8bb0\u5f55\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u53e6\u5916\uff0c\u5728\u4ee5\u7ed3\u6784\u5316\u7684\u65b9\u5f0f\u5b58\u50a8\u6570\u636e\uff0c\u4ee5\u4fbf\u68c0\u7d22\u548c\u5206\u6790\u4ee5\u652f\u6301\u7533\u8bf7\u4eba\u7684\u51b3\u7b56\u65b9\u9762\u53ef\u80fd\u5b58\u5728\u6311\u6218\u3002\u6b64\u5916\uff0c\u968f\u7740\u751f\u4ea7\u8bbe\u5907\u4e92\u8054\u6210\u7f51\uff0c\u7ef4\u62a4\u8bbe\u5907\u6240\u4ea7\u751f\u7684\u8fd9\u4e9b\u6570\u636e\u7684\u7ba1\u7406\u3001\u9690\u79c1\u548c\u5b89\u5168\uff0c\u53ef\u80fd\u5bf9\u4fdd\u6301\u4ea7\u54c1\u8d28\u91cf\u6216\u7ef4\u6301\u836f\u54c1\u751f\u4ea7\u6784\u6210\u6311\u6218\u3002\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 15px 10px; outline: 0px; max-width: 100%; display: inline-block; width: 100%; border-width: 1px; border-style: solid; border-color: rgb(221, 222, 226); background-color: rgb(247, 247, 249); overflow-wrap: break-word !important;box-sizing:border-box;\" class=\"\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; line-height: 1.6;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;text-align:center;\" align=\"center\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">\u4e00\u4e9b\u6f5c\u5728\u7684\u76f8\u5173\u8981\u6c42\u548c\u653f\u7b56<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Regulations:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t21 CFR 211 Subparts D and J\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Draft Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tData Integrity and Compliance with CGMP (April 2016)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016)\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; letter-spacing: 0px;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 15px; color: #576b95;\">3.&nbsp; \u7533\u8bf7\u4eba\u53ef\u80fd\u9700\u8981\u660e\u786e\u4eba\u5de5\u667a\u80fd\u5728\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u5e94\u7528\u662f\u5426\u4ee5\u53ca\u5982\u4f55\u53d7\u5230\u76d1\u7ba1\u90e8\u95e8\u7684\u76d1\u7763<\/span><\/strong>\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u4eba\u5de5\u667a\u80fd\u53ef\u7528\u4e8e\u5404\u79cd\u751f\u4ea7\u64cd\u4f5c\uff0c\u5982\u76d1\u6d4b\u548c\u7ef4\u62a4\u8bbe\u5907\uff0c\u786e\u5b9a\u9700\u8981\u6301\u7eed\u6539\u8fdb\u7684\u9886\u57df\uff0c\u8c03\u5ea6\u548c\u4f9b\u5e94\u94fe\u7269\u6d41\uff0c\u4ee5\u53ca\u539f\u6750\u6599\u7684\u7279\u6027\u3002\u7533\u8bf7\u4eba\u9700\u8981\u4e86\u89e3\u4eba\u5de5\u667a\u80fd\u5728\u53d7\u76d1\u7ba1\u90e8\u95e8\u76d1\u7763\u7684\u751f\u4ea7\u4e1a\u52a1\u4e2d\u7684\u5e94\u7528\uff08\u4f8b\u5982\uff0cCGMP\u5408\u89c4\u6027\u3001\u65b0\u836f\u6216\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u8bc1\u7533\u8bf7\uff09\u3002\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 15px 10px; outline: 0px; max-width: 100%; display: inline-block; width: 100%; border-width: 1px; border-style: solid; border-color: rgb(221, 222, 226); background-color: rgb(247, 247, 249); overflow-wrap: break-word !important;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; line-height: 1.6;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;text-align:center;\" align=\"center\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">\u4e00\u4e9b\u6f5c\u5728\u7684\u76f8\u5173\u8981\u6c42\u548c\u653f\u7b56<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Regulations:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t21 CFR 11, 211.68, 211.84, 211.180, 211.184, 314.50, 314.94, 601.20\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Draft Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q9(R1) Quality Risk Management (June 2022)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q12 Implementation Considerations for FDA-Regulated Products (May 2021)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tData Integrity and Compliance with CGMP (April 2016)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients&nbsp;(September 2016)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q8(R2) Pharmaceutical Development (November 2009)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q10 Pharmaceutical Quality System (April 2009)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q11 Development and Manufacture of Drug Substances (November 2012)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (May 2021)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tQ8, Q9, &amp; Q10 Questions and Answers \u2014 Appendix: Q&amp;As from Training Sessions (July 2012)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tProcess Validation: General Principles and Practices (January 2011)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Compliance Program:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t7346.832 \u2014 Preapproval Inspections (October 2022)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t7356.002 \u2014 Drug Manufacturing Inspections (October 2022)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t7356.002M \u2014 Surveillance Inspections of Protein Drug Substance Manufacturers (October 2021)\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0px;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #576b95;\">4. \u7533\u8bf7\u4eba\u53ef\u80fd\u9700\u8981\u5f00\u53d1\u548c\u9a8c\u8bc1\u7528\u4e8e\u8fc7\u7a0b\u63a7\u5236\u548c\u652f\u6301\u91ca\u653e\u6d4b\u8bd5\u7684AI\u6a21\u578b\u7684\u6807\u51c6<\/span><\/strong>\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u4eba\u5de5\u667a\u80fd\u53ef\u7528\u4e8eAPC\u5e94\u7528\u4e2d\uff0c\u901a\u8fc7\u57fa\u4e8e\u5b9e\u65f6\u6570\u636e\u8c03\u6574\u5de5\u827a\u53c2\u6570\u6765\u63a7\u5236\u751f\u4ea7\u8fc7\u7a0b\u3002\u6b64\u5916\uff0c\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u53ef\u4ee5\u4e0e\u8fc7\u7a0b\u4e2d\u7684\u6750\u6599\u6216\u6700\u7ec8\u4ea7\u54c1\u7684\u5ba1\u67e5\u7ed3\u5408\u8d77\u6765\u4f7f\u7528\uff0c\u4ee5\uff1a(1\uff09\u652f\u6301\u8fc7\u7a0b\u4e2d\u6216\u6700\u7ec8\u4ea7\u54c1\u6d4b\u8bd5\u7684\u5206\u6790\u7a0b\u5e8f\uff0c\uff082\uff09\u652f\u6301\u5b9e\u65f6\u91ca\u653e\u6d4b\u8bd5\uff0c\u6216\uff083\uff09\u9884\u6d4b\u8fc7\u7a0b\u4e2d\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\u3002\u5728\u5f00\u53d1\u548c\u9a8c\u8bc1\u5f71\u54cd\u4ea7\u54c1\u8d28\u91cf\u7684\u6a21\u578b\u65b9\u9762\uff0c\u53ef\u7528\u7684\u884c\u4e1a\u6807\u51c6\u548cFDA\u6307\u5357\u6709\u9650\uff0c\u8fd9\u53ef\u80fd\u5bf9\u5efa\u7acb\u7279\u5b9a\u7528\u9014\u7684\u6a21\u578b\u7684\u53ef\u4fe1\u5ea6\u9020\u6210\u6311\u6218\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u57fa\u7840\u6570\u636e\u7684\u7a33\u5065\u6027\u51b3\u5b9a\u4e86\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u7684\u51b3\u7b56\u3002\u8fd9\u53ef\u80fd\u4f1a\u5728\u907f\u514d\u6a21\u578b\u5f00\u53d1\u548c\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u610f\u5916\u7684\u504f\u89c1\u65b9\u9762\u5e26\u6765\u6311\u6218\u3002\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u4e5f\u53ef\u4ee5\u5b58\u50a8\u5728\u4e3a\u7279\u5b9a\u7528\u4f8b\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u83b7\u5f97\u7684\u77e5\u8bc6\uff0c\u7136\u540e\u5c06\u5176\u5e94\u7528\u4e8e\u4e0d\u540c\u4f46\u76f8\u5173\u7684\u7528\u4f8b\uff0c\u4ee5\u52a0\u901f\u6a21\u578b\u7684\u5f00\u53d1\u3002\u7533\u8bf7\u4eba\u548c\u751f\u4ea7\u5546\u53ef\u80fd\u9700\u8981\u660e\u786e\u5982\u4f55\u5728\u6a21\u578b\u5f00\u53d1\u548c\u9a8c\u8bc1\u4e2d\u8003\u8651\u5c06\u5b66\u4e60\u4ece\u4e00\u4e2a\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u8f6c\u79fb\u5230\u53e6\u4e00\u4e2a\u6a21\u578b\u7684\u53ef\u80fd\u6027\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u968f\u7740\u4eba\u5de5\u667a\u80fd\u65b9\u6cd5\u53d8\u5f97\u8d8a\u6765\u8d8a\u590d\u6742\uff0c\u89e3\u91ca\u6a21\u578b\u8f93\u5165\u7684\u53d8\u5316\u5982\u4f55\u5f71\u54cd\u6a21\u578b\u7684\u8f93\u51fa\u53d8\u5f97\u8d8a\u6765\u8d8a\u6709\u6311\u6218\u6027\u3002\u5728\u8fd9\u4e9b\u60c5\u51b5\u4e0b\uff0c\u7533\u8bf7\u4eba\u53ef\u80fd\u9762\u4e34\u7684\u6311\u6218\u662f\u5982\u4f55\u5b9a\u4e49\u9a8c\u8bc1\u6a21\u578b\u7684\u6807\u51c6\uff0c\u5e76\u7ef4\u6301\u6a21\u578b\u8f93\u51fa\u7684\u53ef\u89e3\u91ca\u6027\u548c\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\u3002\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 15px 10px; outline: 0px; max-width: 100%; display: inline-block; width: 100%; border-width: 1px; border-style: solid; border-color: rgb(221, 222, 226); background-color: rgb(247, 247, 249); overflow-wrap: break-word !important;box-sizing:border-box;\" class=\"\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; line-height: 1.6;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;text-align:center;\" align=\"center\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">\u4e00\u4e9b\u6f5c\u5728\u7684\u76f8\u5173\u8981\u6c42\u548c\u653f\u7b56<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Regulations:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t21 CFR 11, 211.68, 211.110, 211.165, 211.180\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Draft Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q14 Analytical Procedure Development (August 2022)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients&nbsp;<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0px;\">(September 2016)<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\" draggable=\"true\">\n\t\t\t\t\tICH Q8(R2) Pharmaceutical Development (November 2009)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q9 Quality Risk Management (June 2006)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q10 Pharmaceutical Quality System (April 2009)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q11 Development and Manufacture of Drug Substances (November 2012)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tProcess Validation: General Principles and Practices (January 2011)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tDevelopment and Submission of Near Infrared Analytical Procedures (August 2021)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Compliance Program:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t7346.832 \u2014 Preapproval Inspections (October 2022)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t7356.002 \u2014 Drug Manufacturing Inspections (October 2022)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t7356.002M \u2014 Surveillance inspections of Protein Drug Substance Manufacturers&nbsp;<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0px;\">(October 2021)<\/span>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0px;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #576b95;\">5. \u4e0d\u65ad\u5b66\u4e60\u9002\u5e94\u5b9e\u65f6\u6570\u636e\u7684\u4eba\u5de5\u667a\u80fd\u7cfb\u7edf\u53ef\u80fd\u5bf9\u76d1\u7ba1\u8bc4\u4f30\u548c\u76d1\u7763\u63d0\u51fa\u6311\u6218<\/span><\/strong>\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u5728\u76ee\u524d\u7684\u8303\u5f0f\u4e2d\uff0c\u90e8\u7f72\u5728\u751f\u4ea7\u4e2d\u7684\u6a21\u578b\uff08\u5982\u8fc7\u7a0b\u4e2d\u7684\u63a7\u5236\u3001\u5b9e\u65f6\u91ca\u653e\u6d4b\u8bd5\uff09\u662f\u901a\u8fc7\u5236\u836f\u8d28\u91cf\u4f53\u7cfb\u5185\u7684\u53d8\u66f4\u63a7\u5236\u8fc7\u7a0b\uff0c\u6839\u636e\u9700\u8981\u8fdb\u884c\u5f00\u53d1\u3001\u9a8c\u8bc1\u3001\u5b9e\u65bd\u548c\u66f4\u65b0\u3002\u4eba\u5de5\u667a\u80fd\u6a21\u578b\uff08\u4f8b\u5982\uff0c\u57fa\u4e8e\u673a\u5668\u5b66\u4e60\u7684\u6a21\u578b\uff09\u53ef\u4ee5\u6301\u7eed\u5b66\u4e60\uff0c\u5176\u4e2d\u6a21\u578b\u968f\u7740\u65b0\u4fe1\u606f\u7684\u51fa\u73b0\u800c\u4e0d\u65ad\u53d1\u5c55\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u8981\u786e\u5b9a\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u4f55\u65f6\u53ef\u88ab\u89c6\u4e3a\u4e00\u4e2a\u8fc7\u7a0b\u7684\u65e2\u5b9a\u6761\u4ef6\uff0c\u8fd9\u53ef\u80fd\u662f\u4e00\u4e2a\u6311\u6218\u3002\u4f5c\u4e3a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u4e2d\u6a21\u578b\u7ef4\u62a4\u7684\u4e00\u90e8\u5206\uff0c\u786e\u5b9a\u5bf9\u6a21\u578b\u53d8\u5316\u7684\u76d1\u7ba1\u6807\u51c6\u4e5f\u53ef\u80fd\u662f\u4e00\u4e2a\u6311\u6218\u3002\u7533\u8bf7\u4eba\u53ef\u80fd\u9700\u8981\u660e\u786e\uff1a(a)\u5bf9\u6a21\u578b\u751f\u547d\u5468\u671f\u6218\u7565\u7684\u9a8c\u8bc1\u7684\u671f\u671b\uff0c\u4ee5\u53caFDA\u5728\u73b0\u573a\u68c0\u67e5\u671f\u95f4\u5bf9\u4e0d\u65ad\u66f4\u65b0\u7684\u4eba\u5de5\u667a\u80fd\u63a7\u5236\u6a21\u578b\u7684\u68c0\u67e5\u65b9\u6cd5\uff0c\u4ee5\u53ca(b)\u5728\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u5f15\u5165\u751f\u4ea7\u6761\u4ef6\u7684\u53d8\u5316\u540e\u5efa\u7acb\u4ea7\u54c1\u53ef\u6bd4\u6027\u7684\u671f\u671b\uff0c\u7279\u522b\u662f\u5bf9\u751f\u7269\u4ea7\u54c1\u3002\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 40px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 15px 10px; outline: 0px; max-width: 100%; display: inline-block; width: 100%; border-width: 1px; border-style: solid; border-color: rgb(221, 222, 226); background-color: rgb(247, 247, 249); overflow-wrap: break-word !important;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 14px; line-height: 1.6;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;text-align:center;\" align=\"center\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">\u4e00\u4e9b\u6f5c\u5728\u7684\u76f8\u5173\u8981\u6c42\u548c\u653f\u7b56<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Regulations:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t21 CFR 11, 211.68, 211.180, 314.70, 314.97, 601.12\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Draft Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q12 Implementation Considerations for FDA-Regulated Products (May 2021)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #000000;\">Guidance for Industry:<\/span><\/strong>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (September 2016)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tQ8, Q9, &amp; Q10 Questions and Answers \u2014 Appendix: Q&amp;As from Training Sessions (July 2012)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle&nbsp;<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0px;\">Management (May 2021)<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tDevelopment and Submission of Near Infrared Analytical Procedures (August 2021)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tChanges to an Approved NDA or ANDA (April 2004)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tChanges to an Approved Application for Specified Biotechnology and Specified Synthetic&nbsp;<span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0px;\">Biological Products (July 1997)<\/span>\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px 0px 12px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tSUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (October 1997)\n\t\t\t\t<\/p>\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\tSUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (November 1995)\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 35px 0px 10px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); display: flex; flex-flow: row nowrap; text-align: left; justify-content: flex-start;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; display: inline-block; vertical-align: top; width: auto; background-color: rgb(0, 92, 175); flex: 0 0 auto; align-self: flex-start; min-width: 10%; height: auto; border-width: 0px;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;transform:       translate3d(-1px, 0px, 0px);-webkit-transform:       translate3d(-1px, 0px, 0px);-moz-transform:       translate3d(-1px, 0px, 0px);-o-transform:       translate3d(-1px, 0px, 0px);\">\n\t\t\t\t<section style=\"margin: 0px; padding: 0px 10px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 16px; color: rgb(255, 255, 255); line-height: 2.2; letter-spacing: 1px; text-align: justify;\">\n\t\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">06<\/strong>\n\t\t\t\t\t<\/p>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; display: inline-block; vertical-align: top; width: auto; background-color: rgb(245, 245, 245); flex: 100 100 0%; height: auto;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px 10px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 16px; color: rgb(0, 86, 167); line-height: 2.2; letter-spacing: 1px; text-align: justify;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">AI\u95ee\u9898\u548c\u53cd\u9988\u90e8\u5206<\/strong>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t1.\u4f60\u8bbe\u60f3\u54ea\u4e9b\u7c7b\u578b\u7684\u4eba\u5de5\u667a\u80fd\u5e94\u7528\u4f1a\u88ab\u7528\u4e8e\u836f\u54c1\u751f\u4ea7\uff1f\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t2.\u76ee\u524d\u7684\u76d1\u7ba1\u6846\u67b6\u662f\u5426\u6709\u5176\u4ed6\u65b9\u9762\uff08\u4f8b\u5982\uff0c\u4e0a\u9762\u6ca1\u6709\u5217\u51fa\u7684\u65b9\u9762\uff09\u53ef\u80fd\u4f1a\u5f71\u54cd\u4eba\u5de5\u667a\u80fd\u5728\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u5b9e\u65bd\uff0c\u5e76\u5e94\u7531FDA\u8003\u8651\uff1f\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t3.\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u4eba\u5de5\u667a\u80fd\u9886\u57df\u7684\u6307\u5bfc\u662f\u5426\u6709\u76ca\uff1f\u5982\u679c\u662f\u8fd9\u6837\uff0c\u5e94\u8003\u8651\u4eba\u5de5\u667a\u80fd\u6280\u672f\u7684\u54ea\u4e9b\u65b9\u9762\uff1f\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t4.\u751f\u4ea7\u5546\u5728CGMP\u73af\u5883\u4e2d\u5b9e\u65bd\u57fa\u4e8e\u4eba\u5de5\u667a\u80fd\u7684\u6a21\u578b\u7684\u5fc5\u8981\u56e0\u7d20\u662f\u4ec0\u4e48\uff1f\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t5.\u9a8c\u8bc1\u548c\u7ef4\u62a4\u81ea\u5b66\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u7684\u5e38\u89c1\u505a\u6cd5\u662f\u4ec0\u4e48\uff0c\u9700\u8981\u8003\u8651\u54ea\u4e9b\u6b65\u9aa4\u6765\u5efa\u7acb\u6700\u4f73\u505a\u6cd5\uff1f\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t6.\u5728\u836f\u54c1\u751f\u4ea7\u4e2d\uff0c\u7ba1\u7406\u7528\u4e8e\u751f\u6210\u4eba\u5de5\u667a\u80fd\u6a21\u578b\u7684\u6570\u636e\u7684\u5fc5\u8981\u673a\u5236\u662f\u4ec0\u4e48\uff1f\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t7.\u5728\u4e3a\u5236\u836f\u4e1a\u5b9e\u65bd\u6a21\u578b\uff08\u5305\u62ec\u57fa\u4e8e\u4eba\u5de5\u667a\u80fd\u7684\u6a21\u578b\uff09\u7684\u8fc7\u7a0b\u4e2d\uff0c\u662f\u5426\u6709\u5176\u4ed6\u65b9\u9762\u9700\u8981\u8fdb\u4e00\u6b65\u6307\u5bfc\uff1f\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t8.\u672c\u6587\u4ef6\u4e2d\u672a\u6d89\u53ca\u7684\u4eba\u5de5\u667a\u80fd\u5728\u836f\u54c1\u751f\u4ea7\u4e2d\u7684\u5e94\u7528\uff0c\u662f\u5426\u6709FDA\u5e94\u8be5\u8003\u8651\u7684\u65b9\u9762\uff1f\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 35px 0px 10px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); display: flex; flex-flow: row nowrap; text-align: left; justify-content: flex-start;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; display: inline-block; vertical-align: top; width: auto; background-color: rgb(0, 92, 175); flex: 0 0 auto; align-self: flex-start; min-width: 10%; height: auto; border-width: 0px;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;transform:       translate3d(-1px, 0px, 0px);-webkit-transform:       translate3d(-1px, 0px, 0px);-moz-transform:       translate3d(-1px, 0px, 0px);-o-transform:       translate3d(-1px, 0px, 0px);\">\n\t\t\t\t<section style=\"margin: 0px; padding: 0px 10px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 16px; color: rgb(255, 255, 255); line-height: 2.2; letter-spacing: 1px; text-align: justify;\">\n\t\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">07<\/strong>\n\t\t\t\t\t<\/p>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; overflow-wrap: break-word !important; display: inline-block; vertical-align: top; width: auto; background-color: rgb(245, 245, 245); flex: 100 100 0%; height: auto;box-sizing:border-box;\">\n\t\t\t<section style=\"margin: 0px; padding: 0px 10px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 16px; color: rgb(0, 86, 167); line-height: 2.2; letter-spacing: 1px; text-align: justify;\" class=\"\">\n\t\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u603b\u7ed3<\/strong>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\" class=\"\">\n\t\t\t<p style=\"margin: 0px 0px 20px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u672c\u8ba8\u8bba\u6587\u4ef6\u63d0\u51fa\u4e86\u9700\u8981\u8003\u8651\u7684\u9886\u57df\u548c\u6f5c\u5728\u7684\u653f\u7b56\u53d1\u5c55\u3002\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\tCDER \u5728\u8bc4\u4f30\u73b0\u6709\u76d1\u7ba1\u6846\u67b6\u5728\u836f\u54c1\u751f\u4ea7\u4e2d\u5e94\u7528\u4eba\u5de5\u667a\u80fd\u7684\u57fa\u7840\u4e0a\uff0c\u786e\u5b9a\u4e86\u9700\u8981\u8003\u8651\u7684\u9886\u57df\u548c\u6f5c\u5728\u7684\u653f\u7b56\u53d1\u5c55\u3002\u5148\u8fdb\u751f\u4ea7\u8bc4\u4f30\u7684\u76d1\u7ba1\u6846\u67b6\u5c06\u89e3\u51b3\u8fd9\u4e9b\u9886\u57df\u7684\u95ee\u9898\uff0c\u540c\u65f6\u4e5f\u8003\u8651\u6f5c\u5728\u7684\u53d8\u5316\u4f1a\u5982\u4f55\u5f71\u54cd\u73b0\u6709\u7684\u6280\u672f\u548c\u8bbe\u65bd\u3002CDER\u5c06\u5229\u7528\u63d0\u4ea4\u7ed9\u5907\u67e5\u6587\u4ef6\u7684\u53cd\u9988\u610f\u89c1\u4e3a\u672a\u6765\u7684\u653f\u7b56\u5236\u5b9a\u63d0\u4f9b\u53c2\u8003\u3002\u8bf7\u5c06\u60a8\u5bf9\u672c\u8ba8\u8bba\u6587\u4ef6\u7684\u610f\u89c1\u63d0\u4ea4\u81f3 https:\/\/ www.regulations.gov\uff0c\u5907\u67e5\u6587\u4ef6\u53f7\uff1aFDA-2023-N-0487\u3002\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 35px 0px 10px; 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padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; vertical-align: middle; display: inline-block; line-height: 0;\" class=\"\">\n\t\t\t<img decoding=\"async\" class=\"rich_pages wxw-img\" width=\"100%\" data-index=\"3\" src=\"https:\/\/www.ncgt.org.cn\/ncgt\/wp-content\/uploads\/2023\/03\/2-3.png\" _width=\"100%\" alt=\"\u56fe\u7247\" data-fail=\"0\" style=\"margin: 0px; padding: 0px; outline: 0px; vertical-align: middle; width: 100%; overflow-wrap: break-word !important; height: auto !important; visibility: visible !important;;;margin:0px;width:100% !important;box-sizing:border-box;max-width: 100% !important;\" height=\"auto\" border=\"0\" mapurl=\"\" title=\"\u56fe\u7247\" data-ratio=\"1.348148148148148\" data-w=\"1080\"\/>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 25px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); text-align: center; line-height: 0;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; vertical-align: middle; display: inline-block; line-height: 0;\" class=\"\">\n\t\t\t<img decoding=\"async\" class=\"rich_pages wxw-img\" width=\"100%\" data-index=\"4\" src=\"https:\/\/www.ncgt.org.cn\/ncgt\/wp-content\/uploads\/2023\/03\/3-1.png\" _width=\"100%\" alt=\"\u56fe\u7247\" data-fail=\"0\" style=\"margin: 0px; padding: 0px; outline: 0px; vertical-align: middle; width: 100%; overflow-wrap: break-word !important; height: auto !important; visibility: visible !important;;;margin:0px;width:100% !important;box-sizing:border-box;max-width: 100% !important;\" height=\"auto\" border=\"0\" mapurl=\"\" title=\"\u56fe\u7247\" data-ratio=\"0.3351851851851852\" data-w=\"1080\"\/>\n\t\t<\/section>\n\t<\/section>\n\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em; color: rgb(34, 34, 34); font-size: 15px;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"><span style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: #576B95;\">\u9644\u5f55B\uff1a\u4eba\u5de5\u667a\u80fd\u6280\u672f\u6982\u8ff0<\/span><\/strong><br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t<\/p>\n\t<section style=\"margin: 25px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); text-align: center; line-height: 0;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; vertical-align: middle; display: inline-block; line-height: 0;\" class=\"\">\n\t\t\t<img decoding=\"async\" class=\"rich_pages wxw-img\" width=\"100%\" data-index=\"5\" src=\"https:\/\/www.ncgt.org.cn\/ncgt\/wp-content\/uploads\/2023\/03\/4.png\" _width=\"100%\" alt=\"\u56fe\u7247\" data-fail=\"0\" style=\"margin: 0px; padding: 0px; outline: 0px; vertical-align: middle; width: 100%; overflow-wrap: break-word !important; height: auto !important; visibility: visible !important;;;margin:0px;width:100% !important;box-sizing:border-box;max-width: 100% !important;\" height=\"auto\" border=\"0\" mapurl=\"\" title=\"\u56fe\u7247\" data-ratio=\"1.010185185185185\" data-w=\"1080\"\/>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; font-size: 15px; background-color: #ffffff; color: #576b95;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\" class=\"\">\n\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t<strong style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\">\u9644\u5f55C\uff1a\u9996\u5b57\u6bcd\u7f29\u5199\u8bcd\u548c\u7f29\u7565\u8bed<\/strong>\n\t\t<\/p>\n\t<\/section>\n\t<section style=\"margin: 25px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255); text-align: center; line-height: 0;font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; vertical-align: middle; display: inline-block; line-height: 0;\" class=\"\">\n\t\t\t<img decoding=\"async\" class=\"rich_pages wxw-img\" width=\"100%\" data-index=\"6\" src=\"https:\/\/www.ncgt.org.cn\/ncgt\/wp-content\/uploads\/2023\/03\/5.png\" _width=\"100%\" alt=\"\u56fe\u7247\" data-fail=\"0\" style=\"margin: 0px; padding: 0px; outline: 0px; vertical-align: middle; width: 100%; overflow-wrap: break-word !important; height: auto !important; visibility: visible !important;;;margin:0px;width:100% !important;box-sizing:border-box;max-width: 100% !important;\" height=\"auto\" border=\"0\" mapurl=\"\" title=\"\u56fe\u7247\" data-ratio=\"1.4407407407407407\" data-w=\"1080\"\/>\n\t\t<\/section>\n\t<\/section>\n\t<section style=\"margin: 20px 0px 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(34, 34, 34); font-size: 15px; background-color: rgb(255, 255, 255);font-family: system-ui, -apple-system, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;\">\n\t\t<section style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; text-align: left; font-size: 12px; color: #888888;\" class=\"\">\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\t\u53c2\u8003\u8d44\u6599<br style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;\"\/>\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\thttps:\/\/www.fda.gov\/about-fda\/center-drug-evaluation-and-research-cder\/cders-framework-regulatory-advanced-manufacturing-evaluation-frame-initiative\n\t\t\t<\/p>\n\t\t\t<p style=\"margin: 0px; padding: 0px; outline: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; clear: both; min-height: 1em;\">\n\t\t\t\thttps:\/\/www.fda.gov\/media\/165743\/download\n\t\t\t<\/p>\n\t\t<\/section>\n\t<\/section>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>\u6765\u6e90\uff1a\u5148\u8fdb\u7ec6\u80de\u667a\u9020\u7cfb\u7edf\u7814\u53d1\u5e73\u53f0 \u627f\u8f7d\u5355\u4f4d\uff1a\u6df1\u5733\u8d5b\u52a8\u667a\u9020\u79d1\u6280\u6709\u9650\u516c\u53f8 \u65f6\u95f4\uff1a2023-03-20 2023\u5e743\u67082\u65e5\uff0cFDA\u836f\u54c1\u5ba1\u8bc4\u548c\u7814\u7a76\u4e2d\u5fc3\u53d1\u5e03\u4e86\u300aArtificial Intelligence in Drug Manufacturing\u300b\u8ba8\u8bba\u6587\u4ef6\uff0c\u4f9b\u516c\u4f17\u57282023\u5e745\u67081\u65e5\u524d\u63d0\u51fa\u610f\u89c1\u3002 \u8ba8\u8bba\u7a3f\u539f\u6587\uff0c\u8bf7\u70b9\u51fb\uff1aArtificial Intelligence Discussion Paper (fda.gov)<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":3782,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[],"_links":{"self":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts\/3787"}],"collection":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/comments?post=3787"}],"version-history":[{"count":3,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts\/3787\/revisions"}],"predecessor-version":[{"id":3790,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts\/3787\/revisions\/3790"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/media\/3782"}],"wp:attachment":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/media?parent=3787"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/categories?post=3787"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/tags?post=3787"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}