{"id":8506,"date":"2025-07-23T13:48:39","date_gmt":"2025-07-23T05:48:39","guid":{"rendered":"https:\/\/regask.com\/?p=8506"},"modified":"2025-07-23T13:50:16","modified_gmt":"2025-07-23T05:50:16","slug":"%e6%ac%a7%e7%9b%9f-gmp-%e6%8c%87%e5%8d%97-2025-ai-%e8%ae%a1%e7%ae%97%e6%9c%ba%e5%8c%96%e7%b3%bb%e7%bb%9f%e6%96%87%e6%a1%a3%e6%9b%b4%e6%96%b0","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/","title":{"rendered":"\u6b27\u76df\u59d4\u5458\u4f1a\u5c31\u66f4\u65b0\u7248\u542f\u52a8\u516c\u4f17\u54a8\u8be2\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2025\u5e747\u67087\u65e5<\/strong>\uff0c \u8fd9 <a href=\"https:\/\/commission.europa.eu\/about\/departments-and-executive-agencies\/health-and-food-safety_en\"><strong>\u6b27\u76df\u59d4\u5458\u4f1a\u536b\u751f\u4e0e\u98df\u54c1\u5b89\u5168\u603b\u53f8<\/strong><\/a> \u6253\u5f00\u4e86\u4e00\u4e2a <strong>\u516c\u4f17\u54a8\u8be2<\/strong> \u5173\u4e8e\u62df\u8bae\u7684\u4fee\u8ba2 <strong>EudraLex \u7b2c 4 \u5377 \u2013 \u826f\u597d\u751f\u4ea7\u89c4\u8303 (GMP) \u6307\u5357<\/strong>\u3002\u66f4\u65b0\u9002\u7528\u4e8e\uff1a<\/p>\n<ul>\n<li><strong>\u7b2c 4 \u7ae0\uff1a\u6587\u6863<\/strong><\/li>\n<li><strong>\u9644\u4ef6 11\uff1a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf<\/strong><\/li>\n<li><strong>\u9644\u4ef622\uff1a\u4eba\u5de5\u667a\u80fd<\/strong> <em>\uff08\u65b0\u63a8\u51fa\uff09<\/em><\/li>\n<\/ul>\n<p>\u8fd9\u4e9b\u62df\u8bae\u7684\u53d8\u66f4\u65e8\u5728 <strong>\u73b0\u4ee3\u5316 GMP \u5b9e\u8df5<\/strong> \u901a\u8fc7\u52a0\u5f3a <strong>\u6570\u636e\u5b8c\u6574\u6027<\/strong>\uff0c\u6574\u5408 <strong>\u4eba\u5de5\u667a\u80fd\u6cbb\u7406<\/strong>\u5e76\u6539\u8fdb\u76d1\u7763 <strong>\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf<\/strong> \u548c <strong>\u6587\u6863<\/strong> \u5728 <strong>\u533b\u836f\u5236\u9020<\/strong>.<\/p>\n<p><strong>\u4e3b\u8981\u4eae\u70b9\uff1a<\/strong><\/p>\n<ul>\n<li>\u8fd9 <strong>\u66f4\u65b0\u4e86\u7b2c 4 \u7ae0<\/strong> \u5f3a\u8c03 <strong>\u57fa\u4e8e\u98ce\u9669\u7684\u6587\u6863\u5b9e\u8df5<\/strong>\u4ee5\u53ca\u52a0\u5f3a\u7ba1\u7406 <strong>\u7535\u5b50\u8bb0\u5f55<\/strong> \u548c <strong>\u7b7e\u540d<\/strong>\uff0c\u540c\u65f6\u786e\u4fdd <strong>\u53ef\u8bfb\u6027\u548c\u5b8c\u6574\u6027<\/strong> \u6240\u6709\u683c\u5f0f\u7684\u6587\u6863\u3002<\/li>\n<li>\u8fd9 <strong>\u4fee\u8ba2\u540e\u7684\u9644\u4ef611<\/strong> \u5f3a\u5316\u5e94\u7528 <strong>\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\uff08QRM\uff09<\/strong> \u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d <strong>\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf<\/strong>\uff0c\u5f15\u5165\u66f4\u5f3a\u6709\u529b\u7684\u63a7\u5236 <strong>\u5ba1\u8ba1\u5ba1\u5224<\/strong>, <strong>\u7cfb\u7edf\u5b89\u5168<\/strong>\uff0c \u548c <strong>\u4f9b\u5e94\u5546\u76d1\u7763<\/strong>.<\/li>\n<li>\u8fd9 <strong>\u65b0\u5f15\u5165\u7684\u9644\u4ef622<\/strong> \u4e3a\u4f7f\u7528\u5efa\u7acb\u660e\u786e\u7684\u76d1\u7ba1\u6846\u67b6 <strong>GMP\u73af\u5883\u4e2d\u7684\u4eba\u5de5\u667a\u80fd<\/strong>\uff0c\u89e3\u51b3\u4e0e <strong>\u6a21\u578b\u9a8c\u8bc1<\/strong>, <strong>\u8bad\u7ec3\u6570\u636e\u8d28\u91cf<\/strong>, <strong>\u7ee9\u6548\u6307\u6807<\/strong>\uff0c \u548c <strong>\u6301\u7eed\u7684\u4eba\u4e3a\u76d1\u7763<\/strong>.<\/li>\n<\/ul>\n<h4><strong>\u53cd\u9988\u622a\u6b62\u65e5\u671f\uff1a2025\u5e7410\u67087\u65e5<\/strong><\/h4>\n\t<div id=\"gap-8471640\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-8471640 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>\u4e3a\u4ec0\u4e48\u91cd\u8981\uff1a<\/strong><br \/>\u9884\u8ba1\u8fd9\u4e9b\u4fee\u8ba2\u5c06\uff1a<\/p>\n<ul>\n<li>\u63d0\u9ad8 <strong>\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong><\/li>\n<li>\u5bf9\u9f50 <strong>\u65b0\u5174\u6570\u5b57\u6280\u672f<\/strong><\/li>\n<li>\u63a8\u52a8 <strong>\u8fd0\u8425\u6548\u7387<\/strong><\/li>\n<li>\u4ecb\u7ecd <strong>\u6700\u5c0f\u5316\u65b0\u7684\u5408\u89c4\u8d1f\u62c5<\/strong><\/li>\n<\/ul>\n<p><strong>\u5229\u76ca\u76f8\u5173\u8005\u7684\u610f\u89c1\u5c06\u5728\u5236\u5b9a\u5b9e\u7528\u4e14\u7b26\u5408\u6280\u672f\u8fdb\u6b65\u7684\u6307\u5bfc\u65b9\u9488\u65b9\u9762\u53d1\u6325\u5173\u952e\u4f5c\u7528\u3002<\/strong> \u8fd9\u4e9b\u66f4\u65b0\u5bf9\u4e8e <strong>GMP \u4e2d\u7684\u8d28\u91cf\u3001\u76d1\u7ba1\u4e8b\u52a1\u3001IT \u5408\u89c4\u6027\u548c AI \u90e8\u7f72<\/strong>\u53d7\u76d1\u7ba1\u7684\u73af\u5883\u3002<\/p>\n<p><strong>\u540e\u7eed\u6b65\u9aa4Next steps<\/strong><br \/>\u5229\u76ca\u76f8\u5173\u65b9\u5e94\u5ba1\u67e5\u7b2c4\u7ae0\u3001\u9644\u4ef611\u548c\u9644\u4ef622\u7684\u4fee\u8ba2\u8349\u6848\uff0c\u8bc4\u4f30\u5185\u90e8\u5f71\u54cd\uff0c\u5e76\u534f\u8c03\u8de8\u804c\u80fd\u90e8\u95e8\u7684\u53cd\u9988\u610f\u89c1\u3002\u610f\u89c1\u5fc5\u987b\u901a\u8fc7\u4ee5\u4e0b\u65b9\u5f0f\u63d0\u4ea4\uff1a <a href=\"https:\/\/health.ec.europa.eu\/consultations\/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en\">\u6b27\u76df\u59d4\u5458\u4f1a\u95e8\u6237\u7f51\u7ad9 <strong>2025\u5e7410\u67087\u65e5<\/strong>.<\/a><\/p>\n<p><strong>RegASK \u5982\u4f55\u63d0\u4f9b\u5e2e\u52a9<\/strong><br \/>RegASK \u662f\u4e00\u4e2a\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u5e73\u53f0\uff0c\u53ef\u6301\u7eed\u76d1\u63a7\u76d1\u7ba1\u66f4\u65b0\uff0c\u5305\u62ec GMP \u548c AI \u6307\u5357\uff0c\u4ee5\u5e2e\u52a9\u751f\u547d\u79d1\u5b66\u56e2\u961f\u4fdd\u6301\u5408\u89c4\u548c\u51c6\u5907\u3002<br \/><a href=\"https:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a<\/strong><\/a><strong> \u6216\u8005 <\/strong><a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\"><strong>\u9884\u8ba2\u6f14\u793a<\/strong><\/a><\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:1em;margin-bottom:1em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n\t<div id=\"gap-698178811\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-698178811 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/strong><\/h4>\n\t<div id=\"gap-1748997763\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1748997763 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ol>\n<li><strong> \u66f4\u65b0\u540e\u7684\u6b27\u76df GMP \u6307\u5357\u9644\u4ef6 22 \u662f\u4ec0\u4e48\uff1f<\/strong><br \/>\n\u9644\u4ef6 22 \u662f EudraLex \u7b2c 4 \u5377\u4e0b\u65b0\u63d0\u51fa\u7684\u90e8\u5206\u3002\u5b83\u89c4\u5b9a\u4e86\u5728\u5236\u836f\u5236\u9020\u4e2d\u4f7f\u7528\u4eba\u5de5\u667a\u80fd\u7684\u76d1\u7ba1\u8981\u6c42\uff0c\u5305\u62ec\u6a21\u578b\u9a8c\u8bc1\u3001\u8bad\u7ec3\u6570\u636e\u6807\u51c6\u548c\u4eba\u5de5\u76d1\u7763\u3002<\/li>\n<li><strong> \u9644\u4ef6 11 \u4e0b\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u6709\u54ea\u4e9b\u53d8\u5316\uff1f<\/strong><br \/>\n\u66f4\u65b0\u540e\u7684\u9644\u4ef611\u9488\u5bf9\u8ba1\u7b97\u673a\u7cfb\u7edf\u5f15\u5165\u4e86\u66f4\u4e25\u683c\u7684\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u5b9e\u8df5\uff0c\u91cd\u70b9\u5173\u6ce8\u5ba1\u8ba1\u8bd5\u9a8c\u3001\u7535\u5b50\u7b7e\u540d\u3001\u7cfb\u7edf\u5b89\u5168\u548c\u4f9b\u5e94\u5546\u76d1\u7763\u3002<\/li>\n<li><strong> \u6b27\u76dfGMP\u4fee\u8ba2\u540e\u7684\u7b2c4\u7ae0\u5bf9\u6587\u4ef6\u7684\u8981\u6c42\u6709\u54ea\u4e9b\uff1f<\/strong><br \/>\n\u4fee\u8ba2\u540e\u7684\u7b2c\u56db\u7ae0\u5f3a\u8c03\u4e86\u6570\u636e\u5b8c\u6574\u6027\u3001\u57fa\u4e8e\u98ce\u9669\u7684\u6cbb\u7406\u4ee5\u53ca\u5bf9\u6240\u6709\u683c\u5f0f\u6587\u6863\u7684\u59a5\u5584\u5904\u7406\u3002\u6b64\u5916\uff0c\u5b83\u8fd8\u52a0\u5f3a\u4e86\u5bf9\u7535\u5b50\u8bb0\u5f55\u548c\u7b7e\u540d\u7684\u7ba1\u7406\u8981\u6c42\u3002<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>2025\u5e747\u67087\u65e5\uff0c\u6b27\u76df\u59d4\u5458\u4f1a\u5065\u5eb7\u4e0e\u98df\u54c1\u5b89\u5168\u603b\u53f8\u5c31EudraLex\u7b2c\u56db\u5377\u2014\u2014\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff08GMP\uff09\u6307\u5357\u7684\u4fee\u8ba2\u63d0\u6848\u542f\u52a8\u4e86\u516c\u4f17\u54a8\u8be2\u3002\u6b64\u6b21\u4fee\u8ba2\u6d89\u53ca\uff1a\u7b2c\u56db\u7ae0\uff1a\u6587\u4ef6\uff1b\u9644\u4ef611\uff1a\u8ba1\u7b97\u673a\u7cfb\u7edf\uff1b\u9644\u4ef622\uff1a\u4eba\u5de5\u667a\u80fd\uff08\u65b0\u589e\uff09\u3002\u8fd9\u4e9b\u62df\u8bae\u7684\u4fee\u8ba2\u65e8\u5728\u4f7fGMP\u5b9e\u8df5\u73b0\u4ee3\u5316\u2026\u2026<\/p>","protected":false},"author":32,"featured_media":8508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33],"tags":[],"class_list":["post-8506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>European Commission Launches GMP Consultation | RegASK<\/title>\n<meta name=\"description\" content=\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. 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