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class=\"has-text-align-center\"><img decoding=\"async\" src=\"https:\/\/www.nlaelpct.com\/upLoad\/image\/20230630\/16880983805262251.png\" alt=\"45.png\"><br>\u56fd\u5bb6\u7ea7\u4ea7\u4e1a\u5316\u9879\u76ee\u201c\u751f\u7269\u6280\u672f\u4e0e\u4fe1\u606f\u6280\u672f\u878d\u5408\u5e94\u7528\u5de5\u7a0b\u201d<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>\uff08\u56db\uff09\u7f8e\u56fdFDA\u5173\u4e8e\u8fde\u7eed\u6027\u751f\u4ea7\u7684\u89c2\u70b9<\/strong><\/p>\n\n\n\n<p>\u7f8e\u56fdFDA\u65e9\u57282019\u5e742\u6708\u5c31\u53d1\u5e03\u4e86\u6307\u5bfc\u6027\u6587\u4ef6\u300a\u8fde\u7eed\u6027\u751f\u4ea7\u7684\u8d28\u91cf\u8003\u91cf\u300b\uff08\u201cQuality Considerations for Continuous Manufacturing\u201d\uff09\uff0c\u9f13\u52b1\u884c\u4e1a\u751f\u4ea7\u8f6c\u5411\u8fde\u7eed\u6027\u751f\u4ea7\u65b9\u5f0f\u3002\u8be5\u6307\u5bfc\u6027\u6587\u4ef6\u5c31\u7533\u8bf7\u4eba\u5982\u4f55\u5728\u65b0\u836f\u6ce8\u518c\u7533\u8bf7\u3001\u4eff\u5236\u836f\u7533\u8bf7\u53ca\u8865\u5145\u7533\u8bf7\u6750\u6599\u4e2d\u89e3\u51b3\u4ee5\u8fde\u7eed\u6027\u751f\u4ea7\u5de5\u827a\u751f\u4ea7\u4e2d\u7684\u8d28\u91cf\u8003\u91cf\u95ee\u9898\u63d0\u51fa\u4e86\u5efa\u8bae\u53ca\u79d1\u5b66\u539f\u7406\uff0cFDA\u652f\u6301\u5305\u62ec\u751f\u7269\u5236\u5242\u5728\u5185\u7684\u836f\u54c1\u751f\u4ea7\u5546\u5f00\u53d1\u91c7\u7528\u8fde\u7eed\u6027\u751f\u4ea7\u5de5\u827a\u548c\u4ea7\u7ebf\u3002<\/p>\n\n\n\n<p>FDA\u8ba4\u4e3a\uff0c\u8fde\u7eed\u6027\u751f\u4ea7\u7279\u522b\u9002\u5408\u7a81\u7834\u6027\u6cbb\u7597\uff08Breakthrough Therapy\uff09,\u5305\u62ecCGT\u6cbb\u7597\uff0cFDA\u5236\u5b9a\u7a81\u7834\u6027\u6cbb\u7597\u7684\u521d\u8877\u662f\u52a0\u5feb\u4e34\u5e8a\u5f00\u53d1\u901f\u5ea6\uff0c\u5c06\u5173\u952e\u7597\u6cd5\u66f4\u5feb\u5730\u63a8\u5411\u5e02\u573a\u4ee5\u633d\u6551\u66f4\u591a\u751f\u547d\u3002\u9664\u4e86\u901f\u5ea6\u548c\u8d28\u91cf\u7684\u8003\u91cf\uff0cCGT\u4ea7\u54c1\u91c7\u7528\u8fde\u7eed\u6027\u751f\u4ea7\u80fd\u4ea7\u751f\u6279\u91cf\u751f\u4ea7\u4e2d\u65e0\u6cd5\u83b7\u53d6\u7684CMC\uff08chemistry, manufacturing and control\uff0c\u5316\u5b66\u3001\u5236\u9020\u4e0e\u63a7\u5236\uff09\u6570\u636e\uff0c\u5e76\u964d\u4f4e\u603b\u4f53\u751f\u4ea7\u6210\u672c\u3002\u8fde\u7eed\u6027\u751f\u4ea7\u80fd\u66f4\u5145\u5206\u5730\u5c06\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\uff08quality by design\uff09\u7684\u7406\u5ff5\u548c\u539f\u5219\u5d4c\u5165\u5de5\u827a\u5f00\u53d1\u4e2d\u3002<\/p>\n\n\n\n<p>\u4f9d\u636eFDA\u7684\u5b9a\u4e49[ICH Q8(R2),Pharmaceutical Development]\uff0c\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u662f\u4ee5\u7cfb\u7edf\u7684\u5f00\u53d1\u65b9\u6cd5\uff0c\u57fa\u4e8e\u5065\u5168\u7684\u79d1\u5b66\u548c\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\uff0c\u4ece\u5b9a\u4e49\u4ea7\u54c1\u76ee\u6807\u5f00\u59cb\uff0c\u5f3a\u8c03\u901a\u8fc7\u5bf9\u4ea7\u54c1\u548c\u8fc7\u7a0b\u7684\u7406\u89e3\u53ca\u8fc7\u7a0b\u63a7\u5236\uff0c\u5b9e\u73b0\u4ea7\u54c1\u8d28\u91cf\u5b9a\u4e49\u3002\u5de5\u827a\u53c2\u6570\u5728\u8fde\u7eed\u6027\u751f\u4ea7\u4e2d\u4e00\u89c8\u65e0\u9057\uff0c\u8d28\u91cf\u63a7\u5236\u8fc7\u7a0b\u4e5f\u201c\u53d8\u5f97\u201d\u5bb9\u6613\u53ef\u884c\uff0c\u53ef\u4ee5\u901a\u8fc7\u5bf9\u8fde\u7eed\u6027\u751f\u4ea7\u201c\u673a\u5668\u201d\u4e0a\u7684\u201c\u6309\u94ae\u201d\uff0c\u4f9d\u636e\u60a3\u8005\u201c\u539f\u6750\u6599\u201d\u7684\u4e2a\u4f53\u7279\u5f81\u8fdb\u884c\u8c03\u6574\u53c2\u6570\u548c\u6bd4\u7387\uff0c\u5e76\u5feb\u901f\u91c7\u6837\uff0c\u4ee5\u8fbe\u5230\u7ec8\u4ea7\u54c1\u7684\u8d28\u91cf\u76ee\u6807\u3002\u540c\u65f6\u4e5f\u4f7f\u5f97\u7ec6\u80de\u516c\u53f8\u80fd\u591f\u5feb\u901f\u6709\u6548\u5730\u4f18\u5316\u5de5\u827a\uff0c\u63d0\u5347\u4ea7\u54c1\u8d28\u91cf\uff0c\u540c\u65f6\u51cf\u5c11\u6d6a\u8d39\u5e76\u964d\u4f4e\u6210\u672c\u3002\u8fde\u7eed\u751f\u4ea7\u8fd8\u63d0\u4f9b\u4e86\u7acb\u5373\u6269\u5c55\u5230\u5546\u4e1a\u751f\u4ea7\u7684\u80fd\u529b\uff0c\u5e76\u4e14\u6ca1\u6709\u624b\u5de5\u4ea7\u7ebf\u6269\u5927\u4ea7\u80fd\u65f6\u7684\u663e\u8457\u6ede\u540e\u65f6\u95f4\u3002<\/p>\n\n\n\n<p>\u4e3a\u6b64\uff0cFDA\u4e8e2022\u5e74\u4e13\u95e8\u53d1\u5e03\u5173\u4e8e\u201cFDA\u5bf9\u836f\u54c1\u8fde\u7eed\u751f\u4ea7\u7684\u81ea\u6211\u5ba1\u8ba1\u201d\uff08\u201cAn FDA Self-Audit of Continuous Manufacturing for Drug Products \u201d\uff09\uff0c\u4e0e\u6279\u91cf\u751f\u4ea7\u65b9\u5f0f\u76f8\u6bd4\uff0c\u91c7\u7528\u5c01\u95ed\u5f0f\u3001\u8fde\u7eed\u6027\u751f\u4ea7\u7684\u836f\u7269\u7684\u5e73\u5747\u5ba1\u8bc4\u5ba1\u6279\u65f6\u95f4\u7f29\u77ed\u4e863\u4e2a\u6708\u3002\u8be6\u7ec6\u6bd4\u8f83\u5206\u6790\u89c1\u886812-88\u3002<\/p>\n\n\n\n<p class=\"has-text-align-center\">\u886812-88&nbsp; &nbsp;\u8fde\u7eed\u6027\u751f\u4ea7 VS&nbsp;\u6279\u91cf\u751f\u4ea7<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" src=\"https:\/\/www.nlaelpct.com\/upLoad\/image\/20230630\/16880984137360365.png\" alt=\"55555.png\" title=\"55555.png\"\/><\/figure><\/div>\n\n\n<p><\/p>\n\n\n\n<p class=\"has-text-align-center\"><strong>\u2014\u2014\u2014\u2014\u672a\u5b8c\u5f85\u7eed\u2014\u2014\u2014\u2014<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uff08\u4e00\uff09\u9769\u547d\u6027\u6cbb\u7597\u6548\u679c\u7684CAT-T\u9700\u8981\u914d\u5957\u65b0\u7684\u751f\u4ea7\u4ea4\u4ed8\u65b9\u5f0f\uff0c\u4ee5\u91ca\u653e<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":2736,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[4],"tags":[],"_links":{"self":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts\/2739"}],"collection":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/comments?post=2739"}],"version-history":[{"count":4,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts\/2739\/revisions"}],"predecessor-version":[{"id":2749,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/posts\/2739\/revisions\/2749"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/media\/2736"}],"wp:attachment":[{"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/media?parent=2739"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/categories?post=2739"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cellauto.com\/cellauto\/wp-json\/wp\/v2\/tags?post=2739"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}