{"id":3421,"date":"2020-02-12T08:38:24","date_gmt":"2020-02-12T08:38:24","guid":{"rendered":"https:\/\/junglefish.net\/dem\/chime\/?post_type=portfolio&#038;p=3421"},"modified":"2025-06-25T16:14:30","modified_gmt":"2025-06-25T08:14:30","slug":"quality-system","status":"publish","type":"portfolio","link":"https:\/\/chimebiologics.com\/zh\/cdmo-item\/quality-system\/","title":{"rendered":"\u8d28\u91cf\u4f53\u7cfb"},"content":{"rendered":"<div class='flex_column av-41j8e-fa36f75815485dfccfa68c05fc0bdcad av_two_fifth  avia-builder-el-0  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k6g6sogs-0e7fa446d945a6a2ab76f0eb0240f420\">\n.avia-image-container.av-k6g6sogs-0e7fa446d945a6a2ab76f0eb0240f420 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-k6g6sogs-0e7fa446d945a6a2ab76f0eb0240f420 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-k6g6sogs-0e7fa446d945a6a2ab76f0eb0240f420 av-styling-no-styling avia-align-center  avia-builder-el-1  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" class='wp-image-3373 avia-img-lazy-loading-not-3373 avia_image ' src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs.jpg\" alt='' title='CDMO-qs'  height=\"1000\" width=\"800\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs.jpg 800w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs-240x300.jpg 240w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs-768x960.jpg 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs-564x705.jpg 564w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs-450x563.jpg 450w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/div><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-38ep6-5b9abd869c3b83df58f92155e7fd3b9d\">\n.flex_column.av-38ep6-5b9abd869c3b83df58f92155e7fd3b9d{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-38ep6-5b9abd869c3b83df58f92155e7fd3b9d av_three_fifth  avia-builder-el-2  el_after_av_two_fifth  el_before_av_section  avia-builder-el-last  flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-k6g6u1z5-bada71189c63042784d4144d37917bdd'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><\/p>\n<h1>\u8d28\u91cf\u4f53\u7cfb<\/h1>\n<blockquote>\n<p>\u6211\u4eec\u63d0\u4f9b\u5168\u65b9\u4f4d\u7684\u8d28\u91cf\u7ba1\u7406\uff0c\u4e3a\u5ba2\u6237\u63d0\u4f9b\u6301\u7eed\u7a33\u5b9a\u7684\u4ea7\u54c1\u8d28\u91cf\u3002\u6211\u4eec\u5b8c\u5584\u7684\u8d28\u91cf\u4f53\u7cfb\u548c\u5e7f\u6cdb\u7684\u8ba4\u8bc1\u8bc1\u660e\u4e86\u6211\u4eec\u5728\u8d28\u91cf\u3001\u8bda\u4fe1\u548c\u80fd\u529b\u65b9\u9762\u7684\u627f\u8bfa<\/p>\n<\/blockquote>\n<p>\u9f0e\u5eb7\u751f\u7269\u7684\u8d28\u91cf\u7cfb\u7edf\u662f\u5efa\u7acb\u5728\u6cd5\u89c4\u7684\u671f\u671b\uff0c\u9075\u5faaCMC\uff08\u5316\u5b66\uff0c\u751f\u4ea7\u4e0e\u63a7\u5236\uff09\u6d3b\u52a8\u7684\u6cd5\u5f8b\u6cd5\u89c4\u548c\u5176\u4ed6\u6cd5\u5219\uff0c\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u7f8e\u56fd21 CFR\u7b2c210\u3001211\u548c600\u90e8\u5206\u8981\u6c42\uff0c\u826f\u597d\u751f\u4ea7\u7ba1\u7406\u89c4\u8303\uff08\u201ccGMP\u201d\uff09<\/li>\n<li>\u7f8e\u56fd21 CFR\u7b2c11\u90e8\u5206\uff0c\u836f\u54c1\u751f\u4ea7\u4e2d\u8ba1\u7b97\u673a\u7cfb\u7edf\u7684\u8981\u6c42<\/li>\n<li>\u6b27\u76df\u836f\u54c1\u7ba1\u7406\u89c4\u8303(EudraLex)<\/li>\n<li>\u6e56\u5317\u7701\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u9881\u53d1\u300a\u836f\u54c1\u751f\u4ea7\u8bb8\u53ef\u8bc1\u300b<\/li>\n<li>\u9002\u7528\u7684ICH\u6307\u5357<\/li>\n<\/ul>\n<p>\u6211\u4eec\u5efa\u7acb\u5e76\u7ef4\u62a4\u5bf9\u5408\u89c4\u6027\u3001\u79d1\u5b66\u548c\u98ce\u9669\u8fdb\u884c\u6301\u7eed\u6539\u8fdb\u7684\u4f01\u4e1a\u6587\u5316\u548c\u6d41\u7a0b\u3002\u6211\u4eec\u7684\u7cfb\u7edf\u4e0d\u4ec5\u53ef\u4ee5\u6ee1\u8db3\u5ba2\u6237\u5bf9\u5546\u4e1a\u5316\u751f\u4ea7\u9700\u6c42\u7684\u9ad8\u671f\u671b\uff0c\u540c\u65f6\u7075\u6d3b\u9002\u5e94\u5ba2\u6237\u5bf9\u4e34\u5e8a\u9636\u6bb5cGMP\u5408\u89c4\u6027\u7684\u9700\u6c42\u3002<\/p>\n<p><\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_1'  class='avia-section av-2s3qm-b219104a35d6730b9de161db0dcbcff2 main_color avia-section-default avia-no-shadow  avia-builder-el-4  el_after_av_three_fifth  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3421'><div class='entry-content-wrapper clearfix'>\n<section  class='av_textblock_section av-24rdu-e327b1c8784f7269d240ede6f268326b'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h4 style=\"text-align: center;\">\u670d\u52a1\u9879\u76ee<br \/>\n<\/h4>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k7d2ewy1-54b62fc362249b620c16aea745c587c9\">\n#top .hr.hr-invisible.av-k7d2ewy1-54b62fc362249b620c16aea745c587c9{\nheight:20px;\n}\n<\/style>\n<div  class='hr av-k7d2ewy1-54b62fc362249b620c16aea745c587c9 hr-invisible  avia-builder-el-6  el_after_av_textblock  el_before_av_masonry_entries  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div id='av-masonry-1' class='av-masonry av-k6j0j5rr-fb9356f1b1c13bef6b492838ecf1017d noHover av-fixed-size av-large-gap av-hover-overlay-grayscale av-masonry-animation-active av-masonry-col-3 av-caption-always av-caption-style- av-masonry-entries '><div class=\"av-masonry-container isotope av-js-disabled\"><div class='av-masonry-entry isotope-item av-masonry-item-no-image '><\/div><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/cell-line-development\/\"  id='av-masonry-1-item-3405' data-av-masonry-item='3405' class='av-masonry-entry isotope-item post-3405 portfolio type-portfolio status-publish has-post-thumbnail hentry tag-59 portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-cell-line-dev\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-cell-line-dev-1-564x705.jpg);\"  title=\"CDMO-cell-line-dev\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u7ec6\u80de\u682a\u5f00\u53d1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/process-development\/\"  id='av-masonry-1-item-3412' data-av-masonry-item='3412' class='av-masonry-entry isotope-item post-3412 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-proc-dev\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-proc-dev-1-564x705.jpg);\"  title=\"CDMO-proc-dev\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u5de5\u827a\u5f00\u53d1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/protein-science-group\/\"  id='av-masonry-1-item-3408' data-av-masonry-item='3408' class='av-masonry-entry isotope-item post-3408 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-prot-science-grp\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-prot-science-grp-1-564x705.jpg);\"  title=\"CDMO-prot-science-grp\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u5206\u6790\u65b9\u6cd5\u5f00\u53d1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/technology-transfer\/\"  id='av-masonry-1-item-3414' data-av-masonry-item='3414' class='av-masonry-entry isotope-item post-3414 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-tech-transf\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-tech-transf-1-564x705.jpg);\"  title=\"CDMO-tech-transf\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u6280\u672f\u8f6c\u79fb<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/m-ds\/\"  id='av-masonry-1-item-46' data-av-masonry-item='46' class='av-masonry-entry isotope-item post-46 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"manu-DS\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/manu-DS-1-564x705.jpg);\"  title=\"manu-DS\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u539f\u6db2\u751f\u4ea7<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/m-dp\/\"  id='av-masonry-1-item-3386' data-av-masonry-item='3386' class='av-masonry-entry isotope-item post-3386 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services portfolio_entries-manufacturing  av-masonry-item-with-image av-grid-img' title=\"manu-DP\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/manu-DP-1-564x705.jpg);\"  title=\"manu-DP\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u5236\u5242\u751f\u4ea7<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/quality-system\/\"  id='av-masonry-1-item-3421' data-av-masonry-item='3421' class='av-masonry-entry isotope-item post-3421 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-qs\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2011\/12\/CDMO-qs-564x705.jpg);\"  title=\"CDMO-qs\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u8d28\u91cf\u4f53\u7cfb<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/regulatory-cmc-support\/\"  id='av-masonry-1-item-3423' data-av-masonry-item='3423' class='av-masonry-entry isotope-item post-3423 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-reg-CMC-sup\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-reg-CMC-sup-564x705.jpg);\"  title=\"CDMO-reg-CMC-sup\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u6ce8\u518c\u670d\u52a1<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/project-management\/\"  id='av-masonry-1-item-3425' data-av-masonry-item='3425' class='av-masonry-entry isotope-item post-3425 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"CDMO-proj-mgmt\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/02\/CDMO-proj-mgmt-564x705.jpg);\"  title=\"CDMO-proj-mgmt\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u9879\u76ee\u7ba1\u7406<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/data-integrity\/\"  id='av-masonry-1-item-3597' data-av-masonry-item='3597' class='av-masonry-entry isotope-item post-3597 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"data\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/03\/data-564x705.jpg);\"  title=\"data\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u6570\u636e\u5b8c\u6574\u6027<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/zh\/cdmo-item\/client-confidential-information-protection-policy\/\"  id='av-masonry-1-item-3603' data-av-masonry-item='3603' class='av-masonry-entry isotope-item post-3603 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio_entries-cdmo-services  av-masonry-item-with-image av-grid-img' title=\"IP\"   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='av-inner-masonry-sizer'><\/div><figure class='av-inner-masonry main_color'><div class=\"av-masonry-outerimage-container\"><div class='av-masonry-image-container' style=\"background-image: url(https:\/\/chimebiologics.com\/wp-content\/uploads\/2020\/03\/IP-564x705.jpg);\"  title=\"IP\"  ><\/div><\/div><figcaption class='av-inner-masonry-content site-background'><div class='av-inner-masonry-content-pos'><div class='av-inner-masonry-content-pos-content'><div class='avia-arrow'><\/div><h3 class='av-masonry-entry-title entry-title '  itemprop=\"headline\" >\u77e5\u8bc6\u4ea7\u6743\u4fdd\u62a4<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry 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