{"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\/ja\/cdmo-item\/quality-system\/","title":{"rendered":"\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0"},"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>\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0<\/h1>\n<blockquote>\n<p>\u9867\u5ba2\u3078\u6301\u7d9a\u7684\u3067\u5b89\u5b9a\u3057\u305f\u88fd\u54c1\u54c1\u8cea\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306b\u3001\u5305\u62ec\u7684\u306a\u54c1\u8cea\u7ba1\u7406\u3092\u884c\u3044\u307e\u3059\u3002\u5305\u62ec\u7684\u306a\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3068\u5e83\u7bc4\u306a\u8a8d\u8a3c\u306f\u3001\u6211\u3005\u306e\u54c1\u8cea\u3001\u8aa0\u5b9f\u3055\u3001\u80fd\u529b\u3078\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3067\u3059\u3002<\/p>\n<\/blockquote>\n<p>Chime\u00a0Biologics\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u3001\u4ee5\u4e0b\u306eCMC\uff08\u5316\u5b66\u3001\u751f\u7523\u3001\u7ba1\u7406\uff09\u6d3b\u52d5\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u3001\u898f\u5236\u3001\u305d\u306e\u4ed6\u306e\u898f\u5247\u306b\u5f93\u3063\u3066\u3044\u307e\u3059\uff1a<\/p>\n<ul>\n<li>\u7c73\u56fd\u306e21 CFR Part 210\u3001211\u3001600\u3001cGMP\u6e96\u62e0\u3002<\/li>\n<li>\u7c73\u56fd\u306e21 CFR Part 11\u3001\u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u4ef6<\/li>\n<li>EudraLex (\u6b27\u5dde\u9023\u5408\u9069\u6b63\u88fd\u9020\u898f\u7bc4)\u6e96\u62e0<\/li>\n<li>\u6e56\u5317\u7701\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u304c\u767a\u884c\u3059\u308b\u533b\u85ac\u54c1\u88fd\u9020\u8a31\u53ef\u8a3c<\/li>\n<li>\u9069\u7528ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0<\/li>\n<\/ul>\n<p>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u79d1\u5b66\u3001\u30ea\u30b9\u30af\u3092\u7d99\u7d9a\u7684\u306b\u6539\u5584\u3059\u308b\u4f01\u696d\u6587\u5316\u3067\u30d7\u30ed\u30bb\u30b9\u3092\u78ba\u7acb\u3057\u3001\u7dad\u6301\u3057\u307e\u3059\u3002\u5f53\u793e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u5546\u696d\u751f\u7523\u306e\u30cb\u30fc\u30ba\u306b\u5bfe\u3059\u308b\u9ad8\u3044\u9867\u5ba2\u306e\u671f\u5f85\u306b\u5fdc\u3048\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u81e8\u5e8a\u6bb5\u968e\u306b\u304a\u3051\u308bcGMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u5bfe\u3059\u308b\u304a\u5ba2\u69d8\u306e\u8981\u671b\u306b\u3082\u67d4\u8edf\u306b\u5bfe\u5fdc\u3057\u307e\u3059\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;\">\u30b5\u30fc\u30d3\u30b9<\/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\/ja\/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\" >\u7d30\u80de\u682a\u958b\u767a<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\" >\u30d7\u30ed\u30bb\u30b9\u958b\u767a<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\u306e\u958b\u767a<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\u8853\u79fb\u8ee2<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\u88fd\u9020<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\" >\u88fd\u5264\u88fd\u9020<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\" >\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\" >\u7533\u8acb\u30b5\u30fc\u30d3\u30b9<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\" >\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e1\u30f3\u30c8<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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\" >\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\uff08\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30fc\uff09<\/h3><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/chimebiologics.com\/ja\/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 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