﻿{"id":21622,"date":"2018-08-21T19:57:33","date_gmt":"2018-08-21T11:57:33","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/commercial-oligonucleotides-api-manufacture\/cgmp-quality-management-system\/"},"modified":"2021-08-31T10:55:00","modified_gmt":"2021-08-31T02:55:00","slug":"cgmp-quality-management-system","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/commercial-oligonucleotides-api-manufacture\/cgmp-quality-management-system\/","title":{"rendered":"cGMP Quality Management System"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.27.2&#8243; background_color=&#8221;#F2F2F2&#8243; custom_padding=&#8221;0px||0px|&#8221; z_index_tablet=&#8221;500&#8243; box_shadow_horizontal_tablet=&#8221;0px&#8221; box_shadow_vertical_tablet=&#8221;0px&#8221; box_shadow_blur_tablet=&#8221;40px&#8221; box_shadow_spread_tablet=&#8221;0px&#8221; global_module=&#8221;22006&#8243;][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; module_class=&#8221;icon_list&#8221; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;||0px|&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb url=&#8221;\/en\/development\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon1_0919.png&#8221; module_class=&#8221;icon-quick icon-events&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/development\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;]<\/p>\n<h6>Oligonucleotide Manufacturing Process Development<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb url=&#8221;\/en\/analytics-and-chemistry-research\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/\u4e34\u5e8a\u7814\u7a76\u7528\u6838\u9178\u836f\u7269\u751f\u4ea7.png&#8221; module_class=&#8221;icon-quick icon-tools&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/analytics-and-chemistry-research\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;]<\/p>\n<h6>Analytical Methods<br \/> &amp; Stability Study<\/h6>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb url=&#8221;\/en\/clinical-nucleic-acid-drug-manufacture\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon3_0919.png&#8221; module_class=&#8221;icon-quick icon-resource&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/clinical-nucleic-acid-drug-manufacture\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;]<\/p>\n<h6>Oligonucleotide<br \/> Manufacturing for Clinical Phases<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb url=&#8221;\/en\/commercial-oligonucleotides-api-manufacture\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon9_0919.png&#8221; module_class=&#8221;icon-quick icon-buy&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/commercial-oligonucleotides-api-manufacture\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;]<\/p>\n<h6>Oligonucleotide<br \/> Manufacturing for Commercial Phases<\/h6>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb url=&#8221;\/en\/drug-product-fill-and-finish\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon2_0919.png&#8221; module_class=&#8221;icon-quick icon-orders&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/drug-product-fill-and-finish\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;]<\/p>\n<h6>Preparation, aseptic filling or<br \/> lyophilization<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb url=&#8221;\/en\/quality-management-system\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon8_0919.png&#8221; module_class=&#8221;icon-quick icon-user-center&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;0 |||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/quality-management-system\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;]<\/p>\n<h6>Validation &amp; Quality<\/h6>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; custom_padding=&#8221;54px|0px|11px|0px&#8221;][et_pb_row _builder_version=&#8221;3.25&#8243; custom_margin=&#8221;-30px|||&#8221; custom_padding=&#8221;0||2px|0px&#8221; border_color_bottom=&#8221;#00AECC&#8221; border_style_bottom=&#8221;none&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.0.47&#8243; custom_padding=&#8221;|||&#8221; hover_enabled=&#8221;0&#8243; custom_padding__hover=&#8221;|||&#8221; sticky_enabled=&#8221;0&#8243;][et_pb_text _builder_version=&#8221;4.9.4&#8243; text_text_color=&#8221;#242424&#8243; text_font_size=&#8221;22px&#8221; custom_margin=&#8221;||10px|&#8221; custom_margin_phone=&#8221;|||&#8221; custom_margin_last_edited=&#8221;off|desktop&#8221; custom_padding=&#8221;|||&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h1 style=\"font-size: 22px; padding: 0; color: #1e73be;\">cGMP Quality Management System<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;0px|0px|8px|0px|false|false&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.0.47&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.9.4&#8243; custom_margin=&#8221;||10px|&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"text-align: left;\">Based on the cGMP requirements of Chinese CMP (2010), ICH Q7, 21 CFR Part 210 &#038; 211 and Part 11, EudraLex \u2013 Volume 4, etc, RiboBio has utilized risk management tool while combining with nucleic acid drug production process for clinical research to establish the complete cGMP quality management system. It also ensures that all production meet the cGMP and registration requirements to fulfill the quality requirements for treatment or diagnostic oligonucleotide-based API manufacturing.<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.9.4&#8243; custom_margin=&#8221;||15px|&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"text-align: left;\">In 2016, RiboBio obtained China\u2019s first CFDA-approved cGMP oligonucleotide API production license, and has passed over 30 times of GMP audit from global customers.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; column_structure=&#8221;1_3,1_3,1_3&#8243;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/08\/hsy-page-pic2.jpg&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; 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custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/development\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;] Oligonucleotide Manufacturing Process Development [\/et_pb_blurb][et_pb_blurb url=&#8221;\/en\/analytics-and-chemistry-research\/&#8221; image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/\u4e34\u5e8a\u7814\u7a76\u7528\u6838\u9178\u836f\u7269\u751f\u4ea7.png&#8221; module_class=&#8221;icon-quick icon-tools&#8221; _builder_version=&#8221;3.27.2&#8243; header_text_align=&#8221;center&#8221; background_size=&#8221;initial&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; animation=&#8221;off&#8221; link_option_url=&#8221;\/en\/analytics-and-chemistry-research\/&#8221; custom_css_after=&#8221;background:#f00|| &#8220;] Analytical Methods &amp; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":21618,"menu_order":93,"comment_status":"closed","ping_status":"closed","template":"page-hsy.php","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":""},"_links":{"self":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21622"}],"collection":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/comments?post=21622"}],"version-history":[{"count":7,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21622\/revisions"}],"predecessor-version":[{"id":22315,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21622\/revisions\/22315"}],"up":[{"embeddable":true,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21618"}],"wp:attachment":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/media?parent=21622"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}