{"id":21614,"date":"2018-09-25T12:10:24","date_gmt":"2018-09-25T04:10:24","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/clinical-nucleic-acid-drug-manufacture\/risk-management-system\/"},"modified":"2021-08-31T11:10:24","modified_gmt":"2021-08-31T03:10:24","slug":"risk-management-system","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/clinical-nucleic-acid-drug-manufacture\/risk-management-system\/","title":{"rendered":"Risk Management System"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”3.27.2″ background_color=”#F2F2F2″ custom_padding=”0px||0px|” z_index_tablet=”500″ box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” global_module=”22006″][et_pb_row column_structure=”1_3,1_3,1_3″ module_class=”icon_list” _builder_version=”3.25″ custom_padding=”||0px|”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb url=”\/en\/development\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon1_0919.png” module_class=”icon-quick icon-events” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/development\/” custom_css_after=”background:#f00|| “]<\/p>\n

Oligonucleotide Manufacturing Process Development<\/h6>\n
[\/et_pb_blurb][et_pb_blurb url=”\/en\/analytics-and-chemistry-research\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/\u4e34\u5e8a\u7814\u7a76\u7528\u6838\u9178\u836f\u7269\u751f\u4ea7.png” module_class=”icon-quick icon-tools” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/analytics-and-chemistry-research\/” custom_css_after=”background:#f00|| “]<\/p>\n

Analytical Methods
& Stability Study<\/h6>\n
[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb url=”\/en\/clinical-nucleic-acid-drug-manufacture\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon3_0919.png” module_class=”icon-quick icon-resource” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/clinical-nucleic-acid-drug-manufacture\/” custom_css_after=”background:#f00|| “]<\/p>\n

Oligonucleotide
Manufacturing for Clinical Phases<\/h6>\n
[\/et_pb_blurb][et_pb_blurb url=”\/en\/commercial-oligonucleotides-api-manufacture\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon9_0919.png” module_class=”icon-quick icon-buy” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/commercial-oligonucleotides-api-manufacture\/” custom_css_after=”background:#f00|| “]<\/p>\n

Oligonucleotide
Manufacturing for Commercial Phases<\/h6>\n
[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb url=”\/en\/drug-product-fill-and-finish\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon2_0919.png” module_class=”icon-quick icon-orders” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/drug-product-fill-and-finish\/” custom_css_after=”background:#f00|| “]<\/p>\n

Preparation, aseptic filling or
lyophilization<\/h6>\n
[\/et_pb_blurb][et_pb_blurb url=”\/en\/quality-management-system\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon8_0919.png” module_class=”icon-quick icon-user-center” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”0 |||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/quality-management-system\/” custom_css_after=”background:#f00|| “]<\/p>\n

Validation & Quality<\/h6>\n
[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”54px|0px|11px|0px”][et_pb_row _builder_version=”3.25″ custom_margin=”-30px|||” custom_padding=”0||2px|0px” border_color_bottom=”#00AECC” border_style_bottom=”none”][et_pb_column type=”4_4″ _builder_version=”3.0.47″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.4″ text_text_color=”#242424″ text_font_size=”22px” custom_margin=”||10px|” custom_margin_phone=”|||” custom_margin_last_edited=”off|desktop” custom_padding=”|||” hover_enabled=”0″ sticky_enabled=”0″]<\/p>\n

Risk Management System<\/h1>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ custom_padding=”0px|0px|8px|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.0.47″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.4″ custom_margin=”||10px|” hover_enabled=”0″ sticky_enabled=”0″]<\/p>\n
Based on the cGMP requirements of Chinese CMP (2010), ICH Q7, 21 CFR Part 210 & 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.<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.9.4″ text_font=”||||||||” custom_margin=”||5px|” hover_enabled=”0″ sticky_enabled=”0″]<\/p>\n
Our quality management system includes but not limited to:<\/strong><\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.9.4″ custom_margin=”||15px|” hover_enabled=”0″ sticky_enabled=”0″]<\/p>\n
\u25cf \u00a0Personnel and Training Management
\n\u25cf \u00a0Material Supplier and Release Management
\n\u25cf \u00a0Process Control
\n\u25cf \u00a0Validation of Facility and Equipment Confirmation
\n\u25cf \u00a0Lab Quality Control
\n\u25cf \u00a0Product Release Management System
\n\u25cf \u00a0Deviation, Modification, CAPA, Internal Audit, etc<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.9.4″ custom_margin=”||10px|” hover_enabled=”0″ sticky_enabled=”0″]<\/p>\n
In 2016, RiboBio obtained China\u2019s first CFDA-approved cGMP oligonucleotide API product license, and has passed over 30 times of GMP audit from global customers.<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#F4f4f4″ background_image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/07\/bg_pic3.jpg” custom_padding=”10px|0px|10px|0px|false|false” border_width_bottom=”2px” border_color_bottom=”#cccccc” global_module=”21939″][et_pb_row _builder_version=”3.26.8″][et_pb_column type=”4_4″ _builder_version=”3.26.8″][et_pb_button button_url=”\/en\/cro-cdmo-service-for-nucleic-acid-drugs\/” button_text=”Quote for CDMO service” button_alignment=”center” _builder_version=”3.26.8″][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
[et_pb_section fb_built=”1″ _builder_version=”3.27.2″ background_color=”#F2F2F2″ custom_padding=”0px||0px|” z_index_tablet=”500″ box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” global_module=”22006″][et_pb_row column_structure=”1_3,1_3,1_3″ module_class=”icon_list” _builder_version=”3.25″ custom_padding=”||0px|”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb url=”\/en\/development\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon1_0919.png” module_class=”icon-quick icon-events” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/development\/” custom_css_after=”background:#f00|| “] Oligonucleotide Manufacturing Process Development [\/et_pb_blurb][et_pb_blurb url=”\/en\/analytics-and-chemistry-research\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/\u4e34\u5e8a\u7814\u7a76\u7528\u6838\u9178\u836f\u7269\u751f\u4ea7.png” module_class=”icon-quick icon-tools” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” link_option_url=”\/en\/analytics-and-chemistry-research\/” custom_css_after=”background:#f00|| “] Analytical Methods & […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":21598,"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\/21614"}],"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=21614"}],"version-history":[{"count":7,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21614\/revisions"}],"predecessor-version":[{"id":22317,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21614\/revisions\/22317"}],"up":[{"embeddable":true,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21598"}],"wp:attachment":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/media?parent=21614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}