{"id":21602,"date":"2018-08-21T19:49:14","date_gmt":"2018-08-21T11:49:14","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/clinical-nucleic-acid-drug-manufacture\/gmp-production-validation\/"},"modified":"2021-08-30T14:41:39","modified_gmt":"2021-08-30T06:41:39","slug":"gmp-production-validation","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/clinical-nucleic-acid-drug-manufacture\/gmp-production-validation\/","title":{"rendered":"GMP Production Validation"},"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

\"\"GMP Production Validation<\/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

RiboBio provides API manufacturing service for clinical research by following the cGMP requirements of Chinese GMP (2010), ICH Q7, 21 CFR Part 210 & 211 and Part 11, EudraLex \u2013 Volume 4, etc. Based on the production process, design the batch manufacturing records in Chinese and English to meet the submission requirements for global clients; in accordance with related regulations on data integrity, keep the complete digital data and paper records for production submission and verification to fulfill the quality requirements for treatment or diagnostic oligonucleotide-based API manufacturing.<\/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

Case Studies<\/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

One foreign client needs to apply for clinical research in China and overseas; one domestic client hopes to apply for clinical research in US only, which they both require Chinese and English version for all product records and files. RiboBio can provide the files and batch manufacturing records in Chinese and English to meet submission requirements.<\/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\/21602"}],"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=21602"}],"version-history":[{"count":7,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21602\/revisions"}],"predecessor-version":[{"id":22306,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21602\/revisions\/22306"}],"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=21602"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}