{"id":21578,"date":"2018-08-21T19:07:58","date_gmt":"2018-08-21T11:07:58","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/development\/production-process-validation\/"},"modified":"2019-08-23T18:54:39","modified_gmt":"2019-08-23T10:54:39","slug":"production-process-validation","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/development\/production-process-validation\/","title":{"rendered":"Production Process Development and Verification"},"content":{"rendered":"<p>[et_pb_section bb_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; _i=&#8221;0&#8243; _address=&#8221;0&#8243; next_background_color=&#8221;#ffffff&#8221; global_module=&#8221;22006&#8243;][et_pb_row global_parent=&#8221;22006&#8243; 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; _i=&#8221;0&#8243; _address=&#8221;0.0&#8243;][et_pb_column type=&#8221;1_3&#8243; global_parent=&#8221;22006&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.0&#8243;][et_pb_blurb global_parent=&#8221;22006&#8243; 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; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.0.0&#8243; link_option_url=&#8221;\/en\/development\/&#8221;]<\/p>\n<h6>Oligonucleotide Manufacturing Process Development<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb global_parent=&#8221;22006&#8243; 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; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.0.1&#8243; link_option_url=&#8221;\/en\/analytics-and-chemistry-research\/&#8221;]<\/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; global_parent=&#8221;22006&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.1&#8243;][et_pb_blurb global_parent=&#8221;22006&#8243; 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; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.1.0&#8243; link_option_url=&#8221;\/en\/clinical-nucleic-acid-drug-manufacture\/&#8221;]<\/p>\n<h6>Oligonucleotide<br \/> Manufacturing for Clinical Phases<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb global_parent=&#8221;22006&#8243; 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; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.1.1&#8243; link_option_url=&#8221;\/en\/commercial-oligonucleotides-api-manufacture\/&#8221;]<\/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; global_parent=&#8221;22006&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221; _i=&#8221;2&#8243; _address=&#8221;0.0.2&#8243;][et_pb_blurb global_parent=&#8221;22006&#8243; 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; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.2.0&#8243; link_option_url=&#8221;\/en\/drug-product-fill-and-finish\/&#8221;]<\/p>\n<h6>Preparation, aseptic filling or<br \/> lyophilization<\/h6>\n<p>[\/et_pb_blurb][et_pb_blurb global_parent=&#8221;22006&#8243; 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; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;1&#8243; _address=&#8221;0.0.2.1&#8243; link_option_url=&#8221;\/en\/quality-management-system\/&#8221;]<\/p>\n<h6>Validation &amp; Quality<\/h6>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; custom_padding=&#8221;54px|0px|11px|0px&#8221; prev_background_color=&#8221;#F2F2F2&#8243; next_background_color=&#8221;#F4f4f4&#8243;][et_pb_row _builder_version=&#8221;3.25&#8243; border_color_bottom=&#8221;#00AECC&#8221; border_style_bottom=&#8221;none&#8221; custom_margin=&#8221;-30px|||&#8221; custom_padding=&#8221;0||2px|0px&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;3.26.8&#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;]<\/p>\n<h1 style=\"font-size: 22px; padding: 0; color: #1e73be;\"><img loading=\"lazy\" class=\"wp-image-242 alignleft size-full\" src=\"http:\/\/ribobio-test.uin88.com\/wp-content\/uploads\/2018\/04\/shuidi.png\" alt=\"\" width=\"18\" height=\"22\" \/>Production Process Development and Verification<\/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;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;3.26.8&#8243; 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Upon the launch of a project, the project leader and team members will be determined. The team leader is responsible for gathering both the transferor and the receiver, formulating transfer plans, project scope, transfer content, acceptance criteria, deviation handling, responsible party, approver, group task distribution and working out the transfer and verification schedule. The team leader will convene regular meetings and coordinate during the whole project.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; background_color=&#8221;#F4f4f4&#8243; background_image=&#8221;https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/07\/bg_pic3.jpg&#8221; border_width_bottom=&#8221;2px&#8221; border_color_bottom=&#8221;#cccccc&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; prev_background_color=&#8221;#ffffff&#8221; global_module=&#8221;21939&#8243;][et_pb_row global_parent=&#8221;21939&#8243; _builder_version=&#8221;3.26.8&#8243;][et_pb_column type=&#8221;4_4&#8243; global_parent=&#8221;21939&#8243; _builder_version=&#8221;3.26.8&#8243;][et_pb_button global_parent=&#8221;21939&#8243; button_url=&#8221;\/en\/cro-cdmo-service-for-nucleic-acid-drugs\/&#8221; button_text=&#8221;Quote for CDMO service&#8221; button_alignment=&#8221;center&#8221; _builder_version=&#8221;3.26.8&#8243; \/][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[et_pb_section bb_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; _i=&#8221;0&#8243; _address=&#8221;0&#8243; next_background_color=&#8221;#ffffff&#8221; global_module=&#8221;22006&#8243;][et_pb_row global_parent=&#8221;22006&#8243; 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; _i=&#8221;0&#8243; _address=&#8221;0.0&#8243;][et_pb_column type=&#8221;1_3&#8243; global_parent=&#8221;22006&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.0&#8243;][et_pb_blurb global_parent=&#8221;22006&#8243; 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; hover_enabled=&#8221;0&#8243; custom_css_after=&#8221;background:#f00|| &#8221; _i=&#8221;0&#8243; _address=&#8221;0.0.0.0&#8243; link_option_url=&#8221;\/en\/development\/&#8221;] Oligonucleotide Manufacturing Process Development [\/et_pb_blurb][et_pb_blurb global_parent=&#8221;22006&#8243; 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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":21550,"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\/21578"}],"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=21578"}],"version-history":[{"count":7,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21578\/revisions"}],"predecessor-version":[{"id":22087,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21578\/revisions\/22087"}],"up":[{"embeddable":true,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21550"}],"wp:attachment":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/media?parent=21578"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}