[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-168173-en":3,"doc-seo-168173-105":29,"detail-sidebar-cat-1-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":4,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":12},168173,962085571259,"Putri","https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0",1,21,"Paper Templates","ICH M4Q(R2) - Draft version - Quality of the Common Technical Document (Module 3)","ICH M4Q(R2) is a consensus guideline for the Common Technical Document (CTD) used in the registration of human pharmaceuticals, focusing on the quality module. It describes how regulatory submissions should structure Quality-related summaries, including overall development and control strategies, core quality information for drug substances and drug products, and supporting sections such as analytical procedures and facilities. It also addresses development justifications, product lifecycle management, optional quality benefit–risk content, and preparation for public consultation at Step 2.","INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE\nICH HARMONISED GUIDELINE\nTHE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY\nM4Q(R2)\nDraft version\nEndorsed on 14 May 2025\nCurrently under public consultation\nAt Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.\nM4Q(R2)\u000bDocument History\nLegal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times.  In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document.  Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided.\nThe document is provided \"as is\" without warranty of any kind.  In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document.\nThe above-mentioned permissions do not apply to content supplied by third parties.  Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.\nICH Harmonised Guideline\nTHE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY\nM4Q(R2)\nICH Consensus Guideline\n\u0003Table of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc197906009\" \u0014SCOPE AND ORGANIsATION\t\u0013 PAGEREF _Toc197906009 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906010\" \u0014Module 2. COMMON TECHNICAL DOCUMENT SUMMARIES\t\u0013 PAGEREF _Toc197906010 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906011\" \u00142.3. Quality Overview\t\u0013 PAGEREF _Toc197906011 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906012\" \u00142.3.1 General Information\t\u0013 PAGEREF _Toc197906012 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906013\" \u00142.3.2 Overall Development and Overall Control Strategy\t\u0013 PAGEREF _Toc197906013 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906014\" \u00142.3.2.1 Quality Target Product Profile\t\u0013 PAGEREF _Toc197906014 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906015\" \u00142.3.2.2 Overall Development Strategy\t\u0013 PAGEREF _Toc197906015 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906016\" \u00142.3.2.3 Overall Control Strategy Representation\t\u0013 PAGEREF _Toc197906016 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906017\" \u00142.3.3 Core Quality Information\t\u0013 PAGEREF _Toc197906017 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906018\" \u00142.3.3.DS Drug Substances\t\u0013 PAGEREF _Toc197906018 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906019\" \u00142.3.3.SI Substance Intermediates, if Applicable\t\u0013 PAGEREF _Toc197906019 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906020\" \u00142.3.3.SM Starting/Source Materials\t\u0013 PAGEREF _Toc197906020 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906021\" \u00142.3.3.RM Raw Materials\t\u0013 PAGEREF _Toc197906021 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906022\" \u00142.3.3.EX Excipients\t\u0013 PAGEREF _Toc197906022 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906023\" \u00142.3.3.RS Reference Standards and/or Materials\t\u0013 PAGEREF _Toc197906023 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906024\" \u00142.3.3.DP Drug Products\t\u0013 PAGEREF _Toc197906024 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906025\" \u00142.3.3.PI Product Intermediates, if Applicable\t\u0013 PAGEREF _Toc197906025 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906026\" \u00142.3.3.MD Medical Devices, if Applicable\t\u0013 PAGEREF _Toc197906026 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906027\" \u00142.3.3.PM Packaged Medicinal Products for multiconstituent products, if Applicable\t\u0013 PAGEREF _Toc197906027 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc197906028\" \u00142.3.3.PH Pharmaceutical Product after transformation, if Applicable\t\u0013 PAGEREF _Toc197906028 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc1979060","cbCaiokIkKd5uLkI","https://ap.wps.com/l/cbCaiokIkKd5uLkI","docx",391959,59,"English","en",105,"# Scope and Organisation\n## Module 2. 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