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It provides guidance for stress testing, selection of batches, container closure systems, specifications, testing frequency, storage conditions, stability commitment, and evaluation. A revision cover note summarizes changes driven by adoption of ICH Q1F, including updated intermediate storage humidity conditions and alternative long-term storage options, along with documentation expectations for the switch and study data timing.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/ich-harmonised-tripartite-guideline-q1ar2-stability-testing-of-new-drug-substances-and-products/390328/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/ich-harmonised-tripartite-guideline-q1ar2-stability-testing-of-new-drug-substances-and-products/390328.png","ImageObject",300,407,{"name":92,"@type":93},"pixelkiddo","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-04","2026-09-25",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the purpose of the Q1A(R2) guideline?","Question",{"text":112,"@type":113},"It outlines the approach and requirements for stability testing of new drug substances and products, including objectives, scope, and the general principles used for regulatory evaluation.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What changes were introduced in Q1A(R) due to adoption of ICH Q1F?",{"text":117,"@type":113},"The cover note specifies updated intermediate storage conditions (notably changing humidity ranges) and adds alternative suitable storage conditions for certain sections, including semi-permeable container scenarios.",{"name":119,"@type":110,"acceptedAnswer":120},"What documentation is recommended when switching intermediate storage conditions?",{"text":121,"@type":113},"The guideline recommends that the date of the switch and the respective storage conditions be clearly documented and stated in the registration application, and that complete intermediate storage data be provided by a defined timeline after publication.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},390328,1791240600,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":26,"preview_page_count":4},962090883892,"https://ap-avatar.wpscdn.com/avatar/e00115db34f3e0f11b?x-image-process=image/resize,m_fixed,w_180,h_180&k=1790152879550218658","INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE  \nICH HARMONISED TRIPARTITE GUIDELINE  \nSTABILITY TESTING OF  \nNEW DRUG SUBSTANCES AND PRODUCTS  \nQ1A(R2)  \nCurrent Step 4 version  \ndated 6 February 2003  \nThis Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.  \nQ1A(R2) Document History  \n\n| First\u003Cbr>Codification | History | Date | New\u003Cbr>Codification\u003Cbr>November\u003Cbr>2005 |\n| --- | --- | --- | --- |\n| Q1 | Approval by the Steering Committee under Step 2 and release for public consultation. | 16\u003Cbr>September\u003Cbr>1992 | Q1 |\n| Q1A | Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.\u003Cbr>Q1 was renamed Q1A. | 27 October\u003Cbr>1993 | Q1A |\n| Q1A(R) | Approval by the Steering Committee of the first revision under Step 2 and release for public consultation. | 7 October\u003Cbr>1999 | Q1A(R1) |\n| Q1A(R) | Approval by the Steering Committee of the first revision under Step 4 and recommendation for adoption to the three ICH regulatory bodies. | 8\u003Cbr>November\u003Cbr>2000 | Q1A(R1) |\n\nCurrent Step 4 version  \n\n| Q1A(R2) | Approval by the Steering Committee of the second revision directly under Step 4 without further public consultation, to include consequences of the adoption of Q1F (Stability Data Package for Registration Applications in Climatic Zones III and IV), and recommendation for adoption to the three ICH regulatory bodies. | 6 February\u003Cbr>2003 | Q1A(R2) |\n| --- | --- | --- | --- |\n\nCOVER NOTE FOR REVISION OF Q1A(R) STABILITY TESTING OF  \nNEW DRUG SUBSTANCES AND PRODUCTS  \nThe purpose of this note is to outline the changes made in Q1A(R) that result from adoption of ICH Q1F “Stability Data Package for Registration Applications in Climatic Zones III and IV”. These changes are:  \n1. The intermediate storage condition has been changed from 30°C ± 2°C/60% RH ± 5% RH to 30°C ± 2°C/65% RH ± 5% RH in the following sections:  \n􀁸 [2.1.7.1](2.1.7.1) Drug Substance - Storage Conditions -General Case  \n􀁸 [2.2.7.1](2.2.7.1) Drug Product - Storage Conditions -General Case  \n􀁸 [2.2.7.3](2.2.7.3) Drug products packaged in semi-permeable containers  \n􀁸 3 Glossary - “Intermediate testing”  \n2. 30°C ± 2°C/65% RH ± 5% RH can be a suitable alternative long-term storage condition to 25°C ± 2°C/60% RH ± 5% in the following sections:  \n􀁸 [2.1.7.1](2.1.7.1) Drug Substance - Storage Conditions -General Case  \n􀁸 [2.2.7.1](2.2.7.1) Drug Product - Storage Conditions -General Case  \n3. 30°C ± 2°C/35% RH ± 5% RH has been added as a suitable alternative longterm storage condition to 25°C ± 2°C/40% RH ± 5% and the corresponding example for the ratio of water-loss rates has been included in the following section:  \n􀁸 [2.2.7.3](2.2.7.3) Drug products packaged in semi-permeable containers  \nMid-stream switch of the intermediate storage condition from 30°C ± 2°C/60% RH ± 5% RH to 30°C ± 2°C/65% RH ± 5% RH can be appropriate provided that the respective storage conditions and the date of the switch are clearly documented and stated in the registration application.  \nIt is recommended that registration applications contain data from complete studies at the intermediate storage condition 30°C ± 2°C/65% RH ± 5% RH, if applicable, by three years after the date of publication of this revised guideline in the respective ICH tripartite region.  \nSTABILITY TESTING OF  \nNEW DRUG SUBSTANCES AND PRODUCTS  \nICH Harmonised Tripartite Guideline  \nFirst Recommended for Adoption at Step 4 of the ICH Process on 27 October 1993.  \nRevised under Step 2 of the ICH Process on 7 October 1999 and Recommended for Adoption at Step 4 of the ICH Process on 8 November 2000.  \nThis guideline has been Revised a second time and h","cbCaivEHaf5dvueS","https://ap.wps.com/l/cbCaivEHaf5dvueS","pdf",264104,24,"English","# Introduction\n## Objectives of the Guideline\n## Scope of the Guideline\n## General Principles\n# Guidelines\n## Drug Substance\n### General\n### Stress Testing\n### Selection of Batches\n### Container Closure System\n### Specification\n### Testing Frequency\n### Storage Conditions\n### Stability Commitment\n### Evaluation","[{\"question\":\"What is the purpose of the Q1A(R2) guideline?\",\"answer\":\"It outlines the approach and requirements for stability testing of new drug substances and products, including objectives, scope, and the general principles used for regulatory evaluation.\"},{\"question\":\"What changes were introduced in Q1A(R) due to adoption of ICH Q1F?\",\"answer\":\"The cover note specifies updated intermediate storage conditions (notably changing humidity ranges) and adds alternative suitable storage conditions for certain sections, including semi-permeable container scenarios.\"},{\"question\":\"What documentation is recommended when switching intermediate storage conditions?\",\"answer\":\"The guideline recommends that the date of the switch and the respective storage conditions be clearly documented and stated in the registration application, and that complete intermediate storage data be provided by a defined timeline after publication.\"}]","ICH Harmonised Tripartite Guideline - Q1A(R2) - Stability Testing of New Drug Substances and Products | PDF",1790332776]