{"id":1754,"date":"2026-10-06T13:11:32","date_gmt":"2026-10-06T13:11:32","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/q1\/"},"modified":"2026-10-06T13:11:32","modified_gmt":"2026-10-06T13:11:32","slug":"q1","status":"publish","type":"draft_guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/q1\/","title":{"rendered":"Q1 \u2013 Stability Testing of Drug Substances and Drug Products"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2021.<\/p>\n<p>Further to the ICH Management Committee\u2019s endorsement of the Q1\/Q5C Concept Paper and Business Plan in November 2022, the Q1\/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:<\/p>\n<ul>\n<li>Streamlining the series, combining the various guidelines into a single guideline focused on core stability principles;<\/li>\n<li>Promoting harmonised interpretation by addressing potential gaps and areas of ambiguity; addressing additional technical issues, including relevant stability strategies and innovative tools that strengthen the application of risk management;<\/li>\n<li>Considering inclusion of new topics, such as stability considerations for advanced therapies.<\/li>\n<\/ul>\n<p>The envisioned result is a combined guideline, ICH Q1, with integrated annexes and\/or appendices that address specific topics beyond the core stability recommendations and principles, addressing drug product types including substances, intermediates, and devices.<\/p>\n<p>Further information can be found in the Q1\/Q5C Concept Paper and Business Plan.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2021. Further to the ICH Management Committee\u2019s endorsement of the Q1\/Q5C Concept Paper and Business Plan in November 2022, the Q1\/Q5C EWG was established to revise\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1754","draft_guideline","type-draft_guideline","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline\/1754","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/draft_guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline\/1754\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1754"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1754"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1754"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1754"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}