{"id":1685,"date":"2026-10-06T12:35:45","date_gmt":"2026-10-06T12:35:45","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/q8-q9-q10\/"},"modified":"2026-10-06T12:35:45","modified_gmt":"2026-10-06T12:35:45","slug":"q8-q9-q10","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/q8-q9-q10\/","title":{"rendered":"Q8\/Q9\/Q10 \u2013 Implementation"},"content":{"rendered":"<p>ICH Q9(R1) together with ICH Q8(R2) and ICH Q10 form a trio of ICH Quality Guidelines that encourage the further development of science- and risk-based approaches to quality.<\/p>\n<p>The Questions and Answers document developed by the Quality Implementation Working Group (IWG) is intended to facilitate the implementation of the Q8(R2), Q9(R1) and Q10 Guidelines by clarifying key issues, in response to implementation challenges and inconsistencies experienced by implementing parties.<\/p>\n<p>This document has been updated several times, with the most recent version (Q8, Q9 and Q10 Q&amp;As (R5)) approved by the ICH Assembly in October 2024.<\/p>\n<p>The ICH Quality IWG also prepared a Points to Consider document covering topics relevant to the implementation of these three Quality Guidelines to supplement the Questions &amp; Answers document.<\/p>\n<p>Lastly, the IWG has produced a set of Training Materials and an updated ICH Q9(R1) Briefing Pack to support implementation training.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ICH Q9(R1) together with ICH Q8(R2) and ICH Q10 form a trio of ICH Quality Guidelines that encourage the further development of science- and risk-based approaches to quality. The Questions and Answers document developed\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1685","guideline","type-guideline","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1685","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1685\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1685"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1685"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1685"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}