{"id":1688,"date":"2026-10-06T12:40:49","date_gmt":"2026-10-06T12:40:49","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/q11\/"},"modified":"2026-10-06T12:40:49","modified_gmt":"2026-10-06T12:40:49","slug":"q11","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/q11\/","title":{"rendered":"Q11 \u2013 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological\/Biological Entities)"},"content":{"rendered":"<p>The Guideline reached <em>Step 4<\/em> of the ICH process on 1 May 2012.<\/p>\n<p>This Guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S.2.2 \u2013 3.2.S.2.6 (ICH M4Q). It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities.<\/p>\n<p>This Guideline is applicable to drug substances as defined in the Scope sections of ICH Guidelines Q6A and Q6B but might also be appropriate for other types of products following consultation with the appropriate regulatory authorities.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Guideline reached Step 4 of the ICH process on 1 May 2012. This Guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1688","guideline","type-guideline","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1688","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\/1688\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1688"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1688"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1688"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1688"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}