{"id":1690,"date":"2026-10-06T12:40:49","date_gmt":"2026-10-06T12:40:49","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/q13\/"},"modified":"2026-10-06T12:40:49","modified_gmt":"2026-10-06T12:40:49","slug":"q13","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/q13\/","title":{"rendered":"Q13 \u2013 Continuous Manufacturing of Drug Substances and Drug Products"},"content":{"rendered":"<p>The ICH Q13 Guideline reached <em>Step 4<\/em> of the ICH process on 16 November 2022.<\/p>\n<p>The guideline:<\/p>\n<ul>\n<li>Builds on existing ICH Quality Guidelines, provides clarification on continuous manufacturing (CM) concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products;<\/li>\n<li>Focuses on the integrated aspects of a CM system in which two or more unit operations are directly connected;<\/li>\n<li>Describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Q13 Guideline reached Step 4 of the ICH process on 16 November 2022. The guideline builds on existing ICH Quality Guidelines, provides clarification on continuous manufacturing (CM) concepts, describes\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1690","guideline","type-guideline","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1690","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\/1690\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1690"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1690"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1690"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}