{"id":1762,"date":"2026-10-06T13:11:34","date_gmt":"2026-10-06T13:11:34","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/q13-training\/"},"modified":"2026-10-06T13:11:34","modified_gmt":"2026-10-06T13:11:34","slug":"q13-training","status":"publish","type":"draft_guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/q13-training\/","title":{"rendered":"Q13 \u2013 Training on Continuous Manufacturing of Drug Substances and Drug Products"},"content":{"rendered":"<p>The Q13 Training Modules 1-12 aim to facilitate an aligned interpretation and a harmonised implementation of the ICH Q13 <em>Continuous Manufacturing of Drug Substances and Drug Products<\/em> Guideline in ICH and non-ICH regions by:<\/p>\n<ul>\n<li>Illustrating the general concept of Continuous Manufacturing (CM) process operation;<\/li>\n<li>Providing detailed clarification of novel scientific concepts and regulatory expectations pertinent to CM;<\/li>\n<li>Expanding discussion of Annex I-V in Q13 to address some specific CM implementation aspects relevant for different modalities.<\/li>\n<\/ul>\n<p>Further information can be found in the Q13 IWG Concept Paper and Video Training Modules 1-12:<\/p>\n<ul>\n<li>Module 1: Introduction and Training Overview<\/li>\n<li>Module 2: Batch Definition and Batch Size<\/li>\n<li>Module 3: State of Control and Steady State<\/li>\n<li>Module 4: Principles of Process Dynamics and Residence Time Distribution<\/li>\n<li>Module 5: Case-studies on Process Dynamics, Material Traceability, and Sampling Frequency<\/li>\n<li>Module 6: Case-studies on RTD Model Development and Setting Alarm Limits<\/li>\n<li>Module 7: General Pharmaceutical Quality System (PQS) Considerations for Continuous Manufacturing (CM)<\/li>\n<li>Module 8: Demonstration of Material Diversion<\/li>\n<li>Module 9: Process Monitoring and Control<\/li>\n<li>Module 10: Process Models<\/li>\n<li>Module 11: Drug Substance and Drug Product Stability<\/li>\n<li>Module 12: Batch to CM Conversion for Small Molecule Oral Solid<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The Q13 Training Modules 1-12 aim to facilitate an aligned interpretation and a harmonised implementation of the ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Guideline in ICH and non-ICH regions\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1762","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\/1762","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\/1762\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1762"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1762"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1762"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1762"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}