{"id":1858,"date":"2026-10-06T13:36:47","date_gmt":"2026-10-06T13:36:47","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/reflection-papers\/advancing-biopharmaceutical-quality-standards\/"},"modified":"2026-10-06T13:36:47","modified_gmt":"2026-10-06T13:36:47","slug":"advancing-biopharmaceutical-quality-standards","status":"publish","type":"reflection_paper","link":"https:\/\/dev.ich.org\/index.php\/reflection-papers\/advancing-biopharmaceutical-quality-standards\/","title":{"rendered":"Advancing Biopharmaceutical Quality Standards"},"content":{"rendered":"<p>This Reflection Paper was endorsed by the Assembly in June 2018.<\/p>\n<p>This ICH Reflection Paper outlines a strategic approach to enhance the portfolio of ICH Quality-related guidelines to support continual improvement and innovation in biopharmaceutical manufacturing technologies and approaches. Accordingly, ICH will continue to advance the ICH Quality Vision to \u201cdevelop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasising an integrated approach to quality risk management and science\u201d.<\/p>\n<p>This ICH Reflection Paper furthermore describes, in the annex, the remit of the Quality Discussion Group (QDG), which serves as a technical discussion forum for issues relevant to the ICH Quality Vision.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This ICH Reflection Paper outlines a strategic approach to enhance the portfolio of ICH Quality-related guidelines to support continual improvement and innovation in biopharmaceutical manufacturing technologies and approaches.<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1858","reflection_paper","type-reflection_paper","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/reflection_paper\/1858","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/reflection_paper"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/reflection_paper"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/reflection_paper\/1858\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1858"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1858"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1858"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1858"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}