{"id":1689,"date":"2026-10-06T12:40:49","date_gmt":"2026-10-06T12:40:49","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/q12\/"},"modified":"2026-10-06T12:40:49","modified_gmt":"2026-10-06T12:40:49","slug":"q12","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/q12\/","title":{"rendered":"Q12 \u2013 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management"},"content":{"rendered":"<p>This topic was endorsed by the ICH Steering Committee in September 2014.<\/p>\n<p>This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle.<\/p>\n<p>Adoption of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms\u2019 Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.<\/p>\n<p>This new Guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and is composed of a core Guideline and Annexes.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Steering Committee in September 2014. This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC)\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1689","guideline","type-guideline","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1689","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\/1689\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1689"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1689"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1689"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1689"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}