{"id":1683,"date":"2026-10-06T12:35:43","date_gmt":"2026-10-06T12:35:43","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/q6b\/"},"modified":"2026-10-06T12:35:43","modified_gmt":"2026-10-06T12:35:43","slug":"q6b","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/q6b\/","title":{"rendered":"Q6B \u2013 Specifications : Test Procedures and Acceptance Criteria for Biotechnological\/Biological Products"},"content":{"rendered":"<p>The ICH Harmonised Guideline was finalised under <em>Step 4<\/em> in March 1999.<\/p>\n<p>This document provides general principles on the setting and justification of a uniform set of international specifications for proteins and polypeptides which are produced from recombinant or non-recombinant cell-culture expression systems.<\/p>\n<p>The scope of this part is initially limited to well-characterised biotechnological products, although the concepts may be applicable to other biologicals as appropriate.<\/p>\n<p>In view of the nature of the products, the topic of specifications include in-process controls, bulk drug, final product and stability specifications and give guidance for a Harmonised approach to determining appropriate specifications based on safety, process consistency, purity, analytical methodology, product administration and clinical data considerations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Harmonised Guideline was finalised under Step 4 in March 1999. This document provides general principles on the setting and justification of a uniform set of international specifications for proteins and\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[18],"guideline_tag":[],"rd_phase":[],"class_list":["post-1683","guideline","type-guideline","status-publish","hentry","guideline_category-quality"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1683","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\/1683\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1683"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1683"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1683"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1683"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}