{"id":2097,"date":"2022-03-31T11:15:00","date_gmt":"2022-03-31T11:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2022\/03\/31\/ich-q14-draft-guideline-reaches-step-2-ich-process\/"},"modified":"2022-03-31T11:15:00","modified_gmt":"2022-03-31T11:15:00","slug":"ich-q14-draft-guideline-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2022\/03\/31\/ich-q14-draft-guideline-reaches-step-2-ich-process\/","title":{"rendered":"The ICH Q14 Draft Guideline Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH Q14 draft Guideline on Analytical Procedure Development reached Step 2 of the ICH process on 24 March 2022 and now enters the <a href=\"https:\/\/www.ich.org\/page\/public-consultations\">public consultation<\/a> period.<\/p>\n<p>The new guideline is proposed to harmonise the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures. The proposed guidelines Q2(R2) and Q14 are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing, with a view to potentially combine both documents into one, for simplification and clarity.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/www.ich.org\/page\/quality-guidelines\">ICH Q14 webpage<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Q14 draft Guideline on Analytical Procedure Development reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-2097","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2097","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/comments?post=2097"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2097\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2097"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2097"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2097"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}