{"id":2096,"date":"2022-03-31T12:15:00","date_gmt":"2022-03-31T12:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2022\/03\/31\/ich-revision-q2r2-draft-guideline-reaches-step-2-ich-process\/"},"modified":"2022-03-31T12:15:00","modified_gmt":"2022-03-31T12:15:00","slug":"ich-revision-q2r2-draft-guideline-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2022\/03\/31\/ich-revision-q2r2-draft-guideline-reaches-step-2-ich-process\/","title":{"rendered":"The ICH Revision of Q2(R2) Draft Guideline Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH Revision of Q2(R2) draft Guideline on Validation of Analytical Procedures 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 scope of the revision of ICH Q2(R1) will include validation principles that cover analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses. The guideline will continue to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B. 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 Q2(R2) webpage<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Revision of Q2(R2) draft Guideline on Validation of Analytical Procedures 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-2096","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\/2096","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=2096"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2096\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2096"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2096"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2096"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}