{"id":44426,"date":"2020-02-21T15:06:30","date_gmt":"2020-02-21T19:06:30","guid":{"rendered":"https:\/\/caireadydev1.wpenginepowered.com\/life-sciences\/cai-update-second-stakeholders-consultation-on-the-revision-of-annex-1\/"},"modified":"2025-06-21T17:53:47","modified_gmt":"2025-06-21T21:53:47","slug":"update-second-stakeholders-consultation-on-the-revision-of-annex-1","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/blog\/update-second-stakeholders-consultation-on-the-revision-of-annex-1\/","title":{"rendered":"UPDATE: Second Stakeholders&#8217; Consultation on the Revision of Annex 1"},"content":{"rendered":"<p style=\"text-align: left; font-size: 16px;\"><em>The second targeted stakeholders&#8217; consultation on the revision of Annex 1, on the manufacturing of sterile medicinal products, of Eudralex Volume 4<\/em><\/p>\n<p><!--more--><\/p>\n<p style=\"text-align: left; font-size: 16px;\"><em><img decoding=\"async\" style=\"width: 1200px;\" src=\"https:\/\/cdn2.hubspot.net\/hubfs\/705173\/Tablets.png\" alt=\"Tablets\" width=\"1200\" \/><\/em><\/p>\n<h1 style=\"font-size: 18px;\"><span style=\"color: #005d83;\"><strong>Period of Consultation: 20 February 2020 to 20 May 2020<\/strong><\/span><\/h1>\n<p style=\"font-size: 18px;\">Due to widespread interest from the industry following the first targeted consultation, and because of substantial modifications introduced in several sections, it was agreed\u00a0to engage with stakeholders on a second targeted consultation on the updated draft guidance (version 12) focused on the sections and\/or significantly modified paragraphs that raised most concerns.<\/p>\n<h1 style=\"font-size: 18px;\"><span style=\"color: #005d83;\">Acknowledgement<br \/>\n<\/span><\/h1>\n<p style=\"font-size: 18px;\">In order to maintain the global alignment of standards, achieving assurance for the highest quality at the same time, the document will be, in parallel, subject to a second targeted consultation by WHO and PIC\/S.<\/p>\n<h1 style=\"font-size: 18px;\"><span style=\"color: #005d83;\">Targeted stakeholders<\/span><\/h1>\n<p>The following organizations representing relevant stakeholders have accepted taking part in the second consultation and have agreed to receive, compile, and send all comments to the European Commission:<\/p>\n<ul>\n<li>A3P (Association for Products Propres and Parentals)<\/li>\n<li>AESGP (Association of the European Self-Medication Industry)<\/li>\n<li>AnimalhealthEurope<\/li>\n<li>APIC (Active Pharmaceutical Ingredient Committee)<\/li>\n<li>EAEPC (European Association of Euro-Pharmaceutical Companies)<\/li>\n<li>ECA (European Compliance Academy)<\/li>\n<li>EFPIA (European Federation of Pharmaceutical Industries and Associations)<\/li>\n<li>EGGVP (European Group for Generic Veterinary Products)<\/li>\n<li>EIPG (European Industrial Pharmacists Group)<\/li>\n<li>GIRP (European Healthcare Distribution Association)<\/li>\n<li>ISPE (International Society for Pharmaceutical Engineering)<\/li>\n<li>Medicines for Europe<\/li>\n<li>PDA (Parenteral Drug Association)<\/li>\n<li>PHSS (Pharmaceutical &amp; Healthcare Sciences Society)<\/li>\n<li>EQPA (European Qualified Person Association)Vaccines Europe<\/li>\n<\/ul>\n<p style=\"font-size: 15px;\">Reference:<br \/>\n<span style=\"color: #57c1e8;\"><a style=\"color: #57c1e8;\" href=\"https:\/\/www.gmp-compliance.org\/files\/guidemgr\/2020_annex1ps_sterile_medicinal_products_en.pdf\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.gmp-compliance.org\/files\/guidemgr\/2020_annex1ps_sterile_medicinal_products_en.pdf<\/a><\/span><\/p>\n<p style=\"font-size: 16px;\"><span style=\"color: #005d83;\"><strong>About the Author:<\/strong><\/span><\/p>\n<p style=\"font-size: 16px;\"><strong><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\"><img decoding=\"async\" style=\"width: 111px; float: left; margin: 0px 10px 10px 0px;\" src=\"https:\/\/cdn2.hubspot.net\/hubfs\/705173\/Henchion,%20John.jpg\" alt=\"Henchion, John\" width=\"111\" \/><span style=\"color: #57c1e8;\"><a style=\"color: #57c1e8;\" href=\"mailto:john.henchion@cagents.com\" rel=\" noopener\"><span style=\"text-decoration: underline;\">John Henchion<\/span><\/a><\/span><\/span><\/span><\/strong><\/p>\n<p style=\"font-size: 16px;\"><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\">John has more than 2<\/span><\/span><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\">3<\/span><\/span><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\"> years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years\u2019 experience releasing both commercial and clinical material to market. John is a Quality Systems SME. <\/span><\/span><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\">\u00a0H<\/span><\/span><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\">e understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications. John has significant experience in GMP<\/span><\/span><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\">\/ISO<\/span><\/span><span class=\"TextRun BCX0 SCXW146163669\" lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun BCX0 SCXW146163669\"> compliance auditing of manufacturing facilities and supply chain.<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The second targeted stakeholders&#8217; consultation on the revision of Annex 1, on the manufacturing of sterile medicinal products, of Eudralex Volume 4<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[111],"tags":[],"resource-featured-status":[],"resource-type":[819],"class_list":["post-44426","post","type-post","status-publish","format-standard","hentry","category-operations-and-regulatory-consulting-compliance-regulatory","resource-type-blog"],"acf":[],"featured_image_src":null,"featured_image_src_square":null,"author_info":{"display_name":"mikeviele","author_link":"https:\/\/caiready.com\/life-sciences\/blog\/author\/mikeviele\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/44426","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/comments?post=44426"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/44426\/revisions"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=44426"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=44426"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/tags?post=44426"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=44426"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=44426"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}