{"id":44428,"date":"2020-02-06T09:45:00","date_gmt":"2020-02-06T13:45:00","guid":{"rendered":"https:\/\/caireadydev1.wpenginepowered.com\/life-sciences\/cai-quick-glance-regulatory-and-inspection-harmonization\/"},"modified":"2025-06-21T17:54:13","modified_gmt":"2025-06-21T21:54:13","slug":"quick-glance-regulatory-and-inspection-harmonization","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/blog\/quick-glance-regulatory-and-inspection-harmonization\/","title":{"rendered":"Quick Glance: Regulatory and Inspection Harmonization"},"content":{"rendered":"<p><span><img decoding=\"async\" src=\"https:\/\/cdn2.hubspot.net\/hubfs\/705173\/GownedPerson.png\" alt=\"GownedPerson\" width=\"1200\" style=\"width: 1200px;\"><\/span><\/p>\n<p> <!--more--> <\/p>\n<p><span>Regulatory and Inspection Harmonization continues to gather speed. Following the successful US\/EU MRA completed on 11 July this year, a new Pilot Program is planned for Inspection Harmonization of Medicinal Product Sterile Manufacture. This program is scheduled to run for approximately two years and will include the following competent authorities:<\/span><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li><span>Australia &#8211; Therapeutic Goods Administration (TGA) <\/span><\/li>\n<li><span>Canada &#8211; Health Canada (HC) <\/span><\/li>\n<li><span>EMA &#8211; European Medicine Agency <\/span><\/li>\n<li>France &#8211; Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des Produits de Sant\u00e9 (ANSM)<\/li>\n<li><span>Japan &#8211; Pharmaceuticals and Medical Devices Agency (PMDA) <\/span><\/li>\n<li><span>United Kingdom &#8211; Medicines and Healthcare products Regulatory Agency (MHRA)<\/span><\/li>\n<li><span>United States &#8211; Food and Drug Administration (FDA) <\/span><\/li>\n<li><span>World Health Organization (WHO)<\/span><\/li>\n<\/ul>\n<p><span>The Scope includes chemical, and some biotech products (e.g., MABs), but specifically excludes vaccines, ATMPs, and plasma-derived. The pilot includes routine surveillance and for cause, but pre-approval audits inclusion is discretionary. The scope specifically intends to avoid duplicate routine surveillance audits.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #005d83;\"><strong>Inspection Models facilitated within this Pilot Program include:<\/strong><\/span><\/p>\n<ul>\n<li><span>Sole Inspection \u2013 reliance upon Inspection by other Authority (with or without extension)<\/span><\/li>\n<li><span>Joint Inspection \u2013 collaborative planning, Inspection, reporting, CAPA plan reviews<\/span><\/li>\n<li><span>Concurrent Inspection \u2013 two independent inspections at the same time, which will most likely have different scopes, with the expectation that the two independent teams will exchange information.<\/span><\/li>\n<\/ul>\n<p><span>Given the potential global impact of the much-heralded upcoming EU Annex 1 update, this is a very interesting pilot program that will probably be implemented while Annex 1 \u201cManufacture of Sterile Medicinal Products\u201d comes into operation.<\/span><\/p>\n<p><span>One of the complications for this pilot program is the absence of harmonized regulations; effectively, each Competent Authority will rely on its regulatory framework with some references to PICs and WHO standards that align with the EU Annex 1.<\/span><\/p>\n<p><span>All initiatives that move the industry towards harmonization are to be welcomed but spare a thought for the sites that will undergo Concurrent or Joint Inspections as part of this program!<\/span><\/p>\n<p>&nbsp;<\/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 data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><span class=\"NormalTextRun BCX0 SCXW146163669\"><img decoding=\"async\" src=\"https:\/\/cdn2.hubspot.net\/hubfs\/705173\/Henchion,%20John.jpg\" alt=\"Henchion, John\" width=\"111\" style=\"width: 111px; float: left; margin: 0px 10px 10px 0px;\"><a href=\"mailto:john.henchion@cagents.com\" rel=\" noopener\"><span style=\"text-decoration: underline;\">John Henchion<\/span><\/a><\/span><\/span><\/strong><\/p>\n<p style=\"font-size: 16px;\"><span><span data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><span class=\"NormalTextRun BCX0 SCXW146163669\">John has more than 2<\/span><\/span><span data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><span class=\"NormalTextRun BCX0 SCXW146163669\">3<\/span><\/span><span data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><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 data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><span class=\"NormalTextRun BCX0 SCXW146163669\">&nbsp;H<\/span><\/span><span data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><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 data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><span class=\"NormalTextRun BCX0 SCXW146163669\">\/ISO<\/span><\/span><span data-contrast=\"auto\" class=\"TextRun BCX0 SCXW146163669\" xml_lang=\"EN-US\" lang=\"EN-US\"><span class=\"NormalTextRun BCX0 SCXW146163669\"> compliance auditing of manufacturing facilities and supply chain.<\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[113],"tags":[],"resource-featured-status":[],"resource-type":[819],"class_list":["post-44428","post","type-post","status-publish","format-standard","hentry","category-operations-and-regulatory-consulting-industry-quality-compliance-gmp-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\/44428","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=44428"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/44428\/revisions"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=44428"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=44428"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/tags?post=44428"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=44428"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=44428"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}