{"id":236,"date":"2026-07-17T18:24:33","date_gmt":"2026-07-17T16:24:33","guid":{"rendered":"https:\/\/www.pqra.gr\/gmp-inspection-readiness-annex-1-and-the-contamination-control-strategy\/"},"modified":"2026-07-17T18:27:57","modified_gmt":"2026-07-17T16:27:57","slug":"gmp-inspection-readiness-annex-1-and-the-contamination-control-strategy","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/gmp-inspection-readiness-annex-1-and-the-contamination-control-strategy\/","title":{"rendered":"GMP Inspection Readiness: Annex 1 and the Contamination Control Strategy"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>The revised Annex 1 did more than tighten sterile manufacturing rules &mdash; it made the Contamination Control Strategy the organising document of your entire quality approach. Inspectors now read it first.<\/strong><\/p>\n<p>The revision of EudraLex Volume 4, Annex 1 was published on 25 August 2022 and became applicable on 25 August 2023, with a single deferred point &mdash; 8.123, on lyophilisation &mdash; applying from 25 August 2024. It has been fully applicable for nearly two years, which means &#8220;we are still working on it&#8221; is no longer a defensible position.<\/p>\n<h2>The CCS is not a document exercise<\/h2>\n<p>The Contamination Control Strategy must be implemented across the facility, defining critical control points and assessing the effectiveness of every control. Three obligations are routinely underestimated:<\/p>\n<ul>\n<li>It must be <strong>actively reviewed and updated<\/strong> &mdash; not written once and filed.<\/li>\n<li>It must <strong>drive continual improvement<\/strong>.<\/li>\n<li>Its effectiveness must form part of <strong>periodic management review<\/strong>.<\/li>\n<\/ul>\n<p>Encouragingly, Annex 1 does not require you to rebuild what already works: existing control systems may not need replacement, but they must be referenced in the CCS. It is an integrating document, not a demolition project.<\/p>\n<h2>Lyophilisation: the deferred point<\/h2>\n<p>Point 8.123 requires manually loaded or unloaded lyophilisers without barrier separation to be sterilised before each load. Automated or closed-barrier systems may justify a different frequency &mdash; but that justification has to be documented in the CCS.<\/p>\n<h2>Don&#8217;t miss Annex 19<\/h2>\n<p>A revision of Annex 19 (Reference and Retention Samples) was published on 24 June 2026 and becomes applicable on <strong>24 September 2026<\/strong>. It has attracted little commentary, which is precisely why it is worth acting on now rather than discovering it at inspection.<\/p>\n<p>Also on the horizon: a consultation on a revised Chapter 4 (Documentation), a revised Annex 11 (Computerised Systems, still governed by its 2011 version) and an entirely new Annex 22 on Artificial Intelligence closed in October 2025. No final text has been published &mdash; but the direction of travel is clear.<\/p>\n<h2>How findings are classified<\/h2>\n<p>Inspectorates classify deficiencies as Critical, Major or Other, following the PIC\/S approach designed to bring consistency between inspectors. Historically, quality system failings have led published findings year after year &mdash; which is why readiness starts with your QMS, not your cleanroom.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA runs gap assessments, CCS development, remediation and mock inspections &mdash; so that inspection day confirms what you already know.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Prepare for your next inspection &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>The revised Annex 1 did more than tighten sterile manufacturing rules &mdash; it made the Contamination Control Strategy the organising document of your entire quality approach. Inspectors now read it first. The revision of EudraLex Volume 4, Annex 1 was published on 25 August 2022 and became applicable on 25 August 2023, with a single [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":248,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_kadence_starter_templates_imported_post":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-236","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GMP Inspection Readiness: Annex 1 and the Contamination Control Strategy - PQRA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/gmp-inspection-readiness-annex-1-and-the-contamination-control-strategy\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GMP Inspection Readiness: Annex 1 and the Contamination Control Strategy - PQRA\" \/>\n<meta property=\"og:description\" content=\"The revised Annex 1 did more than tighten sterile manufacturing rules &mdash; it made the Contamination Control Strategy the organising document of your entire quality approach. 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