{"id":342,"date":"2026-08-10T15:54:01","date_gmt":"2026-08-10T13:54:01","guid":{"rendered":"https:\/\/www.pqra.gr\/the-qualified-person-the-signature-that-releases-a-batch\/"},"modified":"2026-08-27T11:41:54","modified_gmt":"2026-08-27T09:41:54","slug":"the-qualified-person-the-signature-that-releases-a-batch","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-qualified-person-the-signature-that-releases-a-batch\/","title":{"rendered":"The Qualified Person: The Signature That Releases a Batch"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>No batch of medicine reaches a patient in the EU until one named individual takes personal legal responsibility for it. Understanding the Qualified Person&#8217;s role is fundamental to any manufacturing or import operation.<\/strong><\/p>\n<p>The Qualified Person (QP) is required by Directive 2001\/83\/EC, Articles 48 to 52, with the operational detail set out in Annex 16 of the EU GMP guide. The QP&#8217;s core duty is absolute: no batch may be released until the QP has certified that it was manufactured and tested in accordance with the marketing authorisation and EU GMP.<\/p>\n<h2>Certification versus confirmation<\/h2>\n<p>These two terms are often confused. <strong>Certification<\/strong> is the final act of batch release, where the QP takes full legal responsibility for the batch. <strong>Confirmation<\/strong> is a partial sign-off by a QP for a specific stage &mdash; manufacture or testing at another site &mdash; that feeds into the certifying QP&#8217;s decision. Only certification releases a batch.<\/p>\n<h2>Importing from third countries<\/h2>\n<p>Finished products imported from outside the EEA must, in principle, be <strong>fully re-tested within the EEA<\/strong> and certified by a QP &mdash; unless a Mutual Recognition Agreement or equivalent arrangement applies. This is a frequent point of failure for supply chains that assume third-country testing is sufficient.<\/p>\n<h2>The supply chain must be visible<\/h2>\n<p>Annex 16 requires the QP to have documented visibility of the entire supply chain of both the active substance and the finished product, right up to certification. A QP cannot certify what they cannot see.<\/p>\n<h2>The QP declaration for active substances<\/h2>\n<p>For marketing authorisation applications, the QP of the manufacturing or import site provides a written declaration that the active substance is manufactured to standards at least equivalent to EU GMP. It is a small document with significant weight.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA advises on QP arrangements, batch release, importation testing strategy and the active-substance GMP declaration.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Talk to us about batch release &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>No batch of medicine reaches a patient in the EU until one named individual takes personal legal responsibility for it. Understanding the Qualified Person&#8217;s role is fundamental to any manufacturing or import operation. The Qualified Person (QP) is required by Directive 2001\/83\/EC, Articles 48 to 52, with the operational detail set out in Annex 16 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":356,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,11],"tags":[],"class_list":["post-342","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-quality-assurance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The Qualified Person: The Signature That Releases a Batch - PQRA<\/title>\n<meta name=\"description\" content=\"No batch of medicine reaches a patient in the EU until one named individual takes personal legal responsibility for it.\" \/>\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\/the-qualified-person-the-signature-that-releases-a-batch\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Qualified Person: The Signature That Releases a Batch - 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