{"id":573,"date":"2026-09-11T11:11:42","date_gmt":"2026-09-11T09:11:42","guid":{"rendered":"https:\/\/www.pqra.gr\/self-inspection-under-eu-gmp-chapter-9-the-audit-you-run-on-yourself\/"},"modified":"2026-09-11T11:11:50","modified_gmt":"2026-09-11T09:11:50","slug":"self-inspection-under-eu-gmp-chapter-9-the-audit-you-run-on-yourself","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/self-inspection-under-eu-gmp-chapter-9-the-audit-you-run-on-yourself\/","title":{"rendered":"Self-Inspection Under EU GMP Chapter 9: The Audit You Run on Yourself"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Chapter 9 of the EU GMP Guide is one of the shortest chapters in the guide and one of the most revealing. Self-inspection is the mechanism by which a site demonstrates that it can find its own problems. When an inspector arrives and identifies something obvious that your own programme never raised, the finding is not really about the deficiency. It is about the programme.<\/strong><\/p>\n\n<h2>What Chapter 9 requires<\/h2>\n<p>Self-inspections are to be conducted in order to monitor the implementation of and compliance with GMP principles, and to propose the necessary corrective measures. They should be carried out at regular intervals according to a pre-arranged programme, conducted independently and in detail by designated competent people, and recorded. Records should include observations and proposals for corrective actions, and subsequent actions should themselves be recorded.<\/p>\n<p>The text is deliberately brief. What it does not specify &mdash; frequency, scope, depth &mdash; is what you must justify.<\/p>\n\n<h2>Designing a programme you can defend<\/h2>\n<p>An annual walk through every area in equal measure satisfies the letter of the chapter and very little else. A programme that produces real assurance is weighted by risk and by evidence:<\/p>\n<ul>\n<li><strong>Define the universe.<\/strong> Every GMP area and process, including quality control laboratories, warehousing, utilities, computerised systems, contract givers and contract acceptors.<\/li>\n<li><strong>Rank by risk.<\/strong> Product and patient impact, complexity, rate of change, staff turnover, and history of deviations, complaints or previous findings.<\/li>\n<li><strong>Set depth accordingly.<\/strong> High-risk areas audited more often and more deeply; stable low-risk areas on a longer cycle.<\/li>\n<li><strong>Cover the whole cycle.<\/strong> Ensure every area is reached within a defined period so nothing quietly falls out of scope.<\/li>\n<li><strong>Re-plan on triggers.<\/strong> A major deviation, a recall, a significant change of process or supplier, or a regulatory inspection elsewhere in the group should reopen the schedule.<\/li>\n<\/ul>\n\n<h2>Independence, and the small-site problem<\/h2>\n<p>Competent and designated people must conduct the inspection independently. On a small site the person who knows the process well enough to audit it may be the person who runs it. The answer is not to compromise the principle but to source independence elsewhere &mdash; auditors from another site in the group, from a corporate quality function, or externally. Independence is what distinguishes a self-inspection from a self-assessment.<\/p>\n\n<h2>The part that goes wrong: what happens after<\/h2>\n<p>Most self-inspection programmes fail after the report, not during the audit. Recurring patterns are easy to recognise:<\/p>\n<ul>\n<li>Observations recorded but no corrective actions proposed, which Chapter 9 explicitly expects<\/li>\n<li>Root causes stated as human error, leading to retraining as the standing remedy<\/li>\n<li>Due dates extended repeatedly with no escalation<\/li>\n<li>No effectiveness check, so recurrence is discovered by the next auditor rather than by you<\/li>\n<li>No trending across inspections, so a systemic issue appearing in five areas is closed as five isolated actions<\/li>\n<\/ul>\n<p>Trending is what turns the programme from a compliance activity into a management tool. It is also what senior management review should be looking at.<\/p>\n\n<h2>Using self-inspection to prepare for the real thing<\/h2>\n<p>The most useful self-inspections are run in the conditions of an actual inspection: request documents live rather than in advance, interview operators rather than only supervisors, follow one batch end to end, and time how long retrieval takes. A programme run this way surfaces the gap between the system as written and the system as operated &mdash; which is precisely the gap inspectors are trained to find.<\/p>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA designs and runs self-inspection and internal audit programmes for GMP and GDP operations, provides independent auditors where in-house independence is not achievable, conducts mock inspections, and supports CAPA development, trending and effectiveness verification after findings.<\/p>\n<p>To strengthen your self-inspection programme or arrange an independent GMP audit, <a href=\"\/el\/contact\/\">contact PQRA<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Chapter 9 of the EU GMP Guide is one of the shortest chapters in the guide and one of the most revealing. Self-inspection is the mechanism by which a site demonstrates that it can find its own problems. When an inspector arrives and identifies something obvious that your own programme never raised, the finding is [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":574,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-573","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Self-Inspection Under EU GMP Chapter 9: The Audit You Run on Yourself - 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\/self-inspection-under-eu-gmp-chapter-9-the-audit-you-run-on-yourself\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Self-Inspection Under EU GMP Chapter 9: The Audit You Run on Yourself - PQRA\" \/>\n<meta property=\"og:description\" content=\"Chapter 9 of the EU GMP Guide is one of the shortest chapters in the guide and one of the most revealing. 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