{"id":545,"date":"2026-09-01T06:12:02","date_gmt":"2026-09-01T04:12:02","guid":{"rendered":"https:\/\/www.pqra.gr\/outsourced-activities-and-quality-agreements-what-eu-gmp-chapter-7-requires\/"},"modified":"2026-09-01T06:12:23","modified_gmt":"2026-09-01T04:12:23","slug":"outsourced-activities-and-quality-agreements-what-eu-gmp-chapter-7-requires","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/outsourced-activities-and-quality-agreements-what-eu-gmp-chapter-7-requires\/","title":{"rendered":"Outsourced Activities and Quality Agreements: What EU GMP Chapter 7 Requires"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Almost every pharmaceutical company outsources something &mdash; a manufacturing step, analytical testing, storage, transport, calibration, a hosted computerised system. What no company can outsource is responsibility for it. Chapter 7 of the EU GMP Guide has made that point since it came into operation on 31 January 2013, and it remains a dependable source of inspection findings for organisations that treat a signed commercial supply contract as though it were a quality agreement.<\/strong><\/p>\n\n<h2>From contract manufacture to outsourced activities<\/h2>\n<p>The revision that took effect in 2013 retitled the chapter from &ldquo;Contract Manufacture and Analysis&rdquo; to &ldquo;Outsourced Activities&rdquo;. The change of name was deliberate. The chapter was aligned with ICH Q10 on the pharmaceutical quality system and its scope was widened beyond the manufacture and testing of batches to any GMP-regulated activity placed with a third party.<\/p>\n<p>In practice that pulls in work many quality systems still handle as procurement rather than as GMP: contract analytical and microbiological laboratories, sterilisation and irradiation services, qualification and calibration providers, hosting and maintenance of GxP computerised systems, warehousing, and consultancy that feeds into GMP-critical decisions.<\/p>\n\n<h2>The Contract Giver carries the responsibility<\/h2>\n<p>Chapter 7 places ultimate responsibility on the Contract Giver and expects it to be discharged through documented processes built on quality risk management principles. Before any activity is placed, the Contract Giver must assess the legality, suitability and competence of the Contract Acceptor. Once it is placed, the obligation does not stop:<\/p>\n<ul>\n<li>reviewing the records and results generated by the Contract Acceptor;<\/li>\n<li>satisfying itself that all products and materials delivered have been processed in accordance with GMP and with the marketing authorisation;<\/li>\n<li>reviewing the quality of the Contract Acceptor&rsquo;s performance on a continuing basis, and identifying and implementing any needed improvement.<\/li>\n<\/ul>\n<p>&ldquo;Continuing&rdquo; is the operative word. An initial audit report filed three years ago and never revisited does not meet this standard.<\/p>\n\n<h2>What the written agreement has to say<\/h2>\n<p>A written agreement is required, and it has to be specific about who does what. Chapter 7 expects responsibility to be assigned step by step across areas including knowledge management, technology transfer, supply chain, subcontracting, quality and purchasing of materials, testing and release of materials, and the conduct of production and quality controls. Two clauses repay close attention:<\/p>\n<ul>\n<li><strong>Audit rights.<\/strong> The agreement must permit the Contract Giver to audit the outsourced activities, whether they are performed by the Contract Acceptor or by mutually agreed subcontractors.<\/li>\n<li><strong>Control of change.<\/strong> The Contract Acceptor must not introduce unauthorised changes that may adversely affect the quality of the outsourced activity.<\/li>\n<\/ul>\n<p>A generic template signed by procurement, never reviewed by Quality, and silent on subcontracting is precisely the document inspectors ask to see.<\/p>\n\n<h2>Distribution is governed by an equivalent rule<\/h2>\n<p>Companies whose outsourcing sits on the distribution side should not assume the question goes away. The EU Guidelines on Good Distribution Practice (2013\/C 343\/01) contain their own Chapter 7, with the same architecture: a written contract establishing the duties of each party, a contract giver responsible for assessing the competence of the contract acceptor, and an audit of the contract acceptor before the outsourced activity begins and again whenever it changes, at a frequency set on risk. Onward subcontracting requires the contract giver&rsquo;s prior evaluation and approval, together with an audit of the third party.<\/p>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA works with pharmaceutical companies and healthcare innovators in Greece and across the EU to make outsourcing arrangements defensible under inspection. We map the full population of outsourced GMP and GDP activities, including the ones sitting outside the quality system; draft and remediate quality agreements so responsibilities are allocated step by step rather than in general terms; run risk-based qualification and periodic audits of contract manufacturers, laboratories and logistics providers; and build the performance review and change-control mechanisms that keep oversight active between audits.<\/p>\n<p>If you are placing a new activity with a third party, or you suspect your existing agreements would not survive close reading, <a href=\"\/el\/contact\/\">get in touch with PQRA<\/a> to discuss how we can help.<\/p>","protected":false},"excerpt":{"rendered":"<p>Almost every pharmaceutical company outsources something &mdash; a manufacturing step, analytical testing, storage, transport, calibration, a hosted computerised system. What no company can outsource is responsibility for it. Chapter 7 of the EU GMP Guide has made that point since it came into operation on 31 January 2013, and it remains a dependable source of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":546,"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-545","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>Outsourced Activities and Quality Agreements: What EU GMP Chapter 7 Requires - 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\/outsourced-activities-and-quality-agreements-what-eu-gmp-chapter-7-requires\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Outsourced Activities and Quality Agreements: What EU GMP Chapter 7 Requires - PQRA\" \/>\n<meta property=\"og:description\" content=\"Almost every pharmaceutical company outsources something &mdash; a manufacturing step, analytical testing, storage, transport, calibration, a hosted computerised system. 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