{"id":648,"date":"2025-11-26T20:43:03","date_gmt":"2025-11-26T19:43:03","guid":{"rendered":"https:\/\/www.darqa.org\/?p=648"},"modified":"2026-08-11T12:55:51","modified_gmt":"2026-08-11T10:55:51","slug":"report-2025-gmp-theme-day-impurities-in-the-spotlight","status":"publish","type":"post","link":"https:\/\/www.darqa.org\/index.php\/language\/en\/2025\/11\/26\/report-2025-gmp-theme-day-impurities-in-the-spotlight\/","title":{"rendered":"Report on the 2025 GMP Theme Day \u2013 Impurities in the Spotlight: GMP\u2019s Dirty Secrets"},"content":{"rendered":"<p><em>Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.<\/em><\/p>\n<p><strong>Event language:<\/strong> This event was held in Dutch.<\/p>\n<p>On 7 November 2025, impurities took centre stage during the annual GMP Theme Day, and several Dirty Secrets were revealed.<\/p>\n<p>One presentation addressed the development of a holistic Contamination Control Strategy using a CCS tool.<\/p>\n<p>Impurities also play an important role in the early development of a product. This was explained in greater detail from a CMC perspective.&nbsp;<\/p>\n<p>Impurities can originate not only from the product itself, but also from manufacturing materials or primary packaging, entering the product in the form of Extractables &amp;&nbsp;Leachables.<\/p>\n<p>After the break, the programme continued with a presentation on Elemental Impurities that included an enjoyable quiz. The winner went home with a delicious chocolate letter.&nbsp;<\/p>\n<p>The selection and management of CMOs in relation to technology transfer were then discussed.<\/p>\n<p>Several presentations from the ECA conference on Annex 22 were summarised, prompting the question: is AI the future?<\/p>\n<p>The day concluded with an update on ICH Q5, followed by a case study and panel discussion on \u201cImpurities in the Spotlight\u2014GMP\u2019s Dirty Secrets\u201d.<\/p>\n<p>It was a successful day, offering insights from several perspectives into how to identify, reduce and prevent product impurities.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The GMP Theme Day focused on impurities, from Contamination Control Strategy and extractables and leachables to CMO selection, technology transfer, Annex 22 and ICH Q5.<\/p>\n","protected":false},"author":9,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[68],"tags":[],"class_list":["post-648","post","type-post","status-publish","format-standard","hentry","category-uncategorised-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts\/648","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/comments?post=648"}],"version-history":[{"count":1,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts\/648\/revisions"}],"predecessor-version":[{"id":667,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts\/648\/revisions\/667"}],"wp:attachment":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/media?parent=648"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/categories?post=648"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/tags?post=648"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}