{"id":6884,"date":"2024-05-16T12:28:42","date_gmt":"2024-05-16T11:28:42","guid":{"rendered":"https:\/\/almacgroup.com\/clinical-services\/?page_id=6884"},"modified":"2025-05-13T10:45:36","modified_gmt":"2025-05-13T09:45:36","slug":"qualified-person-services","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/clinical-services\/clinical-trial-supply\/qualified-person-services\/","title":{"rendered":"Qualified Person Services"},"content":{"rendered":"\n<!-- Half image, half text -->\n<section class=\"u-bg-white t-theme-component-overwrite\" id=\"halfMediaTextBlock\">\n    <div class=\"c-half-media-text \">\n        <div class=\"o-wrapper\">\n                                                        <article class=\"o-grid u-bg-white\">\n                            <div class=\"u-width-half u-width-7\/12@l u-width-full@m c-half-media__repeat-text none u-bg-white\">\n                                                                    <h2 class=\"u-m-b3\">The API manufacture process presents many challenges for you to overcome<\/h2>\n                                                                <h5>A Qualified Person assumes personal responsibility for certifying each batch of material prior to release into EU, EEA or UK clinical trials.<\/h5>\n<p>Named on the Manufacturer\u2019s and Importer\u2019s License, their certification legally confirms that materials have been manufactured in full compliance with GMP and all relevant EU regulation, along with the Clinical Trial Application and Product Specification File. <\/p>\n                                                            <\/div>\n                            <div class=\"u-width-half u-width-5\/12@l u-width-full@m u-flex c-half-media__repeat-image\">\n                                                                    <img decoding=\"async\" data-src=\"https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/QP-Services-Supporting-Image.jpg\" alt=\"The API manufacture process presents many challenges for you to overcome\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" class=\"lazyload\" style=\"--smush-placeholder-width: 768px; --smush-placeholder-aspect-ratio: 768\/432;\"><noscript><img decoding=\"async\" class=\"\" src=\"https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/QP-Services-Supporting-Image.jpg\" alt=\"The API manufacture process presents many challenges for you to overcome\"><\/noscript>\n                                                            <\/div>\n                        <\/article>\n                                        <\/div>\n    <\/div>\n<\/section>\n\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h2 style=\"text-align: center;\">QP Qualifications<\/h2>\n<p>A QP must have qualifications in Chemistry, Pharmacy or Microbiology. They must also have wide ranging technical knowledge and experience within the pharmaceutical industry.<\/p>\n<p>Access to an appropriately qualified, in-house QP resource isn\u2019t achievable for most sponsors, which is why many choose to outsource this highly specialist function to experts like us. Widely known and respected, our QPs have experience across a wide range of product types and dosage forms, while our highly experienced support team can assist you in the release of IMPs for use in clinical trials, including importation into the EU. <\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h2 style=\"text-align: center;\">Why choose Almac?<\/h2>\n<p>If you\u2019re looking for QP Services that deliver full compliance and provide expert support at every step of the process, look no further. We recognise that QP requirements can be a complex task to get to grips with, which is why we offer<strong> easy-to-follow release procedures<\/strong> that provide you with a consistent, secure, and structured approach that has been repeatedly reviewed during MHRA inspections. It\u2019s also the reason behind our <strong>QP Facilitation Program<\/strong>, an on-site initiative that simplifies and expedites the QP release process.<\/p>\n<p>We know that the evolving regulatory landscape can make keeping up to date with your precise compliance obligations difficult. That\u2019s why our highly skilled experts proactively ensure continued compliance by providing you with up to the second information on regulatory guidance and expectations.<\/p>\n<p>And when it comes to importing clinical supply into the EU, our global auditing of third-party manufacturing, testing, packaging, and labelling facilities (delivered on site or via our virtual auditing solution) safeguards compliance, while keeping your vital clinical trial timelines on track.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<!-- thirds_media_text.php -->\n<!-- Two thirds text, One third Media -->\n<section class=\"u-bg-white t-theme-component-overwrite\"  id=\"thirdsMediaBlock\">\n\t<div class=\"c-half-media-text\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t<article class=\"o-grid \">\n\t\t\t\t\t\t\t<div class=\"u-width-2\/3 u-width-full@m c-half-media__repeat-text none u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h2 class=\"u-m-b3\">Olive McCormick<\/h2>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3>Director of Quality<\/h3>\n<p>\u201cQualified Person requirements are often viewed as a minefield by many sponsors. I Supply With Care because it matters to me that our clients feel confident taking on the challenge and have all the knowledge and support they need to excel. <\/p>\n<p>\nI Supply With Care because by educating and mentoring clients in the requirements of EU legislation, and by performing audits of manufacturing, testing, and packaging sites all over the world, we champion compliance and patient safety.\u201d<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"u-width-1\/3 u-width-full@m c-half-media__repeat-image\">\n\t\t\t\t                <!-- \n-->\n\n\n\t\t\t\t\t\t\t\t\t<img decoding=\"async\" data-src=\"https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/Olive-McCormick.png\" alt=\"\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" class=\"lazyload\" style=\"--smush-placeholder-width: 485px; --smush-placeholder-aspect-ratio: 485\/360;\"><noscript><img decoding=\"async\" src=\"https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/Olive-McCormick.png\" alt=\"\"><\/noscript>\n\t\t\t\t                \t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/article>\n\n\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/section>\n\n\n\n\n<section class=\"u-m-b3\">\n    <div class=\"o-wrapper\">\n        <div class=\"o-grid o-grid--fill\">\n            <div class=\"o-grid__item u-width-half u-width-7\/12@l u-width-full@m u-m-b2@m\">\n                <header class=\"u-p6 u-p2@l\">\n                    <h2 class=\"u-m-b3\">Changes to the Annex 1 Requirements<\/h2>\n                    <p class=\"u-text-18 u-m-b2\">Understanding how the Annex 1 changes impact customers and knowledge on industry expectations in regard to key areas.\u2028Register below to view a video explaining the changes<\/p>\n                                        <div class=\"u-flex u-flex-align-center u-flex-direction-column@m\">\n\n                                                    \n                            <a style=\"background-color: #fff;\" href=\"https:\/\/www.almacgroup.com\/clinical-services\/registration\" class=\"c-btn c-btn-secondary c-btn--red u-width-full@m u-align-center u-m-r2 u-m-b2@m u-m-r0@m\">Register\n                                Now<\/a>\n                        \n                            <p class=\"u-m-b0 u-m-b2@m\">Already registered? <a class=\"u-underline-text\" style=\"color: #44555F !important;\" href=\"https:\/\/www.almacgroup.com\/clinical-services\/login\">Login<\/a><\/p>\n                            \n                                                \n                    <\/div>\n                <\/header>\n            <\/div>\n            <div class=\"o-grid__item u-width-half u-width-5\/12@l u-width-full@m\">\n                <img decoding=\"async\" data-src=\"https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/Changes-to-the-Annex-1-Requirements.jpg\" alt=\"\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" class=\"lazyload\" style=\"--smush-placeholder-width: 768px; --smush-placeholder-aspect-ratio: 768\/432;\"><noscript><img decoding=\"async\" src=\"https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/Changes-to-the-Annex-1-Requirements.jpg\" alt=\"\"><\/noscript>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<!-- Stats -->\n<div class=\"c-stats js-stats u-bg-none\">\n\t<div class=\"o-wrapper\">\n\t\t<div class=\"o-grid o-grid--center\">\n\t\t\t\n            \t\t\t\t<div class=\"o-grid__item u-width-1\/6 u-width-4\/12@l u-width-full@s c-stats__stat u-p-b4\">\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-stats__number count u-c-dark-grey\"><span>350<\/span>+<\/div>\n\t\t\t\t\t\t\t            <div class=\"c-stats__text u-c-dark-grey\">Quality Staff<\/div>\n\t\t        <\/div>\n\t\t    \t\t\t\t<div class=\"o-grid__item u-width-1\/6 u-width-4\/12@l u-width-full@s c-stats__stat u-p-b4\">\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-stats__number count u-c-dark-grey\"><span>10<\/span>+<\/div>\n\t\t\t\t\t\t\t            <div class=\"c-stats__text u-c-dark-grey\">Qualified Persons<\/div>\n\t\t        <\/div>\n\t\t    \t\t\t\t<div class=\"o-grid__item u-width-1\/6 u-width-4\/12@l u-width-full@s c-stats__stat u-p-b4\">\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-stats__number count u-c-dark-grey\"><span>800<\/span><\/div>\n\t\t\t\t\t\t\t            <div class=\"c-stats__text u-c-dark-grey\">Customer Audits in the last 5 years globally<\/div>\n\t\t        <\/div>\n\t\t    \t\t<\/div>\n\t<\/div>\n<\/div>\n<!-- \/ Stats -->\n\n\n<!-- Full Image Panel with centre text and button -->\n\n<article class=\"c-full-image-panel c-overlay__none lazyload\" style=\"background-image:inherit\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/05\/Rectangle-8.png&#039;)\">\n\t<div class=\"o-wrapper c-full-image-panel__gradient-inner\">\n\t\t<div class=\"o-grid o-grid--center\">\n\t\t\t<div class=\"c-full-image-panel__text u-width-half u-width-10\/12@l u-a-center\">\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<h2 class=\"u-c-white u-normal u-m-b4\"><h2>Related resources<\/h2><p>Visit the resources section for more QP Services resources<\/p><\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<a class=\"c-btn c-btn--white\" href=\"\/clinical-services\/resources\/?topic=qualified-person\">Related Resources<\/a>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div> <!-- \/owrapper -->\n<\/article>\n\n\n<!-- TX1 title-image.php -->\n\t\t\t<div class=\"c-box-link-title-image inside bottom black strip-none standard left\">\n\t\t\t<div class=\"o-wrapper\">\n\t\t\t\t<div class=\"o-grid u-flex-align-stretch\">\n\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t<h2 class=\"u-p-b4 u-a-center\">Other clinical trial supply solutions<\/h2>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"o-grid u-flex-align-stretch u-m-b6@m u-overflow-hidden u-overflow-initial@l \">\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article class=\"o-grid__item u-width-4\/12 u-width-6\/12@m u-width-full@s\" id=\"\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- Show the correct button based off pop up to show or not -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/clinical-services\/clinical-trial-supply\/packaging-labelling-solutions\/\">\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<header class=\"c-link-box__image lazyload\" \n                                                                        role=\"img\" aria-label=\"\" \n                                                                        style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/Image.png&#039;)\">\n   \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-link-box__content strip-none\">\n\t\t\t\t\t\t\t\t\t\t<div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-m-b2\">Packaging &#038; Labelling Solutions<\/h3>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"u-m-b2\">\n\t\t\t\t\t\t\t\t\t\t\t\tUnderstanding and delivering your Global Clinical Supply Chain.\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\n\n    <div class=\"  u-m-t-auto \">\n                            <div class=\"c-btn c-btn-red c-btn--\">Find out more<\/div>\n                    <\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<!-- Only show pop up if acf is checked to show it -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/article>\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article class=\"o-grid__item u-width-4\/12 u-width-6\/12@m u-width-full@s\" id=\"\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- Show the correct button based off pop up to show or not -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/clinical-services\/clinical-trial-supply\/storage-distribution-returns\/\">\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<header class=\"c-link-box__image lazyload\" \n                                                                        role=\"img\" aria-label=\"\" \n                                                                        style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/Image-1.png&#039;)\">\n   \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-link-box__content strip-none\">\n\t\t\t\t\t\t\t\t\t\t<div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-m-b2\">Distribution including Storage and Return<\/h3>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"u-m-b2\">\n\t\t\t\t\t\t\t\t\t\t\t\tWe\u2019ve harnessed over 25 years\u2019 experience managing thousands of clinical programs worldwide to develop our robust clinical storage and distribution offering.\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\n\n    <div class=\"  u-m-t-auto \">\n                            <div class=\"c-btn c-btn-red c-btn--\">Find out more<\/div>\n                    <\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<!-- Only show pop up if acf is checked to show it -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/article>\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article class=\"o-grid__item u-width-4\/12 u-width-6\/12@m u-width-full@s\" id=\"\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- Show the correct button based off pop up to show or not -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/clinical-services\/clinical-trial-supply\/commercial-drug-procurement\/\">\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<header class=\"c-link-box__image lazyload\" \n                                                                        role=\"img\" aria-label=\"\" \n                                                                        style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/clinical-services\/wp-content\/uploads\/sites\/7\/2024\/07\/Image-8.png&#039;)\">\n   \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/header>\n\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"c-link-box__content strip-none\">\n\t\t\t\t\t\t\t\t\t\t<div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-m-b2\">Commercial Drug Procurement<\/h3>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"u-m-b2\">\n\t\t\t\t\t\t\t\t\t\t\t\tWe\u2019re here to deliver global logistics excellence.\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\n\n    <div class=\"  u-m-t-auto \">\n                            <div class=\"c-btn c-btn-red c-btn--\">Find out more<\/div>\n                    <\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<!-- Only show pop up if acf is checked to show it -->\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/article>\n\n\t\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\n\n<!-- Full Image Panel with centre text and button 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-->\n<\/article>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":6731,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-clinical-services-default.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6884","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Qualified Person Services - Clinical Services<\/title>\n<meta name=\"description\" content=\"A Qualified Person assumes personal responsibility for certifying each batch of material prior to release into EU, EEA or UK clinical trials.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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