{"id":32626,"date":"2022-04-15T15:41:46","date_gmt":"2022-04-15T13:41:46","guid":{"rendered":"https:\/\/www.unither-pharma.com\/?post_type=publication&#038;p=32626"},"modified":"2026-04-15T15:42:48","modified_gmt":"2026-04-15T13:42:48","slug":"comment-evaluer-la-qualite-dun-dispositif-pharmaceutique","status":"publish","type":"publication","link":"https:\/\/www.unither-pharma.com\/fr\/publication\/comment-evaluer-la-qualite-dun-dispositif-pharmaceutique\/","title":{"rendered":"Comment \u00e9valuer la qualit\u00e9 d&rsquo;un dispositif pharmaceutique ?"},"content":{"rendered":"\r\n\r\nDepuis toujours, la <strong>sant\u00e9<\/strong> est un sujet cl\u00e9 de notre vie. Tout le monde d\u00e9sire la pr\u00e9server et l\u2019am\u00e9liorer. Dans ce but, de nombreuses avanc\u00e9es technologiques et scientifiques ont \u00e9t\u00e9 mises en place et continuent \u00e0 \u00eatre d\u00e9velopp\u00e9es.\r\n\r\n\r\n\r\nDes dispositifs pharmaceutiques permettent notamment de gu\u00e9rir de multiples maladies ou, \u00a0au moins, de les ralentir. Bien s\u00fbr, la qualit\u00e9 doit \u00eatre au rendez-vous pour pr\u00e9tendre \u00e0 de tels effets. Mais alors, une question l\u00e9gitime se pose : comment \u00e9valuer la qualit\u00e9 d\u2019un <strong>dispositif pharmaceutique<\/strong> ?\r\n\r\n\r\n<h2 class=\"wp-block-heading\">D\u00e9veloppement du produit<\/h2>\r\n\r\n\r\nAu cours de la conception d\u2019un produit, il y a de multiples essais permettant de v\u00e9rifier constamment la qualit\u00e9 de celui-ci. Cela signifie que le projet est suivi de tr\u00e8s pr\u00e8s par une \u00e9quipe d\u00e9di\u00e9e, et cela, depuis son commencement jusqu&rsquo;\u00e0 sa commercialisation. Cette \u00e9quipe est compos\u00e9e d&rsquo;experts dans le domaine et dispose d\u2019<strong>\u00e9quipements modernes<\/strong> et homologu\u00e9s. Voici les diff\u00e9rents moyens et proc\u00e9d\u00e9 utilis\u00e9s pour garantir une bonne qualit\u00e9 :\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n \t<li>validation des m\u00e9thodes analytiques apr\u00e8s d\u00e9veloppement.<\/li>\r\n \t<li>transfert de ces m\u00e9thodes.<\/li>\r\n \t<li>utilisation de chambres climatiques pour le stockage des produits en suivant des conditions recommand\u00e9es par<strong> l\u2019ICH et L\u2019OMS<\/strong> (exposition lumineuse, humidit\u00e9, etc).<\/li>\r\n \t<li>\u00e9tudes de stabilit\u00e9 afin de d\u00e9terminer les conditions de stockage optimal. La dur\u00e9e de p\u00e9remption du produit peut ensuite \u00eatre calcul\u00e9e.<\/li>\r\n \t<li>dernier contr\u00f4le de qualit\u00e9 avant la lib\u00e9ration des lots pour leur commercialisation<\/li>\r\n \t<li>les substances inconnues doivent aussi \u00eatre identifi\u00e9es et caract\u00e9ris\u00e9es<\/li>\r\n<\/ul>\r\n\r\n\r\nDans le cadre du stockage, le programme ICH permet d\u2019assurer des conditions gr\u00e2ce \u00e0 une surveillance soutenue. Un syst\u00e8me d\u2019enregistrement reli\u00e9 \u00e0 des alarmes de s\u00e9curit\u00e9 permet de garantir la<strong> stabilit\u00e9 des produits<\/strong>. En fonction du volume de la chambre, tout est minutieusement calibr\u00e9.\r\n\r\n\r\n\r\nConcernant l\u2019\u00e9quipement, une large gamme rend possible l&rsquo;obtention de contr\u00f4le pouss\u00e9. Tout est mis en \u0153uvre afin de d\u00e9tecter le moindre probl\u00e8me dans la composition qui pourrait \u00eatre ind\u00e9sirable. Notre sant\u00e9 et notre vie en d\u00e9pendent !\r\n\r\n\r\n\r\nOn comprend qu\u2019un dispositif pharmaceutique tr\u00e8s r\u00e9glement\u00e9 et contr\u00f4l\u00e9 comme mentionn\u00e9 ci-dessus permet d\u2019aboutir \u00e0 une <strong>qualit\u00e9<\/strong> exemplaire.\r\n\r\n\r\n<h2 class=\"wp-block-heading\">Unither Pharmaceuticals<\/h2>\r\n\r\n\r\nC\u2019est justement la conduite que notre entreprise suit \u00e0 la lettre afin de vous garantir des produits fiables et de haute qualit\u00e9. Depuis plus de 30 ans, nous produisons des produits pharmaceutiques en sous-traitance et r\u00e9pondons au besoin de nos clients. Hormis la production, l\u2019innovation et le d\u00e9veloppement sont aussi au c\u0153ur de nos pr\u00e9occupations.\r\n\r\n\r\n\r\nNos<strong> unit\u00e9s de production<\/strong> sont inspect\u00e9es r\u00e9guli\u00e8rement par diverses agences. Que ce soient nos process ou nos installations, tout est jug\u00e9 conforme selon la r\u00e9glementation en vigueur.\r\n\r\n\r\n\r\nNous d\u00e9sirons constamment \u00e9voluer et fournir des prestations de qualit\u00e9 pour nos clients. Pour cela, nous cherchons \u00e0 rester \u00e0 la pointe de la technologie et \u00e0 continuer d\u2019innover. Nous nous penchons particuli\u00e8rement vers le \u00a0domaine du conditionnement afin d\u2019offrir des <strong>solutions adapt\u00e9es<\/strong> \u00e0 la situation de chacun de nos clients. La sant\u00e9 est un domaine important et il nous tient fortement \u00e0 c\u0153ur de faire notre maximum pour garantir une qualit\u00e9 \u00e9lev\u00e9e.\r\n\r\n","protected":false},"excerpt":{"rendered":"<p>Depuis toujours, la sant\u00e9 est un sujet cl\u00e9 de notre vie. Tout le monde d\u00e9sire la pr\u00e9server et l\u2019am\u00e9liorer. Dans ce but, de nombreuses avanc\u00e9es technologiques et scientifiques ont \u00e9t\u00e9 mises en place et continuent \u00e0 \u00eatre d\u00e9velopp\u00e9es. Des dispositifs pharmaceutiques permettent notamment de gu\u00e9rir de multiples maladies ou, \u00a0au moins, de les ralentir. Bien [&hellip;]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","meta":{"_acf_changed":false},"topic":[],"media_type":[],"class_list":["post-32626","publication","type-publication","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Comment \u00e9valuer la qualit\u00e9 d&#039;un dispositif pharmaceutique ? | Unither<\/title>\n<meta name=\"description\" content=\"Comment \u00e9valuer la qualit\u00e9 d&#039;un dispositif pharmaceutique ? | Unither\" \/>\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.unither-pharma.com\/fr\/publication\/comment-evaluer-la-qualite-dun-dispositif-pharmaceutique\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Comment \u00e9valuer la qualit\u00e9 d&#039;un dispositif pharmaceutique ? 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