{"id":80384,"date":"2021-07-08T13:58:29","date_gmt":"2021-07-08T11:58:29","guid":{"rendered":"https:\/\/www.newsteo.com\/?page_id=80384"},"modified":"2021-10-13T16:57:26","modified_gmt":"2021-10-13T14:57:26","slug":"sante-reglements-textes","status":"publish","type":"page","link":"https:\/\/www.newsteo.com\/fr\/assistance\/base-de-connaissance\/divers\/sante-reglements-textes\/","title":{"rendered":"Sant\u00e9 : r\u00e8glements, textes"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container fusion-parallax-none nonhundred-percent-fullwidth non-hundred-percent-height-scrolling recherche-base-de-connaissance\" 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style=\"--awb-bg-size:cover;--awb-margin-top:20px;--awb-margin-bottom:50px;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-column-wrapper-legacy\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-one title-menu-3-base\" style=\"--awb-margin-bottom:10px;--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h1 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\">Sant\u00e9 : r\u00e8glements, textes<\/h1><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-bottom:40px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:#e0dede;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-1\"><p>Les produits Newsteo vont vous aider \u00e0 \u00eatre conforme aux textes et r\u00e8glements impos\u00e9s dans le secteur de la sant\u00e9 et des laboratoires.<\/p>\n<p>&gt;\u00a0<a href=\"https:\/\/www.newsteo.com\/fr\/applications\/laboratoires_medical\/\" target=\"_blank\" rel=\"noopener noreferrer\">Conna\u00eetre les data loggers Newsteo pour le secteur de la sant\u00e9<\/a><br \/>\nPlusieurs r\u00e8glements ou recommandations s&rsquo;appliquent \u00e0 ce secteur.<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:30px;margin-bottom:30px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:#e0dede;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><p style=\"text-align: left;\"><strong>GBEA :\u00a0Guide de Bonne Ex\u00e9cution des Analyses m\u00e9dicales<\/strong><\/p>\n<p>\u200bExtraits du texte:<br \/>\n<em>III-2.2.3. Transport et transmission des \u00e9chantillons : Le transport des \u00e9chantillons doit respecter des r\u00e8gles qui assurent l&rsquo;int\u00e9grit\u00e9 de l&rsquo;\u00e9chantillon et la s\u00e9curit\u00e9 des personnels. Celles-ci s&rsquo;appliquent aussi aux \u00e9chantillons qui transitent par une pharmacie. Des proc\u00e9dures et des modes op\u00e9ratoires \u00e9crits par le laboratoire qui effectue l&rsquo;analyse doivent fixer les conditions particuli\u00e8res de d\u00e9lai de transport, de temp\u00e9rature de conservation et d&rsquo;int\u00e9grit\u00e9 de l&#8217;emballage des \u00e9chantillons biologiques.\u00a0<strong>Des indicateurs de dur\u00e9e de transmission et de rupture de la cha\u00eene du froid doivent \u00eatre mis en place lorsque les modalit\u00e9s de l&rsquo;analyse le pr\u00e9voient<\/strong>. Le biologiste transmetteur doit s&rsquo;assurer du respect de ces conditions.<\/em>\u200b<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:30px;margin-bottom:30px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:#e0dede;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\"><p style=\"text-align: left;\"><strong>CFR21 part 11<\/strong><\/p>\n<p>Le\u00a0<em>21 CFR part 11\u00a0<\/em>d\u00e9signe une r\u00e9glementation de la FDA (Food and Drug Administration) relative aux documents \u00e9lectroniques et aux signatures \u00e9lectroniques dans l&rsquo;industrie pharmaceutique. Elle d\u00e9finit les crit\u00e8res selon lesquels des documents \u00e9lectroniques et les signatures \u00e9lectroniques sont consid\u00e9r\u00e9s comme digne de confiance, fiable et \u00e9quivalent \u00e0 des dossiers papier.<br \/>\nLa version CFR21 du logiciel RF Monitor de Newsteo permet d&rsquo;\u00eatre conforme \u00e0 cette norme.<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:30px;margin-bottom:30px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:#e0dede;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-4\"><p style=\"text-align: left;\"><strong>Bonnes pratiques de distribution en gros des m\u00e9dicaments \u00e0 usage humain et des produits mentionn\u00e9s \u00e0 l&rsquo;article L. 5136-1 du code de la sant\u00e9 publique N\u00b0 2000\/9 bis\u00a0<\/strong><br \/>\n<strong>ARRETE DU 30 JUIN 2000 relatif aux bonnes pratiques de distribution en gros des m\u00e9dicaments \u00e0 usage humain et des produits mentionn\u00e9s \u00e0 l&rsquo;article L. 5136-1 du code de la sant\u00e9 publique NOR : MESPO022172A (Journal officiel du 19 juillet 2000)<\/strong><\/p>\n<p><a href=\"http:\/\/www.csrp.fr\/documentation\/guide-des-bonnes-pratiques\" target=\"_blank\" rel=\"noopener noreferrer\">&gt; T\u00e9l\u00e9charger le texte<\/a><br \/>\n<strong>\u200b<\/strong><br \/>\nExtraits du texte:<br \/>\n<em>CHAPITRE Ier GESTION DE LA QUALIT\u00c9 ASSURANCE DE LA QUALITE DE LA DISTRIBUTION EN GROS\u00a0<\/em><br \/>\n<em>1.2. Pour atteindre cet objectif, un syst\u00e8me d&rsquo;assurance de la qualit\u00e9 appropri\u00e9 \u00e0 la distribution en gros des produits pharmaceutiques doit garantir que :\u00a0\u00a0<\/em><br \/>\n<em>g) Les conditions de conservation sont respect\u00e9es \u00e0 tout moment, y compris au cours du transport ;\u00a0\u00a0<\/em><br \/>\n<em>CHAPITRE III\u00a0 LOCAUX ET MAT\u00c9RIEL\u00a0 STOCKAGE<\/em><br \/>\n<em>3.19. La temp\u00e9rature doit \u00eatre contr\u00f4l\u00e9e et enregistr\u00e9e p\u00e9riodiquement. Les enregistrements de temp\u00e9rature doivent \u00eatre r\u00e9guli\u00e8rement examin\u00e9s.<\/em><br \/>\n<em>3.20. Quand des conditions de temp\u00e9rature sp\u00e9cifiques sont exig\u00e9es, les zones de stockage doivent \u00eatre \u00e9quip\u00e9es d&rsquo;enregistreurs de temp\u00e9rature et\/ou d&rsquo;autres dispositifs indiquant le moment o\u00f9 les limites de temp\u00e9rature requise n&rsquo;ont pas \u00e9t\u00e9 respect\u00e9es ainsi que la dur\u00e9e pendant laquelle ces limites n&rsquo;ont pas \u00e9t\u00e9 respect\u00e9es.<\/em><br \/>\n<em>3.22. Les enregistrements de temp\u00e9rature doivent \u00eatre conserv\u00e9s, de pr\u00e9f\u00e9rence, pendant une dur\u00e9e au moins \u00e9gale \u00e0 trois ans et en tout \u00e9tat de cause coh\u00e9rente avec la dur\u00e9e de vie des produits.\u00a0\u00a0\u00a0<\/em><br \/>\n<em>CHAPITRE V PREPARATION ET LIVRAISON DES COMMANDES LIVRAISON\u00a0\u00a0<\/em><br \/>\n<em>5.14. Des \u00e9quipements sp\u00e9ciaux appropri\u00e9s doivent \u00eatre utilis\u00e9s pour le transport des produits pharmaceutiques dont le stockage exige des conditions particuli\u00e8res de conservation<\/em><br \/>\n<em>CHAPITRE VII DOCUMENTATION DOCUMENTS RENDUS OBLIGATOIRES PAR LA REGLEMENTATION PHARMACEUTIQUE<\/em><br \/>\n<em>7.1. Il s&rsquo;agit notamment des documents suivants :\u00a0<\/em><br \/>\n<em>&#8211; registres et documents obligatoires li\u00e9s \u00e0 la surveillance des produits soumis \u00e0 une r\u00e9glementation particuli\u00e8re;\u00a0\u00a0<\/em><br \/>\n<em>7.3. Ces documents doivent pouvoir \u00eatre mis \u00e0 la disposition des autorit\u00e9s comp\u00e9tentes pendant toute leur dur\u00e9e l\u00e9gale de d\u00e9tention.\u00a0\u00a0<\/em><br \/>\n<em>7.4. Toute documentation doit \u00eatre pr\u00e9sent\u00e9e sur demande aux autorit\u00e9s comp\u00e9tentes.\u00a0<\/em><br \/>\n<em>\u00a0Nature des documents\u00a0\u00a0<\/em><br \/>\n<em>7.7. Des proc\u00e9dures \u00e9crites doivent \u00eatre \u00e9tablies notamment pour :\u00a0<\/em><br \/>\n<em>j) Le suivi des produits soumis \u00e0 une r\u00e9glementation particuli\u00e8re ;<\/em><\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":28,"featured_media":0,"parent":80320,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-80384","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/pages\/80384","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/users\/28"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/comments?post=80384"}],"version-history":[{"count":0,"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/pages\/80384\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/pages\/80320"}],"wp:attachment":[{"href":"https:\/\/www.newsteo.com\/fr\/wp-json\/wp\/v2\/media?parent=80384"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}