{"id":15928,"date":"2020-01-29T16:20:00","date_gmt":"2020-01-29T16:20:00","guid":{"rendered":"https:\/\/www.cosmed.fr\/newsletter\/newsletter-123\/"},"modified":"2021-04-09T07:21:02","modified_gmt":"2021-04-09T07:21:02","slug":"newsletter-123","status":"publish","type":"newsletter","link":"http:\/\/www.cosmed.fr\/en\/newsletter\/newsletter-123\/","title":{"rendered":"Newsletter 123"},"content":{"rendered":"
\n

D\u00e9livrance de certificats BPF par l’ANSM :\u00a0 pr\u00e9parez vos documents !<\/h2>\n

Fin 2019, les Minist\u00e8res Fran\u00e7ais de l\u2019Industrie et de la Sant\u00e9 ont pris des dispositions visant \u00e0 organiser la d\u00e9livrance des certificats de Bonnes Pratiques de Fabrication (BPF) par l\u2019Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des produits de sant\u00e9 (ANSM) pour l’exportation de produits cosm\u00e9tiques vers les pays hors Union Europ\u00e9enne (cf. newsletter 122 du 10\/01\/2020).<\/p>\n

Les d\u00e9crets sont actuellement en cours de finalisation. Lors d’une r\u00e9union au Minist\u00e8re de la Sant\u00e9 le lundi 27 janvier avec les organisations professionnelles (Cosmed et Febea), les autorit\u00e9s ont communiqu\u00e9 une liste des documents qui seront \u00e0 fournir par t\u00e9l\u00e9-enregistrement sur le site internet de l\u2019ANSM. Cette liste est peu susceptible d’\u00e9volution de sorte que les entreprises peuvent d’ores et d\u00e9j\u00e0 regrouper leurs pi\u00e8ces en vue d’un d\u00e9p\u00f4t\u00a0 :
\n– Liste des proc\u00e9dures couvrant les exigences d\u00e9crites par les BPF ou le Manuel qualit\u00e9 ;
\n– Organigramme des fonctions permettant la compr\u00e9hension de l\u2019organisation et du fonctionnement de la soci\u00e9t\u00e9, avec les effectifs par domaine d\u2019activit\u00e9 ;
\n– Proc\u00e9dure d’hygi\u00e8ne du personnel ;
\n– Proc\u00e9dure d\u2019entretien des locaux ;
\n– Proc\u00e9dure de gestion des installations de production d\u2019eau et sp\u00e9cifications de l\u2019eau utilis\u00e9e pour la fabrication des produits ;
\n– Proc\u00e9dure relative au contr\u00f4le des mati\u00e8res premi\u00e8res et des articles de conditionnent, des produits vrac et des produits finis ;
\n– Proc\u00e9dure de lib\u00e9ration des produits finis ;
\n– Proc\u00e9dure de gestion des non-conformit\u00e9s ;
\n– Proc\u00e9dure(s) relative(s) aux audits internes ;
\n– D\u00e9claration de conformit\u00e9 de la soci\u00e9t\u00e9 \u00e0 la Norme NF EN ISO 22716.<\/p>\n

Le calendrier d’application de ces dispositions reste encore \u00e0 \u00eatre pr\u00e9ciser. Selon toute vraisemblance les d\u00e9crets devraient \u00eatre publi\u00e9s d’ici quelques semaines.<\/p>\n

Cosmed accompagne les entreprises dans la mise en conformit\u00e9 aux exigences BPF. Plusieurs solutions peuvent \u00eatre envisag\u00e9es : formation en intra entreprise<\/a>, outil de diagnostic<\/a> (visant \u00e0 identifier les points critiques de votre syst\u00e8me BPF et les risques engendr\u00e9s par la non-conformit\u00e9 aux exigences de la norme 22716).
\nContactez formation@cosmed.fr.<\/div>\n","protected":false},"featured_media":0,"template":"","class_list":["post-15928","newsletter","type-newsletter","status-publish","hentry"],"acf":[],"yoast_head":"\nNewsletter 123 - Cosmed Certificats BPF ANSM norme iso 22716<\/title>\n<meta name=\"description\" content=\"D\u00e9livrance de certificats BPF par l'ANSM :\u00a0 pr\u00e9parez vos documents ! \u00a0\" \/>\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.cosmed.fr\/en\/newsletter\/newsletter-123\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Newsletter 123 - Cosmed Certificats BPF ANSM norme iso 22716\" \/>\n<meta property=\"og:description\" content=\"D\u00e9livrance de certificats BPF par l'ANSM :\u00a0 pr\u00e9parez vos documents ! \u00a0\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.cosmed.fr\/en\/newsletter\/newsletter-123\/\" \/>\n<meta property=\"og:site_name\" content=\"Cosmed\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-09T07:21:02+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.cosmed.fr\/en\/newsletter\/newsletter-123\/\",\"url\":\"https:\/\/www.cosmed.fr\/en\/newsletter\/newsletter-123\/\",\"name\":\"Newsletter 123 - Cosmed Certificats BPF ANSM norme iso 22716\",\"isPartOf\":{\"@id\":\"https:\/\/www.cosmed.fr\/en\/#website\"},\"datePublished\":\"2020-01-29T16:20:00+00:00\",\"dateModified\":\"2021-04-09T07:21:02+00:00\",\"description\":\"D\u00e9livrance de certificats BPF par l'ANSM :\u00a0 pr\u00e9parez vos documents ! 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