{"id":64,"date":"2022-10-10T03:06:09","date_gmt":"2022-10-10T03:06:09","guid":{"rendered":"https:\/\/zenithpv.ca\/?p=64"},"modified":"2025-10-25T13:34:11","modified_gmt":"2025-10-25T17:34:11","slug":"preparation-a-laudit-gvp-votre-guide-pour-reussir-votre-audit-de-pharmacovigilance","status":"publish","type":"post","link":"https:\/\/zenithpv.ca\/fr\/2022\/10\/10\/preparation-a-laudit-gvp-votre-guide-pour-reussir-votre-audit-de-pharmacovigilance\/","title":{"rendered":"Pr\u00e9paration \u00e0 l&#039;audit GVP\u00a0: votre guide pour r\u00e9ussir votre audit de pharmacovigilance"},"content":{"rendered":"<p>L&#039;inspection GVP de Sant\u00e9 Canada est con\u00e7ue pour \u00e9valuer la conformit\u00e9 des titulaires d&#039;autorisations de mise sur le march\u00e9 \u00e9trangers et locaux aux lignes directrices GVP, afin de garantir qu&#039;un syst\u00e8me ad\u00e9quat est en place pour surveiller l&#039;utilisation s\u00fbre et efficace des m\u00e9dicaments.<sup>1<\/sup> \u00c0 ce titre, l\u2019\u00e9valuation de la conformit\u00e9 est essentielle \u00e0 la continuit\u00e9 des soins et \u00e0 l\u2019am\u00e9lioration de la sant\u00e9 des patients.<\/p>\n<p>Sant\u00e9 Canada a clairement \u00e9tabli des lignes directrices et des exigences exigeant que tous les titulaires d&#039;autorisation de mise en march\u00e9 (DAMM) effectuent des audits de leurs syst\u00e8mes de pharmacovigilance, y compris des audits ax\u00e9s sur les risques de leurs proc\u00e9dures op\u00e9rationnelles normalis\u00e9es et de leurs syst\u00e8mes. Cette exigence n&#039;est pas nouvelle. Pourtant, il est difficile de comprendre pourquoi de nombreux DAMM peinent \u00e0 g\u00e9rer les audits et les inspections qui y sont associ\u00e9s.<\/p>\n<p>Bien que ses cycles soient pr\u00e9visibles, HC peut auditer n&#039;importe quelle organisation \u00e0 tout moment. Les entreprises les moins observ\u00e9es maintiennent constamment leurs syst\u00e8mes PV \u00e0 jour et adoptent une approche ax\u00e9e sur la qualit\u00e9 et l&#039;apprentissage. C&#039;est ce qui les distingue des entreprises qui \u00e9chouent lors des audits.<\/p>\n<p>L&#039;objectif principal d&#039;un audit photovolta\u00efque par les autorit\u00e9s de r\u00e9gulation est de garantir le respect des normes et l&#039;int\u00e9grit\u00e9 des donn\u00e9es. L&#039;important n&#039;est pas de r\u00e9ussir l&#039;audit GVP pr\u00e9vu, mais d&#039;anticiper et d&#039;\u00eatre pr\u00eat \u00e0 tout moment pour garantir l&#039;efficacit\u00e9 et la conformit\u00e9 du syst\u00e8me photovolta\u00efque.<\/p>\n<p>Cela n\u00e9cessite que le titulaire de l&#039;autorisation de mise sur le march\u00e9 effectue un travail quotidien continu et diligent pour garantir la conformit\u00e9 aux directives GVP et, ce faisant, il peut \u00eatre pr\u00eat \u00e0 \u00eatre audit\u00e9 \u00e0 tout moment, et pas seulement lorsqu&#039;un audit est annonc\u00e9.<\/p>\n<p>D&#039;apr\u00e8s notre exp\u00e9rience, les domaines communs dans lesquels les MAH ont tendance \u00e0 \u00e9chouer \u00e0 maintenir un syst\u00e8me PV conforme incluent, sans s&#039;y limiter, les suivants, malgr\u00e9 les SOP qui peuvent \u00eatre en place <sup>2,3<\/sup>:<\/p>\n<ul>\n<li>D\u00e9faut de d\u00e9montrer des proc\u00e9dures ad\u00e9quates pour la gestion du traitement et de la gestion des ADR<\/li>\n<li>Manque de qualification ad\u00e9quate des travaux effectu\u00e9s par les partenaires de services externes ;<\/li>\n<li>Formation et dossiers de formation et surveillance PV insuffisants ou mal document\u00e9s ;<\/li>\n<li>Absence d&#039;accords PV multipartites d\u00e9crivant les responsabilit\u00e9s respectives de chaque partie en mati\u00e8re de PV<\/li>\n<li>Collecte et gestion incoh\u00e9rentes ou inad\u00e9quates des informations sur la s\u00e9curit\u00e9<\/li>\n<li>D\u00e9faillances de l&#039;\u00e9valuation continue de la s\u00e9curit\u00e9, notamment en ce qui concerne la gestion des b\u00e9n\u00e9fices et des risques, la gestion des signaux et les rapports agr\u00e9g\u00e9s (ASR et PSUR)<\/li>\n<li>Manque de personnel qualifi\u00e9 et de ressources ad\u00e9quates<\/li>\n<li>D\u00e9faut de garantir un archivage\/des sauvegardes s\u00fbrs, un archivage num\u00e9rique et une planification de la continuit\u00e9 des activit\u00e9s<\/li>\n<li>Manque de prise en compte des observations d\u2019inspection GVP pass\u00e9es et de la mise en \u0153uvre des CAPA.<\/li>\n<\/ul>\n<p>Les entreprises les plus performantes n&#039;attendent pas l&#039;annonce de la date du prochain audit. Les \u00e9valuations de pr\u00e9paration \u00e0 l&#039;audit font partie de leur cycle d&#039;am\u00e9lioration continue et sont r\u00e9alis\u00e9es p\u00e9riodiquement, chaque ann\u00e9e. Gr\u00e2ce \u00e0 une planification ad\u00e9quate et au soutien de nos experts qui la planifient et la mettent en \u0153uvre pour vous, vous aussi pouvez envisager votre prochain audit en toute confiance et obtenir une note de r\u00e9clamation.<\/p>\n<p>R\u00e9f\u00e9rences:<\/p>\n<ol>\n<li>\u00c0 propos des inspections de bonnes pratiques de pharmacovigilance (BPP) : <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/inspecting-monitoring-drug-health-products\/drug-health-product-inspections\/about-good-pharmacovigilance-practices-gvp-inspections.html\">\u00c0 propos des inspections des bonnes pratiques de pharmacovigilance (BPV) \u2013 Canada.ca<\/a><\/li>\n<li>Lignes directrices sur les bonnes pratiques de pharmacovigilance (BPP) (GUI-0102) : <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/good-manufacturing-practices\/guidance-documents\/pharmacovigilance-guidelines-0102.html\">Lignes directrices sur les bonnes pratiques de pharmacovigilance (BPP) (GUI-0102) \u2013 Canada.ca<\/a><\/li>\n<li>Guide Zenith PV pour un manuel d&#039;audit r\u00e9ussi<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>L&#039;inspection GVP de Sant\u00e9 Canada est con\u00e7ue pour \u00e9valuer la conformit\u00e9 des titulaires d&#039;autorisations de mise sur le march\u00e9 \u00e9trangers et locaux aux lignes directrices GVP, afin de garantir qu&#039;un syst\u00e8me ad\u00e9quat est en place pour surveiller l&#039;utilisation s\u00fbre et efficace des m\u00e9dicaments.1 \u00c0 ce titre, l&#039;\u00e9valuation de la conformit\u00e9 est essentielle \u00e0 la continuit\u00e9 des soins et \u00e0 l&#039;am\u00e9lioration des patients.<\/p>","protected":false},"author":1,"featured_media":419,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[],"class_list":["post-64","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all-articles"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.2 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>GVP Audit Readiness: Your guide to pharmacovigilance audit success - ZenithPV<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/zenithpv.ca\/fr\/2022\/10\/10\/preparation-a-laudit-gvp-votre-guide-pour-reussir-votre-audit-de-pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_CA\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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