{"id":2809,"date":"2022-11-13T23:02:24","date_gmt":"2022-11-13T23:02:24","guid":{"rendered":"https:\/\/zenithpv.ca\/?p=577"},"modified":"2025-10-25T13:32:45","modified_gmt":"2025-10-25T17:32:45","slug":"le-coin-des-experts-pilote-daudit-gvp","status":"publish","type":"post","link":"https:\/\/zenithpv.ca\/fr\/2022\/11\/13\/le-coin-des-experts-pilote-daudit-gvp\/","title":{"rendered":"Coin des experts \u2013 Pilote d&#039;audit GVP"},"content":{"rendered":"<p>Au Canada, le programme d&#039;inspection des bonnes pratiques de pharmacovigilance (BPP) vise \u00e0 garantir que les \u00e9tablissements pharmaceutiques se conforment aux exigences r\u00e9glementaires post-approbation d\u00e9crites dans les lignes directrices sur les Bonnes pratiques de pharmacovigilance (BPP) [GUI-0102]. Les titulaires d&#039;autorisation de mise en march\u00e9 (DAMM) au Canada sont inspect\u00e9s selon une approche d&#039;\u00e9valuation des risques qui \u00e9tablit la fr\u00e9quence \u00e0 laquelle ils sont inspect\u00e9s par Sant\u00e9 Canada.<\/p>\n<p>Les inspections r\u00e9guli\u00e8res du GVP portent principalement sur la gestion et le traitement des effets ind\u00e9sirables des m\u00e9dicaments (EIM), ainsi que sur la pr\u00e9paration des rapports de synth\u00e8se annuels (RSA) apr\u00e8s l&#039;approbation d&#039;un m\u00e9dicament. Elles sont men\u00e9es sur site, \u00e0 distance ou en mode hybride, et visent \u00e0 examiner minutieusement toute la documentation relative au syst\u00e8me de PV, en lieu et place du titulaire de l&#039;autorisation de mise sur le march\u00e9 (TAMM) audit\u00e9.<\/p>\n<p>Sant\u00e9 Canada a r\u00e9cemment lanc\u00e9 un projet pilote d&#039;audit des VPV pour les titulaires d&#039;AMM \u00e0 faible risque. Notre auteur invit\u00e9, <strong>Randy Levitt<\/strong>, <strong>Doctorat<\/strong> &#8211; <em>Directeur, Pharmacovigilance et Affaires m\u00e9dicales chez Paladin Labs Inc.<\/em>. fournit des informations suppl\u00e9mentaires sur le projet pilote d&#039;audit et des r\u00e9flexions li\u00e9es aux audits GVP r\u00e9guliers.<\/p>\n<h1>Voici un r\u00e9sum\u00e9 de notre discussion avec Randy<\/h1>\n<p><strong>Qu\u2019est-ce que ce projet pilote d\u2019audit et pourquoi est-il important ?<\/strong><\/p>\n<p>En juin 2022, Sant\u00e9 Canada a annonc\u00e9 un projet pilote visant \u00e0 \u00e9valuer la conformit\u00e9 aux bonnes pratiques de fabrication (BVP) des titulaires d&#039;autorisation de mise sur le march\u00e9 (DAMM) \u00e0 faible risque. \u00c0 l&#039;instar de ce que fait la MHRA depuis des ann\u00e9es au Royaume-Uni, ce projet permettra \u00e0 l&#039;Inspectorat de concentrer ses ressources sur les DAM \u00e0 risque \u00e9lev\u00e9, car il utilisera une approche fond\u00e9e sur le risque pour planifier les inspections, qui tiendra compte de multiples facteurs, tels que le portefeuille de produits du titulaire d&#039;autorisation de mise sur le march\u00e9 et son historique de conformit\u00e9.<\/p>\n<p><strong>Comment le HC identifie-t-il les titulaires d\u2019une autorisation de mise sur le march\u00e9 (AMM) \u00e0 faible risque et comment les cible-t-il ?<\/strong><\/p>\n<p>Sant\u00e9 Canada a d\u00e9fini les \u201c\u00a0titulaires d&#039;autorisation de mise sur le march\u00e9 (DAMM) \u00e0 faible risque\u00a0\u201d comme les titulaires d&#039;autorisation de mise sur le march\u00e9 (DAMM) \u00e9trangers et locaux qui d\u00e9tiennent des m\u00e9dicaments ne pr\u00e9sentant pas de risque pour la s\u00e9curit\u00e9 de la population et ne sont pas susceptibles de provoquer de nombreux effets ind\u00e9sirables graves. Cela inclut \u00e9galement les DAMM ne pr\u00e9sentant aucun signe de mauvaise conformit\u00e9 aux BVP.<\/p>\n<p><strong>Quels m\u00e9dicaments sont couverts par le champ d\u2019application de l\u2019audit pilote ?<\/strong><\/p>\n<ul>\n<li>Produits pharmaceutiques (en vente libre et sur ordonnance)<\/li>\n<li>Produits biologiques, y compris les produits biotechnologiques, les vaccins et le sang fractionn\u00e9<\/li>\n<li>produits<\/li>\n<li>produits radiopharmaceutiques<\/li>\n<li>gaz m\u00e9dicaux<\/li>\n<\/ul>\n<p><strong>En quoi est-ce diff\u00e9rent d\u2019un audit GVP p\u00e9riodique ?\u00a0<\/strong><\/p>\n<p>Sant\u00e9 Canada a inform\u00e9 les titulaires d&#039;autorisation de mise sur le march\u00e9 (DAMM) s\u00e9lectionn\u00e9s en juillet 2022 de leur participation au projet pilote. Ces derniers ont \u00e9t\u00e9 invit\u00e9s \u00e0 r\u00e9pondre \u00e0 un questionnaire et \u00e0 fournir les documents requis avant la fin ao\u00fbt 2022, lesquels seront examin\u00e9s par les inspecteurs de la VP. Le questionnaire servira \u00e0 \u00e9valuer si le titulaire d&#039;autorisation de mise sur le march\u00e9 (DAMM) dispose de proc\u00e9dures et de syst\u00e8mes ad\u00e9quats pour se conformer aux exigences canadiennes de la VP et permettra d&#039;\u00e9valuer sa compr\u00e9hension de ces exigences. Si la r\u00e9ponse du titulaire d&#039;autorisation de mise sur le march\u00e9 est jug\u00e9e insatisfaisante, une inspection sera planifi\u00e9e entre septembre 2022 et mars 2023.<\/p>\n<p>De plus, Sant\u00e9 Canada pourrait d\u00e9cider d&#039;inspecter un certain nombre de titulaires d&#039;autorisation de mise sur le march\u00e9 (DAMM) ayant fourni une r\u00e9ponse satisfaisante afin d&#039;en v\u00e9rifier l&#039;exactitude. Tous les DAMM invit\u00e9s \u00e0 r\u00e9pondre au questionnaire seront inform\u00e9s des r\u00e9sultats de l&#039;examen par les inspecteurs.<\/p>\n<p><strong>Quels sont les principaux domaines sur lesquels les titulaires d\u2019AMM devraient se concentrer s\u2019ils sont s\u00e9lectionn\u00e9s pour un audit GVP p\u00e9riodique suite \u00e0 leur r\u00e9ponse au projet d\u2019audit pilote ? <\/strong><\/p>\n<p>Les titulaires d&#039;autorisation de mise sur le march\u00e9 doivent d\u00e9montrer la mise en place de proc\u00e9dures et de syst\u00e8mes ad\u00e9quats pour se conformer aux exigences canadiennes en mati\u00e8re de bonnes pratiques de fabrication (BVP). En pr\u00e9paration d&#039;un audit BVP, les titulaires d&#039;autorisation de mise sur le march\u00e9 doivent tenir compte des points suivants\u00a0:<\/p>\n<ul>\n<li>Proc\u00e9dures op\u00e9rationnelles standard PV (SOP PV) et SOP associ\u00e9es (par exemple, informations m\u00e9dicales, r\u00e9clamations sur les produits)<\/li>\n<li>Syst\u00e8me et base de donn\u00e9es de pharmacovigilance<\/li>\n<li>Documentation incluant, sans s&#039;y limiter, les dossiers de formation, les enqu\u00eates sur les \u00e9carts, les accords PV, etc.<\/li>\n<\/ul>\n<p>R\u00e9cemment, Sant\u00e9 Canada a ajout\u00e9 les \u00e9l\u00e9ments suivants \u00e0 son inspection GVP standard :<\/p>\n<ul>\n<li>Plans de gestion des risques (conform\u00e9ment \u00e0 <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/reports-publications\/medeffect-canada\/profile-guidance-document-submission-risk-management-plans-follow-commitments.html\"><strong>ce<\/strong><\/a> document d&#039;orientation)<\/li>\n<li>Aviser Sant\u00e9 Canada des actions \u00e9trang\u00e8res (conform\u00e9ment \u00e0 <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/applications-submissions\/guidance-documents\/foreign-actions-profile\/guidance-document.html\"><strong>ce<\/strong><\/a> document d&#039;orientation)<\/li>\n<\/ul>\n<p><strong>Les r\u00e9sultats de l\u2019\u00e9valuation seront-ils publi\u00e9s en ligne ?<\/strong><\/p>\n<p>Les r\u00e9sultats de l&#039;\u00e9tape d&#039;\u00e9valuation du questionnaire ne seront pas rendus publics par Sant\u00e9 Canada. Les r\u00e9sultats des inspections r\u00e9guli\u00e8res du programme GVP seront toutefois publi\u00e9s.<\/p>\n<p><strong>\u00c0 propos de Zenith PV\u00a0<\/strong><\/p>\n<p>Si vous avez \u00e9t\u00e9 inform\u00e9 d&#039;une \u00e9valuation ou s\u00e9lectionn\u00e9 pour un audit, veuillez communiquer avec nous pour toute question concernant cet avis. Notre \u00e9quipe d&#039;experts en PV vous fournira les conseils et le soutien n\u00e9cessaires pour vous conformer \u00e0 l&#039;audit et aux exigences de Sant\u00e9 Canada en mati\u00e8re de bonnes pratiques de fabrication.<\/p>\n<p>Zenith PV peut vous accompagner dans l&#039;audit global ou dans des parties sp\u00e9cifiques de votre audit, telles que les plans de gestion des risques, apr\u00e8s une s\u00e9ance d&#039;\u00e9valuation des \u00e9carts gratuite avec votre \u00e9quipe.<\/p>\n<p>Appelez-nous aujourd&#039;hui pour planifier un appel d&#039;\u00e9valuation des \u00e9carts gratuit d&#039;une heure.<\/p>\n<p>R\u00e9f\u00e9rence:<\/p>\n<ul>\n<li><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<\/ul>","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":2818,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[],"class_list":["post-2809","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) - 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