{"id":8260,"date":"2025-04-28T11:23:26","date_gmt":"2025-04-28T10:23:26","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8260"},"modified":"2025-04-28T11:23:26","modified_gmt":"2025-04-28T10:23:26","slug":"boas-praticas-fabricacao-medicamentos","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/boas-praticas-fabricacao-medicamentos\/","title":{"rendered":"Anvisa publica nova resolu\u00e7\u00e3o sobre Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o de Medicamentos"},"content":{"rendered":"<h2>Publica\u00e7\u00e3o no Di\u00e1rio Oficial da Uni\u00e3o<\/h2>\n<p class=\"\" data-start=\"313\" data-end=\"649\">A Anvisa (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) publicou na passada quarta-feira, <strong data-start=\"394\" data-end=\"417\">23 de abril de 2025<\/strong>, a <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-da-diretoria-colegiada-anvisa-n-972-de-22-de-abril-de-2025-625449326\"><strong data-start=\"421\" data-end=\"475\">Resolu\u00e7\u00e3o da Diretoria Colegiada (RDC) n\u00ba 972\/2025<\/strong><\/a>, no <em data-start=\"480\" data-end=\"505\">Di\u00e1rio Oficial da Uni\u00e3o<\/em>. O novo texto atualiza a <a href=\"https:\/\/anvisalegis.datalegis.net\/action\/ActionDatalegis.php?acao=abrirTextoAto&amp;link=S&amp;tipo=RDC&amp;numeroAto=00000658&amp;seqAto=000&amp;valorAno=2022&amp;orgao=RDC\/DC\/ANVISA\/MS&amp;cod_modulo=310&amp;cod_menu=8542\"><strong data-start=\"531\" data-end=\"550\">RDC n\u00ba 658\/2022<\/strong><\/a>, que estabelece as <strong data-start=\"570\" data-end=\"638\">Diretrizes Gerais de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o de Medicamentos<\/strong> no Brasil.<\/p>\n<h2><strong>Principais mudan\u00e7as na RDC n\u00ba 658\/2022<\/strong><\/h2>\n<p class=\"\" data-start=\"703\" data-end=\"847\">A principal altera\u00e7\u00e3o trazida pela RDC n\u00ba 972\/2025 est\u00e1 no artigo 372. A nova reda\u00e7\u00e3o permite mais flexibilidade para as empresas farmac\u00eauticas:<\/p>\n<ul data-start=\"849\" data-end=\"1286\">\n<li class=\"\" data-start=\"849\" data-end=\"1124\">\n<p class=\"\" data-start=\"851\" data-end=\"1124\"><strong data-start=\"851\" data-end=\"881\">Controle on-line opcional:<\/strong><br data-start=\"881\" data-end=\"884\" \/>A implementa\u00e7\u00e3o do controle on-line, prevista no artigo 215, poder\u00e1 ser dispensada <strong data-start=\"969\" data-end=\"1003\">mediante justificativa t\u00e9cnica<\/strong>, desde que a empresa adote <strong data-start=\"1031\" data-end=\"1071\">estrat\u00e9gias de controle alternativas<\/strong> com base no <strong data-start=\"1084\" data-end=\"1123\">gerenciamento de risco da qualidade<\/strong>.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1126\" data-end=\"1286\">\n<p class=\"\" data-start=\"1128\" data-end=\"1286\"><strong data-start=\"1128\" data-end=\"1156\">Revoga\u00e7\u00e3o de par\u00e1grafos:<\/strong><br data-start=\"1156\" data-end=\"1159\" \/>Foram <strong data-start=\"1167\" data-end=\"1208\">revogados o \u00a71\u00ba e o \u00a72\u00ba do artigo 372<\/strong>, que anteriormente detalhavam exig\u00eancias espec\u00edficas para o controle on-line.<\/p>\n<\/li>\n<\/ul>\n<h2 data-start=\"1293\" data-end=\"1339\">Quando a nova resolu\u00e7\u00e3o entra em vigor?<\/h2>\n<p class=\"\" data-start=\"1341\" data-end=\"1442\">A RDC n\u00ba 972\/2025 <strong data-start=\"1359\" data-end=\"1404\">entrou em vigor na data da sua publica\u00e7\u00e3o<\/strong>, ou seja, <strong data-start=\"1415\" data-end=\"1441\">em 23 de abril de 2025<\/strong>.<\/p>\n<h2 data-start=\"1449\" data-end=\"1510\">Documento de Perguntas e Respostas ainda n\u00e3o dispon\u00edvel<\/h2>\n<p class=\"\" data-start=\"1512\" data-end=\"1761\">A Anvisa havia sinalizado durante a <strong data-start=\"1548\" data-end=\"1580\">6\u00aa Reuni\u00e3o Ordin\u00e1ria P\u00fablica<\/strong>, realizada em 16 de abril de 2025, que o <strong data-start=\"1622\" data-end=\"1660\">documento de Perguntas e Respostas<\/strong> seria atualizado, especialmente no que diz respeito ao <strong data-start=\"1716\" data-end=\"1760\">local de guarda das amostras de reten\u00e7\u00e3o<\/strong>.<\/p>\n<p class=\"\" data-start=\"1763\" data-end=\"1947\">At\u00e9 o momento, este material <strong data-start=\"1792\" data-end=\"1838\">ainda n\u00e3o foi disponibilizado pela Ag\u00eancia<\/strong>. Assim que houver publica\u00e7\u00e3o oficial, as informa\u00e7\u00f5es ser\u00e3o repassadas aos profissionais e empresas do setor.<\/p>\n<h2 data-start=\"1954\" data-end=\"2014\">Leitura recomendada: Voto n\u00ba 86\/2025\/SEI\/DIRE4\/Anvisa<\/h2>\n<p class=\"\" data-start=\"2016\" data-end=\"2198\">Para compreender melhor o contexto e os argumentos por tr\u00e1s das altera\u00e7\u00f5es, \u00e9 recomendada a leitura do <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/composicao\/diretoria-colegiada\/reunioes-da-diretoria\/votos\/2025\/rop-6.2025\/2-2-e-2-3.pdf\"><strong data-start=\"2119\" data-end=\"2155\">Voto n\u00ba 86\/2025\/SEI\/DIRE4\/Anvisa<\/strong><\/a>, aprovado durante a reuni\u00e3o de 16\/04\/2025.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Anvisa (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) publicou na passada quarta-feira, 23 de abril de 2025, a Resolu\u00e7\u00e3o da Diretoria Colegiada (RDC) n\u00ba 972\/2025, no Di\u00e1rio Oficial da Uni\u00e3o. O novo texto atualiza a RDC n\u00ba 658\/2022, que estabelece as Diretrizes Gerais de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o de Medicamentos no Brasil.<\/p>\n","protected":false},"author":9,"featured_media":8262,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[84,67,68,53,65,60,69],"tags":[86,70],"class_list":["post-8260","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa","category-els","category-els-group","category-geral","category-medicamentos","category-noticias","category-questoes-regulatorias","tag-anvisa","tag-medicamentos"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>RDC n\u00ba 658\/2022: Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o de Medicamentos<\/title>\n<meta name=\"description\" content=\"Anvisa atualiza a RDC n\u00ba 658\/2022, que estabelece as Diretrizes Gerais de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o de Medicamentos no Brasil.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa\" \/>\n<meta property=\"og:description\" content=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa para garantir o abastecimento de produtos cr\u00edticos.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/els-solutions.com\/pt-pt\/boas-praticas-fabricacao-medicamentos\/\" \/>\n<meta property=\"og:site_name\" content=\"ELS Group - 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