{"id":8261,"date":"2025-04-28T11:23:26","date_gmt":"2025-04-28T10:23:26","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8261"},"modified":"2025-04-28T11:22:46","modified_gmt":"2025-04-28T10:22:46","slug":"good-manufacturing-practices-for-medicines","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/good-manufacturing-practices-for-medicines\/","title":{"rendered":"Anvisa publishes new resolution on Good Manufacturing Practices for Medicines"},"content":{"rendered":"<h2><strong>Publication in the Federal Official Gazette<\/strong><\/h2>\n<p>Anvisa (National Health Surveillance Agency) published Collegiate Board Resolution <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>(RDC) No. 972\/2025 in the Federal Official Gazette<\/strong><\/a> last Wednesday, <strong>April 23, 2025.<\/strong> The new text updates <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>RDC 658\/2022<\/strong><\/a>, which establishes the <strong>General Guidelines for Good Manufacturing Practices for Medicines<\/strong> in Brazil.<\/p>\n<h2><strong>Main changes to RDC 658\/2022<\/strong><\/h2>\n<p>The main change brought about by RDC 972\/2025 is in article 372. The new wording allows more flexibility for pharmaceutical companies:<\/p>\n<ul>\n<li><strong>Optional online control:<\/strong><\/li>\n<\/ul>\n<p>The implementation of online control, provided for in article 215, may be waived upon <strong>technical justification<\/strong>, provided that the company adopts <strong>alternative control strategies<\/strong> based on <strong>quality risk management<\/strong>.<\/p>\n<ul>\n<li><strong>Repeal of paragraphs:<\/strong><\/li>\n<\/ul>\n<p><strong>Paragraphs 1 and 2 of article 372<\/strong>, which previously detailed specific requirements for online control, have been repealed.<\/p>\n<h2><strong>When does the new resolution come into force?<\/strong><\/h2>\n<p>RDC No. 972\/2025 came into force on the date of its publication, i.e. on <strong>April 23, 2025<\/strong>.<\/p>\n<h2><strong>Questions and Answers document not yet available<\/strong><\/h2>\n<p>Anvisa had signaled during the <strong>6th Ordinary Public Meeting<\/strong>, held on April 16, 2025, that the <strong>Questions and Answers document <\/strong>would be updated, especially with regard to the <strong>storage location of retention samples<\/strong>.<\/p>\n<p>To date, this material <strong>has not been made available by the Agency.<\/strong> As soon as it is officially published, the information will be passed on to professionals and companies in the sector.<\/p>\n<h2><strong>Recommended reading: Vote No. 86\/2025\/SEI\/DIRE4\/Anvisa<\/strong><\/h2>\n<p>To better understand the context and arguments behind the changes, we recommend reading <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>Vote No. 86\/2025\/SEI\/DIRE4\/Anvisa<\/strong><\/a>, approved during the meeting of April 16, 2025.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Anvisa (National Health Surveillance Agency) published Collegiate Board Resolution (RDC) No. 972\/2025 in the Federal Official Gazette last Wednesday, April 23, 2025. The new text updates RDC 658\/2022, which establishes the General Guidelines for Good Manufacturing Practices for Medicines in Brazil.<\/p>\n","protected":false},"author":9,"featured_media":8263,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[101,164,54,189,222,102,95],"tags":[104,223,62,103],"class_list":["post-8261","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-els-group-en","category-general","category-geral-en","category-medicines","category-noticias-en","category-regulations","tag-anvisa-en","tag-medicine","tag-news","tag-regulations"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>RDC 658\/2022: Good Manufacturing Practices for Medicines<\/title>\n<meta name=\"description\" content=\"Anvisa updates RDC 658\/2022, which establishes the General Guidelines for Good Manufacturing Practices for Medicines in Brazil.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RDC 658\/2022: Good Manufacturing Practices for Medicines\" \/>\n<meta property=\"og:description\" content=\"Anvisa updates RDC 658\/2022, which establishes the General Guidelines for Good Manufacturing Practices for Medicines in Brazil.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/els-solutions.com\/en\/good-manufacturing-practices-for-medicines\/\" \/>\n<meta property=\"og:site_name\" content=\"ELS Group - 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