{"id":31018,"date":"2020-12-02T14:24:21","date_gmt":"2020-12-02T17:24:21","guid":{"rendered":"https:\/\/radiolifefm.com.br\/noticias\/?p=31018"},"modified":"2026-04-16T07:36:17","modified_gmt":"2026-04-16T10:36:17","slug":"anvisa-inicia-inspecao-de-fabricacao-de-vacinas-na-china","status":"publish","type":"post","link":"https:\/\/radiolifefm.com.br\/noticias\/anvisa-inicia-inspecao-de-fabricacao-de-vacinas-na-china\/","title":{"rendered":"Anvisa inicia inspe\u00e7\u00e3o de fabrica\u00e7\u00e3o de vacinas na China"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<p>Uma equipe de inspetores, designados pela Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa), j\u00e1 est\u00e1 na\u00a0China\u00a0em miss\u00e3o para vistoriar as empresas Sinovac e Wuxi Biologics, envolvidas nas pesquisas de vacinas contra a covid-19. A viagem ser\u00e1 at\u00e9 11 de dezembro.<\/p>\n<p>&nbsp;<\/p>\n<p>Ontem (30), no primeiro dia de inspe\u00e7\u00e3o, eles verificaram as\u00a0 pr\u00e1ticas de fabrica\u00e7\u00e3o da vacina CoronaVac, da Sinovac, que est\u00e1 em fase de testes no Brasil, em parceria com o Instituto Butantan. Caso seja eficaz, o \u00f3rg\u00e3o passar\u00e1 a fabricar a vacina com os insumos da Sinovac e, posteriormente, com insumos pr\u00f3prios.<\/p>\n<p>&nbsp;<\/p>\n<p>Foram analisados os pontos do sistema de gest\u00e3o da qualidade farmac\u00eautica da empresa, como o gerenciamento de risco, gerenciamento de documentos e plano mestre de valida\u00e7\u00e3o, al\u00e9m dos requisitos t\u00e9cnicos dos bancos de sementes e celulares (part\u00edculas virais e c\u00e9lulas hospedeiras utilizadas na fabrica\u00e7\u00e3o da vacina).<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Procedimentos de amostragem<\/strong><\/p>\n<p>De acordo com a Anvisa, outra parte da equipe dedicou-se \u00e0 verifica\u00e7\u00e3o das condi\u00e7\u00f5es aplic\u00e1veis aos procedimentos de amostragem de mat\u00e9rias-primas, qualifica\u00e7\u00e3o de fornecedores, sistema de numera\u00e7\u00e3o de lotes e qualifica\u00e7\u00e3o de transporte.<\/p>\n<p>&nbsp;<\/p>\n<p>Em comunicado, a Anvisa esclareceu que a equipe segue uma agenda de trabalho que se estender\u00e1 at\u00e9 sexta-feira (4) na empresa Sinovac.<\/p>\n<p>&nbsp;<\/p>\n<p>\u201cO cronograma inclui em cada dia diferentes requisitos t\u00e9cnicos a serem constatados para avaliar se a fabrica\u00e7\u00e3o da vacina transcorre de acordo com o regulamento de Boas Pr\u00e1ticas da Ag\u00eancia, o qual est\u00e1 a par e passo com os regulamentos utilizados pelas principais ag\u00eancias sanit\u00e1rias internacionais\u201d, informou a ag\u00eancia reguladora.<\/p>\n<p>&nbsp;<\/p>\n<p>Do dia 7 ao dia 11, a equipe estar\u00e1 na Wuxi Biologics, que produz os insumos para a vacina da farmac\u00eautica AstraZeneca, que est\u00e1 desenvolvendo o imunizante em parceria com a Universidade de Oxford. Essa vacina tamb\u00e9m est\u00e1 sendo testada no Brasil e, em caso de sucesso, ser\u00e1 fabricada no pa\u00eds pela Funda\u00e7\u00e3o Oswaldo Cruz (Fiocruz), do Minist\u00e9rio da Sa\u00fade.<\/p>\n<p>&nbsp;<\/p>\n<p>Fonte: Adamantina Net<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Uma equipe de inspetores, designados pela Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa), j\u00e1 est\u00e1 na\u00a0China\u00a0em miss\u00e3o para vistoriar as empresas Sinovac e Wuxi Biologics, envolvidas nas pesquisas de vacinas contra a covid-19. A viagem ser\u00e1 at\u00e9 11 de dezembro. &nbsp; Ontem (30), no primeiro dia de inspe\u00e7\u00e3o, eles verificaram as\u00a0 pr\u00e1ticas de fabrica\u00e7\u00e3o da vacina [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":24340,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[35],"tags":[],"class_list":["post-31018","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anvisa inicia inspe\u00e7\u00e3o de fabrica\u00e7\u00e3o de vacinas na China - R\u00e1dio Life FM<\/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:\/\/radiolifefm.com.br\/noticias\/anvisa-inicia-inspecao-de-fabricacao-de-vacinas-na-china\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anvisa inicia inspe\u00e7\u00e3o de fabrica\u00e7\u00e3o de vacinas na China - R\u00e1dio Life FM\" \/>\n<meta property=\"og:description\" content=\"Uma equipe de inspetores, designados pela Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa), j\u00e1 est\u00e1 na\u00a0China\u00a0em miss\u00e3o para vistoriar as empresas Sinovac e Wuxi Biologics, envolvidas nas pesquisas de vacinas contra a covid-19. 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