{"id":9772,"date":"2026-09-22T14:37:36","date_gmt":"2026-09-22T12:37:36","guid":{"rendered":"https:\/\/antaresvisiongroup.com\/lifescience\/?page_id=9772"},"modified":"2026-09-22T14:37:36","modified_gmt":"2026-09-22T12:37:36","slug":"solucoes-de-rastreabilidade-para-o-setor-farmaceutico","status":"publish","type":"page","link":"https:\/\/antaresvisiongroup.com\/lifescience\/pt\/solucoes-de-rastreabilidade-para-o-setor-farmaceutico\/","title":{"rendered":"Solu\u00e7\u00f5es de rastreabilidade para o setor farmac\u00eautico"},"content":{"rendered":"\n<div class=\"kbreadcrumb\" id=\"k_year\">\n    <div class=\"pure-container\">\n        <div class=\"pure-g\">\n            <div class=\"pure-u-1-1\">\n                <div class=\"breadcrumbs\"><a href=\"https:\/\/antaresvisiongroup.com\/lifescience\">Home<\/a> | <\/div>            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div class=\"k-block-css\" hidden 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o setor farmac\u00eautico<\/strong><\/strong><\/strong><\/h1>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n<p class=\"wp-block-paragraph\"><strong>Software de serializa\u00e7\u00e3o, agrega\u00e7\u00e3o e rastreabilidade para fabricantes farmac\u00eauticos, CMO\/CDMO e titulares de autoriza\u00e7\u00f5es de introdu\u00e7\u00e3o no mercado (MAH) que operam em mercados globais regulamentados.<\/strong><\/p>\n\n\n<p class=\"wp-block-paragraph\">O Antares Vision Group apoia programas de rastreabilidade farmac\u00eautica em todas as camadas de embalagem e execu\u00e7\u00e3o da cadeia de abastecimento: desde a serializa\u00e7\u00e3o e agrega\u00e7\u00e3o ao n\u00edvel da linha de produ\u00e7\u00e3o at\u00e9 \u00e0 gest\u00e3o de instala\u00e7\u00f5es, rastreabilidade empresarial e conectividade regulamentar. O resultado \u00e9 uma arquitetura validada que ajuda os fabricantes a atribuir uma identidade \u00fanica a cada embalagem de medicamento, a criar hierarquias digitais de embalagem, a gerir eventos serializados e a trocar dados de conformidade com parceiros comerciais e sistemas regulamentares.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n<p class=\"wp-block-paragraph\">Um sistema de rastreabilidade farmac\u00eautica n\u00e3o \u00e9 apenas uma tecnologia aplicada \u00e0 linha de embalagem. Trata-se de uma arquitetura multin\u00edvel que liga o hardware de serializa\u00e7\u00e3o, a verifica\u00e7\u00e3o por vis\u00e3o, a agrega\u00e7\u00e3o, o software ao n\u00edvel da unidade, os sistemas empresariais e a conectividade regulamentar espec\u00edfica do mercado.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>O que \u00e9 o sistema de rastreabilidade farmac\u00eautica?<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">O rastreio e localiza\u00e7\u00e3o de produtos farmac\u00eauticos consiste na capacidade operacional de identificar, verificar e reconstituir o hist\u00f3rico de movimenta\u00e7\u00e3o dos medicamentos ao longo da cadeia de abastecimento. Combina a serializa\u00e7\u00e3o ao n\u00edvel do artigo, a agrega\u00e7\u00e3o de dados e a rastreabilidade baseada em eventos para criar uma cadeia de cust\u00f3dia audit\u00e1vel, desde o fabrico e a embalagem at\u00e9 \u00e0 distribui\u00e7\u00e3o e \u00e0 dispensa.<\/p>\n\n\n<p class=\"wp-block-paragraph\">Uma solu\u00e7\u00e3o de rastreabilidade farmac\u00eautica liga o equipamento da linha de embalagem ao software de serializa\u00e7\u00e3o, aos sistemas da f\u00e1brica e da empresa, aos dados de ERP\/MES e \u00e0s redes externas de entidades reguladoras ou de parceiros comerciais. Ajuda as empresas farmac\u00eauticas a gerir os requisitos de conformidade, ao mesmo tempo que melhora a visibilidade sobre produtos serializados, lotes, remessas e exce\u00e7\u00f5es.<\/p>\n\n\n<p class=\"wp-block-paragraph\">A serializa\u00e7\u00e3o atribui a cada embalagem uma identidade \u00fanica. A agrega\u00e7\u00e3o associa essa identidade \u00e0s caixas e aos paletes. O sistema de acompanhamento e rastreabilidade regista o que acontece a essas identidades ao longo das etapas de fabrico, embalagem, armazenamento, expedi\u00e7\u00e3o, verifica\u00e7\u00e3o e desativa\u00e7\u00e3o.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>Serializa\u00e7\u00e3o, agrega\u00e7\u00e3o e rastreabilidade: qual \u00e9 a diferen\u00e7a?<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">Embora sejam frequentemente utilizadas em conjunto, a serializa\u00e7\u00e3o, a agrega\u00e7\u00e3o e o sistema de rastreabilidade descrevem diferentes n\u00edveis do mesmo programa de rastreabilidade.<\/p>\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Camada<\/strong><\/td><td><strong>Papel na rastreabilidade farmac\u00eautica<\/strong><\/td><td><strong>\u00c2mbito t\u00edpico<\/strong><\/td><\/tr><tr><td>Serializa\u00e7\u00e3o<\/td><td>Atribui e verifica um identificador \u00fanico a cada unidade comercializ\u00e1vel, normalmente codificado num c\u00f3digo DataMatrix 2D que inclui o c\u00f3digo do produto, o n\u00famero de s\u00e9rie, o lote e a data de validade.<\/td><td>Linha de embalagem; impress\u00e3o e verifica\u00e7\u00e3o; gest\u00e3o de rejei\u00e7\u00f5es.<\/td><\/tr><tr><td>Agrega\u00e7\u00e3o<\/td><td>Cria rela\u00e7\u00f5es de hierarquia entre unidades serializadas, pacotes, caixas e paletes, permitindo a digitaliza\u00e7\u00e3o e o manuseamento de remessas a um n\u00edvel superior.<\/td><td>Linha de produ\u00e7\u00e3o, embalagem em caixas, paletiza\u00e7\u00e3o, esta\u00e7\u00f5es de agrupamento manuais ou automatizadas.<\/td><\/tr><tr><td>Rastreio e localiza\u00e7\u00e3o<\/td><td>Gere dados serializados, hierarquias de agrega\u00e7\u00e3o, eventos EPCIS ou espec\u00edficos do mercado, relat\u00f3rios regulamentares e troca de informa\u00e7\u00f5es com parceiros comerciais.<\/td><td>Conectividade entre instala\u00e7\u00f5es, empresas, cadeias de abastecimento e entidades reguladoras.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n<p class=\"wp-block-paragraph\">Esta distin\u00e7\u00e3o \u00e9 importante para a conce\u00e7\u00e3o da solu\u00e7\u00e3o. Um sistema de serializa\u00e7\u00e3o ao n\u00edvel da linha de produ\u00e7\u00e3o pode ser suficiente para uma \u00fanica linha de embalagem, enquanto uma solu\u00e7\u00e3o completa de rastreabilidade farmac\u00eautica abrange v\u00e1rias instala\u00e7\u00f5es, mercados e parceiros comerciais.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>Como funciona um sistema de rastreabilidade de produtos farmac\u00eauticos<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">Um sistema de rastreabilidade funciona atrav\u00e9s de uma sequ\u00eancia de opera\u00e7\u00f5es interligadas relacionadas com dados e embalagem. Cada etapa deve estar sincronizada com as ordens de produ\u00e7\u00e3o, os dados mestre, os registos de lotes, os formatos de embalagem e os requisitos regulamentares do mercado de destino.<\/p>\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Passo<\/strong><\/td><td><strong>Processo<\/strong><\/td><td><strong>O que acontece<\/strong><\/td><\/tr><tr><td>1<\/td><td>Gest\u00e3o de n\u00fameros de s\u00e9rie<\/td><td>Os n\u00fameros de s\u00e9rie s\u00e3o gerados, solicitados ou recebidos de acordo com as regras do mercado e a governa\u00e7\u00e3o empresarial.<\/td><\/tr><tr><td>2<\/td><td>Serializa\u00e7\u00e3o ao n\u00edvel da linha<\/td><td>Os c\u00f3digos s\u00e3o impressos, lidos e verificados em cada unidade comercializ\u00e1vel ao ritmo da linha de embalagem; as embalagens n\u00e3o conformes s\u00e3o rejeitadas.<\/td><\/tr><tr><td>3<\/td><td>Agrega\u00e7\u00e3o<\/td><td>As rela\u00e7\u00f5es pai-filho s\u00e3o criadas entre artigos, conjuntos, caixas e paletes atrav\u00e9s de fluxos de trabalho manuais ou automatizados.<\/td><\/tr><tr><td>4<\/td><td>Coloca\u00e7\u00e3o em funcionamento e registo de eventos<\/td><td>As unidades serializadas e as hierarquias de agrega\u00e7\u00e3o est\u00e3o associadas a eventos de lote, produ\u00e7\u00e3o e embalagem.<\/td><\/tr><tr><td>5<\/td><td>Comunica\u00e7\u00e3o, interc\u00e2mbio e verifica\u00e7\u00e3o<\/td><td>Os eventos s\u00e3o comunicados aos sistemas reguladores ou partilhados com os parceiros comerciais, apoiando os processos de envio, rece\u00e7\u00e3o, verifica\u00e7\u00e3o, recolha e desativa\u00e7\u00e3o.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>Software de Rastreio e Localiza\u00e7\u00e3o: Da rastreabilidade ao n\u00edvel da linha de produ\u00e7\u00e3o \u00e0 rastreabilidade empresarial<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">O software de rastreabilidade farmac\u00eautica \u00e9 a camada de aplica\u00e7\u00e3o que liga as opera\u00e7\u00f5es de embalagem aos requisitos de conformidade da unidade, da empresa e externos. Numa arquitetura t\u00edpica, est\u00e1 estruturado em v\u00e1rios n\u00edveis:<\/p>\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>N\u00edvel<\/strong><\/td><td><strong>Fun\u00e7\u00e3o<\/strong><\/td><td><strong>Principais utilizadores e decis\u00f5es<\/strong><\/td><\/tr><tr><td>L1\/L2 &#8211; N\u00edvel de linha e de m\u00e1quina<\/td><td>Controla impressoras, c\u00e2maras, dispositivos de rejei\u00e7\u00e3o, esta\u00e7\u00f5es de serializa\u00e7\u00e3o e equipamento de agrega\u00e7\u00e3o. Gere as opera\u00e7\u00f5es de impress\u00e3o e verifica\u00e7\u00e3o e a execu\u00e7\u00e3o da linha de produ\u00e7\u00e3o.<\/td><td>Engenharia de embalagens, produ\u00e7\u00e3o, fabricantes de equipamento original (OEM), integradores de sistemas.<\/td><\/tr><tr><td>L3 &#8211; N\u00edvel do local<\/td><td>Coordena a serializa\u00e7\u00e3o e a agrega\u00e7\u00e3o em v\u00e1rias linhas de produ\u00e7\u00e3o, gere a execu\u00e7\u00e3o de lotes, o retrabalho, as opera\u00e7\u00f5es de armaz\u00e9m e a elabora\u00e7\u00e3o de relat\u00f3rios ao n\u00edvel da unidade.<\/td><td>Respons\u00e1veis pela unidade de embalagem, controlo de qualidade, opera\u00e7\u00f5es e serializa\u00e7\u00e3o.<\/td><\/tr><tr><td>L4 &#8211; N\u00edvel empresarial<\/td><td>Gere conjuntos de n\u00fameros de s\u00e9rie, governa\u00e7\u00e3o em v\u00e1rias localiza\u00e7\u00f5es, integra\u00e7\u00e3o ERP\/MES, alinhamento de dados mestre e fluxos de trabalho de conformidade espec\u00edficos de cada mercado.<\/td><td>Equipas de serializa\u00e7\u00e3o empresarial, TI\/OT, cadeia de abastecimento, conformidade regulamentar, titulares de autoriza\u00e7\u00f5es de introdu\u00e7\u00e3o no mercado (MAHs).<\/td><\/tr><tr><td>L5 \/ Sistemas externos<\/td><td>Representa reposit\u00f3rios regulamentares, sistemas nacionais, portais governamentais ou redes de parceiros comerciais utilizados para fins de conformidade e interc\u00e2mbio de dados.<\/td><td>Entidades reguladoras, parceiros comerciais, distribuidores, grossistas, pontos de venda.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n<p class=\"wp-block-paragraph\">Esta estrutura em v\u00e1rios n\u00edveis reflete a forma como os projetos de serializa\u00e7\u00e3o farmac\u00eautica s\u00e3o implementados na pr\u00e1tica. O hardware e a integra\u00e7\u00e3o da linha de produ\u00e7\u00e3o s\u00e3o fundamentais ao n\u00edvel da embalagem, enquanto o software empresarial de rastreabilidade e monitoriza\u00e7\u00e3o assume um papel central quando o mesmo fabricante tem de coordenar v\u00e1rias instala\u00e7\u00f5es, CMOs, mercados e rela\u00e7\u00f5es regulat\u00f3rias.<\/p>\n\n\n<h3 class=\"wp-block-heading\"><strong>Principais funcionalidades do software<\/strong><\/h3>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Gera\u00e7\u00e3o, importa\u00e7\u00e3o, atribui\u00e7\u00e3o e gest\u00e3o do ciclo de vida de n\u00fameros de s\u00e9rie.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Controlo de \u00abimprimir e verificar\u00bb com inspe\u00e7\u00e3o visual integrada de c\u00f3digos 1D\/2D e dados leg\u00edveis a olho nu.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Fluxos de trabalho de agrupamento manuais e automatizados para pacotes, caixas e paletes.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Opera\u00e7\u00f5es de retrabalho, tratamento de exce\u00e7\u00f5es, desativa\u00e7\u00e3o e reativa\u00e7\u00e3o.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Gest\u00e3o de eventos e interc\u00e2mbio de dados com parceiros comerciais compat\u00edveis com o EPCIS.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Integra\u00e7\u00e3o entre ERP e MES para dados mestre, ordens de produ\u00e7\u00e3o, dados de lotes e informa\u00e7\u00f5es de expedi\u00e7\u00e3o.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Pain\u00e9is de controlo relativos ao estado da serializa\u00e7\u00e3o, relat\u00f3rios regulamentares, desempenho das linhas de produ\u00e7\u00e3o e exce\u00e7\u00f5es de conformidade.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Apoio \u00e0 valida\u00e7\u00e3o em ambientes GxP, incluindo documenta\u00e7\u00e3o de IQ\/OQ\/PQ, quando aplic\u00e1vel.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>Conce\u00e7\u00e3o de uma solu\u00e7\u00e3o de rastreabilidade para embalagens farmac\u00eauticas<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">Uma solu\u00e7\u00e3o de rastreabilidade deve ser concebida de acordo com os formatos de embalagem do fabricante, a configura\u00e7\u00e3o da linha de produ\u00e7\u00e3o, o \u00e2mbito de mercado, o portf\u00f3lio de produtos, a rede de CMO\/CDMO e o panorama inform\u00e1tico. A arquitetura adequada pode variar desde uma atualiza\u00e7\u00e3o de serializa\u00e7\u00e3o numa \u00fanica linha at\u00e9 uma plataforma empresarial global para serializa\u00e7\u00e3o em v\u00e1rias instala\u00e7\u00f5es e relat\u00f3rios regulamentares.<\/p>\n\n\n<p class=\"wp-block-paragraph\">Ao n\u00edvel da linha de embalagem, os sistemas de serializa\u00e7\u00e3o e agrega\u00e7\u00e3o podem ser integrados em equipamentos novos ou existentes, quer diretamente, quer em colabora\u00e7\u00e3o com fabricantes de equipamento original (OEM) e integradores de sistemas. Ao n\u00edvel das instala\u00e7\u00f5es e da empresa, o software de rastreabilidade \u00e9 normalmente selecionado e gerido pelos fabricantes farmac\u00eauticos, pelos CMO\/CDMO ou pelos titulares da autoriza\u00e7\u00e3o de introdu\u00e7\u00e3o no mercado (MAH), uma vez que envolve a estrat\u00e9gia de conformidade, a integra\u00e7\u00e3o com o ERP, a gest\u00e3o dos n\u00fameros de s\u00e9rie, a apresenta\u00e7\u00e3o de relat\u00f3rios de mercado e a troca de dados com os parceiros comerciais.<\/p>\n\n\n<h3 class=\"wp-block-heading\"><strong>Decis\u00f5es-chave de conce\u00e7\u00e3o<\/strong><\/h3>\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u00c2mbito regulamentar: quais os mercados que exigem serializa\u00e7\u00e3o, agrega\u00e7\u00e3o, comunica\u00e7\u00e3o de dados, verifica\u00e7\u00e3o ou interc\u00e2mbio de dados atrav\u00e9s do EPCIS.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Integra\u00e7\u00e3o de linhas: nova linha de embalagem, integra\u00e7\u00e3o de m\u00e1quinas OEM, adapta\u00e7\u00e3o ou moderniza\u00e7\u00e3o de equipamento existente.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Modelo de agrega\u00e7\u00e3o: esta\u00e7\u00f5es de trabalho de agrega\u00e7\u00e3o manual, agrega\u00e7\u00e3o semiautom\u00e1tica de caixas ou agrega\u00e7\u00e3o totalmente automatizada de caixas e paletes.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 N\u00edvel de software: apenas ao n\u00edvel da linha, serializa\u00e7\u00e3o ao n\u00edvel do local, rastreabilidade empresarial ou arquitetura multin\u00edvel completa.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Modelo de implementa\u00e7\u00e3o: no local, na nuvem ou h\u00edbrido, dependendo da pol\u00edtica de TI, da estrat\u00e9gia de valida\u00e7\u00e3o e dos requisitos de conectividade.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 N\u00edvel de integra\u00e7\u00e3o entre ERP e MES: apenas troca de dados mestre ou integra\u00e7\u00e3o total com ordens de produ\u00e7\u00e3o, registos de lotes e processos de expedi\u00e7\u00e3o.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Abordagem de valida\u00e7\u00e3o: documenta\u00e7\u00e3o, testes e controlo de altera\u00e7\u00f5es necess\u00e1rios para uma implementa\u00e7\u00e3o em conformidade com as normas GxP e para futuras atualiza\u00e7\u00f5es.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Conectividade com os parceiros comerciais: integra\u00e7\u00e3o direta, modelo de hub ou plataforma de interc\u00e2mbio espec\u00edfica para cada mercado, em conformidade com a DSCSA, a FMD da UE e outros requisitos.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>Requisitos de rastreabilidade de produtos farmac\u00eauticos nos mercados globais<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">Os requisitos de serializa\u00e7\u00e3o e rastreabilidade de produtos farmac\u00eauticos est\u00e3o agora estabelecidos em muitos mercados regulamentados, mas n\u00e3o s\u00e3o id\u00eanticos de pa\u00eds para pa\u00eds. Algumas regulamenta\u00e7\u00f5es centram-se na autentica\u00e7\u00e3o e na retirada de circula\u00e7\u00e3o das embalagens; outras exigem a agrega\u00e7\u00e3o, a troca de informa\u00e7\u00f5es sobre eventos na cadeia de abastecimento, a apresenta\u00e7\u00e3o de relat\u00f3rios \u00e0s autoridades ou a interoperabilidade entre parceiros comerciais.<\/p>\n\n\n<p class=\"wp-block-paragraph\">Nos Estados Unidos, a DSCSA assenta num sistema eletr\u00f3nico e interoper\u00e1vel de rastreabilidade e verifica\u00e7\u00e3o de produtos entre parceiros comerciais autorizados. O EPCIS \u00e9 amplamente utilizado para apoiar a troca padronizada de dados, mas a arquitetura baseia-se na troca interoper\u00e1vel, em vez de num \u00fanico reposit\u00f3rio nacional. Na Uni\u00e3o Europeia, a Diretiva relativa aos Medicamentos Falsificados centra-se na autentica\u00e7\u00e3o ao n\u00edvel da embalagem atrav\u00e9s de um identificador \u00fanico e de um dispositivo anti-adultera\u00e7\u00e3o, com verifica\u00e7\u00e3o e desativa\u00e7\u00e3o atrav\u00e9s do sistema europeu e nacional de verifica\u00e7\u00e3o de medicamentos. A agrega\u00e7\u00e3o n\u00e3o \u00e9 um requisito geral da Diretiva relativa aos Medicamentos Falsificados da UE, embora os fabricantes a implementem frequentemente para apoiar outros mercados e promover a efici\u00eancia operacional.<\/p>\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Mercado ou quadro de refer\u00eancia<\/strong><\/td><td><strong>Principal foco para os fabricantes<\/strong><\/td><td><strong>Nota de implementa\u00e7\u00e3o<\/strong><\/td><\/tr><tr><td>DSCSA &#8211; Estados Unidos<\/td><td>Rastreabilidade de produtos serializados, verifica\u00e7\u00e3o e interc\u00e2mbio de dados interoper\u00e1vel com parceiros comerciais autorizados.<\/td><td>A troca de dados baseada no EPCIS \u00e9 frequentemente utilizada para dados de transa\u00e7\u00f5es normalizados.<\/td><\/tr><tr><td>FMD da UE &#8211; Uni\u00e3o Europeia<\/td><td>Identificador \u00fanico, dispositivo anti-adultera\u00e7\u00e3o, carregamento no reposit\u00f3rio, verifica\u00e7\u00e3o e desativa\u00e7\u00e3o.<\/td><td>A agrega\u00e7\u00e3o n\u00e3o \u00e9, em geral, exigida pela FMD da UE, mas pode ser utilizada para outros mercados ou opera\u00e7\u00f5es.<\/td><\/tr><tr><td>GS1 EPCIS \/ CBV<\/td><td>Recolha e troca padronizadas de dados de eventos que descrevem o qu\u00ea, quando, onde e porqu\u00ea na cadeia de abastecimento.<\/td><td>\u00datil para a DSCSA, o interc\u00e2mbio entre parceiros e as arquiteturas de rastreabilidade global.<\/td><\/tr><tr><td>Outros mercados regulamentados<\/td><td>Requisitos espec\u00edficos de cada mercado em mat\u00e9ria de serializa\u00e7\u00e3o, agrega\u00e7\u00e3o, comunica\u00e7\u00e3o de dados e verifica\u00e7\u00e3o.<\/td><td>Os requisitos variam consoante o pa\u00eds e devem ser configurados de acordo com a regulamenta\u00e7\u00e3o local em vigor.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n<p class=\"wp-block-paragraph\">Para os fabricantes multinacionais e as CMO\/CDMO, o desafio pr\u00e1tico consiste em gerir estes diferentes requisitos numa \u00fanica arquitetura coerente de serializa\u00e7\u00e3o e rastreabilidade, reduzindo a duplica\u00e7\u00e3o e, ao mesmo tempo, garantindo a conformidade com os requisitos dos mercados locais.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>Solu\u00e7\u00f5es de rastreabilidade e localiza\u00e7\u00e3o para o setor farmac\u00eautico do Antares Vision Group<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">O Antares Vision Group fornece solu\u00e7\u00f5es farmac\u00eauticas de rastreio e localiza\u00e7\u00e3o que abrangem todo o conjunto de solu\u00e7\u00f5es de serializa\u00e7\u00e3o e rastreabilidade: hardware de linha de produ\u00e7\u00e3o, verifica\u00e7\u00e3o por vis\u00e3o, sistemas de agrega\u00e7\u00e3o, software ao n\u00edvel da unidade, rastreabilidade empresarial e conectividade regulamentar. Esta abordagem integrada ajuda os fabricantes a gerir os produtos serializados, desde a linha de embalagem at\u00e9 \u00e0 cadeia de abastecimento em geral.<\/p>\n\n\n<p class=\"wp-block-paragraph\">A plataforma do Antares Vision Group foi concebida para apoiar fabricantes farmac\u00eauticos, CMOs\/CDMOs e titulares de autoriza\u00e7\u00f5es de introdu\u00e7\u00e3o no mercado (MAHs) que necessitem de uma arquitetura de rastreabilidade escal\u00e1vel, validada e flex\u00edvel, abrangendo v\u00e1rias linhas de embalagem, instala\u00e7\u00f5es e mercados. Combina o controlo operacional ao n\u00edvel da linha de produ\u00e7\u00e3o com funcionalidades de software para a gest\u00e3o do ciclo de vida da serializa\u00e7\u00e3o, agrega\u00e7\u00e3o, tratamento de eventos compat\u00edvel com EPCIS, integra\u00e7\u00e3o com ERP\/MES, relat\u00f3rios regulamentares e gest\u00e3o de exce\u00e7\u00f5es.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Funcionalidades da plataforma<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Serializa\u00e7\u00e3o ao n\u00edvel da linha de produ\u00e7\u00e3o com controlo da impress\u00e3o, inspe\u00e7\u00e3o, verifica\u00e7\u00e3o e rejei\u00e7\u00e3o.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Agrega\u00e7\u00e3o manual, semiautom\u00e1tica e autom\u00e1tica para hierarquias de artigos, lotes, caixas e paletes.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Gest\u00e3o, a n\u00edvel da unidade, de lotes, linhas de produ\u00e7\u00e3o, opera\u00e7\u00f5es de retrabalho, eventos de armaz\u00e9m e exce\u00e7\u00f5es de serializa\u00e7\u00e3o.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Rastreabilidade empresarial para a gest\u00e3o de n\u00fameros de s\u00e9rie, coordena\u00e7\u00e3o entre v\u00e1rias instala\u00e7\u00f5es e fluxos de trabalho espec\u00edficos de cada mercado.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Gest\u00e3o de eventos compat\u00edvel com o EPCIS para garantir a visibilidade da cadeia de abastecimento e a troca de dados entre parceiros comerciais.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Integra\u00e7\u00e3o com sistemas ERP\/MES e equipamento de embalagem atrav\u00e9s de interfaces validadas e de engenharia espec\u00edfica para cada projeto.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Modelos de implementa\u00e7\u00e3o adaptados aos requisitos de TI e de valida\u00e7\u00e3o dos clientes, incluindo arquiteturas no local, na nuvem ou h\u00edbridas.<\/p>\n\n\n<p class=\"wp-block-paragraph\">\u2022 Apoio \u00e0 valida\u00e7\u00e3o e pacotes de documenta\u00e7\u00e3o para ambientes farmac\u00eauticos sujeitos a regulamenta\u00e7\u00e3o.<\/p>\n\n\n<p class=\"wp-block-paragraph\">O Antares Vision Group combina software de rastreio e localiza\u00e7\u00e3o com especializa\u00e7\u00e3o em serializa\u00e7\u00e3o ao n\u00edvel da linha de produ\u00e7\u00e3o, vis\u00e3o computacional e agrega\u00e7\u00e3o. Isto \u00e9 especialmente relevante para projetos que necessitam de alinhar o desempenho do hardware, a integridade dos dados, a conformidade regulamentar e a escalabilidade empresarial numa \u00fanica solu\u00e7\u00e3o validada.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n<h2 class=\"wp-block-heading\"><strong>Software de serializa\u00e7\u00e3o farmac\u00eautica, rastreabilidade e integra\u00e7\u00e3o com a linha de embalagem<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">Um sistema de rastreabilidade e localiza\u00e7\u00e3o de produtos farmac\u00eauticos abrange v\u00e1rios aspetos interligados. As sec\u00e7\u00f5es seguintes abordam termos de pesquisa comuns e \u00e1reas de decis\u00e3o utilizadas pelos fabricantes farmac\u00eauticos na avalia\u00e7\u00e3o de solu\u00e7\u00f5es de serializa\u00e7\u00e3o e rastreabilidade.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Software de serializa\u00e7\u00e3o farmac\u00eautica<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">O software de serializa\u00e7\u00e3o farmac\u00eautica gere a cria\u00e7\u00e3o, a atribui\u00e7\u00e3o, a impress\u00e3o, a verifica\u00e7\u00e3o e o estado do ciclo de vida dos n\u00fameros de s\u00e9rie utilizados nas embalagens dos medicamentos. Constitui a base do sistema de rastreabilidade farmac\u00eautica, uma vez que todos os eventos subsequentes dependem de uma identidade do produto corretamente atribu\u00edda e verificada.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Software de rastreio e localiza\u00e7\u00e3o<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">O software de rastreio e localiza\u00e7\u00e3o alarga a serializa\u00e7\u00e3o para al\u00e9m da linha de embalagem. Este software regista as rela\u00e7\u00f5es de agrega\u00e7\u00e3o, gere eventos serializados, suporta o EPCIS ou a troca de dados espec\u00edfica do mercado, integra-se com sistemas ERP\/MES e permite a elabora\u00e7\u00e3o de relat\u00f3rios regulamentares em todas as instala\u00e7\u00f5es e mercados.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Serializa\u00e7\u00e3o e agrega\u00e7\u00e3o<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">A serializa\u00e7\u00e3o identifica cada unidade individual comercializ\u00e1vel. A agrega\u00e7\u00e3o associa essa unidade a n\u00edveis de embalagem superiores, tais como pacotes, caixas e paletes. Em conjunto, a serializa\u00e7\u00e3o e a agrega\u00e7\u00e3o permitem uma verifica\u00e7\u00e3o eficiente das remessas, opera\u00e7\u00f5es de armaz\u00e9m, recolhas de produtos e comunica\u00e7\u00e3o de eventos na cadeia de abastecimento.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Moderniza\u00e7\u00e3o e renova\u00e7\u00e3o de sistemas de serializa\u00e7\u00e3o<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">Muitas empresas farmac\u00eauticas precisam de modernizar as linhas de serializa\u00e7\u00e3o existentes, em vez de substituir todo o equipamento de embalagem. Os projetos de adapta\u00e7\u00e3o e renova\u00e7\u00e3o podem envolver novas c\u00e2maras, impressoras, controladores, esta\u00e7\u00f5es de trabalho de agrega\u00e7\u00e3o, atualiza\u00e7\u00f5es de software ou a migra\u00e7\u00e3o para uma arquitetura de site ou empresarial mais escal\u00e1vel.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Integra\u00e7\u00e3o OEM<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">Ao n\u00edvel da linha de produ\u00e7\u00e3o, os m\u00f3dulos de serializa\u00e7\u00e3o e agrega\u00e7\u00e3o s\u00e3o frequentemente integrados nas m\u00e1quinas de embalagem. A coopera\u00e7\u00e3o com os fabricantes de equipamento original (OEM) pode, por isso, ser importante para novas linhas de produ\u00e7\u00e3o, enquanto o cliente farmac\u00eautico final define normalmente a tecnologia de serializa\u00e7\u00e3o preferida, os requisitos de conformidade, a arquitetura de dados e as expectativas em mat\u00e9ria de valida\u00e7\u00e3o.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Serializa\u00e7\u00e3o da FMD na UE<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">A serializa\u00e7\u00e3o ao abrigo da Diretiva FMD da UE exige que as embalagens de medicamentos sujeitos a receita m\u00e9dica abrangidas por esta diretiva incluam um identificador \u00fanico e um dispositivo anti-adultera\u00e7\u00e3o, com verifica\u00e7\u00e3o e desativa\u00e7\u00e3o atrav\u00e9s do sistema de reposit\u00f3rios europeu e nacional. Os fabricantes que vendem em v\u00e1rias regi\u00f5es implementam frequentemente capacidades mais abrangentes de rastreabilidade para dar resposta a requisitos que v\u00e3o al\u00e9m da Diretiva FMD da UE.<\/p>\n\n\n<h2 class=\"wp-block-heading\"><strong>Conformidade com a DSCSA<\/strong><\/h2>\n\n\n<p class=\"wp-block-paragraph\">A conformidade com a DSCSA exige que os intervenientes na cadeia de abastecimento farmac\u00eautica nos Estados Unidos apoiem o rastreio e a verifica\u00e7\u00e3o eletr\u00f3nicos e interoper\u00e1veis dos produtos. Para os fabricantes, isto torna a qualidade dos dados serializados, a precis\u00e3o da agrega\u00e7\u00e3o, a troca de dados compat\u00edvel com o EPCIS e a conectividade com os parceiros elementos cr\u00edticos da arquitetura de rastreio e localiza\u00e7\u00e3o.<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"pure-container kbutton \"\n style=\"\">\n            <a class=\"gtm__conditionButton kbutton__button\" href=\"https:\/\/antaresvisiongroup.com\/lifescience\/track-and-trace\/\" target=\"\"\n                    >\n            <div class=\"kbutton__buttonTitle\">DISCOVER OUR SOLUTIONS<\/div>\n            <svg id=\"Livello_button\" data-name=\"Livello 2\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" width=\"14\" height=\"14\" viewBox=\"0 0 14 14\">\n           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class=\"kfaq__title\">Perguntas Frequentes (FAQ)<\/h2>\n                                    <\/div>\n\n                <div class=\"pure-u-1-1 kfaq__colLeft\">\n                    <div class=\"kfaq__colLeftContDesc tabs__container\">\n                        \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck1\">\n                                <label class=\"tab__singleTitle\" for=\"chck1\"><h3>What is a pharmaceutical track and trace system?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>A pharmaceutical track and trace system is a validated technology architecture that manages serialization, aggregation and traceability data for drug products. It connects packaging line hardware, software, ERP\/MES systems, regulatory reporting and trading partner exchange to support product identification, verification and supply chain visibility.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck2\">\n                                <label class=\"tab__singleTitle\" for=\"chck2\"><h3>What is the difference between serialization and track and trace?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>Serialization assigns a unique identity to each saleable unit. Track and trace records what happens to that identity across packaging, aggregation, warehousing, shipping, verification and decommissioning events. Serialization is one component of a broader track and trace architecture.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck3\">\n                                <label class=\"tab__singleTitle\" for=\"chck3\"><h3>What does pharmaceutical serialization software do?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>Pharmaceutical serialization software manages serial number generation or import, allocation to production batches, print-and-verify operations, code status, exception handling and data exchange with higher-level systems. It ensures that each pack can be uniquely identified and controlled throughout its lifecycle.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck4\">\n                                <label class=\"tab__singleTitle\" for=\"chck4\"><h3>What is aggregation in pharmaceutical track and trace?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>Aggregation creates a digital parent-child relationship between serialized units and higher packaging levels such as bundles, cases and pallets. This allows operators and supply chain partners to scan a case or pallet and know which serialized units it contains.<\/p>\n<p>&nbsp;<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck5\">\n                                <label class=\"tab__singleTitle\" for=\"chck5\"><h3>What is EPCIS in pharma track and trace?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>EPCIS is a GS1 standard used to capture and exchange event data across the supply chain. In pharmaceutical track and trace, EPCIS-compatible event management can support standardized communication of serialization, aggregation, shipment and verification data between systems and trading partners.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck6\">\n                                <label class=\"tab__singleTitle\" for=\"chck6\"><h3>What are L1, L2, L3 and L4 in serialization?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>L1 and L2 usually refer to machine and line-level control, including printers, cameras, reject systems and serialization stations. L3 manages serialization at site level across lines and operations. L4 manages enterprise-level serial number governance, ERP integration, multi-site coordination and regulatory connectivity.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck7\">\n                                <label class=\"tab__singleTitle\" for=\"chck7\"><h3>Is aggregation required by EU FMD?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>EU FMD requires a unique identifier and anti-tampering device for medicinal products in scope, with verification and decommissioning through the repository system. Aggregation is not a general EU FMD requirement, but it is often implemented to support other regulations, DSCSA-related operations and logistics efficiency.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck8\">\n                                <label class=\"tab__singleTitle\" for=\"chck8\"><h3>Who should evaluate a track and trace solution?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>Evaluation usually involves serialization managers, packaging engineering, QA, IT\/OT, supply chain, regulatory compliance and operations. OEMs and system integrators may be involved for line-level integration, while enterprise software and regulatory connectivity are typically governed by the pharmaceutical manufacturer, CMO\/CDMO or MAH.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck9\">\n                                <label class=\"tab__singleTitle\" for=\"chck9\"><h3>Can track and trace be implemented as a retrofit?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>Yes. Serialization and aggregation systems can often be retrofitted or upgraded on existing packaging lines. Retrofit projects may include cameras, printers, controllers, reject systems, aggregation workstations, software migration, regulatory connectivity upgrades or integration with enterprise systems.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                            \n                            <div class=\"tab__single\">\n                                <input type=\"checkbox\" id=\"chck10\">\n                                <label class=\"tab__singleTitle\" for=\"chck10\"><h3>Why choose an integrated track and trace solution?<\/h3><\/label>\n                                <div class=\"tab__singleContent\">\n                                    <div class=\"tab__singleContentInt\">\n                                        <p>An integrated solution helps align line performance, data integrity, aggregation accuracy, regulatory compliance and enterprise scalability. This reduces the risk of disconnected systems and supports more reliable serialization data across packaging, site and supply chain operations.<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                <\/div>\n\n            <\/div>\n        <\/div>\n    <\/div>\n\n<\/div>\n\n<div class=\"k-block-css\" hidden 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