The prequalification of medicines: Comparative analysis between WHO and Anvisa
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2017 |
| Outros Autores: | , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | por eng |
| Título da fonte: | Vigilância Sanitária em Debate |
| Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/796 |
Resumo: | The production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial complex is inserted, compliance with Good Manufacturing Practices (GMP) of the World Health Organization (WHO) is essential to export its drugs via international organizations. The objectives of this article were to identify the main technical requirements recommended by WHO and enforced by the Brazilian Health Regulatory Agency (Anvisa), for compliance and recognition of GMP for medicinal products, and to compare them critically, to obtain the prequalification of medicines. This literature and documentary review promoted a comprehensive approach on national regulations and WHO guidelines. This work enabled to show a high degree of harmonization concerning the topics/subtopics compared between WHO and the national standards guides imposed by Anvisa about GMP, which demonstrates an integration of the national legislation in the international context, corroborating the alignment between Anvisa and WHO regarding compliance with GMP. |
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The prequalification of medicines: Comparative analysis between WHO and AnvisaA pré-qualificação de medicamentos: análise comparativa entre OMS e AnvisaBoas Práticas de FabricaçãoGestão da QualidadeLaboratório Farmacêutico OficialPré-qualificaçãoVigilância SanitáriaGood Manufacturing PracticesQuality ManagementOfficial Pharmaceutical LaboratoryPrequalificationSanitary SurveillanceThe production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial complex is inserted, compliance with Good Manufacturing Practices (GMP) of the World Health Organization (WHO) is essential to export its drugs via international organizations. The objectives of this article were to identify the main technical requirements recommended by WHO and enforced by the Brazilian Health Regulatory Agency (Anvisa), for compliance and recognition of GMP for medicinal products, and to compare them critically, to obtain the prequalification of medicines. This literature and documentary review promoted a comprehensive approach on national regulations and WHO guidelines. This work enabled to show a high degree of harmonization concerning the topics/subtopics compared between WHO and the national standards guides imposed by Anvisa about GMP, which demonstrates an integration of the national legislation in the international context, corroborating the alignment between Anvisa and WHO regarding compliance with GMP.A produção de medicamentos com qualidade, segurança e eficácia é fundamental para atender às demandas nacionais e internacionais, com o fito de subsidiar a assistência farmacêutica no âmbito da saúde pública. Diante do papel estratégico em que o complexo fabril público de saúde está inserido, o cumprimento das Boas Práticas de Fabricação (BPF) da Organização Mundial de Saúde (OMS) é essencial para a exportação de seus medicamentos via organismos internacionais. Os objetivos deste artigo foram identificar os principais requisitos técnicos recomendados pela OMS e exigidos pela Agência Nacional de Vigilância Sanitária (Anvisa), para o cumprimento e reconhecimento das BPF de medicamentos, e compará-los, de maneira crítica, em prol da obtenção da pré-qualificação de medicamentos. A metodologia empregada promoveu uma abordagem abrangente acerca das regulamentações nacionais e dos guias da OMS, por intermédio da seguinte técnica de coleta de dados: pesquisa bibliográfica e documental. O presente trabalho possibilitou evidenciar um alto grau de harmonização acerca dos tópicos/subtópicos comparados entre os guias da OMS e a normatização nacional imposta pela Anvisa em BPF, o que demonstra uma inserção da legislação nacional no contexto internacional, corroborando o alinhamento entre a Anvisa e OMS, no tocante ao cumprimento das BPF.Instituto Nacional de Controle de Qualidade em Saúde2017-05-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/79610.22239/2317-269X.00796Health Surveillance under Debate: Society, Science & Technology ; Vol. 5 No. 2 (2017): May; 24-33Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 2 (2017): Puede; 24-33Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 2 (2017): Maio; 24-332317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/796/377https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/796/455Copyright (c) 2017 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessCouto, Marcus Vinicius Lima doMedina, FernandoCosta, Hudson Eduardo Souza daDantas, Silvania IacovinoBermudez, Jorge Antonio ZepedaRech, NorbertoCosta, Jorge Carlos Santos da2023-06-27T15:19:44Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/796Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:19:44Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.none.fl_str_mv |
The prequalification of medicines: Comparative analysis between WHO and Anvisa A pré-qualificação de medicamentos: análise comparativa entre OMS e Anvisa |
| title |
The prequalification of medicines: Comparative analysis between WHO and Anvisa |
| spellingShingle |
The prequalification of medicines: Comparative analysis between WHO and Anvisa Couto, Marcus Vinicius Lima do Boas Práticas de Fabricação Gestão da Qualidade Laboratório Farmacêutico Oficial Pré-qualificação Vigilância Sanitária Good Manufacturing Practices Quality Management Official Pharmaceutical Laboratory Prequalification Sanitary Surveillance |
| title_short |
The prequalification of medicines: Comparative analysis between WHO and Anvisa |
| title_full |
The prequalification of medicines: Comparative analysis between WHO and Anvisa |
| title_fullStr |
The prequalification of medicines: Comparative analysis between WHO and Anvisa |
| title_full_unstemmed |
The prequalification of medicines: Comparative analysis between WHO and Anvisa |
| title_sort |
The prequalification of medicines: Comparative analysis between WHO and Anvisa |
| author |
Couto, Marcus Vinicius Lima do |
| author_facet |
Couto, Marcus Vinicius Lima do Medina, Fernando Costa, Hudson Eduardo Souza da Dantas, Silvania Iacovino Bermudez, Jorge Antonio Zepeda Rech, Norberto Costa, Jorge Carlos Santos da |
| author_role |
author |
| author2 |
Medina, Fernando Costa, Hudson Eduardo Souza da Dantas, Silvania Iacovino Bermudez, Jorge Antonio Zepeda Rech, Norberto Costa, Jorge Carlos Santos da |
| author2_role |
author author author author author author |
| dc.contributor.author.fl_str_mv |
Couto, Marcus Vinicius Lima do Medina, Fernando Costa, Hudson Eduardo Souza da Dantas, Silvania Iacovino Bermudez, Jorge Antonio Zepeda Rech, Norberto Costa, Jorge Carlos Santos da |
| dc.subject.por.fl_str_mv |
Boas Práticas de Fabricação Gestão da Qualidade Laboratório Farmacêutico Oficial Pré-qualificação Vigilância Sanitária Good Manufacturing Practices Quality Management Official Pharmaceutical Laboratory Prequalification Sanitary Surveillance |
| topic |
Boas Práticas de Fabricação Gestão da Qualidade Laboratório Farmacêutico Oficial Pré-qualificação Vigilância Sanitária Good Manufacturing Practices Quality Management Official Pharmaceutical Laboratory Prequalification Sanitary Surveillance |
| description |
The production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial complex is inserted, compliance with Good Manufacturing Practices (GMP) of the World Health Organization (WHO) is essential to export its drugs via international organizations. The objectives of this article were to identify the main technical requirements recommended by WHO and enforced by the Brazilian Health Regulatory Agency (Anvisa), for compliance and recognition of GMP for medicinal products, and to compare them critically, to obtain the prequalification of medicines. This literature and documentary review promoted a comprehensive approach on national regulations and WHO guidelines. This work enabled to show a high degree of harmonization concerning the topics/subtopics compared between WHO and the national standards guides imposed by Anvisa about GMP, which demonstrates an integration of the national legislation in the international context, corroborating the alignment between Anvisa and WHO regarding compliance with GMP. |
| publishDate |
2017 |
| dc.date.none.fl_str_mv |
2017-05-31 |
| dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/796 10.22239/2317-269X.00796 |
| url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/796 |
| identifier_str_mv |
10.22239/2317-269X.00796 |
| dc.language.iso.fl_str_mv |
por eng |
| language |
por eng |
| dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/796/377 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/796/455 |
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https://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
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https://creativecommons.org/licenses/by-nc-nd/4.0 |
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openAccess |
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application/pdf application/pdf |
| dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
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Instituto Nacional de Controle de Qualidade em Saúde |
| dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 5 No. 2 (2017): May; 24-33 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 2 (2017): Puede; 24-33 Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 2 (2017): Maio; 24-33 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
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FIOCRUZ |
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Vigilância Sanitária em Debate |
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Vigilância Sanitária em Debate |
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Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
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incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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1797042044726673408 |