Good manufacturing practices of medicines and their determinants

Detalhes bibliográficos
Autor(a) principal: Vogler, Marcelo
Data de Publicação: 2017
Outros Autores: Gratieri, Tais, Gelfuso, Guilherme Martins, Cunha Filho, Marcílio Sérgio Soares
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/918
Resumo: Good Manufacturing Practices (GMP) ensure that drugs are consistently produced and controlled according to previously established quality standards. They are designed to manage and minimize the inherent risks involved in the manufacture of drugs in order to ensure the quality, efficacy and safety of the finished product. Since their inception as we know them today, several versions have taken place in Brazil and worldwide. This work proposes to analyze GMP, through the analysis of the content of Brazilian regulatory frameworks, identifying the determinants that can explain their evolution over the last decades. GMP were broken down into topics and subtopics and their versions present in the five regulatory frameworks studied were evaluated. It was possible to verify, in the evolution of drug manufacturing requirements, the interference of technological innovation and the influence of new practices related to quality, identifying the GMP transformation dynamics.
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spelling Good manufacturing practices of medicines and their determinantsAs boas práticas de fabricação de medicamentos e suas determinantesBoas Práticas de FabricaçãoRegulação e Fiscalização em SaúdeRegulamentação GovernamentalTecnologia FarmacêuticaIndústria FarmacêuticaVigilância SanitáriaGood Manufacturing PracticesHealth Care Coordination and MonitoringGovernment RegulationPharmaceutical TechnologyDrug IndustrySanitary SurveillanceGood Manufacturing Practices (GMP) ensure that drugs are consistently produced and controlled according to previously established quality standards. They are designed to manage and minimize the inherent risks involved in the manufacture of drugs in order to ensure the quality, efficacy and safety of the finished product. Since their inception as we know them today, several versions have taken place in Brazil and worldwide. This work proposes to analyze GMP, through the analysis of the content of Brazilian regulatory frameworks, identifying the determinants that can explain their evolution over the last decades. GMP were broken down into topics and subtopics and their versions present in the five regulatory frameworks studied were evaluated. It was possible to verify, in the evolution of drug manufacturing requirements, the interference of technological innovation and the influence of new practices related to quality, identifying the GMP transformation dynamics.As Boas Práticas de Fabricação (BPF) garantem que os medicamentos sejam consistentemente produzidos e controlados de acordo com padrões de qualidade previamente estabelecidos. Têm por objetivo gerenciar e minimizar os riscos inerentes à fabricação de medicamentos com vista a garantir a qualidade, eficácia e segurança do produto acabado. Desde o seu surgimento da forma como conhecemos hoje, várias versões se sucederam no Brasil e no mundo. Esse trabalho se propõe a analisar as BPF, por meio da análise de conteúdo dos marcos regulatórios brasileiros, identificando as determinantes que podem explicar a sua evolução através das últimas décadas. As BPF foram decompostas em temas e subtemas e suas versões, presentes nos cinco marcos regulatórios estudados, foram avaliadas. Foi possível comprovar, na evolução dos requisitos de fabricação de medicamentos, a interferência da inovação tecnológica e a influência de novas práticas relacionadas à qualidade, identificando, dessa forma, a dinâmica de transformação 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/91810.22239/2317-269X.00918Health Surveillance under Debate: Society, Science & Technology ; Vol. 5 No. 2 (2017): May; 34-41Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 2 (2017): Puede; 34-41Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 2 (2017): Maio; 34-412317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/918/388https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/918/1000Copyright (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/openAccessVogler, MarceloGratieri, TaisGelfuso, Guilherme MartinsCunha Filho, Marcílio Sérgio Soares2023-06-27T15:19:44Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/918Revistahttps://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 Good manufacturing practices of medicines and their determinants
As boas práticas de fabricação de medicamentos e suas determinantes
title Good manufacturing practices of medicines and their determinants
spellingShingle Good manufacturing practices of medicines and their determinants
Vogler, Marcelo
Boas Práticas de Fabricação
Regulação e Fiscalização em Saúde
Regulamentação Governamental
Tecnologia Farmacêutica
Indústria Farmacêutica
Vigilância Sanitária
Good Manufacturing Practices
Health Care Coordination and Monitoring
Government Regulation
Pharmaceutical Technology
Drug Industry
Sanitary Surveillance
title_short Good manufacturing practices of medicines and their determinants
title_full Good manufacturing practices of medicines and their determinants
title_fullStr Good manufacturing practices of medicines and their determinants
title_full_unstemmed Good manufacturing practices of medicines and their determinants
title_sort Good manufacturing practices of medicines and their determinants
author Vogler, Marcelo
author_facet Vogler, Marcelo
Gratieri, Tais
Gelfuso, Guilherme Martins
Cunha Filho, Marcílio Sérgio Soares
author_role author
author2 Gratieri, Tais
Gelfuso, Guilherme Martins
Cunha Filho, Marcílio Sérgio Soares
author2_role author
author
author
dc.contributor.author.fl_str_mv Vogler, Marcelo
Gratieri, Tais
Gelfuso, Guilherme Martins
Cunha Filho, Marcílio Sérgio Soares
dc.subject.por.fl_str_mv Boas Práticas de Fabricação
Regulação e Fiscalização em Saúde
Regulamentação Governamental
Tecnologia Farmacêutica
Indústria Farmacêutica
Vigilância Sanitária
Good Manufacturing Practices
Health Care Coordination and Monitoring
Government Regulation
Pharmaceutical Technology
Drug Industry
Sanitary Surveillance
topic Boas Práticas de Fabricação
Regulação e Fiscalização em Saúde
Regulamentação Governamental
Tecnologia Farmacêutica
Indústria Farmacêutica
Vigilância Sanitária
Good Manufacturing Practices
Health Care Coordination and Monitoring
Government Regulation
Pharmaceutical Technology
Drug Industry
Sanitary Surveillance
description Good Manufacturing Practices (GMP) ensure that drugs are consistently produced and controlled according to previously established quality standards. They are designed to manage and minimize the inherent risks involved in the manufacture of drugs in order to ensure the quality, efficacy and safety of the finished product. Since their inception as we know them today, several versions have taken place in Brazil and worldwide. This work proposes to analyze GMP, through the analysis of the content of Brazilian regulatory frameworks, identifying the determinants that can explain their evolution over the last decades. GMP were broken down into topics and subtopics and their versions present in the five regulatory frameworks studied were evaluated. It was possible to verify, in the evolution of drug manufacturing requirements, the interference of technological innovation and the influence of new practices related to quality, identifying the GMP transformation dynamics.
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/918
10.22239/2317-269X.00918
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/918
identifier_str_mv 10.22239/2317-269X.00918
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/918/388
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/918/1000
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv 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; 34-41
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 2 (2017): Puede; 34-41
Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 2 (2017): Maio; 34-41
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
_version_ 1797042044787490816

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