Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials

Detalhes bibliográficos
Autor(a) principal: Carlos Eduardo de Oliveira Pereira
Data de Publicação: 2017
Outros Autores: Mateus Araújo Castro e Souza, Gerson Antônio Pianetti, Scheilla Vitorino Carvalho de Souza
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFMG
Texto Completo: http://hdl.handle.net/1843/40310
Resumo: CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico
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spelling 2022-03-22T17:30:12Z2022-03-22T17:30:12Z201722637210.1007/s00769-017-1251-209491775http://hdl.handle.net/1843/40310CNPq - Conselho Nacional de Desenvolvimento Científico e TecnológicoAn historical review indicated that the provision of proficiency testing (PT) in the pharmaceutical area in Brazil is critical. Three providers were identified in the period between 2002 and 2015; only one provider was regular, but none was accredited according to the requirements of ISO 17043. A PT was organized without registration fees for educational purposes for the determination of mefenamic acid (2-[(2,3-dimethylphenyl)amino]benzoic acid) in raw materials. Proficiency test items consisted of a mixture of mefenamic acid and polyvinylpyrrolidone in the mass ratio 90:10. This proportion was used to simulate an adulterated raw material. Homogeneity and stability testing was performed and indicated that the materials were suitable for use in the PT scheme. First, 68 pharmaceutical laboratories, of which five were ISO 17025 accredited, were contacted to disseminate information about the specific PT and the benefits of this important quality assurance tool. Then, the proficiency test items were sent to the 13 registered participants, of which two were ISO 17025 accredited. In addition, the participating laboratories were surveyed regarding the technical and management aspects of their quality management system (QMS), such as the status of the accreditation process according to the ISO 17025 requirements, staff training, equipment calibration and participation in other PT schemes. All 11 participants that reported results in the study adopted the United States Pharmacopoeia Official Method. Only one laboratory, representing 9.1 % of the participants, had an unsatisfactory z-score result. Factors such as the reduced number of ISO 17025 accredited laboratories, the low number of participants in the educational PT, the high proportion of laboratories that participated for the first time and the portion of the participants who did not know about PT and its importance were considered as determinants for the restricted availability of the PT supply for medicines, as evidenced in the present study in Brazil. Thus, an urgent need for nationwide actions was identified to promote the critical consciousness of managers regarding QMS in pharmaceutical laboratories, including the importance of participation in PT schemes, as well as the importance of encouraging the providers already structured to broaden their scope in this area.engUniversidade Federal de Minas GeraisUFMGBrasilFAR - DEPARTAMENTO DE ALIMENTOSFAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOSAccreditation and Quality AssuranceFarmáciaTeste de proficiênciaProficiency testingPharmaceutical analysisMefenamic acidISO 17043Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materialsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://link.springer.com/article/10.1007/s00769-017-1251-2Carlos Eduardo de Oliveira PereiraMateus Araújo Castro e SouzaGerson Antônio PianettiScheilla Vitorino Carvalho de Souzaapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGORIGINAL2017_Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials.pdf2017_Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials.pdfapplication/pdf559452https://repositorio.ufmg.br/bitstream/1843/40310/2/2017_Overview%20of%20proficiency%20testing%20provision%20in%20pharmaceutical%20area%20in%20Brazil%20and%20an%20educational%20scheme%20for%20determining%20mefenamic%20acid%20in%20raw%20materials.pdfd80c4298831f491339ad23158279f3abMD52LICENSELicense.txtLicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
title Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
spellingShingle Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
Carlos Eduardo de Oliveira Pereira
Proficiency testing
Pharmaceutical analysis
Mefenamic acid
ISO 17043
Farmácia
Teste de proficiência
title_short Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
title_full Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
title_fullStr Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
title_full_unstemmed Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
title_sort Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials
author Carlos Eduardo de Oliveira Pereira
author_facet Carlos Eduardo de Oliveira Pereira
Mateus Araújo Castro e Souza
Gerson Antônio Pianetti
Scheilla Vitorino Carvalho de Souza
author_role author
author2 Mateus Araújo Castro e Souza
Gerson Antônio Pianetti
Scheilla Vitorino Carvalho de Souza
author2_role author
author
author
dc.contributor.author.fl_str_mv Carlos Eduardo de Oliveira Pereira
Mateus Araújo Castro e Souza
Gerson Antônio Pianetti
Scheilla Vitorino Carvalho de Souza
dc.subject.por.fl_str_mv Proficiency testing
Pharmaceutical analysis
Mefenamic acid
ISO 17043
topic Proficiency testing
Pharmaceutical analysis
Mefenamic acid
ISO 17043
Farmácia
Teste de proficiência
dc.subject.other.pt_BR.fl_str_mv Farmácia
Teste de proficiência
description CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico
publishDate 2017
dc.date.issued.fl_str_mv 2017
dc.date.accessioned.fl_str_mv 2022-03-22T17:30:12Z
dc.date.available.fl_str_mv 2022-03-22T17:30:12Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/1843/40310
dc.identifier.doi.pt_BR.fl_str_mv 10.1007/s00769-017-1251-2
dc.identifier.issn.pt_BR.fl_str_mv 09491775
identifier_str_mv 10.1007/s00769-017-1251-2
09491775
url http://hdl.handle.net/1843/40310
dc.language.iso.fl_str_mv eng
language eng
dc.relation.ispartof.pt_BR.fl_str_mv Accreditation and Quality Assurance
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.publisher.initials.fl_str_mv UFMG
dc.publisher.country.fl_str_mv Brasil
dc.publisher.department.fl_str_mv FAR - DEPARTAMENTO DE ALIMENTOS
FAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOS
publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFMG
instname:Universidade Federal de Minas Gerais (UFMG)
instacron:UFMG
instname_str Universidade Federal de Minas Gerais (UFMG)
instacron_str UFMG
institution UFMG
reponame_str Repositório Institucional da UFMG
collection Repositório Institucional da UFMG
bitstream.url.fl_str_mv https://repositorio.ufmg.br/bitstream/1843/40310/2/2017_Overview%20of%20proficiency%20testing%20provision%20in%20pharmaceutical%20area%20in%20Brazil%20and%20an%20educational%20scheme%20for%20determining%20mefenamic%20acid%20in%20raw%20materials.pdf
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