VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Química Nova (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422020000801190 |
Resumo: | Analytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is very common to observe misunderstandings in the execution of validation and data interpretation. The misguided approaches of validation guidelines, allied with a disregard for the peculiarities of the analytical techniques, the nature of the sample, and the analytical purpose, have significantly contributed to oversights in analytical validation. This work aims to present a critical overview of the validation process in pharmaceutical analysis, addressing relevant aspects of various analytical performance parameters, their different means of accomplishment and limitations in face of the analytical techniques, the nature of the sample, and the analytical purpose. To help in the planning and execution of the validation process, some case studies are discussed, mainly in the area of high-performance liquid chromatography (HPLC). |
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VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODSanalytical validationpharmaceutical analysisanalytical methodAnalytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is very common to observe misunderstandings in the execution of validation and data interpretation. The misguided approaches of validation guidelines, allied with a disregard for the peculiarities of the analytical techniques, the nature of the sample, and the analytical purpose, have significantly contributed to oversights in analytical validation. This work aims to present a critical overview of the validation process in pharmaceutical analysis, addressing relevant aspects of various analytical performance parameters, their different means of accomplishment and limitations in face of the analytical techniques, the nature of the sample, and the analytical purpose. To help in the planning and execution of the validation process, some case studies are discussed, mainly in the area of high-performance liquid chromatography (HPLC).Sociedade Brasileira de Química2020-09-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422020000801190Química Nova v.43 n.8 2020reponame:Química Nova (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.21577/0100-4042.20170589info:eu-repo/semantics/openAccessMarson,Breno M.Concentino,VictorJunkert,Allan M.Fachi,Mariana M.Vilhena,Raquel O.Pontarolo,Robertoeng2020-10-13T00:00:00Zoai:scielo:S0100-40422020000801190Revistahttps://www.scielo.br/j/qn/ONGhttps://old.scielo.br/oai/scielo-oai.phpquimicanova@sbq.org.br1678-70640100-4042opendoar:2020-10-13T00:00Química Nova (Online) - Sociedade Brasileira de Química (SBQ)false |
dc.title.none.fl_str_mv |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS |
title |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS |
spellingShingle |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS Marson,Breno M. analytical validation pharmaceutical analysis analytical method |
title_short |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS |
title_full |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS |
title_fullStr |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS |
title_full_unstemmed |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS |
title_sort |
VALIDATION OF ANALYTICAL METHODS IN A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED ON HPLC METHODS |
author |
Marson,Breno M. |
author_facet |
Marson,Breno M. Concentino,Victor Junkert,Allan M. Fachi,Mariana M. Vilhena,Raquel O. Pontarolo,Roberto |
author_role |
author |
author2 |
Concentino,Victor Junkert,Allan M. Fachi,Mariana M. Vilhena,Raquel O. Pontarolo,Roberto |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Marson,Breno M. Concentino,Victor Junkert,Allan M. Fachi,Mariana M. Vilhena,Raquel O. Pontarolo,Roberto |
dc.subject.por.fl_str_mv |
analytical validation pharmaceutical analysis analytical method |
topic |
analytical validation pharmaceutical analysis analytical method |
description |
Analytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is very common to observe misunderstandings in the execution of validation and data interpretation. The misguided approaches of validation guidelines, allied with a disregard for the peculiarities of the analytical techniques, the nature of the sample, and the analytical purpose, have significantly contributed to oversights in analytical validation. This work aims to present a critical overview of the validation process in pharmaceutical analysis, addressing relevant aspects of various analytical performance parameters, their different means of accomplishment and limitations in face of the analytical techniques, the nature of the sample, and the analytical purpose. To help in the planning and execution of the validation process, some case studies are discussed, mainly in the area of high-performance liquid chromatography (HPLC). |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-09-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422020000801190 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422020000801190 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.21577/0100-4042.20170589 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Sociedade Brasileira de Química |
publisher.none.fl_str_mv |
Sociedade Brasileira de Química |
dc.source.none.fl_str_mv |
Química Nova v.43 n.8 2020 reponame:Química Nova (Online) instname:Sociedade Brasileira de Química (SBQ) instacron:SBQ |
instname_str |
Sociedade Brasileira de Química (SBQ) |
instacron_str |
SBQ |
institution |
SBQ |
reponame_str |
Química Nova (Online) |
collection |
Química Nova (Online) |
repository.name.fl_str_mv |
Química Nova (Online) - Sociedade Brasileira de Química (SBQ) |
repository.mail.fl_str_mv |
quimicanova@sbq.org.br |
_version_ |
1750318120628649984 |