Statistical process control of manufacturing tablets for antiretroviral therapy
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Pharmaceutical Sciences |
Texto Completo: | https://www.revistas.usp.br/bjps/article/view/213090 |
Resumo: | In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular “Chopin Tavares de Lima” (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment. |
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Brazilian Journal of Pharmaceutical Sciences |
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Statistical process control of manufacturing tablets for antiretroviral therapyCapability indicesControl chartsHIV treatmentManufacturing processQuality toolsIn this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular “Chopin Tavares de Lima” (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2023-06-13info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/21309010.1590/s2175-97902023e22099 Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023)Brazilian Journal of Pharmaceutical Sciences; v. 59 (2023)Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023)2175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/213090/195064Copyright (c) 2023 Brazilian Journal of Pharmaceutical Scienceshttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessRocha, Nataly Paredes dada Silva, Osvaldo Cirilo Barbosa, Eduardo JoséSoares, Gidel Oliveira, RobertoMonteiro, Lis MarieBou-Chacra, Nádia Araci 2023-06-13T14:15:36Zoai:revistas.usp.br:article/213090Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2023-06-13T14:15:36Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Statistical process control of manufacturing tablets for antiretroviral therapy |
title |
Statistical process control of manufacturing tablets for antiretroviral therapy |
spellingShingle |
Statistical process control of manufacturing tablets for antiretroviral therapy Rocha, Nataly Paredes da Capability indices Control charts HIV treatment Manufacturing process Quality tools |
title_short |
Statistical process control of manufacturing tablets for antiretroviral therapy |
title_full |
Statistical process control of manufacturing tablets for antiretroviral therapy |
title_fullStr |
Statistical process control of manufacturing tablets for antiretroviral therapy |
title_full_unstemmed |
Statistical process control of manufacturing tablets for antiretroviral therapy |
title_sort |
Statistical process control of manufacturing tablets for antiretroviral therapy |
author |
Rocha, Nataly Paredes da |
author_facet |
Rocha, Nataly Paredes da da Silva, Osvaldo Cirilo Barbosa, Eduardo José Soares, Gidel Oliveira, Roberto Monteiro, Lis Marie Bou-Chacra, Nádia Araci |
author_role |
author |
author2 |
da Silva, Osvaldo Cirilo Barbosa, Eduardo José Soares, Gidel Oliveira, Roberto Monteiro, Lis Marie Bou-Chacra, Nádia Araci |
author2_role |
author author author author author author |
dc.contributor.author.fl_str_mv |
Rocha, Nataly Paredes da da Silva, Osvaldo Cirilo Barbosa, Eduardo José Soares, Gidel Oliveira, Roberto Monteiro, Lis Marie Bou-Chacra, Nádia Araci |
dc.subject.por.fl_str_mv |
Capability indices Control charts HIV treatment Manufacturing process Quality tools |
topic |
Capability indices Control charts HIV treatment Manufacturing process Quality tools |
description |
In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular “Chopin Tavares de Lima” (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-06-13 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/213090 10.1590/s2175-97902023e22099 |
url |
https://www.revistas.usp.br/bjps/article/view/213090 |
identifier_str_mv |
10.1590/s2175-97902023e22099 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/213090/195064 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2023 Brazilian Journal of Pharmaceutical Sciences https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2023 Brazilian Journal of Pharmaceutical Sciences https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
dc.source.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023) Brazilian Journal of Pharmaceutical Sciences; v. 59 (2023) Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023) 2175-9790 1984-8250 reponame:Brazilian Journal of Pharmaceutical Sciences instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Brazilian Journal of Pharmaceutical Sciences |
collection |
Brazilian Journal of Pharmaceutical Sciences |
repository.name.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
bjps@usp.br||elizabeth.igne@gmail.com |
_version_ |
1800222918131580928 |