Evaluation of the quality control data records for the measles, mumps, rubella vaccine products used in the Brazilian National Immunization Program in the period from 1999 to 2007
This study aimed at evaluating the quality control protocols attested on the measles, mumps and rubella vaccines by manufacturers, and being used in the Brazilian National Immunization Program from 1999 to 2007. Analytical data on the protocols of 512 vaccine batches attested by respective manufactu...
| Autores: | , , , |
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| Formato: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2010 |
| País: | Brasil |
| Recursos: | Instituto Adolfo Lutz |
| Repositorio: | Revista do Instituto Adolfo Lutz (Online) |
| Idioma: | portugués |
| OAI Identifier: | oai:ojs.periodicos.saude.sp.gov.br:article/32644 |
| Acesso em linha: | https://periodicos.saude.sp.gov.br/RIAL/article/view/32644 |
| Access Level: | acceso abierto |
| Palavra-chave: | quality control measles mumps rubella vaccine (MMR) Brazil controle da qualidade vacina sarampo caxumba rubéola (VSCR) Brasil |
| Resumo: | This study aimed at evaluating the quality control protocols attested on the measles, mumps and rubella vaccines by manufacturers, and being used in the Brazilian National Immunization Program from 1999 to 2007. Analytical data on the protocols of 512 vaccine batches attested by respective manufacturers, and kept at INCQS/FIOCRUZ - Sample Management System, were analyzed. Vaccines produced by nine different laboratories , were evaluated considering: (i) potency testing, (ii) identity assay, (iii) thermo stability, (iv) bacterial and fungal sterility assay, (v) residual humidity contents, and (vi) vaccine production and respective quality control protocols stated by manufacturers. Unsatisfactory findings on quality were detected in 12and 11 vaccine batches, produced by four laboratories, which were employed by Vaccination Program in 1999 and 2001, respectively. From 2002 on, all the vaccines quality data have been satisfactory, and in compliance with the Brazilian Pharmacopeia parameters. |
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